Thursday, July 24, 2008

Viagra for Women, No to Breast Exams and More Bad News for Vytorin

Sorry I have not posted for a while. With the start of a new school year (the medical school academic calendar goes from July to July) I have been kneed deep in multiple projects. Here are a few short takes on some recent items in the news.

Viagra for Women
The Wall Street Journal and others have recently reported about using Viagra in women. This comes from a study in JAMA that found that in women who had experienced sexual dysfunction after taking an antidepressant like Prozac or Celexa, the 49 women who took Viagra compared to the 49 women who took placebo had an improvement in sexual function.
There are a few caveats here. In addition to being a relatively small study, the outcome measure was a sexual function score based on a doctor rated scale between 1 (normal) and 7 (most extreme sexual dysfunction). Though the difference between the groups was statistically significant, the difference was less than a point on this scale. More importantly, the women studied here were very specific: depressed women who had no problems with sexual functioning until they had started an anti-depressant. Maybe instead of taking a second pill, they should have switched to another anti-depressant that doesn't cause sexual dysfunction, like bupropion.

Bottom Line: Sexual dysfunction in women is a MAJOR problem that doesn't seem to have a lot of funded research, and thus no real proven treatment options. If Viagra really worked for women, you would know about it, as I am sure countless women have tried this on their own. Male erectile function is both a nerve and blood flow problem, and Viagra (a vasodilator) clearly works on this second component. Female sexual dysfunction is much more complicated, and likely due to multiple factors, of which blood flow is probably only a minor component. More research is needed on this important problem, including studies on Viagra, but for now, I would not recommend Viagra for women.

No More Breast Exams
Several sources, including MSNBC recommend "Ladies, give your breasts a rest." This is based on a recently released review of the literature that showed that after studying thousands of women, not only was there no improvement in picking up breast cancer, but because of increased numbers of likely unnecessary biopsies, doing self breast exams may have also actually have caused harm.

Bottom Line: Breast cancer is one of the leading cause of cancer, and leading cause of cancer deaths in women. Early detection and treatment can save lives. On the other hand, not all screening is best for every patient. In addition, there is a risk to any screening, even if it is something as seemingly harmless as examining your own breasts, because if you find something, that you will need a test, which often (biopsy) has side effects. This study shows that making general recommendations for everyone may not be a great idea. For example, the incidence of breast cancer in women under 35 is about the same as the risk for breast cancer in men, and you don't see men examining their breasts! Though others suggest young women do self-breast exams to "get in the habit early", based on this study this practice is not warranted. On the other hand, patients at high risk may benefit from self-breast exams, such as women above 50, especially with a family history. In other words, some ladies can (and should) "take a rest", but not necessarily everyone.

More Bad News for Vytorin.
As reported in several sources, including Forbes, the most recent study on Vytorin was not exactly positive. The SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) trial compared Vytorin to placebo in about 1800 paients with aortic stenosis, a stiffening of one of the heart valves. The primary endpoint was a combination of aortic valve events (valve-replacement surgery, heart failure, and cardiovascular mortality) and ischemic events (nonfatal MI, coronary, CABG, need for catheterization, unstable angina, and cardiovascular death). The study found no difference in the primary outcome, but did find a small difference in the secondary ischemic outcome. However, there was also a non-significant increase in cancer diagnosis in the Vytorin group.

Bottom line: On the one hand, the cancer increase is probably nothing to worry about, since this wasn't statistically significant and has not been seen in other trials. On the other hand, you can't make too much of a secondary endpoint (ischemic events) when Vytorin is compared to placebo. Lowering ldl cholesterol does matter. The issue is whether or not Vytorin is worth the extra cost (of generic simvistatin) or whether, when necessary, it is better to use a more potent statin like Lipitor or Crestor. With ENHANCE and SEAS, studies with Vytorin have failed to show why treating two sources of cholesterol is better then treating one (despite the drug company's huge advertising campaign suggesting this is important). Though I will add Zetia when I can't get to goal with another statin, I see no role for Vytorin anymore.

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