Much has happened in health related news in the past week since I have been away. In my mind, most notably news about Singulair and Vytorin; ironically both Merck products.
FDA looks into Singulair, risks of suicidal thoughts
As reported by USAToday and other sources, last week, the FDA announced this early communication about reports about possible links with the popular asthma and allergy drug and suicidal thoughts. Similar to previous post about the Spiriva warning, and my initial post when the FDA decided to release these warnings, this is another example of information that is really helpful to no one, confusing to patients, and disastrous to physicians who will be bombarded with phone calls from concerned patients and parents. Though reports of possible suicidal though are very serious and should certainly be investigated, such a warning is premature. Singulair is extremely common, with millions of prescriptions sold, so if there really were a link to suicidal thought and this medication, we would probably know about it by now. There is no real biologically plausible explanation for the connection.
Bottom Line: Singulair is a very clean and safe drug, and this report is no reason to stop it.
What you will not hear elsewhere: Though Singulair is likely safe, it is ridiculously over prescribed. Singulair is indicated for the treatment of allergies and asthma. For allergies, It has not been shown to be more effective than Claritin (which is now generic and over-the-counter). In fact, when Merck-Schering were trying to add Singulair to Claritin, they found it no more effective than Claritin alone (sound familiar?). In this case, they decided not to manufacture this new pill. The most effective agents for allergic rhinitis are inhaled nasal corticosteroids. Flonase is now available as generic fluticasone, and is much more effective then Singulair (which is not generic), Claritin or the combination of the two. Regarding asthma, the updated 2007 NIH guidelines recommend inhaled corticosteroids for asthmatics of all ages. The data is overwhelming, clear and convincing. Singulair, which has much less of an effect is considered alternative therapy by the NIH. Yet, Singulair remains one of the most commonly prescribed drugs for asthma.
More on Vytorin
Despite all the "shocking" headlines, from CNN to ABC news, there really isn't anything new here. My favorite was the video from the Today Show on NBC that titled this a "health alert." However, this story clearly hits home for many. My post on the letter I received from Merck on this matter has thus far been my most viewed post. The results that were reported in the latest cardiology meeting and in the New England Journal simultaneously confirm what was announced in January. Vytorin (zetia plus zocor) did lower cholesterol more than Zocor alone, but there was no difference in its ability to prevent clogging of the arteries. This is important news because this means that there continuing evidence that there may be more to the cholesterol story than just lowering "bad" cholesterol or ldl.
Bottom Line: Though the news does reinforce not using Vytorin as initial therapy, it does not mean that Zetia is completely useless. Some patients have side effects from statin medications, and if they can not take a statin (or take it at a dose they need to lower their cholesterol), then Zetia currently the best option.
What you will not hear elsewhere: There will be multiple comments about how Merck promoted this drug (remember the ads with family members dressed to look very similar to cholesterol containing foods?). The New England Journal has a very interesting piece on the differences in use of Vytorin and Zetia between Canada and the US, which (correctly) suggests that much of this may be do to direct to consumer advertisement (which is not allowed in Canada). However, what is not discussed is that one major determining factor in what a physician prescribes for their patient is which drug happens to be preferred by their insurance company's prescription formulary. The only patients I wrote prescriptions for Vytorin for were my patients who had Aetna insurance. Until very recently, if you were an Aetna patient, the only cholesterol lowering options you had were Zocor and Vytorin. Thus, for those patients who needed a stronger statin the Zocor (such as Lipitor or Crestor-Crestor is now finally on Aetna's formulary), I had no choice but to go with Vytorin, despite limited data. Why would Aetna choose this over Lipitor (the most popular cholesterol drug) or Crestor (new kid on the block)? Merck had obviously given Aetna a much better price then the competition on their cholesterol lowering drugs.
Finally, don't throw out surrogate markers just yet. Even more evidence that LDL cholesterol may not be the only thing that is important, just announced in the Wall Street Journal today that Astra Zeneca was stopping a Crestor trial early because patients clearly benefited from the drug. The Jupiter trial (which we were involved in) took patients with relatively normal LDL cholesterol, but high CRP levels (which have also been associated with increased risk) and randomized them to placebo or Crestor 20mg. Though the results have not been published, clearly a significant amount of patients taking Crestor had fewer heart attacks or strokes.