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(Hypertension. 2003;41:431.)
© 2003 American Heart Association, Inc.

Scientific Contributions

Outcomes With Nifedipine GITS or Co-Amilozide in Hypertensive Diabetics and Nondiabetics in Intervention as a Goal in Hypertension (INSIGHT)

Giuseppe Mancia; Morris Brown; Alain Castaigne; Peter de Leeuw; Christopher R. Palmer; Talma Rosenthal; Gilbert Wagener; Luis M. Ruilope

From the University of Milano-Bicocca, St Gerardo Hospital (G.M.), Monza, Milan, Italy; Clinical Pharmacology Unit, University of Cambridge (M.B.), Cambridge, UK; Hopital Henri-Mondor (A.C.), Creteil, Paris, France; the Department of Internal Medicine, University Hospital Maastricht (P.d.L.), Maastricht, The Netherlands; the Centre for Applied Medical Statistics, University of Cambridge (C.R.P.), UK; the Hypertension Unit, The Chaim Sheba Medical Centre, University of Tel Aviv (T.R.), Israel; Bayer AG, Pharma Research Center (G.W.), Wuppertal, Germany; and Unidad de Hipertension, Hospital 12 de Octubre (L.M.R.), Madrid, Spain.

Correspondence to G. Mancia, Clinica Medica, Ospedale San Gerardo di Monza, Universita degli Studi Milano-Bicocca, Via Donizetti 106-20052, Monza (Mi), Italy. E-mail giuseppe.mancia{at}unimib.it

To investigate the impact of treatment on cardiovascular mortality and morbidity, we assessed outcomes in patients with hypertension and diabetes who received co-amilozide or nifedipine in the International Nifedipine GITS Study: Intervention as a Goal in Hypertension. Participants had to be 55 to 80 years of age, with hypertension (150/95 or 160 mm Hg) and at least one additional cardiovascular risk factor. Patients received 30 mg nifedipine once daily or co-amilozide (25 mg hydrochlorothiazide and 2.5 mg amiloride) daily. Doses were doubled if target blood pressures (<140/90 mm Hg) were not achieved. Primary (composite of cardiovascular death, myocardial infarction, heart failure, and stroke) and secondary outcomes (composite of primary outcomes, including all-cause mortality and death from vascular and nonvascular causes) were assessed by means of intent-to-treat analyses. There was no significant difference in the incidence of primary outcomes between nifedipine-treated and co-amilozide–treated patients with diabetes at baseline (n=1302) (8.3% versus 8.4%; relative risk, 0.99, 95% CI, 0.69 to 1.42; P=1.00). A significant benefit for nifedipine-treated patients was seen for the composite secondary outcome (14.2% versus 18.7%; relative risk, 0.76, 95% CI, 0.59 to 0.97; P=0.03). Among patients without diabetes at baseline (n=5019), there was a significant difference in the incidence of new diabetes (nifedipine 4.3% versus co-amilozide 5.6%, P=0.023). Nifedipine GITS once daily is as effective as diuretic therapy in reducing cardiovascular complications in hypertensive diabetics. Nifedipine-treated patients were also less likely to have diabetes or have secondary events (a composite of all-cause mortality, death from a vascular cause, and death from a nonvascular cause) than co-amilozide recipients. Our results suggest that nifedipine could be considered as first-line therapy for hypertensive diabetics.

Key Words: calcium channel blockers • diabetes mellitus • diuretics • nifedipine • mortality • morbidity

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