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FAU Researcher reports statin research
Published July 3rd, 2008
By John Johnston
Managing Editor
In the June issue of the American Journal of Cardiovascular Drugs, Florida Atlantic University researcher Dr. Charles H. Hennekens has written the lead article in a discussion of the strengths and limitations of fixed-dose combination therapy with statins.
Statins are a class of drugs used to lower LDL ("bad") cholesterol and triglycerides by inhibiting the body’s production of them.
At least 12 million Americans take cholesterol-lowering drugs, mostly statins, and experts' recommend that another 23 million should be taking the cholesterol-lowering drug. Statins reduce risks of heart attack, stroke and deaths from cardio-vascular disease (CVD).
Dr. Hennekens is the first Sir Richard Doll Research Professor in the Charles E. Schmidt College of Biomedical Science and a renowned expert who has done research on numerous causal, therapeutic and preventive factors in the treatment and prevention of CVD -- most notably the study of low-dose aspirin in this regard.
Fixed-dose combination drugs that include statins first appeared on the market in 2004. For example, Pravigard contains pravastatin to inhibit hardening of the arteries and aspirin to inhibit the formation of blood clots in blood vessels. More recently, Vytorin combined simvastatin to reduce the production of LDL cholesterol and ezetimibe to reduce absorption.
“The controversies surrounding fixed-dose combination statins have drawn attention to Vytorin as well as issues in drug development and approval,” said Hennekens.
Pros and Cons
In his article, “Fixed-dose Combination Therapy with Statins,” Hennekens cites the positive side of such therapy as:
- Increased compliance.
- Convenience.
- Cost savings.
In contrast, potential limitations include:
- Reduced flexibility in dosing.
- Exposure of some patients to unrequired therapies.
- Increased risks of adverse effects without additional benefits.
“The current FDA policy for fixed-dose combination drugs was established in 1971, and its primary goal was to implement the efficacy requirement added in 1962 to the Federal Food, Drug, and Cosmetic Act (FDCA),” said Hennekens. “The objective was to remove numerous fixed-dose combination products from the market that lacked a reasonable medical basis for combined use.”
According to Hennekens, the fixed-dose combination drug approval policy “remains a valid framework and includes four key components, namely efficacy, safety, independent contribution and medical need.”
The article briefly describes the FDA regulatory process for the approved fixed-dose combination therapies with statins including niacin/lovastatin (trade name Advicor), ezetimibe/simvastatin (trade name Vytorin), amlodipine/atorvastatin (trade name Caduet) and aspirin/pravastatin (trade name Pravigard PAC).
Hennekens’ said that regulatory approval of fixed-dose drug combination products includes consideration of numerous issues. For example, the efficacy of both products combined should be demonstrated to be greater than either agent alone. Finally, “there must be an unmet need and the demonstration of a population at risk that would benefit from the fixed-dose drug combination,” he said.
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