Fluvastatin: clinical and safety profile
Alberto Corsini1, Terry A Jacobson, Christie M Ballantyne
1University of Milan, Milan, Italy.
Drugs
|June 18, 2004
Summary
Statins, including fluvastatin, significantly reduce major coronary events. Fluvastatin demonstrates a strong benefit-to-risk profile, offering pleiotropic benefits beyond cholesterol reduction.
Area of Science:
- Cardiology
- Pharmacology
Background:
- HMG-CoA reductase inhibitors (statins) reduce major coronary events and death.
- Statin therapy may offer pleiotropic benefits independent of cholesterol reduction.
- Clinical differences exist among statins regarding benefits and safety.
Purpose of the Study:
- To evaluate the benefit-to-risk profile of available statins.
- To assess fluvastatin's efficacy and safety in diverse populations.
- To highlight fluvastatin's pleiotropic effects.
Main Methods:
- Review of randomized clinical outcome trials.
- Analysis of safety records and effects on lipoproteins.
- Examination of evidence for beneficial pleiotropic properties.
Main Results:
- Fluvastatin shows substantial benefits in diverse populations.
- Effective for secondary prevention post-coronary intervention.
- Effective for primary prevention in renal transplant recipients.
- Demonstrated pleiotropic benefits in experimental and clinical studies.
Conclusions:
- Fluvastatin exhibits a strong benefit-to-risk profile.
- Both fluvastatin and fluvastatin XL 80mg are effective and safe.
- Clinical outcomes and safety data support fluvastatin's use.
Related Concept Videos
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:19Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:20Lipid-Lowering Drugs: Statins and Miscellaneous Agents
Hyperlipidemia, a medical condition often referred to as high cholesterol, is characterized by abnormally elevated levels of lipids in the bloodstream. When present in excess, these lipids, specifically cholesterol and triglycerides, can lead to serious health complications, often involving cardiovascular diseases. Illnesses like atherosclerosis, heart attacks, and pancreatitis have all been linked to untreated hyperlipidemia. This means controlling and regulating cholesterol and triglyceride...
01:18Cardiovascular Drugs: Classification based on Therapeutic Indications
Cardiovascular diseases, encompassing a range of conditions, can significantly affect the heart's operations and the overall circulatory system. These conditions impair the heart's ability to pump blood, leading to a deficit in oxygen supply to crucial organs. Anomalies in the heart's electrical system, known as arrhythmias, can cause heartbeats to accelerate or slow down. Usually, heart rates increase during physical activity and decrease while resting or sleeping. However, frequent irregular...
01:29Cholesterol: Significance and Regulation
Although not a source of energy, cholesterol plays a significant role as a foundational structure for bile salts, steroid hormones, and vitamin D, as well as being a crucial component of plasma membranes. Approximately 15% of blood cholesterol is derived from our diet, with the remainder synthesized from acetyl CoA by the liver and intestines. Cholesterol is eliminated from the body through its conversion into bile salts, which are eventually discarded in the feces.
Considering cholesterol and...
Considering cholesterol and...
01:16Therapeutic Drug Monitoring: Overview and Classification
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...