|NATIONAL INSTITUTES OF HEALTH
||National Heart, Lung, and Blood Institute|
|EMBARGOED BY JOURNAL
Tuesday, December 17, 2002
9:30 a.m. ET
Compared to participants who were taking the diuretic, those on the ACE inhibitor had
"The take-home message is that doctors should begin drug treatment for high blood pressure with a diuretic," said Dr. Paul Whelton, Senior Vice-President for Health Sciences at Tulane University in New Orleans, LA, and an ALLHAT Regional Coordinator. "A great majority of patients can tolerate a diuretic but, for those who can't, then a calcium-channel blocker, an ACE-inhibitor, or a beta blocker may be used to start treatment.
"ALLHAT's findings also indicate that most patients will need more than one drug to adequately control their blood pressure, and one of the drugs used should be a diuretic," he continued.
"Those who are now on a calcium channel blocker or an ACE inhibitor or another hypertension drug besides a diuretic should not stop taking their medication," he added. "But they should certainly talk with their doctor about adding or switching to a diuretic for their treatment."
"ALLHAT's findings refine the current clinical guidelines that recommend starting therapy for hypertension with a diuretic or a beta blocker," said Dr. Jeffrey Cutler, NHLBI Senior Advisor. "The new findings will allow doctors to achieve better blood pressure control and, more importantly, better cardiovascular health for their patients. And, it will do this at a more affordable price for their patients.
"I want to stress," he continued, "that people should not stop or change their blood pressure-lowering medication on their own. They should talk with their doctor about the treatment that's best for them."
Current blood pressure control recommendations are given in The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, issued by the NHLBI's National High Blood Pressure Education Program in 1997. The report is available online at http://www.nhlbi.nih.gov/guidelines/hypertension/jncintro.htm.
ALLHAT's cholesterol study, the first one done exclusively in patients with high blood pressure, involved 10,355 of the hypertension trial's participants. At the start of the trial, they had moderately elevated blood cholesterol but were judged by their doctors not to need cholesterol-lowering medication. All had at least one heart disease risk factor in addition to high blood pressure and elevated cholesterol. About 49 percent of them were women, 38 percent were black, and 23 percent were Hispanic. About 35 percent had type 2 diabetes, and about 14 percent had heart disease at the start of the study. They were followed for an average of 4.8 years.
Participants were assigned to receive either pravastatin, an HMG CoA reductase inhibitor (statin), or usual care, which at the start of the study involved no cholesterol-lowering drug. Both groups followed a cholesterol-lowering diet. The study was not blinded, and participants and their health care providers knew what treatment was received.
Pravastatin was chosen for the trial because it had been shown in prior studies to safely yield long-term total cholesterol reductions of 20 percent or more, an improvement necessary to gauge the therapy's effects on heart disease and overall deaths in ALLHAT's relatively short span (average of 5 years).
During the trial, those in the usual care group were prescribed a cholesterol-lowering drug (not provided by the study) when their doctor felt it was warranted by changes in their condition, such as a heart attack or marked cholesterol increase. Of those in the usual care group, 32 percent who had heart disease at the start of the study and 29 percent of those without heart disease at the outset used a cholesterol-lowering drug.
After 4 years, both the statin and usual care groups had reductions in total and low density lipoprotein (LDL) cholesterol. Total cholesterol dropped by 17.2 percent in the pravastatin group and 7.6 percent in the usual care group–a modest 9.6 percent difference.
There were no significant differences between the pravastatin and usual care groups in overall mortality or in mortality from any single cause. There were 631 deaths in the pravastatin group and 641 in the usual care group.
There also were only modest, non-significant differences in the rates of fatal and nonfatal heart attacks or strokes between the pravastatin and usual care groups. There were 380 coronary heart disease events and 209 strokes in the pravastatin group, compared with 421 heart disease events and 231 strokes in the usual care group.
Rates of heart failure and cancer also were similar in the two groups.
Results for death rates did not differ by age, gender, race, or the presence of type 2 diabetes.
"Both the pravastatin and usual care groups had substantial cholesterol reductions," said Whelton. "This is probably because many of those in the usual care group received a cholesterol-lowering drug. The magnitude of the trend toward increasing use of cholesterol-lowering drugs in usual care during the 8 years of the trial reflects the impact on clinical practice of the many positive statin trials that have taken place in those years. This trend was not fully anticipated when ALLHAT began in 1994. Thus, no difference was found between the groups in deaths and only a modest difference in the rates of heart attack and stroke."
"The ALLHAT findings," said Cutler, "when considered along with the results of other statin trials in which larger reductions in total and LDL cholesterol were associated with proportionally greater reductions in heart attacks and mortality, are consistent with the current national guidelines about the need to aggressively lower high cholesterol."
Current cholesterol-lowering guidelines are in the Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, released in May 2001 by the NHLBI's National Cholesterol Education Program. The report is available online at http://www.nhlbi.nih.gov/guidelines/cholesterol/index.htm.
To arrange an interview about ALLHAT, contact the NHLBI Communications Office at (301) 496-4236.
NHLBI is part of the National Institutes of Health (NIH), the Federal Government's primary agency for biomedical and behavioral research. NIH is a component of the U.S. Department of Health and Human Services. NHLBI press releases and other materials including information about high blood pressure, high blood cholesterol, and heart disease, are available online at www.nhlbi.nih.gov.