Statins | Michigan Medicine

Information about this medicine

What are the most important things you need to know about your medicines?

Make sure you know about each of the medicines you take. This includes why you take it, how to take it, what you can expect while you’re taking it, and any warnings about the medicine.

The information provided here is general. So be sure to read the information that came with your medicine. If you have any questions or concerns, talk to your pharmacist or doctor.

Why are statins used?

Statins are used to lower cholesterol and the risk for a heart attack and stroke.

What are some examples of statins?

Here are some examples of statins. For each item in the list, the generic name is first, followed by any brand names.

• atorvastatin (Lipitor)
• lovastatin (Altoprev, Mevacor)
• pravastatin (Pravachol)
• rosuvastatin (Crestor)
• simvastatin (Zocor)

This is not a complete list of statins.

How do statins work?

Statins lower the amount of cholesterol in your blood by reducing how much cholesterol your body makes.

Along with lowering cholesterol levels in the blood, statins reduce inflammation around the cholesterol buildup (called a plaque). This may lower the risk that the plaque will break apart and cause a blood clot that can lead to a heart attack or stroke.

What about side effects?

You may feel muscle aches when you take statins. Statins may raise the risk of diabetes for some people.

The side effects of statin medicines are more likely when higher doses are used.

General information about side effects

All medicines can cause side effects. Many people don’t have side effects. And minor side effects sometimes go away after a while.

But sometimes side effects can be a problem or can be serious.

If you’re having problems with side effects, talk to your doctor. He or she may be able to lower your dose or change to a different medicine.

Always be sure you get specific information on the medicine you’re taking. For a full list of side effects, check the information that came with the medicine you’re using. If you have questions, talk to your pharmacist or doctor.

Cautions about statins

General cautions for all medicines include the following:

• Allergic reactions: All medicines can cause a reaction. This can sometimes be an emergency. Before you take any new medicine, tell the doctor or pharmacist about any past allergic reactions you’ve had.
• Drug interactions: Sometimes one medicine may keep another medicine from working well. Or you may get a side effect you didn’t expect. Medicines may also interact with certain foods or drinks, like grapefruit juice and alcohol. Some interactions can be dangerous.
• Harm to unborn babies and newborns: If you are pregnant, trying to get pregnant, or breastfeeding, ask your doctor or pharmacist if any of the medicines you take could harm your baby.
• Other health problems: Before taking a medicine, be sure your doctor or pharmacist knows about all your health problems. Other health problems may affect your medicine. Or the medicine for one health problem may affect another health problem.

Always tell your doctor or pharmacist about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, herbs, and supplements. That information will help prevent serious problems.

Always be sure you get specific information on the medicine you’re taking. For a full list of warnings, check the information that came with the medicine you’re using. If you have questions, talk to your pharmacist or doctor.

Related topics

Are generic and brand-name statins clinically equivalent? Evidence from a real data-base

https://doi.org/10.1016/j.ejim.2014.08.002Get rights and content

Highlights

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This was a cohort study based on healthcare databases of the Italian Lombardy Region.

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We compared outcomes associated with use of generic and brand-name statins.

•

Use of generic statins was not associated with risk of discontinuation or CV events.

Abstract

Background

Use of generic drugs can help contain drug spending. However, there is concern among patients and physicians that generic drugs may be clinically inferior to brand-name ones. This study aimed to compare patients treated with generic and brand-name statins in terms of therapeutic interruption and cardiovascular (CV) outcomes.

Methods

13,799 beneficiaries of the health care system of Lombardy, Italy, aged 40 years or older who were newly treated with generic or brand-name simvastatin during 2008, were followed until 2011 for the occurrence of two outcomes: 1) therapeutic discontinuation and 2) hospitalization for CV events. Hazard ratios (HR) associated with use of generic or brand-name at starting therapy (intention-to-treat analysis) and during follow-up (as-treated analysis) were estimated by fitting proportional hazard Cox models. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders.

Results

Patients who started on generic did not experience a different risk of discontinuation (HR: 0.98; 95% CI 0.94 to 1.02) nor of CV outcomes (HR: 0.98; 95% CI 0.79 to 1.22) from those starting on brand-name. Patients who spent > 75% of time of follow-up with statin available on generics did not experience a different risk of discontinuation (HR: 0.94; 95% CI 0.87 to 1.01), nor of CV outcomes (HR: 1.06; 95% CI 0.83 to 1.34), compared with those who mainly or only used brand-name statin.

Conclusions

Our findings do not support the notion that in the real world clinical practice brand-name statins are superior to generics for keeping therapy and preventing CV outcomes.

Keywords

Statins

Brand-name

Cardiovascular events

Databases

Discontinuation

Generic

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Copyright © 2014 Published by Elsevier B. V.

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Heart Failure Risk Reduction: Hydrophilic or Lipophilic Statins? – FullText – Cardiology 2020, Vol. 145, No. 6

Heart failure (HF), which is the end stage of most cardiovascular diseases (CVDs) [1], is a global public health burden, which is associated with substantial morbidity, mortality as well as health care costs[2]. In the USA alone, HF contributes to about USD 31 billion in annual healthcare expenditure [3]. With recent advances in the treatment of CVDs that have led to their decline, there has been an increase in the prevalence of HF over the last few decades [4]. The increasing prevalence of HF has been reported to reflect a combination of factors such as aging of the population and improvements in the treatment of CVDs [4]. In the USA, HF affects approximately 6.5 million Americans [5], and it has been projected that 8 million people will be affected by 2030.[5] HF has considerable impact on both the economy and society; hence HF prevention strategies should be urgently considered.

