Statin no better than usual care in reducing risk of morbidity, mortality.

2003 JAN 8 - (NewsRx.com & NewsRx.net) -- Pravastatin, a statin drug used to reduce cholesterol, does not reduce the death rate or incidence of coronary heart disease events in patients with moderately high cholesterol and well-controlled high blood pressure, when compared to usual care, according to researchers in Texas and Washington.

The role levels of low-density lipoprotein cholesterol (LDL-C, the "bad" cholesterol) play in the development of coronary heart disease (CHD) is well-established. Trials in the 1970s and 1980s showed that lowering LDL-C reduced the incidence of CHD-related events such as heart attack, but the average reduction in LDL-C for these trials was only 10%.

In the 1980s, a more powerful class of drugs, statins, were developed which could reduce total cholesterol by approximately 20% or more. Studies have demonstrated that statins administered to individuals with risk factors for CHD reduce CHD events. However, many of these studies were too small to assess all-cause mortality or outcomes in important subgroups.

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) evaluated the impact of sustained cholesterol reductions on deaths in an older population with high blood pressure and moderately high cholesterol with at least one other CHD risk factor using pravastatin in all patients vs. usual care, which could include lowering cholesterol using statins if the patient's physician chose to prescribe it.

ALLHAT-LLT was a randomized, nonblinded trial conducted from February 1994 through March 2002 at 513 North American clinical centers. Jeffrey L. Probstfield, MD, of the University of Washington Medical Center, Seattle, and Barry R. Davis, MD, PhD, from the University of Texas - Houston Health Science Center, and colleagues enrolled 10,355 people aged 55 or older with high LDL-C levels (120-180 mg/dL) in their study.

All participants were also enrolled in ALLHAT, a study comparing treatments to lower blood pressure. The average age of the participants was 66 years, 49% were women, 38% black, and 23% Hispanic. Fourteen percent had a history of CHD and 35% of participants had type 2 diabetes. Of the participants, 5170 were assigned to the pravastatin group (40 mg/day) and 5185 were assigned to usual care.

Results were reported in the December 18, 2002, issue of the Journal of the American Medical Association.