Rosuvastatin and Antacids: Pharmacokinetic Interactions and Clinical Implications
How does the combination of antacids containing aluminum hydroxide and magnesium hydroxide affect rosuvastatin pharmacokinetics. What are the potential clinical implications of this interaction. How can healthcare providers mitigate the impact of antacids on rosuvastatin efficacy.
Understanding Rosuvastatin: Mechanism of Action and Clinical Use
Rosuvastatin is a potent member of the statin class of medications, widely prescribed for the management of dyslipidemia. As a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, rosuvastatin effectively lowers cholesterol levels by blocking a key enzyme in cholesterol synthesis. Its high efficacy in reducing low-density lipoprotein (LDL) cholesterol has made it a popular choice among healthcare providers for patients at risk of cardiovascular disease.
How does rosuvastatin work at the molecular level? The drug competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis. This inhibition leads to decreased cholesterol production in the liver, which in turn triggers an upregulation of LDL receptors on hepatocyte surfaces. The increased number of LDL receptors enhances the clearance of LDL particles from the bloodstream, resulting in lower circulating LDL cholesterol levels.
Clinical Applications of Rosuvastatin
- Primary hypercholesterolemia treatment
- Prevention of cardiovascular events in high-risk patients
- Management of mixed dyslipidemia
- Slowing the progression of atherosclerosis
Given its widespread use and the likelihood of concomitant medication use in patients with cardiovascular risk factors, understanding potential drug interactions with rosuvastatin is crucial for optimal patient care.
The Role of Antacids in Gastrointestinal Health
Antacids play a significant role in managing various gastrointestinal conditions, primarily by neutralizing stomach acid. Combination antacid preparations containing aluminum hydroxide and magnesium hydroxide, such as the co-magaldrox 195/220 used in this study, are commonly used for their synergistic effects and reduced side effects compared to single-agent formulations.
How do antacids containing aluminum hydroxide and magnesium hydroxide work? These compounds react with hydrochloric acid in the stomach to form water and neutral salts, effectively raising the pH of the stomach contents. This neutralization provides rapid relief from symptoms associated with excess stomach acid, such as heartburn, indigestion, and acid reflux.
Common Indications for Antacid Use
- Gastroesophageal reflux disease (GERD)
- Peptic ulcer disease
- Dyspepsia
- Stress-induced gastritis
Given the prevalence of both cardiovascular disease and gastrointestinal disorders in the general population, it is not uncommon for patients to be prescribed both statins and antacids. This potential for co-administration underscores the importance of investigating drug interactions between these medication classes.
Study Design: Assessing the Impact of Antacids on Rosuvastatin Pharmacokinetics
The research team conducted a randomized, open-label, three-way crossover trial to evaluate the effect of a combination antacid preparation on rosuvastatin pharmacokinetics. This study design allows for within-subject comparisons, reducing variability and increasing the power to detect differences between treatment conditions.
How was the study structured to assess the antacid-rosuvastatin interaction? The trial involved 14 healthy male volunteers who received three different treatment regimens in a randomized order:
- Rosuvastatin 40 mg alone
- Rosuvastatin 40 mg plus 20 mL antacid suspension taken simultaneously
- Rosuvastatin 40 mg plus 20 mL antacid suspension taken 2 hours after rosuvastatin
Each treatment was separated by a washout period of at least 7 days to ensure complete elimination of the previous dose and to prevent carryover effects. The primary pharmacokinetic parameters measured were the area under the rosuvastatin plasma concentration-time curve from time zero to the last quantifiable concentration (AUC(0-t)) and the maximum observed rosuvastatin plasma concentration (C(max)).
Key Aspects of the Study Methodology
- Use of a high dose (40 mg) of rosuvastatin to maximize the potential for detecting an interaction
- Inclusion of both simultaneous and separated administration of antacid to assess timing effects
- Measurement of both AUC and C(max) to capture overall exposure and peak concentrations
This comprehensive approach allows for a thorough evaluation of the potential impact of antacids on rosuvastatin pharmacokinetics under different administration scenarios.
Results: Quantifying the Impact of Antacids on Rosuvastatin Pharmacokinetics
The study findings revealed a significant interaction between the antacid preparation and rosuvastatin, with the magnitude of the effect varying based on the timing of administration. These results have important implications for clinical practice and patient management.
What was the effect of simultaneous antacid administration on rosuvastatin pharmacokinetics? When rosuvastatin and the antacid were given at the same time, the following changes were observed:
- Rosuvastatin AUC(0-t) was reduced by 54% (90% confidence interval [CI]: 0.40-0.53)
- Rosuvastatin C(max) was reduced by 50% (90% CI: 0.41-0.60)
These substantial reductions in both overall exposure (AUC) and peak concentration (C(max)) indicate a clinically significant interaction that could potentially compromise the efficacy of rosuvastatin therapy.