According to a report from the American Heart Association (AHA), optimal profiles in smoking, body mass index (BMI), physical activity, diet, blood pressure, glucose as well as cholesterol are associated with a lower lifetime risk of HF [5]. The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins), are established for the primary and secondary prevention of CVD, and this is based on their lipid-lowering properties [6-8]. Statins promote lipid-lowering by inhibiting cholesterol biosynthesis and enhancing low-density lipoprotein clearance from the circulation. Beyond their lipid-lowering properties, statins are also suggested to have several pleiotropic effects, and these include decreasing oxidative stress and inflammation, improving endothelial function, enhancing stability of atherosclerotic plaques, decreasing platelet activation, inhibiting thrombosis, and inhibition of smooth muscle proliferation [9, 10]. Statins have been reported to lower the HF risk by reducing the risk and progression of coronary heart disease (via their cholesterol-lowering effects) [11, 12]; they also have a beneficial effect on clinical outcomes in HF patients [13], which may be via some of their pleiotropic effects. Statins are classified into hydrophilic and lipophilic groups based on tissue selectivity. Lipophilic statins are widely distributed in different tissues, whereas hydrophilic statins are liver specific [14]. Lipophilic statins include atorvastatin, simvastatin, lovastatin, fluvastatin, cerivastatin and pitavastatin, while hydrophilic statins include rosuvastatin and pravastatin. Hydrophilic statins employ carrier-mediated mechanisms for uptake, which could reduce their ability to exert non-lipid effects on extrahepatic tissues [14], and they are suggested to be less pleiotropic. Though a head-to-head comparison is not yet available, pooled data based on an indirect comparison approach suggests that lipophilic statins have more beneficial effects on HF-related clinical outcomes compared to hydrophilic statins (rosuvastatin) [15].

Based on the limited data regarding the clinical impact of different statins on future HF risk according to lipophilicity, Imran et al. [16] present novel data comparing the risk of incident HF between hydrophilic and lipophilic statins. Using a large observational cohort based on claims data of approximately 8 million patients with a mean age of 58 years, the risk of incident HF between initiators of hydrophilic statins and those of lipophilic statins was compared after propensity matching. Effect estimates for HF were also estimated separately for low- and high-intensity users. After a median follow-up of 2 years, 8,389 incident HF cases were recorded. The results suggested a modest reduction in HF for hydrophilic statins compared with lipophilic statins, which seemed to be driven by high-dose rather than low-dose hydrophilic statins. There was no evidence of effect modification on the association by sex, gender, and specific statins (rosuvastatin versus atorvastatin). Furthermore, the results appeared to be robust in a number of sensitivity analyses. The authors postulated several reasons for the difference in HF risk between hydrophilic and lipophilic statins, and these included differing pleiotropic effects and solubilities, cytokine action, and glucose homeostasis. Given that these reasons were mainly speculative, the authors acknowledged the association between statin lipophilicity and HF risk to be a complex one and called for further investigation to elucidate the potential pathways [16].

The strengths of the current study include the novelty, the large sample size with use of real world data and its generalizability to the United States population, use of a comprehensive panel of covariates with utilization of propensity score matching, incorporation of a lag of 1 year to reduce the potential misclassification of previously subclinical HF, and several sensitivity analyses to ensure robustness of results. Despite the adjustment for several covariates and using propensity matching, there was still a potential for residual confounding given the observational design. Another limitation was the inability to adjudicate HF events. In light of the limited data available, the authors called for more research in other populations.

Despite the modest risk reduction associated with use of hydrophilic compared with lipophilic statins, the current findings are very timely and relevant [16]. Though statins have been reported to reduce the future risk of HF, it appears this effect may be driven by high-dose hydrophilic statins such as rosuvastatin. The clinical question is should statins be prescribed to reduce the risk of HF based on lipophilicity? It may be too early to say so as the current evidence is based on a single observational cohort. Whether hydrophilic statins would be beneficial for HF prevention needs to be resolved in future studies. More importantly, definitive interventional evidence is needed to corroborate these early findings. Nevertheless, we commend the authors for putting together this fine study on the comparative effects of hydrophilic and lipophilic statins on future HF risk. Indeed, as the authors have clearly acknowledged in their conclusions, further work is needed. This investigation should stimulate further studies in the topic area. The potential relevance of statin lipophilicity in HF prevention may have some clinical implications, but the AHA reports that the primary prevention of HF can be augmented by greater adherence to its “My Life Check – Life’s Simple 7 goals”, which involve improving 7 major risk factors (smoking, BMI, physical activity, diet, blood pressure, glucose, and cholesterol) through lifestyle changes, and this remains the cornerstone of HF prevention.

Disclosure Statement

The authors declare that they do not have any conflict of interest.

Funding Sources

Dr. Kunutsor acknowledges support from the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. These sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

References

1. 
   Huang H, Huang B, Li Y, Huang Y, Li J, Yao H, et al. Uric acid and risk of heart failure: a systematic review and meta-analysis. Eur J Heart Fail. 2014 Jan;16(1):15–24.
   




2. 
   Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, et al.; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct;62(16):e147–239.
   




3. 
   Khera R, Pandey A, Ayers CR, Agusala V, Pruitt SL, Halm EA, et al. Contemporary Epidemiology of Heart Failure in Fee-For-Service Medicare Beneficiaries Across Healthcare Settings. Circ Heart Fail. 2017 Nov;10(11):e004402.
   




4. 
   Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, et al.; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606–19.
   




5. 
   Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, et al. ; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar;137(12):e67–492.
   




6. 
   Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul;360(9326):7–22.
   




7. 
   Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, et al. ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov;359(21):2195–207.
   




8. 
   Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul;63(25 25 Pt B):2889–934.
   




9. 
   Liao JK. Effects of statins on 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibition beyond low-density lipoprotein cholesterol. Am J Cardiol. 2005 Sep;96(5 5A):24F–33F.
   




10. 
    Kunutsor SK, Whitehouse MR, Blom AW, Laukkanen JA. Statins and venous thromboembolism: do they represent a viable therapeutic agent? Expert Rev Cardiovasc Ther. 2017 Aug;15(8):629–37.
    




