Blog Archives

Why the new indication for Vytorin and Zetia should not be approved

I have a guest post up at Merrill Goozner’s blog explaining why Merck’s application for a new indication for its drugs Vytorin (simvastatin/ezetimibe) and Zetia (ezetimibe) should not be approved.  The proposed indication is for the reduction of major cardiovascular events in patients with chronic kidney disease and is based on the results of the SHARP trial.  However, because SHARP compared the combination of simvastatin and ezetimibe with placebo — there was no simvastatin arm — we have no way of knowing if ezetimibe contributed anything to the result.  The FDA requires that combination drugs have additive effects over either drug alone.  Merck has not shown that ezetimibe contributed anything to the effect in SHARP, so the new indication should not be approved.

Addendum January 25, 2012:  Merck issued a press release today stating that the FDA did not approve the new indication.  “Because SHARP studied the combination of simvastatin and ezetimibe compared with placebo, it was not designed to assess the independent contributions of each drug to the observed effect; for this reason, the FDA did not approve a new indication for VYTORIN or for ZETIA® (ezetimibe) and the study’s efficacy results have not been incorporated into the label for ZETIA.”  The SHARP results were incorporated into the Vytorin label (see pages 27-28).

Addendum, May 5, 2015:  Unfortunately, the GoozNews blog is no longer up on the web.

Review of CNN special “The Last Heart Attack”

I have a guest  post up on Gary Schwitzer’s blog critiquing Sanjay Gupta’s promotion of calcium scans and overhyping of extreme diets.

Does garlic lower cholesterol?

Like my last post, this post is inspired by Harriet Hall’s recent review of The Mayo Clinic Book of Home Remedies on the Science-Based Medicine blog. For elevated cholesterol, the book recommends trying “natural products,” including garlic.

In 2007, the results of a randomized controlled trial of garlic on cholesterol concentrations on adults with moderate hypercholesterolemia were reported in Archives of Internal Medicine. The trial evaluated raw garlic and two commonly used garlic supplements. None of the forms of garlic, including raw garlic, when given at an approximate dose of a 4 gram clove per day, 6 days a week for 6 months, had statistically or clinically significant effects on LDL-C or other plasma lipid concentrations.

In addition, a meta-analysis was published in 2008 that did not find beneficial effects of garlic on total cholesterol, LDL, triglycerides, or apoB.

Based on the above, it seems like a waste of time and effort for anyone to try to lower their cholesterol with garlic.

References

Gardner, et al., Effect of raw garlic vs commercial garlic supplements on plasma lipid concentrations in adults with moderate hypercholesterolemia: a randomized clinical trial. Arch Intern Med. 2007;167(4):346-353.

Khoo, et al., Garlic supplementation and serum cholesterol: a meta-analysis. Journal of Clinical Pharmacy and Therapeutics. Volume 34, Issue 2, pages 133–145, April 2009.