מתוך medicontext.co.il

By Martha Kerr

ANAHEIM, CA (Reuters Health) – Results of the British Heart Protection Study, released here Tuesday morning to a standing room-only crowd, show that in patients at high risk for cardiovascular disease, lowering cholesterol levels–regardless of whether the level is considered abnormally high–sharply reduces the risk of adverse cardiac events.

Principal investigator Dr. Rory Collins of Oxford University presented attendees of the American Heart Association's 2001 Scientific Sessions with findings from a randomized controlled study of 20,536 patients with hypertension, coronary artery disease, other occlusive artery disease, and/or a history of myocardial infarction, other heart disease, stroke or diabetes.

Patients were randomized to one of four treatment arms: monotherapy with simvastatin (Zocor, Merck) 40 mg a day; simvastatin 40 mg and a combination of antioxidant vitamins (vitamin C 250 mg, vitamin E 600 mg and beta-carotene 20 mg); vitamins alone; or placebo. Patients also received standard care, including aspirin, anticoagulants, nitrates, beta-blockers, ACE inhibitors, calcium channel blockers and nonstudy statins, according to the judgment of the patient's physician. Patients were followed for an average of 5 years.

Dr. Collins announced that "there was no evidence of any benefit at all" from antioxidant vitamins. "On the other hand, there was no evidence of any harm."

It was a different story with simvastatin therapy. "The results were just remarkable," Dr. Collins reported. The risks of all-cause mortality, cardiovascular mortality, major cardiac events, stroke and revascularization were reduced by one-third in all high-risk groups, including women, patients over age 70 and diabetics.

Furthermore, risk reduction occurred in patients with total cholesterol levels below 200 mg/dL (5 mmol/L) or LDL cholesterol levels below 120 mg/dL (3 mmol/L), a group not normally targeted for statin therapy under the National Cholesterol Education Program (NCEP) guidelines. This is the first time that cholesterol lowering in high-risk patients with "normal" cholesterol levels has been shown to reduce risk, Dr. Collins said.

There was "no good evidence" that simvastatin therapy had any adverse effect on nonvascular death or cancer rates. The drug was well tolerated, with a very low incidence of elevated liver enzymes (0.8% in the simvastatin group compared with 0.6% in the placebo group) and elevated muscle enzymes (0.09% in the simvastatin group compared with 0.05% in the placebo group).

"I think this will change the way we practice medicine," Dr. Collins declared. "If an extra 10 million patients take statins, it will save 50,000 lives a year…But these findings are relevant to tens of millions."

The AHA's chief science officer, Dr. Sidney Smith of the University of North Carolina, Chapel Hill, commented that using Dr. Collins' criteria, the total number of people eligible for statin therapy in the US is around 36 million, which is in accordance with the latest NCEP guidelines. He added that the study findings reinforce the need for long-term statin therapy.