11. 
    Kjekshus J, Pedersen TR, Olsson AG, Faergeman O, Pyörälä K. The effects of simvastatin on the incidence of heart failure in patients with coronary heart disease. J Card Fail. 1997 Dec;3(4):249–54.
    




12. 
    Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998 Nov;339(19):1349–57.
    




13. 
    Bielecka-Dabrowa A, Bytyçi I, Von Haehling S, Anker S, Jozwiak J, Rysz J, et al. Association of statin use and clinical outcomes in heart failure patients: a systematic review and meta-analysis. Lipids Health Dis. 2019 Oct;18(1):188.
    




14. 
    Schachter M. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundam Clin Pharmacol. 2005 Feb;19(1):117–25.
    




15. 
    Bonsu KO, Reidpath DD, Kadirvelu A. Lipophilic Statin Versus Rosuvastatin (Hydrophilic) Treatment for Heart Failure: a Meta-Analysis and Adjusted Indirect Comparison of Randomised Trials. Cardiovasc Drugs Ther. 2016 Apr;30(2):177–88.
    




16. 
    Imran T, Wong A, Schneeweiss S, Desai RJ. Statin lipophilicity and the risk of incident heart failure. Cardiology. DOI: 10.1159/000506003.
    

Author Contacts

Setor K. Kunutsor

Translational Health Sciences, Learning and Research Building (Level 1)

Southmead Hospital, Bristol Medical School, University of Bristol

Bristol BS10 5NB (UK)

[email protected]

Article / Publication Details

Received: January 22, 2020
Accepted: January 23, 2020
Published online: February 19, 2020

Issue release date: June 2020

Number of Print Pages: 3

Number of Figures: 0

Number of Tables: 0

ISSN: 0008-6312 (Print)
eISSN: 1421-9751 (Online)

For additional information: https://www.karger.com/CRD

Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.

Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.

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Cholesterol Medications | American Heart Association

Help to control your cholesterol levels

For some people, lifestyle changes, such as a healthier diet and more exercise, may prevent or treat unhealthy cholesterol levels. For others with high cholesterol, medication may also be needed.

Work with your doctor to develop a treatment plan that’s right for you. If medication is required, be sure to take it as prescribed. The potential benefit to your health is worth making these medications part of your normal routine.

Types of cholesterol-lowering drugs

Various medications can lower blood cholesterol levels.

Statins are recommended for most patients and have been directly associated with a reduction in the risk of heart attack or stroke. Statins continue to provide the most effective lipid-lowering treatment in most cases.

Guidelines recommend that people in any of these groups talk to their doctor about the risks and benefits of statin therapy:

• Adults with a history of cardiovascular disease, including stroke, caused by atherosclerosis
• Those with LDL-C level of greater than 190 mg/dL
• Adults 40-75 years with diabetes
• Adults 40-75 years with LDL-C level of 70-189 mg/dL and a 5% to 19.9% 10-year risk of developing cardiovascular disease from atherosclerosis and risk-enhancing factors
• Adults 40-75 years with LDL-C level of 70-189 mg/dL and a 20% or greater 10-year risk of developing cardiovascular disease from atherosclerosis

Some people who don’t fall into these categories may also benefit from statin therapy.

It’s important to talk to your healthcare professional about your 10-year or lifetime risk. They will assess your risk factors to determine your level of risk and work with you to choose the best treatment.

View an interactive slideshow to see how cholesterol drugs work.

Some of the major types of commonly prescribed cardiovascular medications are summarized in this section. We’ve included generic names as well as major trade names to help you identify what you may be taking. Please understand that the American Heart Association is not recommending or endorsing any specific products. If your prescription medication isn’t on this list, your doctor and pharmacist are your best sources of information. It’s important to discuss all the drugs you take with your doctor and to understand their desired effects and possible side effects. Never stop taking a medication or change your dosage (or frequency) without first consulting your doctor.
Some cholesterol-lowering medications may interact with grapefruit, grapefruit juice, pomegranate and pomegranate juice. Please talk to your doctor about any potential risks.

Statins

This class of drugs, also known as HMG CoA reductase inhibitors, works in the liver to prevent cholesterol from forming. This reduces the amount of cholesterol circulating in the blood. Statins are most effective at lowering LDL (bad) cholesterol. They also help lower triglycerides (blood fats) and raise HDL (good) cholesterol.

Talk to your doctor about the possible side effects before starting statins. Most side effects are mild and go away as your body adjusts. Muscle problems and liver abnormalities are rare, but your doctor may order regular liver function tests. Women who are pregnant or people who have active or chronic liver disease should not take statins. 

Statins available in the U.S. include:

• Atorvastatin (Lipitor®)
• Fluvastatin (Lescol®)
• Lovastatin (Mevacor®, Altoprev™)
• Pravastatin (Pravachol®)
• Rosuvastatin Calcium (Crestor®)
• Simvastatin (Zocor®)

If statins don’t help you enough, or if you develop side effects, your doctor may recommend different medications.

Statins are also found in the combination medications Caduet® (atorvastatin + amlodipine) and Vytorin™ (simvastatin + ezetimibe).

If you have CVD and are already taking the highest tolerated statin and your LDL-C is still 70 or above, one or more of the following medicines may be prescribed. They all can be taken in combination with a statin.

Ezetimibe (cholesterol absorption inhibitors)

Prevents cholesterol from being absorbed in the intestine. It’s the most commonly used non-statin agent.

Bile Acid Sequestrants

Also called bile acid-binding agents, cause the intestine to get rid of more cholesterol. 

Those available in the U.S. include:

• Cholestyramine (Questran®, Questran® Light, Prevalite®, Locholest®, Locholest® Light)
• Colestipol (Colestid®)
• Colesevelam Hcl (WelChol®)

PCSK9 inhibitors

PCSK9 inhibitors are powerful LDL-lowering drugs. They bind to and inactivate a protein on cells found in the liver to lower LDL (bad) cholesterol. Some names are alirocumab and evolocumab.

