University of California, San Diego Statin Study - UCSD Statin Study

Apr 14, 2008
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Trial Sponsor:
National Heart, Lung, and Blood Institute; National Institutes of Health; and UCSD General Clinical Research Center
Date Published:
01/01/2008
Date Updated:
04/14/2008
Original Posted Date:
04/14/2008
References

Description:

The goal of the trial was to evaluate if statins (simvastatin or pravastatin) affect blood pressure (BP) compared with placebo in patients without cardiovascular disease or diabetes.

Hypothesis:

Statin medications will be more effective in lowering BP.

Study Design

Study Design:

Patients Screened: 2,403
Patients Enrolled: 973
Mean Follow Up: 8 months
Mean Patient Age: 57
Female: 32

Patient Populations:

LDL cholesterol level between 115 and 190 mg/dl, and ability to participate in the study for 8 months

Exclusions:

Known cardiovascular disease and diabetes

Primary Endpoints:

Noncardiac (central nervous system) endpoints

Secondary Endpoints:

BP (this was not a priori stated as a formal primary or secondary endpoint)

Drug/Procedures Used:

Patients without cardiovascular disease or diabetes and with low-density lipoprotein (LDL) cholesterol levels between 115 and 190 mg/dl were randomized to 6 months of pravastatin 40 mg (n = 323), simvastatin 20 mg (n = 322), or placebo (n = 328).

Principal Findings:

At baseline, systolic BP (SBP) was 126 mm Hg in the pravastatin arm, 127 mm Hg in the simvastatin arm, and 127 mm Hg in the placebo arm. LDL cholesterol was 153 mg/dl, 150 mg/dl, and 151 mg/dl, respectively.

At follow-up, there was a 2.2 mm Hg reduction in SBP in the combined statin group compared with placebo (p = 0.02). Excluding patients with elevated SBP at baseline (>140 mm Hg) in whom a letter was sent to their primary care physician, which may have influenced BP treatment, the mean reduction in SBP was 2.9 mm Hg compared with placebo (p = 0.001).

Patients in the combined statin group who had high-density lipoprotein (HDL) cholesterol >50 mg/dl had a 4.7 mm Hg reduction in SBP compared with placebo (p < 0.001). In contrast, patients in the combined statin group who had HDL cholesterol <50 mg/dl had a nonsignificant 1.5 mm Hg reduction in SBP (p = 0.30).

Interpretation:

Among patients without cardiovascular disease or diabetes and mean LDL cholesterol of 150-153 mg/dl, 6 months of statins produced beneficial effects on BP. Pravastatin or simvastatin were associated with a 2.2 mm Hg reduction in SBP compared with placebo. The reduction in SBP appeared to be greater among individuals with high HDL cholesterol.

Although this was a post-hoc analysis of a trial designed to test the effects of statins on central nervous system outcomes, these findings potentially add to the long list of pleiotropic effects of statins.

References:

Golomb BA, Dimsdale JE, White HL, et al. Reduction in blood pressure with statins: results from the UCSD statin study, a randomized trial. Arch Intern Med 2008;168:721-727.

Keywords: Follow-Up Studies, Hyperlipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypolipidemic Agents, Pravastatin, Nervous System, Blood Pressure, Hypercholesterolemia, Simvastatin, Hypertension, Diabetes Mellitus


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