How did separating the administration of rosuvastatin and antacid affect the interaction? When the antacid was given 2 hours after rosuvastatin, the impact was notably less pronounced:
- Rosuvastatin AUC(0-t) was reduced by 22% (90% CI: 0.68-0.90)
- Rosuvastatin C(max) was reduced by 16% (90% CI: 0.70-1.01)
While still demonstrating a reduction in rosuvastatin exposure, the separated administration resulted in a markedly smaller effect compared to simultaneous dosing. This finding suggests that timing of administration could be a crucial factor in managing this drug interaction.
Mechanisms of Interaction: Understanding the Pharmacokinetic Interference
The observed reduction in rosuvastatin exposure when co-administered with antacids can be attributed to several potential mechanisms. Understanding these mechanisms is crucial for developing strategies to mitigate the interaction and optimize therapy.
Why do antacids interfere with rosuvastatin absorption? Several factors may contribute to this interaction:
- Increased gastric pH: Antacids raise the pH of the stomach, which can affect the solubility and ionization state of rosuvastatin, potentially reducing its absorption.
- Formation of insoluble complexes: The metal cations in the antacid (aluminum and magnesium) may form insoluble complexes with rosuvastatin, preventing its absorption.
- Altered gastrointestinal motility: Some antacids can affect gastrointestinal transit time, which may influence the absorption of co-administered medications.
- Adsorption: The antacid components may adsorb rosuvastatin onto their surfaces, reducing the amount available for absorption.
The reduced impact observed with separated administration suggests that the interaction is primarily occurring in the gastrointestinal tract during the absorption phase. By allowing time for rosuvastatin to be absorbed before introducing the antacid, the extent of the interaction is diminished.
Potential Long-term Implications
While this study focused on single-dose pharmacokinetics, it raises questions about the potential long-term effects of repeated antacid use on rosuvastatin efficacy. Chronic reduction in rosuvastatin exposure could lead to suboptimal lipid control and potentially compromise the cardiovascular protective effects of statin therapy.
Clinical Implications: Optimizing Rosuvastatin Therapy in Patients Using Antacids
The significant reduction in rosuvastatin exposure observed with concomitant antacid use has important implications for clinical practice. Healthcare providers must carefully consider how to manage patients who require both rosuvastatin and antacid therapy to ensure optimal treatment outcomes.
How can clinicians mitigate the impact of this interaction? Several strategies can be employed:
- Temporal separation: Advise patients to take rosuvastatin and antacids at different times of the day, with at least 2 hours between doses.
- Dose adjustment: In cases where temporal separation is not feasible, consider increasing the rosuvastatin dose to compensate for reduced absorption.
- Alternative medications: Explore the use of proton pump inhibitors or H2 receptor antagonists instead of antacids for acid suppression, as these may have less impact on rosuvastatin pharmacokinetics.
- Monitoring: Regularly assess lipid levels to ensure that therapeutic goals are being met, especially in patients using both medications.
It is important to note that while the study demonstrated a significant interaction, the effect of repeated antacid administration was not evaluated. Clinicians should be aware that chronic antacid use might potentially result in a stronger interaction than observed in this single-dose study.
Patient Education and Adherence
Effective communication with patients is crucial to ensure adherence to medication schedules and minimize the risk of interactions. Patients should be educated about the potential for interaction between rosuvastatin and antacids, and provided with clear instructions on how to time their medications to optimize therapy.
Future Research Directions: Expanding Our Understanding of Statin-Antacid Interactions
While this study provides valuable insights into the interaction between rosuvastatin and a specific antacid preparation, several areas warrant further investigation to enhance our understanding and improve patient care.
What are the key areas for future research in statin-antacid interactions?
- Long-term effects: Investigate the impact of chronic antacid use on rosuvastatin efficacy and lipid control over extended periods.
- Other statin medications: Assess whether similar interactions occur with other statins, and if there are differences in the magnitude of effect across the class.
- Different antacid formulations: Evaluate the interaction potential of various antacid preparations, including those with different active ingredients or dosage forms.
- Patient-specific factors: Explore how individual patient characteristics (e.g., genetics, comorbidities) may influence the extent of the interaction.
- Clinical outcomes: Conduct large-scale observational studies to determine if the pharmacokinetic interaction translates to differences in cardiovascular outcomes in real-world settings.
