Washington: It was really Sunday Nightmare for the executives of Merck and Schering-Plough, who were virtually baffled by a panel of experts that urged doctors not to use their top-selling drugs, Zetia and Vytorin at the American College of Cardiology Meeting. The panel felt that the makers of the drugs had not proved the drugs were safe. Things got worse on Monday morning when rival AstraZeneca announced that it had stopped its 15,000-patient clinical trial of its Crestor because an independent safety committee has found proof that the drug prevents heart attacks, strokes and deaths; the result came six months ahead of schedule.

The American College of Cardiology panel and two editorials in The New England Journal of Medicine recommended doctors not to use Zetia, a kind of cholesterol drug that works differently from statins, and Vytorin, a combo pill of Zetia and the statin Zocor. On the contrary, the panel recommended the doses of statins where there is proven evidence.

AstraZeneca’s announcement is great new for two reasons. First, Crestor has definitive proof that it has lifesaving benefits like other statin drugs, such as Lipitor, Zocor and Pravachol. Second, studies have proven that these medicines can prevent heart attacks even in patients who have normal cholesterol but have other risk factors for heart disease  

According to AstraZeneca, the patients in the Crestor trial had high levels of C-reactive protein (CRP) in the blood. The protein is thought to be a measure of inflammation in the arteries, and inflamed arteries are more likely to develop the clots that cause heart attacks and strokes. The experiment was designed to test whether people who had normal levels of bad cholesterol but high CRP could be helped by statin therapy. Up until now, evidence for statins has been mainly in people with high "bad" cholesterol, properly known as low-density lipoprotein (LDL).

Roger Blumenthal, who directs preventative cardiology at Johns Hopkins University said, "It's splendid news, and that's sort of what they were waiting for to decide where CRP fit. This is a boon to AstraZeneca and the field."

Steven E. Nissen of the Cleveland Clinic, who had recommended Zetia be treated as a "last resort" months ago, said "We now have data for every statin marketed that shows a reduction in morbidity and mortality. This really does emphasize what the panel said yesterday. Whatever statins do, and however they do it, it really works across the entire class. It really is a tremendous emphasis that statins are the first choice and why they are the first choice." It was Nissen who raised concerns about Merck's Vioxx in 2001, before the drug was yanked from the market, and with whom Merck and Schering-Plough had scrapped plans to do a Vytorin imaging trial.

The majority of cardiologists interviewed at the American College of Cardiology meeting favored the pullback of Merck and Schering-Plough drugs until there are more studies on how exactly they works. Merck and Schering-Plough have one trial testing whether Zetia prevents heart attack and stroke; the study is not expected to end until 2012. The Zetia trial started exactly three years after the Crestor trial that was just halted.