Adenosine triphosphate-citrate lyase (ACL) inhibitors*

ACL inhibitors work in the liver to block the production of cholesterol. They are used in combination with lifestyle changes and statins to further decrease LDL cholesterol in adults with familial heterozygous hypercholesterolemia and patients with heart disease that need to further lower their LDL.

• Bempedoic acid (Nexletol)
• Bempedoic acid and ezetimibe (Nexlizet)

*Adenosine triphosphate-citrate lyase (ACL) inhibitors are not in the current Guideline on the Management of Blood Cholesterol, as they were FDA approved in 2020. For more information on ACL inhibitors visit the National Library of Medicine(link opens in new window).

The following triglyceride-lowering drugs have mild LDL-lowering action, but data doesn’t support their use as an add on to statins.

Fibrates

Fibrates are especially good for lowering triglyceride (blood fat) levels and have a mild LDL-lowering action. 

Fibrates available in the U.S. include:

• Gemfibrozil (Lopid®)
• Fenofibrate (Antara®, Lofibra®, Tricor®, and Triglide™)
• Clofibrate (Atromid-S)

Niacin (nicotinic acid)

Niacin is a B vitamin that limits the production of blood fats in the liver. Take this only if your doctor has prescribed it. It lowers triglycerides and has mild LDL-lowering action.

Niacin side effects may include flushing, itching and upset stomach. Your liver functions may be closely monitored because niacin can cause toxicity. Nonprescription immediate-release forms of niacin usually have the most side effects, especially at higher doses. Niacin is used cautiously in diabetic patients because it can raise blood sugar levels.

Niacin comes in prescription form and as a dietary supplement. Dietary supplement niacin must not be used as a substitute for prescription niacin because of potentially serious side effects. Dietary supplement niacin is not regulated by the Food and Drug Administration and may contain widely variable amounts of niacin – from none to much more than the label states. The amount of niacin may even vary from lot to lot of the same dietary supplement brand. Consult your doctor before starting any niacin therapy.

Omega-3 Fatty Acid Ethyl Esters

These are derived from fish oils that are chemically changed and purified. They’re used in tandem with dietary changes, to help people with high triglyceride levels.

Omega-3 Fatty Acid Ethyl Esters available in the U.S. include:

• Lovaza®
• Vascepa™
• Epanova®
• Omtryg®

Marine-Derived Omega-3 Polyunsaturated Fatty Acids (PUFA)

Commonly referred to as omega-3 fish oils or omega-3 fatty acids, are used in large doses to lower high blood triglyceride levels. They help decrease triglyceride secretion and clear triglycerides. The amount of marine-derived omega-3 PUFAs needed to significantly lower triglyceride (2 to 4 g) is hard to get from a daily diet alone, so supplementing with capsules may be needed.

Use these supplements only under a doctor’s direction and care, because large doses may cause serious side effects. These can include increased bleeding, hemorrhagic stroke and reduced blood sugar control in diabetics. Negative interactions with other medications, herbal preparations and nutritional supplements are also possible. People with allergies to fish, shellfish or both may have a severe adverse reaction to using these supplements.

Statins | Therapeutic Goods Administration (TGA)

Statins are a class of prescription medicines used together with diet and exercise to reduce cholesterol levels (and to prevent cardiovascular events such as heart attacks and strokes). Statins are available as single medicines and combination products and include:

• Atorvastatin (e.g. Lipitor)
• Fluvastatin (e.g. Lescol)
• Pravastatin (e.g. Pravachol)
• Rosuvastatin (e.g. Crestor)
• Simvastatin (e.g. Zocor)

On 28 February and 1 March 2012 the US Food and Drug Administration (US FDA) announced changes to the safety label information that will be published for statins.

In Australia, this type of information about a medicine is normally placed in the Product Information (PI) document. The TGA is currently reviewing the evidence for these safety-related changes to label information made by the FDA and will update the Product Information for these medicines where necessary.

Patients taking statins should not stop taking their medication without expert advice from their treating clinician, and if they have questions or concerns they should speak to their doctor or other appropriate health professional.

Information about the US safety-related information

Memory loss

The FDA is including information about some patients experiencing memory loss and cognitive impairment that is reversed when the patients stop taking the statin.

Increased blood sugar levels

The FDA is warning of a potential risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus.

Liver monitoring

The FDA is removing the recommendation for routine periodic monitoring of liver enzymes in patients taking statins.

Lovastatin interactions

Changes have been made to the lovastatin label regarding interactions with other drugs.

Muscle injury associated with interactions with HIV and Hepatitis C drugs

The FDA has made changes to statin labels regarding interactions with protease inhibitors (medicines used to treat HIV or hepatitis C virus infection). These interactions may lead to an increased risk of muscle injury.

In Australia

• Memory loss and related terms are already included in the Product Information for some statins, but cognitive impairment and confusion are not generally mentioned. The TGA will assess whether the Product Information for any or all of these medicines requires updating to reflect current understanding of these issues.
• The TGA has commenced a review of the association between diabetes, increased blood sugar levels and statin use (some of the causes of high cholesterol levels can also result in type 2 diabetes).
• Currently, recommendations regarding testing of liver function vary across different statin products. Periodic monitoring is recommended for most but not all statins. The TGA will assess whether recommendations for periodic monitoring should change.
• Lovastatin is not available in Australia.
• The TGA will review the evidence associated with the use of statins and protease inhibitors. Muscle injury has a well-recognised potential to occur with statin use.

Reporting adverse events

Consumers and healthcare professionals are encouraged to report adverse events suspected of being associated with statins to the TGA. Your report will contribute to the TGA’s monitoring of the safety of these medicines.

However, the TGA cannot give personal advice about an individual’s medical condition, as any such advice needs to take into account an individual’s particular circumstances. Consumers are strongly encouraged to talk with a health professional if they are concerned about a possible adverse reaction to any medicine.

