Zetia and Vytorin: Never Say Never

Washington, DCIf there is one thing to be said about pharmaceutical companies, it remains that they never, ever give up. Not until a product is deemed so unsafe that it is physically pulled from the market, will a manufacturer finally wave the white flag. This is especially true in the statin sector, which is the biggest piece of the pie with potential to get even bigger. Thus, when Zetia and Vytorin came under attack in 2008, manufacturers Merck & Co. and Schering-Plough basically bided their time.

Their patience paid off. Now, according to The Washington Post (11/18/14), there is renewed optimism for the combination of Zocor (simvastatin), a drug that lowers LDL cholesterol, and Zetia (ezetimibe), which works to prevent absorption of cholesterol. Yes, Vytorin side effects are still a concern, as they are for most statins (although, since Vytorin is a combination drug and not a lone statin per se, its profile is somewhat unique). However, new research suggests there is more to Vytorin than the “expensive placebo” it was made out to be in 2008.

What a difference seven years can make.

It was in 2008 that the results of the ENHANCE study cast a pall over Vytorin. While seen to be effective in lowering levels of the so-called “bad” LDL cholesterol, it was not seen to effectively decrease the risk for heart attack and negative cardiovascular events. In other words, if Vytorin is no more effective than Zocor (a statin) alone in reducing cholesterol, then why waste the money?

Merck and Schering-Plough were accused of sitting on the data for some two years in order to minimize the fallout and preserve sales until the ENHANCE data was finally released. Vytorin lawsuits followed, as investors felt they had been harmed by the alleged suppression of data and the subsequent delay in releasing the results. Merck and Schering-Plough eventually settled, in 2013, for $688 million while doggedly standing behind Vytorin and waiting for the results of this latest study, IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), to be released.

This time, the results of the nine-year study were favorable. And this time Merck and Schering-Plough wasted little time in releasing the results, positive as they were. At a gathering of the American Heart Association in Chicago this past November, researchers presented their findings: that study participants taking Vytorin presented with fewer heart attacks, strokes and repeat hospitalizations than those control subjects taking statins alone, according to The Washington Post.

Bingo. Merck and Schering-Plough finally had a response to the verbal slam against Vytorin as an “expensive placebo” almost seven years before.

That said, it’s too early for unbridled platitudes.

The study results still need to be peer-reviewed, a process now ongoing. What’s more, the manufacturers also need to submit study findings to the US Food and Drug Administration (FDA), in an attempt to seek the FDA’s blessing to market Vytorin as an effective therapy to reduce cardiovascular events, beyond the simple lowering of LDL cholesterol.

And lest the reader becomes seduced by the headlines, there remain significant risks and the potential for Vytorin side effects. There’s the rare potential for Vytorin liver damage. Many statin patients suffer from muscle pain, and Vytorin patients are no different. There remains the potential for rhabdomyolysis from the Zocor side of Vytorin, a condition characterized by the breaking down of muscle tissue that is eventually absorbed into the bloodstream. Rhabdomyolysis can be fatal.

This is especially true if rhabdomyolysis affects the heart muscle. Statin cardiomyopathy is a rare, but known side effect of all statins in general and includes Vytorin, given that the combo drug is based on a statin (Zocor). To that end, with statin cardiomyopathy, a medication designed to reduce the risk of heart attack may, in reality, lead to a Vytorin heart attack.

Merck and Schering-Plough can be forgiven for feeling bullish about Vytorin these days following the events of 2006 through 2008 and the settlement in 2013. That said, it’s still too early to sound the clarion call of Vytorin’s superiority, just yet…