- Mitigation strategies: Develop and test novel approaches to minimize the impact of the interaction, such as formulation modifications or alternative dosing regimens.
By addressing these research questions, we can refine our approach to managing patients who require both statin therapy and antacid treatment, ultimately improving cardiovascular outcomes and quality of care.
Pharmacogenomic Considerations
An intriguing area for future research is the role of pharmacogenomics in modulating the interaction between statins and antacids. Genetic variations in drug-metabolizing enzymes or transporters could potentially influence the extent of the interaction and help identify patients at higher risk for clinically significant effects.
The effect of a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide on rosuvastatin pharmacokinetics
Clinical Trial
. 2008 Apr;24(4):1231-5.
doi: 10.1185/030079908×280662.
Epub 2008 Mar 19.
Paul D Martin
1
, Dennis W Schneck, Aaron L Dane, Michael J Warwick
Affiliations
Affiliation
- 1 AstraZeneca, Alderley Park, Cheshire, UK. [email protected]
PMID:
18355422
DOI:
10.1185/030079908×280662
Clinical Trial
Paul D Martin et al.
Curr Med Res Opin.
2008 Apr.
. 2008 Apr;24(4):1231-5.
doi: 10.1185/030079908×280662.
Epub 2008 Mar 19.
Authors
Paul D Martin
1
, Dennis W Schneck, Aaron L Dane, Michael J Warwick
Affiliation
- 1 AstraZeneca, Alderley Park, Cheshire, UK. [email protected]
PMID:
18355422
DOI:
10.1185/030079908×280662
Abstract
Objective:
Rosuvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor used for the treatment of dyslipidaemia, may be co-administered with antacids in clinical practice.
This trial assessed the effect of simultaneous and separated administration of an antacid preparation containing aluminium hydroxide 220 mg/5 mL and magnesium hydroxide 195 mg/5 mL (co-magaldrox 195/220) on the pharmacokinetics of rosuvastatin.
Research design and methods:
A randomised, open-label, three-way crossover trial was performed. Healthy male volunteers (n = 14) received a single dose of rosuvastatin 40 mg alone, rosuvastatin 40 mg plus 20 mL antacid suspension taken simultaneously, and rosuvastatin 40 mg plus 20 mL antacid suspension taken 2 h after rosuvastatin on three separate occasions with a washout of > or = 7 days between each.
Main outcome measures:
The primary parameters were area under the rosuvastatin plasma concentration-time curve from time zero to the last quantifiable concentration (AUC(0-t)) and maximum observed rosuvastatin plasma concentration (C(max)) in the absence and presence of antacid.
Results:
When rosuvastatin and antacid were given simultaneously, the antacid reduced the rosuvastatin AUC(0-t) by 54% (90% confidence interval [CI] for the treatment 0.40-0.53) and C(max) by 50% (90% CI 0.41-0.60). When the antacid was given 2 h after rosuvastatin, the antacid reduced the rosuvastatin AUC(0-t) by 22% (90% CI 0.68-0.90) and the C(max) by 16% (90% CI 0.70-1.01). The effect of repeated antacid administration was not studied and it cannot be discounted that this may have resulted in a stronger interaction than that observed here.
Conclusions:
Simultaneous dosing with rosuvastatin and antacid resulted in a decrease in rosuvastatin systemic exposure of approximately 50%. This effect was mitigated when antacid was administered 2 h after rosuvastatin.
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Rosuvastatin and Tums Antacid Naturals Interactions
This report displays the potential drug interactions for the following 2 drugs:
- rosuvastatin
- Tums Antacid Naturals (calcium carbonate)
Edit list (add/remove drugs)
- Consumer
- Professional
Interactions between your drugs
Taking the rosuvastatin and calcium carbonate doses too close together may interfere with the absorption of rosuvastatin and reduce its effectiveness.
To prevent or minimize the interaction, rosuvastatin and calcium carbonate dosing should be separated by at least two hours. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.
Switch to professional interaction data
Drug and food interactions
Calcium absorption may be increased by taking it with food. However, foods high in oxalic acid (spinach or rhubarb), or phytic acid (bran and whole grains) may decrease calcium absorption. Calcium may be taken with food to increase absorption. Consider spacing calcium administration for at least 2 hours before or after consuming foods high in oxalic acid or phytic acid. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.
Switch to professional interaction data
Therapeutic duplication warnings
No warnings were found for your selected drugs.
Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.
