Major Outcomes in Moderately Hypercholesterolemic, Hypertensive Patients Randomized to Pravastatin versus Usual Care

Original Citation

Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs. usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.

Overall Study Question

These investigators compared pravastatin to “usual care” (i.e. care according to their primary care physician; vigorous cholesterol-lowering was discouraged) for the treatment of hypercholesterolemia. The primary outcome was all cause mortality.  Secondary outcomes were fatal coronary heart disease (CHD) or non-fatal myocardial infarction combined, cause-specific mortality, and cancer.

Patients

10,355 patients with hypertension and with an LDL of 3.1 to 4.9 mmol/L (2.6 to 3.3 mmol/L if history of coronary heart disease) and fasting triglycerides lower than 3.9 mmol/L. Their mean age was 66.  49%of participants were women, 35% had diabetes, 14% had a history of heart disease, and 23% were smokers.

Treatment

Patients were randomized in a non-blinded fashion to receive either pravastatin 40 mg PO daily or usual care for the treatment of hypercholesterolemia.

Duration

The mean duration of follow up was 4.8 years.

Results

Cholesterol differences at 4 years

Total cholesterol was 9.6% lower in the pravastatin group than with usual care; LDL was 17% lower in pravastatin group; HDL was 0.9% higher in pravastatin group. By year 4, 17% of patients in the usual care group were on a statin as compared to 84% in the pravastatin group.

NSS = not statistically significant

How does this study contribute to the drug therapy of hypercholesterolemia?

This study suggests that, in this patient population, there is no benefit to using pravastatin for 5 years, as compared to usual care. The results may have been due to the magnitude of the difference in cholesterol between the groups as other studies have shown that statins reduce coronary heart disease events compared to placebo.

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