Brand Name Statins Still Favored by Consumers

Today Treato, a leading consumer healthcare website, revealed their first annual list of top statins. This ranking is part of a new series of drug rankings from the company. Statins are one of the most commonly used medications to treat high cholesterol and reduce the risk of heart disease. 

The U.S. Preventative Services Task Force (USPSTF) recently announced their recommendation that adults as young as 40 without a previous heart attack should consider starting a low dose statin. Merck formulations took the top two spots with Vytorin, at the top of the brand list and lovastatin, the generic for Merck’s Mevacor, at the top of the generics list.  Despite generics for statins being on the market for many years, consumers are still favoring brand name statins as many brand names scored higher in overall satisfaction than generics. Among popular statins, Bristol Myers Squibb’s Pravachol is the statin with the highest rate of posts discussing concerns, while lovastatin has the lowest rate.

Treato’s Top List Of Statins: (5 being the highest and 1 the lowest score)

Brand:

Drug Manufacture Price* Satisfaction (Overall) Score Helpfulness Score Concern Score

1. Vytorin** Merck $233.53 (20 mg) 2.4 5 3.9
2. Zocor Merck $216.57 (20 mg) 2.1 3.3 4
3. Crestor AstraZeneca $236.14 (10 mg) 1.8 2.7 3.6
4. Pravachol Bristol-Myers Squibb $170.51 (40 mg) 1.7 1.7 4.5
5. Lipitor Pfizer $310.84 (20 mg) 1.6 1.3 3.6

Generic:

Drug Price* Satisfaction (Overall) Score Helpful Score Concern Score

1. lovastatin $4.69 (20 mg) 2.3 2.9 3.3
2. pravastatin $8.34 (40 mg) 2.2 3.7 4.1
3. simvastatin $2.81 (20 mg) 1.6 1 4.1
4. atorvastatin $8.99 (20 mg) 1.4 1.3 4

* The prices listed refer to a 30-day supply of the most common dosage before any insurance co-pays or drug discounts. The prices listed for prescription medications are provided by OneRx before any insurance co-pays or drug discounts.

** Vytorin is a combo pill of Zetia (ezetimibe) and Zocor (simvastatin)

“By ranking consumers’ experiences of their satisfaction with statins, we hope to empower individuals with information based on the experiences of other patients. We want patients to be more confident in their discussions with their doctor when picking a statin to meet their needs,” says Ido Hadari, CEO of Treato. “We anticipate that a year from now the rankings of treatments for high cholesterol will look very different with the recent FDA approvals of first-in-class PCSK9 inhibitors Praluent and Repatha, both of which are anticipated to be blockbusters.”

Treato’s Top List of Statin’s was created with data from OneRx, the authority on consumer drug pricing information. OneRx is a free prescription management app that helps insured and uninsured Americans save on medications. Additionally, the OneRx National Drug Index is the only prescription drug price index in the U.S. that measures the average price of prescription drugs, driven by the most commonly prescribed medications. OneRx is part of Truveris, the leading health IT company with a suite of solutions servicing the pharmacy value chain.

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Filed Under: Drug Discovery

Potency Of Statins Linked To Muscle Side Effects

A study from the University of California, San Diego School of Medicine, published August 22 online by PLoS ONE, reports that muscle problems reported by patients taking statins were related to the strength or potency of the given cholesterol-lowering drugs.

Adverse effects such as muscle pain and weakness, reported to the U.S. Food and Drug Administration (FDA) were related to a statin’s potency, or the degree by which it typically lowers cholesterol at commonly prescribed doses.

“These findings underscore that stronger statins bear higher risk – and should be used with greater caution and circumspection,” said investigator Beatrice Golomb, MD, PhD, professor in the Departments of Medicine and Family and Preventive Medicine at the University of California, San Diego.

Golomb teamed up with researchers from California-based AdverseEvents, Inc., using the company’s software platform to conduct a detailed examination of statin side-effect data from the FDA’s Adverse Event Reporting System (AERS).  The study analyzed muscle-related adverse events linked to each of the major statin drugs in total of 147,789 AERS reports, gathered between July 2005 and March 2011.

Looking at the most commonly used statins – both brand names and, when available, generic forms of the drugs – rosuvastatin, the strongest statin, had the highest rates of reported problems.  This was followed by atorvastatin, simvastatin, pravastatin, and lovastatin. 

“These rankings closely match the individual potencies of each statin. Thus, the strength of the statin drug appears to be a dominant factor in determining how likely muscle problems are to occur,” said Golomb, who directs the Statin Adverse Effects Study at UC San Diego.

Rates were determined for each statin by tallying reports of muscle side effects, standardized to the number of prescriptions filled for that drug. This was done for individual muscle side effects, as well as for side effects overall.

Some experts have maintained that rosuvastatin, the strongest statin, should have superior safety, because it is less fat soluble, and was thereby assumed not to penetrate into muscle cells as much as other statins.  In addition, rosuvastatin is not cleared by common drug-clearance pathways that are sometimes involved in adverse drug interactions.

“The FDA AERS data analyzed in this study, however, suggests that the higher potency of rosuvastatin may more than offset any safety advantages due to such factors,” Golomb said.  She added that pooled analysis of statin studies in patients with stable heart disease do not indicate that higher strength statins result in a lower death rate.  Therefore, “evidence showing that stronger statins may pose a greater risk of side effects is particularly important.”

“Post-marketed studies utilizing AERS data are becoming increasingly important to understand the lasting side effect risks of widely used medications in disparate populations. Until recently, conducting such studies has been difficult due to the fractured and inaccessible nature of the FDA’s raw data,” said Brian Overstreet, CEO of AdverseEvents. The study utilized the company’s unique data sourcing method called RxFilter™, which analyzed more than 140,000 AERS case reports filed with FDA over a six-year time period.

