Major Finding: Among diabetes patients at high cardiovascular risk, those treated to a mean systolic blood pressure of 119.3 mm Hg had a 1.87%/year rate of nonfatal MI, nonfatal stroke, or cardiovascular death over 4.7 years, compared with 2.09%/year in patients treated to a mean systolic blood pressure of 133.5 mm Hg. The difference was not statistically significant.
Data Source: ACCORD blood pressure trial, a randomized, controlled study of 4,733 patients with type 2 diabetes.
Disclosures: Dr. Cushman has received consultant fees and honoraria from Novartis, Sanofi-Aventis, Theravance, and Takeda, and served on data and safety monitoring boards of Novartis and Gilead. Dr. Bakris reported financial relationships with Abbott, GlaxoSmithKline, Novartis, Merck, Gilead, and other companies. Dr. Cooper-DeHoff and Dr. Simons-Morton had no disclosures.
ATLANTA — The official U.S. guideline that patients with diabetes should receive treatment to a blood pressure target of less than 130/80 mm Hg became suspect following reports from a pair of large studies showing no benefit in these patients beyond a goal systolic pressure of less than 140 mm Hg.
In a controlled trial with more than 4,700 U.S. patients with type 2 diabetes randomized to an intensive antihypertensive regimen with a goal systolic pressure of less than 120 mm Hg or to a standard-therapy arm aiming for less than 140 mm Hg, “the results provided no conclusive evidence that the intensive blood pressure control strategy reduces the rate of a composite of major cardiovascular disease events,” Dr. William C. Cushman said at the annual meeting of the American College of Cardiology.
“We were surprised by the findings” from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) blood pressure trial, said Dr. Cushman, chief of the preventive medicine section at the VA Medical Center in Memphis. “The evidence supports less than 140 mm Hg. There generally was thinking that if you're dealing with [high cardiovascular risk], such as patients with diabetes, it makes sense that their goal pressure should be more intense.” The results “clearly say that we can't think that way anymore” and should influence recommendations expected in about a year from the Eighth Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8), he said in an interview.
The existing hypertension treatment guidelines of the National Heart, Blood, and Lung Institute, JNC 7, have a blood pressure treatment target of less than 130/80 mm Hg for patients with diabetes (JAMA 2003;289:2560-71). Dr. Cushman was a member of the JNC 7 panel, and is a member of the group now working on JNC 8.
The JNC 7 blood pressure target for patients with diabetes “was an extrapolation based on observational data. The guidelines were beyond evidence from randomized, controlled trials,” said Dr. Denise Simons-Morton, project director for ACCORD and director of the NHLBI division responsible for the JNC guidelines. The new ACCORD findings show that this extrapolation was a mistake, and that current evidence cannot support a goal systolic pressure that is more aggressive than the target of less than 140 mm Hg, she said in an interview.
Because of the way that JNC 8 is being prepared, the ACCORD results may be too late for inclusion in the new guidelines, said Dr. George Bakris, professor of medicine at the University of Chicago, who was a member of the JNC 7 writing committee but is not a member of the JNC 8 panel. But, he added in an interview, “all other guidelines” on treating hypertension in patients with diabetes, including those from the American Diabetes Association and various international societies, “will have to revise their blood pressure goals” based on the ACCORD results. In an editorial last year, Dr. Bakris and an associate called the goal of a systolic pressure below 130 mm Hg in patients with chronic kidney disease “questionable” (J. Clin. Hypertension 2009;11:345-7).
The 2,362 patients in the intensive-treatment arm of the ACCORD blood pressure trial reached a mean systolic pressure of 119.3 mm Hg after the first year while receiving an average of 3.4 antihypertensive drugs; those patients had a 1.87%/year rate of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death during an average follow-up of 4.7 years. The 2,371 patients in the standard-therapy arm reached a mean systolic pressure of 133.5 mm Hg after the first year and received an average of 2.1 drugs; they had a 2.09%/year rate for the combined end point. The difference in rates between the two groups was not statistically significant. Concurrently with Dr. Cushman's report at the meeting, the results were posted online (N. Engl. J. Med. 2010 March 14 [doi:10.1056/NEJMoa1001286]).