Drug Truths

A site devoted to teaching about drug discovery and development.

Long-Term Benefits of Statin Therapy Again Confirmed

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For those who have heart disease, changes in diet and exercise are often not sufficient to reduce the risk of having a heart attack or a stroke.  Some type of medication is usually required for these patients to help them control their high lipid levels, particularly LDL, the so-called “bad” cholesterol.  As discussed recently in this blog, the usefulness of niacin, one of the drugs used for decades by heart disease patients, has been called into question.  Long-term outcomes studies with niacin are starting to show that niacin offers little, if any, benefit over statins, the relative newcomers to cardiovascular therapy.

As the industry evaluates the new information on the long-term usage of niacin, it’s natural to pose the same questions about statins.  Are their protective benefits maintained over many years of use?  Are patients exposed to these drugs for long periods susceptible to other diseases?  Over the past few years, studies have appeared showing that statins like Lipitor (atorvastatin) can, in fact, reduce the occurrence of heart attacks and strokes in patients with heart disease.  Now, a new study reported in The Lancet (November 23, 2011) from the Heart Protection Study (HPS) Collaborative Group offers further evidence for the value of this class of medicines.

The trial design was pretty simple.  This group of patients at high risk of heart attacks and/or strokes was given either 40 mg of simvastatin or placebo for slightly over 5 years, then post-trial follow-up occurred for another 5+ years bringing the duration of the study to 11 years.  Not surprisingly, those patients on simvastatin had an average decrease in LDL cholesterol of 40mg/dL and, more importantly, a decrease of 23% in major vascular events.  This benefit continued throughout the post-trial follow-up period.  Equally important was the fact that there was no evidence of “emerging hazards” (e.g., cancer) resulting from long-term simvastatin use.

The lead author of the HPS, Dr. Richard Bulbulia of the University of Oxford, commented: “All of those at increased vascular risk should start taking statins early and continue taking them long-term.”  He also commented that these results should provide reassurance to patients and physicians about the safety of statins and that the results should translate to other members of this class of medicines such as atorvastatin and Crestor.

The HPS has provided valuable results at a time when health care providers are struggling with increasing rates of obesity, diabetes and heart disease.  But this study is important for another reason.  Medications designed for controlling a chronic disease that patients will need to take for decades – not only heart disease, but also diseases like osteoporosis, depression or even cancer – will need this type of long-term outcome study, not just to provide patients and physicians with all-important risk-benefit data, but also to justify to payers the value of new medications.  These studies add time to the development of a new drug and greatly increase development costs.  But they are invaluable.


Written by johnlamattina

November 30, 2011 at 10:02 am

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