So first we find out that maybe Zetia (ezitimibe) isn't all it's cracked up to be. In an earlier study of patients with familial hypercholesterolemia--as in big-time LDL-cholesterol elevations of 300 and beyond-- the addition of Zetia to Zocor, a combination also known as Vytorin, did not slow down progression of arterial disease as measured in the carotid artery. Worst case scenario, we thought, was that Zetia wasn't really much use, and perhaps, we theorized, these high LDL patients do not represent our typical everyday high cholesterol patients so why compare outcomes in the one to clinical courses in the other?
Until now. Just out this week in the New England Journal of Medicine are the results of the SEAS trial(1), as in Simvastatin and Ezetimibe in Aortic Stenosis. This study compares the use of Vytorin to placebo in old folks with narrowing of their aortic valves. Mattered not in these elderly valves whether the owners used Vytorin with respect to progression of the stenosis or cardiac disease in general. What mattered, however, mattered a lot in fact, is that the seniors randomized to active treatment were significantly more likely to get cancer and borderline more likely to die of it.
In this same issue of the NEJM, another group looked at cancer data from two other Zetia studies. After studying the combined data from these larger, ongoing trials, they concluded:
There was no overall excess of cancer (313 active-treatment vs. 326 control) and no significant excess at any particular site. Among patients assigned to ezetimibe, there were more, albeit not significantly more, deaths from cancer (97, vs. 72 in the control group; P=0.07)... The available results from these three trials do not provide credible evidence of any adverse effect of ezetimibe on rates of cancer.
Oh gad, now what to do? An accompanying editorial theorizes that Zetia might not only interfere with the absorption of cholesterol but also other molecules that affect the growth of cancer cells. And the doctors conclude: "Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug."
I think I'm done with Zetia.
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(1) Rossebø AB, Pedersen TR, Boman K, et al. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 2008;359. DOI: 10.1056/NEJMoa0804602.
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4 comments:
Oh good ...so I took Zetia from the time it came on the market till about 6 months ago ... AND I've been on either Imuran or Cellcept for 15 years ...
nice ..thanks makers of Zetia ... I needed that.
Yep ... At least with Imuran or Cellcept I KNEW I was increasing my cancer risk!
(appropriate word verification
xqrroar ... ROAR indeed)
Well one other story. I had been taking zocor for 10 years and in 2005 the doctor put my on vytorin. In Dec 2006 I was diagnosed with Kidney cancer. Last CT scan in June 2005 showed no cancer. Lucky I have Kidney stones or they never would have found it. I stopped Vytorin in 2007 and am now back on zocor. Don't know the connect but I'll never take Vytorin again.
Anon: Wow, what a story. Isn't interesting to be in a situation where kidney stones are lucky!
I had a patient with upper abdominal pain. We did a CT scan and found a malignant tumor on kidney which hadn't spread so she was cured by surgery. Post-op, she still had upper abdominal pain which was probably caused by an expanding waistline (due to weight gain) pressing on her lower rib cage. Thank heavens, in that case, for fat!
well, I am begining to wonder about zetia now too. I took it since 2006 and on july 2009 got diagnosed with colon cancer....
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