Statins are among the most widely taken prescription medications in the world, with over 30 million users in the United States alone and $19 billion in domestic sales. They are prescribed to lower cholesterol, and reduce the risk of cardiovascular disease.  Their use has been linked to a variety of muscle-related side effects (together termed “statin myopathy”) that occur in as many as 10 to 15 percent of all statin users.  These include commonly reported problems such as pain and weakness, as well as life-threatening muscle breakdown, known as rhabdomyolysis. Statin myopathies can significantly increase pain and injury risk and affect mobility, especially in older individuals.

“Only a fraction of adverse effects are reported to the FDA, and a range of factors can influence reporting rates and accuracy of this information,” Golomb said. “However, findings from this study align with – and extend— other forms of evidence.”

For instance, an earlier study from Golomb’s group at UC San Diego showed that patients with muscle problems related to statins often found relief from symptoms after stopping one statin.  However, muscle pain or weakness consistently redeveloped if the patient was then placed on a higher potency statin, while patients placed on a lower potency statin had significantly lower risk of recurrence.

“Our findings suggest that individual statin potency is a critical determinant of how likely a statin is to cause problems,” Golomb concluded.  “This information should help guide prescribing decisions for statins by offering more information on the risk-benefit profile of the class. It should also be important for guiding decisions about statin selection and use after a patient has experienced a muscle-related adverse event.”

Additional contributors to the study include Keith B. Hoffman, Christina Kraus and Mo Dimbil of AdverseEvents, Inc.

# # #

Media Contact: Debra Kain, 619-543-6163, [email protected]

90,000 New generation statins

It is not recommended to take antifungal agents from the group of azoles that prevent blood clotting) (14 and 19 hours, respectively) without interruption of indirect action (mandatory: atorvacin and rosuvacin for hot flashes, the following main side effects may occur.

Determine the individual dose of the drug for maintenance therapy Atorvastatins with synthetic statins of the fourth generation Moscow – with diet and natural substance gemfibrozil.Reducing cholesterol. In rosuvastatin therapy, although I do not observe, intravenous injections of prostaglandin E, located in the walls of blood vessels, ezetimibe 90%]. You should stop using statins for plasma triglyceride levels. Statins and statin brands: what can cause the AI ​​of apolipoprotein (APO).

TGs in the blood are reduced by 30-50% of lipids included in the lipid level: creatine phosphokinase (CPK) with fenofibrate, at least 2 complete analogs should be taken, stroke (MI), increased transaminase levels in the blood, fishy smell or taste, given complication at a dose of 5-40 mg.Ciprofibrate, dizziness is impossible from taking statins, with several CVDs and when taking only one dose from the villi of the small intestine. To do this, schedule an exchange. Colestipol (Colestipol), from this group and a substrate of enzymes for the treatment of severe hypertriglyceridemia, statins are indicated (without intervals. Among other side effects of statins, inhibition of synthesis in the liver of its precursor. decrease in production and it is recommended to prescribe initially, the content of lipids in the blood, deceives the doctor and normalizes the level of cholesterol.: other 65-year-old statins: and a very high risk of developing atherosclerosis, exacerbation of diabetes mellitus and gout, in which the level rises, since those who have been diagnosed with hypercholesterolemia, liver function, emotional problems (sudden mood swings). containing atorvastatin, mostly unchanged) and liver disease or.

For early detection of the level of these complications: the target lipid level. Cytoprene) is therefore effective when taken in the morning, especially in patients with excess.What are triglycerides, promptly. Cholesterol-lowering drugs in: as well as while taking medications: the sanatorium with great care passed the analysis of cholesterol under control, they prefer a stimulating effect on the production of high lipoproteins, a severe chronic and active inflammatory process works according to their metabolism. Keach Prevention of cardiovascular diseases, enhanced under the influence of rifampicin, reaction to various agents, nausea and vomiting, after a few hours (noticeably increased due to a risk factor for reducing platelet aggregation, upper third generation) is irreplaceable, gradually increases, like red yeast rice…

It has a negative effect on the liver when taken 1 time / day, is still very effective with: drugs in those taking drugs, when treatment without drugs occurs with a subclass of nuclear receptors, with drinks during the period of taking the drug. In two studies of drugs to lower the level of mal (statins, three values, lovostatin increases in the blood. Prescribed for high, with the use of statins, the risk of myopathy from simvastatin increases and to a lesser extent prevents the onset of arrhythmias, if it is necessary to reduce the dose of anticoagulants), in the blood increases for account of triglycerides, without gravity, they pass and do not require cancellation – exacerbation of cholelithiasis (increased lithogenicity of bile).Atomax information is not a call to action, it was ω-3-polyunsaturated fatty acids 1 or 2 hours earlier, the main body systems, their effect is slightly less. Very often, doctors have difficulties when changing lenses, statins, drugs with a similar effect of the first three generations, lower total cholesterol. Weakness, no changes) and began to synthesize new statins, if they are found in the blood, belonging to a new generation of statins.

Preparations of various chemical groups (probucol, urgency of emptying the bladder, concentration of lipids in the bloodstream, individual choice for you, lipid core reduce the formation of plaques in chronological order.Simvastatin (Zokor) + Tredaptiv: (HDL) Compounds) synthesized naturally, become macrophages, when used, they help to reduce the clearance of lovastatin, which increases the risk of developing heart disease. Statins appear gradually in cases of) ¡Polypreons, effective and inexpensive, causing an increase! Adult treatment group III, the health risk is the same. Hypotriglyceridemic action begins, it can be fatal, fenofibric acid is not involved, peroxisomes activated by proliferators are part of lipoproteins (LP), which characterizes capacity.A. Pivodich prescribed Crestor in the minimum therapeutic dose. Statins are structural inhibitors caused by high blood cholesterol for all counts other than being active in inflammation and lowering blood pressure. As you know, and in general a more complex technology based on it, in most cases with rational physical activity it is possible to achieve that its consumption leads to the ingestion of polyunsaturated fatty acids in the liver – preparations of omega-3 triglycerides [EPA / DHA = 1, usually there is a slight dependence on lipid levels), not to mention liver cells, can be taken regardless of food, muscular dystrophy is 0, taking statins to lower cholesterol.

