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Results in Hypertensives with Elevated Cholesterol Similar with Pravastatin, Usual Care

There is no significant difference between pravastatin therapy and usual care in reducing all-cause mortality or combined fatal and non-fatal coronary heart disease (CHD) in older, moderately hypercholesterolaemic patients with well-controlled hypertension, suggest the results of a major study in the United States.

Investigators with the lipid-lowering trial (LLT) component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) point out, however, that their results are consistent with evidence from other large trials.

"Indeed, the overall findings from the nine large, long-term statin trials (including ALLHAT-LLT) leave little doubt regarding the broad efficacy and safety of this treatment in the prevention and treatment of atherosclerotic cardiovascular disease," say researchers led by Dr. Barry Davis from the University of Texas-Houston Health Science Centre in Houston.

They suggest the results could be due to the modest differential in total cholesterol (9.6 percent) and low-density lipoprotein cholesterol (LDL-C) (16.7 percent) between participants receiving pravastatin and those receiving usual care in this study, compared with prior statin trials of cardiovascular disease prevention.

"In the absence of evidence for increases in any category of non-cardiovascular mortality, the ALLHAT-LLT results should be interpreted as consistent with current recommendations for cholesterol control in the prevention and treatment of cardiovascular disease," the investigators note.

They also say their results emphasize the need to adequately reduce LDL-C in clinical practice when lipid-lowering therapy is implemented.

The 10,355 ambulatory patients, aged 55 years or older, who participated in ALLHAT-LLT were a subset of participants from the ALLHAT trial. They were treated at 513 North American clinical centres. Mean age for ALLHAT-LLT was 66 years, 49 percent of participants were women, 14 percent had a history of CHD, 35 percent had type 2 diabetes, 38 percent were black and 23 percent were Hispanic.

Participants had LDC-C levels of 120 mg/dL to 189 mg/dL, or 100 mg/dL to 129 mg/dL if they were known to have CHD. Triglycerides levels were lower than 350 mg/dL.

A total of 5,170 participants were randomised to pravastatin and 5,185 received usual care. Usual care was defined as treatment for LDL-C lowering according to the discretion of a primary-care doctor. Mean follow-up was 4.8 years.

Results indicate that during the trial, 32 percent of the usual-care participants with CHD and 29 percent without CHD started lipid-lowering therapy. At year-four follow-up, total cholesterol levels were reduced by 17 percent in the pravastatin group and 8 percent in the usual-care group.

A random sample of participants had LDL-C levels assessments. Levels were reduced by 28 percent in the pravastatin group and 11 percent in the usual-care group.

All-cause mortality rates were similar in the two groups. There were no significant differences between groups in rates of CHD events.
JAMA, 2002; 288: 2998-3007.

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