AT THE ADA ANNUAL SCIENTIFIC SESSIONS

SAN DIEGO (FRONTLINE MEDICAL NEWS) – Treating systolic hypertension to a target of 120 mm Hg instead of 140 mm Hg significantly reduced the rate of cardiovascular events in high-risk patients with prediabetes, according to a post-hoc analysis of the multicenter, randomized, controlled, open-label Systolic Blood Pressure Intervention Trial ( SPRINT ).

Thus, prediabetes did not undercut the cardiovascular benefits of intensive systolic blood pressure (SBP) control in older, high-risk, hypertensive patients, Adam P. Bress, PharmD, MS , and his associates concluded in a late-breaking poster presented at the annual scientific sessions of the American Diabetes Association.

Clinicians continue to debate optimal SBP targets, especially in patients with diabetes or prediabetes. SPRINT, which was conducted at 102 clinical sites in the United States, randomly assigned adults aged 50 years and older who had a high risk of cardiovascular disease and average baseline SBPs of 130 to 180 mm Hg to antihypertensive therapy targeted to less than 140 mm Hg (standard control) or less than 120 mm Hg (intensive control). The primary endpoint was a composite of myocardial infarction, acute coronary syndrome without myocardial infarction, stroke, acute decompensated heart failure, and cardiovascular death. These outcomes affected about 1.6% of intensive control patients and 2.2% of standard control patients in the SPRINT trial each year (hazard ratio, 0.75; P less than .001) – a difference so stark that investigators stopped the trial early ( N Engl J Med. 2015;373:2103-16 ).

In contrast, intensive SBP control did not prevent cardiovascular events, compared with standard control among diabetic patients in the randomized, nonblinded ACCORD BP trial ( N Engl J Med. 2010; 362:1575-85 ).

To help clarify SBP targets for prediabetic individuals, Dr. Bress and his associates parsed cardiovascular outcomes in SPRINT based on baseline fasting serum glucose (FSG) levels. More than 5,400 normoglycemic (average FSG, 91 mg per dL) patients and more than 3,800 prediabetic (average FSG, 110 mg per dL) patients were followed for a median of 3.3 years, after which 101 (1.6%) prediabetic intensive control patients and 144 (2.3%) prediabetic standard control patients experienced the combined primary endpoint (HR, 0.7; 95% confidence interval, 0.5-0.9). The hazard ratio for normoglycemic patients was similar (0.9) and approached statistical significance.

Intensive SBP control also was associated with lower rates of individual cardiovascular outcomes and all-cause mortality, compared with standard control in both normoglycemic and prediabetic patients, Dr. Bress and his associates reported. Wide confidence intervals precluded statistical significance for most individual outcomes, but intensive control was associated with a significantly lower risk of all-cause mortality in normoglycemic patients (0.7% vs. 1.4% with standard control; HR, 0.7; 95% CI, 0.5-0.9).

Serious adverse events affected about 37% of patients in all subgroups. Hypotension, syncope, bradycardia, and electrolyte abnormalities were slightly more common in the intensive control groups than the standard control groups, regardless of baseline FPG levels.

SPRINT was sponsored by the National Heart, Lung, and Blood Institute. The National Institute on Aging, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and Wake Forest University Health Sciences provided additional support. Dr. Bress disclosed research support from Novartis and the National Institutes of Health.

cenews@frontlinemedcom.com

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