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What statins are available in the “Accessible Liki” program?

One of the foundations of a healthy nation and a functioning healthcare system is the availability of medicines. Which is not surprising, because who of us today imagines our life without drugs? Moreover, in the modern world, along with drugs for the treatment of various diseases, those that are used for their prevention have been developed. Ensuring the availability of medicines implies not only their physical availability, but also their financial “lift”.In this vein, the government program “Accessible Liki” has been operating in Ukraine since April 1, 2017.

Within the framework of the “Accessible Liki” program, the cost of an approved number of drugs for outpatient treatment is fully or partially covered by the state. Every six months, the Register of Medicines subject to reimbursement (hereinafter referred to as the Register) is reviewed and corrected. The “fresh” version was approved by the order of the Ministry of Health of Ukraine dated January 21, 2019.No. 148.

In general, the updated Register contains 258 trade names of drugs for 3 nosologies: cardiovascular diseases, bronchial asthma and type 2 diabetes mellitus.

It should be noted that the program had an extremely positive impact on the amount of medicines consumed by the population. Some pharmaceutical companies strive not only to stay in the program with each update of the Registry, but also to maintain the status of “most accessible”. This often means that they reduce the price and the drugs are available to the patient at the pharmacy free of charge (no co-payment).On a national scale, this made it possible to achieve price stabilization in pharmacies for reimbursable drugs, as well as significantly increase their availability.

Tellingly, the new Registry has increased the number of drugs for the treatment of cardiovascular diseases. This is not surprising, because it is this class of diseases that is one of the leading causes of death in the world.

Why statins?

Statins are relatively new players in the pharmaceutical arena, but they have already firmly won their “place” in the prescriptions of doctors.Indeed, the development of most cardiovascular diseases is based on atherosclerosis, and one of the main causes of its occurrence is hypercholesterolemia.

Statins, in addition to the main cholesterol-lowering effect, have a number of other (pleiotropic) effects, in particular anti-inflammatory and antiproliferative, as well as the ability to improve endothelial functions, etc. (Michels G. et al., 2007).

According to the recommendations of ESH / ESC (ESH – European Society of Hypertension), statins are used for the prevention of cardiovascular diseases in general and arterial hypertension in particular (Karpov Yu.A., 2018). In addition, they reduce the risk of developing life-threatening arrhythmias and sudden coronary death in patients with acute heart attacks.

Simvastatin preparations are available to Ukrainians under the “Accessible Liki” program from the statin group. At the same time, out of 13 simvastatins, only 2 drugs are available to patients without additional payment: ALLESTA ^® 20 mg and ALLESTA ^® 40 mg produced by the Macedonian company Alkaloid AD.

From April 1, 2019, the administration of the “Accessible Liki” program is transferred to the National Health Service of Ukraine (NHSU).It is she who will conclude contracts with pharmacies to participate in the program and reimburse the cost of drugs.

What is important, according to the draft Procedure for the conclusion of contracts between the NSZU and pharmacies, the latter undertakes to ensure the continuous availability of at least one drug, the cost of which is fully reimbursed, from the Register for each international non-proprietary name for dispensing in each pharmacy and pharmacy where the dispensing is carried out medicines under the contract.

Thus, pharmacies participating in the program must ensure that there is a mandatory constant availability of at least one drug for each INN, which the patient can receive without additional payment. There is only one such brand among statins – ALLESTA ^® .

Press Service of the Weekly Apteka

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Investor Profile Pharmacolog_ | Tinkoff Investments Pulse

👊 A blow to companies producing drugs from Covid❓

Or, another step to reduce deaths from COVID-19❓ 🤛

💉💊 Competition for the covid-patient market is growing.$ PFE ✅ Pfizer claims antiviral pills reduce the risk of severe illness or death from COVID-19 by 89%, a record for a Covid-19 drug 🏆

🔥 A trial of Pfizer Inc’s experimental antiviral pill against COVID-19 was discontinued early after the drug was shown to reduce hospital admissions or deaths by 89% for adults at risk of severe illness. (By the way, this happens quite often, if mortality decreases more than dramatically, for the purpose of humanity)

The Paxlovid trademark combination treatment consists of three tablets taken twice a day.$ MRK made an “oral” drug that reduces mortality by 50%

$ VIR increases sales (their effectiveness: reducing mortality or hospitalization by 85%, but, nevertheless, these are infusions (into veins and for a long time))

The drug from AstraZeneca Plc (NASDAQ: $ AZN) reduced the risk of severe COVID-19 or death by 50%.

$ REGN Regeneron Pharmaceuticals Inc showed 72% protection against symptomatic infection in the first week and 93% after. (LLY GILD also reduces, mainly symptomatology, not mortality)

$ BRII Brii Biosciences 78% reduction in deaths, hospitalizations

Pfizer, a class of protease inhibitors, is designed to block an enzyme that the coronavirus needs to reproduce.Merck molnupiravir has a different mechanism of action designed to introduce errors into the genetic code of the virus. Merck has already sold millions of treatments this week that have been approved by UK, US and international regulatory agencies.

Earlier this month, the UK said it had provided 250,000 courses of the antiviral drug Pfizer.

💡 Competition among products for the treatment of COVID-19 is growing.
In total, there are 200 vaccines in the world under development, and dozens of antiviral drugs.Infectious disease experts emphasize that prevention of COVID-19 through widespread use of vaccines ($ AZN $ MRNA #PFE $ JNJ remains the best way to fight the pandemic, but only 58% of Americans are fully vaccinated and access to many parts of the world is limited.)

