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This article originally posted 23 March, 2010 and appeared in

Issue 514

Tight Blood Pressure Control Not Supported in Patients with Diabetes and

Coronary Artery Disease

Current blood pressure (BP) guidelines for individuals with diabetes

(systolic BP [sBP] <130 mm Hg) based on the notion that lower is better were

not supported

by results of the International Verapamil SR-Trandolapril (INVEST) study.

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The INVEST findings revealed, in fact, a BP threshold below which patients

with both diabetes and coronary artery disease have increased cardiovascular

risk, said Rhonda M. -DeHoff, PharmD, University of Florida,

Gainesville, FL.

Given the lack of evidence supporting SBP of <130 mm Hg, especially in

diabetic patients, INVEST was conducted with an intent to determine the

effect of

SBP reduction on adverse cardiovascular outcomes in a cohort of 6,400

patients (mean age ~66 years) with diabetes and coronary artery disease.

The study tested the hypothesis that diabetic individuals who achieved SBP

levels less than 130 mm Hg would have reduced cardiovascular outcomes

compared

with those achieving levels between > =130 and <140 mm Hg.

Patients were randomised to BP-lowering therapy based on either a

calcium-channel blocker or a beta blocker plus an angiotensin-converting

enzyme inhibitor

and/or a thiazide diuretic. The target was a BP of <130 mm Hg/<85 mm Hg.

For the analysis, patients were categorised according to the degree of BP

control actually achieved: SBPs of >=140 mm Hg (not controlled), between

>=130

mm Hg but <140 mm Hg (usual control), and <130 mm Hg (tight control). SBP

control levels were distributed evenly with about one-third of patients

falling

into each of the groups.

The primary outcome was first occurrence of all-cause mortality, nonfatal

myocardial infarction (MI), or nonfatal stroke.

During a mean follow-up of 2.7 years, combined death, MI, and stroke risk

was not different between the tight-control and usual-control groups (12.7%

vs

12.6%). Similarly, nonfatal MI (1.3% vs 1.7%), and nonfatal stroke (1.0% vs

1.3%) were similar for the 2 groups.

All-cause mortality was higher in the tight-control group (11.0%) than in

the usual-control group (10.2%).

Extended follow-up out to >=5 years of the US cohort (n = 5,077) revealed a

strong trend (P = .058) toward higher mortality for tight control than for

usual control. After adjustment for baseline variables, the excess mortality

hazard for tight control was 15%. The excess hazard in the US cohort was in

patients with SBP <115 mm Hg, Dr. -DeHoff said.

" We concluded that in individuals with diabetes and documented coronary

artery disease, systolic blood pressures <130 mm Hg are not beneficial, and

we

can probably rethink lower goals in this population. " She added, " Efforts

can be put toward lifestyle modification, where we know we can achieve

benefit. "

Results were reported at the 59th Annual Scientific Sessions of the American

College of Cardiology (ACC) during a Late-Breaking clinical trial

presentation.

[Presentation title: Rethinking Lower Blood Pressure Goals for Diabetic

Patients With Coronary Artery Disease -- Findings From the International

Verapamil

SR - Trandolapril Study (INVEST). Late-Breaking Clinical Trials I]

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