Follow-up of blood-pressure lowering and glucose control in type 2 diabetes

Sophia Zoungas, John Chalmers, Bruce Neal, Laurent Billot, Qiang Li, Yoichiro Hirakawa, Hisatomi Arima, Helen Monaghan, Rohina Joshi, Stephen Colagiuri, Mark Cooper, Paul Glasziou, Diederick Grobbee, Pavel Hamet, Stephen Harrap, S Heller, Liu Lisheng, Giuseppe Mancia, Michel Marre, David MatthewsCarl Mogensen, Vlado Perkovic, Neil Poulter, A Rodgers, Bryan Williams, Stephen MacMahon, Anushka Patel, Mark Woodward

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    534 Citations (Scopus)

    Abstract

    Background In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the 6-year post-trial follow-up.

    Methods We invited surviving participants, who had previously been assigned to perindopril- indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. The primary end points were death from any cause and major macrovascular events.

    Results The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure-lowering comparison) or 5.4 years (glucose-control comparison). Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit. The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure-lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up; the hazard ratios were 0.91 (95% confidence interval [CI], 0.84 to 0.99; P = 0.03) and 0.88 (95% CI, 0.77 to 0.99; P = 0.04), respectively. No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucosecontrol group and the standard-glucose-control group; the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and 1.00 (95% CI, 0.92 to 1.08), respectively.

    Conclusions The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure-lowering therapy were attenuated but still evident at the end of follow-up. There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events.

    Original languageEnglish
    Pages (from-to)1392-1406
    Number of pages15
    JournalNew England Journal of Medicine
    Volume371
    Issue number15
    DOIs
    Publication statusPublished - 9 Oct 2014

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