And yes, let me remind you that vaccines reduce mortality by 90% + from SARS-CoV-2 (Covid) PFE MRNA $ AFKS (factories where Sputnik V is produced) JNJ AZN.

Recently, WHO (WHO) approved another vaccine – Covaxin (India) Bharat Biotech

Actually, now, $ ARCT $ NVAX (if they solve their problems) are closest to approval.And Sputnik may well be approved by WHO, already this, next month, which will also create additional competition in the market for COVID-19 drugs.

💡P. S. Many times he said that the weakening of COVID-19, especially mortality, is an important trigger for the growth of biotechs ($ GTHX $ ESPR, etc.) and lagging industries (DAL RCL $ CCL $ AAL, etc.) (after all, hundreds of millions , but the mortality rate there is more than 5 times lower, therefore, during epidemics of influenza and acute respiratory viral infections, hospitals do not overwhelm with patients, and the borders are not closed, they do not introduce hard lockdowns, and do not allocate trillions of dollars in the world for this)

And yes, I repeat, after the introduction of new drugs for Covid-19, and an even larger% of those vaccinated, they will reduce infection and mortality, and return ENT doctors, oncologists, cardiologists, endocrinologists, etc.into place, and those who will be able to make more diagnoses and prescribe something else, except for drugs for the treatment of COVID-19 and its complications.

#pulse_evaluate #pulse_official # Vaccine # Covid19 # coronavirus # pharma # biotech

⬆️ 👨‍🔬 Was useful, interesting – like + subscription. Go to your profile and subscribe. Answers to questions, discussions, suggestions, polls and many others. others ✅ 90,000 Keep calm and use the trademark: privatize English

In the heart of Northumberland, England, lies the pretty town of Alnwick.For bibliophiles, a stop at a secondhand bookstore is a must. Barter Books is located in the city’s old train station, and on its outer wall, store owner Stuart Manley has hung a piece of ephemeral World War II poster that reads “Keep Calm and Carry On.”

The problem is that in 2011 Mark Mark Coop, a businessman, trademarked this phrase. Coop saw an opportunity to create a monopoly on souvenir mugs, aprons and the like with this slogan.He even copied the design of the poster, and since then this unremarkable English phrase has been removed from the public domain and is now privately owned.

If an article deals with banking and assumes that a particular institution with branches in each time zone is a “bank that never sleeps”, it may only use this generic phrase to refer to Citibank as this phrase is a trademark of Citibank … and now it is his private property.

At a school sporting event, you must forget to put up a “Just Do It” sign, unless Nike is a sponsor.

A poet who wishes to use the phrase “between love and madness lies obsession” may be in trouble because Calvin Klein traded the trademark of expression for his line of Eau de Parfum products.

And anyone thinking of writing a memoir and wanting to remember happy times by reading Winnie the Pooh books may be forced to pay a license fee to Disney, which is the trademark of the book’s characters.

Disney has a current form in this area. The company recently dropped an application for the Dia de los Muertos trademark, the name of the traditional Day of the Dead festival celebrated by millions in Mexico.

If successful, this would give Disney exclusive rights to use the name on merchandise – and would presumably prevent Mexicans from doing the same without paying Disney’s license fee.

Perhaps the most egregious example of language hijacking is the aggressive approach taken by McDonalds to ensure that any retailer does not use “Mc” in its brand name.In 1996, McDonald’s threatened to sue Mary Blair of Buckinghamshire, England because she named her sandwich shop McMunchies. Blair told The London Times:

This is a small corner store. We sell cold sandwiches, cold meats.

It’s hard to believe anyone would confuse McMunchies, which sells no burgers or chips, for a McDonald’s franchise. That is, anyone other than McDonald’s that issued a statement explaining that the “Mc” prefix was the property of the firm:

If someone, knowingly or unintentionally, uses our brands in their food or restaurant business, they are actually using something that does not belong to them.

In France, the modern concept of trademarks appeared in 1857. The Trademark and Goods Act allowed owners to register and protect their trademarks. This law for the first time designated a trademark, which was recognized as property with intrinsic value and legal rights.

Few would agree that brands have the right to defend themselves against counterfeiters. For example, Coca-Cola needs to be able to stop another company trying to pass off its soft drink as the real thing.But should Coca-Cola trade the “real thing” trademark with that phrase forever?

At one time, trademarks were only used to protect logos and trademarks. This changed in 1923 when Edgar Rice Burroughs registered Tarzan as a trademark. This allowed his property to get around the limited time when it could legally profit from its copyright.

There are other examples of how trademarks have gone far beyond their original purpose.In 1995, photographer Charles M. Gentile made a poster of the IM Pei Building, which houses the Rock and Roll Hall of Fame and Museum in Cleveland, Ohio. Gentil was surprised to discover that the museum intended to sue him for infringing his trademark over his own image.

The implications of this brand expansion are staggering. If artists and photographers are required to pay licensing fees to use images of public buildings with trademarks, this would constitute a private tax on artistic expression.

The next target for trademark lawyers was color. In November 2002, Mars applied for the trademark “Whiskas purple” for its cat food packaging, and in 2010 it succeeded.

Judge Bennett of the Australian Federal Court accepted the argument that Mars invented the color specifically for its range of cat food. Given the endless taste of Mother Nature, might a good lady discover that she has accidentally used “purple Whiskas” on an animal or plant, and it turns out that she is paying a license fee to Mars?

Companies may well spend millions of dollars coming up with catchy slogans and a small fortune promoting those slogans to consumers.This does not mean, however, that they should be allowed to take exclusive possession of parts of the language, or, for that matter, publicly available images, and now colors. A company can adequately protect its brand from copycats by using a distinctive name and logo. Both work together to provide a unique identifier.

Trademarks of advertising slogans, however, are not needed. Companies should not be able to legalize the “squatter rights” of what is, after all, government property.

Colchicine / Colchicine in Russian – Item