For decades, a core principle of cardiology has been the theory that lowering cholesterol is always beneficial. But now some prominent cardiologists are questioning that theory.
Because the link between excessive LDL cholesterol and cardiovascular disease has been so widely accepted, the FDA has generally not required drug companies to prove that cholesterol medicines actually reduce heart attacks. Proof that a drug lowers LDL cholesterol has been enough to win approval.
But despite widespread use of cholesterol-lowering drugs, heart disease remains the biggest killer in the United States and other industrialized nations. And in the last 13 months, the two important clinical trials have thrown the hypothesis into doubt. Pfizer’s torcetrapib was shown to actually cause heart attacks and strokes, and more recently Vytorin, a combination of Zetia with Zocor, failed to reduce the growth of fatty arterial plaque.
Merck has now asked the FDA to approve Cordaptive, which raises HDL cholesterol and lowers LDL, without waiting for the results of an events trial. Doctors, patients and the drug industry are now waiting to see if the FDA is still willing to accept the theory that lower cholesterol is always a good thing.