See also
- Rosuvastatin drug interactions
- Rosuvastatin uses and side effects
- Tums Antacid Naturals drug interactions
- Drug Interactions Checker
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Drug Interaction Classification
| Major | Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. |
|---|---|
| Moderate | Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. |
| Minor | Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. |
| Unknown | No interaction information available. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Rosuvastatin: instruction, price, analogues | Biofarm
film-coated tablets (Rosuvastatin)
Manufacturer:
Biofarm
Composition and form of release
You can pay for medicines with a card pidtrimka
Classification
Atherosclerosis of the aorta | ICD I70. 0 |
Atherosclerosis of the arteries of the extremities | ICD I70.2 |
Atherosclerotic heart disease | ICD I25.1 |
Hypertensive heart disease without (congestive) heart failure | ICD I11.9 |
Hypertension (AH) with heart disease and heart failure (HF) | ICD I11.0 |
| Other specified lesions of cerebral vessels | ICD I67.8 |
Other forms of angina pectoris | ICD I20.8 |
| Cerebral infarction caused by thrombosis of the cerebral arteries | ICD I63.3 |
Post-infarction coronary heart disease (CHD), (past myocardial infarction) | ICD I25.2 |
Ischemic heart disease with hypertension (CHD with HT) | ICD I25. 9 |
Ischemic heart disease with angina pectoris | ICD I25.0 |
Unstable angina Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris) | ICD I20.0 |
Acute transmural (with Q wave) infarction of the inferior myocardial wall Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome with ST segment elevation (MI with Q wave) | ICD I21. 1 |
Acute transmural infarction of the anterior myocardial wall Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris) | ICD I21.0 |
Persistent atrial fibrillation Manual of cardiology (edited by V.N. Kovalenko, 2008) … Clinical protocol for providing medical care to patients with atrial fibrillation (flutter) | ICD I48.1 |
Recurrent myocardial infarction, unspecified Manual of cardiology (ed. | ICD I22.9 |
| Consequences of cerebral infarction | ICD I69.3 |
Angina | ICD I20.9 |
Juvenile arterial hypertension | ICD I10 |
V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris)Date added: 07/05/2023
© Compendium 2019
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5 herbs and spices that can reduce the effect of drugs
- Health
Many seemingly harmless herbs and herbal preparations can interact with various drugs and reduce their effect.
So, when prescribing dietary supplements for yourself, you should be very careful.
March 4, 20231
- Source:
- iStockphoto
We know about the health benefits of garlic and green tea, both recognized as powerful antioxidants. It is very useful to use them in the diet in moderation, but it can be unsafe to get involved in preparations based on them. And not only them. There are other herbs and spices that seriously affect the effectiveness of the pharmaceutical preparations you take, writes ProNews.
Turmeric
This spice and dietary supplements with curcumin are often called “fool’s gold”. Science considers its antitumor, anti-inflammatory and antibacterial properties to be only potential. But the interaction of curcumin with drugs can even be dangerous.
There is evidence that curcumin may reduce the effect of many antidepressants and neuroleptics. It is also known to interact with anticoagulants, antacids, drugs to control blood pressure.
– Whole turmeric, turmeric extract or pure curcumin are credited with at least 175 different beneficial physiological effects and more than 600 different indications, explains renowned physician, toxicologist Alexei Vodovozov. “But if you search the available databases for relevant studies, it turns out that of them are at the preclinical stage, , that is, cell cultures and laboratory animals (mice and rats). And the results found are of interest mainly to mice and rats, because they are transferred to humans very, very rarely.
Read also
Garlic
Garlic extract can reduce the concentration of cardiac glycosides, glucocorticoids – drugs that transport P-glycoprotein protein across the cell membrane – such as colchicine, quinidine, desloratadine, digoxin, rosuvastatin and others , writes ProNews
Garlic extract can also thin the blood like aspirin, which can be a problem if you are taking blood thinners.
– It happens that people take both aspirin and anticoagulants, then the risk of bleeding increases exponentially.
I have had such cases. People go to the hospital to the surgeons on the operating table, because they have gastrointestinal bleeding, , doctor Boris Shelyapin told Doctor Peter earlier.
Green tea
Everyone knows about the benefits of green tea – it has antioxidant properties, anti-inflammatory, promotes the expansion of cerebral vessels, improves its nutrition, oxygen supply. All this is true, if you drink 2-3 cups of quality green tea a day. Although it is not shown to everyone – after all, a drink can lower blood pressure and harm ulcers.
Taking green tea extract as a dietary supplement can also be hazardous to health. There is evidence that green tea extract may reduce the effectiveness of some statins and some beta-blockers used to treat hypertension. Also concentrated green tea supplements may interact with some vasoconstrictors.
Thistle or milk thistle
This plant is believed to have many beneficial properties, and the active substance silymarin contained in it is called the first “protector” of the liver.