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(Hypertension. 2003;41:1063.)
© 2003 American Heart Association, Inc.

Scientific Contributions

Effect of Low-Dose Perindopril/Indapamide on Albuminuria in Diabetes

Preterax in Albuminuria Regression: PREMIER

Carl Erik Mogensen; Giancarlo Viberti; Serge Halimi; Eberhard Ritz; Luis Ruilope; György Jermendy; Jiri Widimsky; Pinchas Sareli; Jan Taton; Juan Rull; Gürbüz Erdogan; Pieter W. De Leeuw; Arthur Ribeiro; Ramiro Sanchez; Rachid Mechmeche; John Nolan; Jana Sirotiakova; Ahmed Hamani; André Scheen; Bernhard Hess; Anton Luger; Stephen M. Thomas

From Aarhus Komunehospital (C.E.M.), Aarhus, Denmark; Guy’s Hospital, King’s College (G.V., S.M.T.), London, UK; CHU (S.H.), Grenoble, France; Fakultät f.klin. Medizin (E.R.), Heidelberg, Germany; Hospital 12 de Octubre (L.R.), Madrid, Spain; Bajcsy Zsilinsky Korhaz III Belosztaly (G.J.), Budapest, Hungary; IKEM (J.W.), Prague, Czech Republic; University of the Witwatersrand (P.S.), Johannesburg, South Africa; Katredra I Klinika Chorob (J.T.), Warszawa, Poland; Instituto Nacional de la Nutricion (J.R.), Mexico City, Mexico; Ankara Üniversitesi Tip Fakültesi (G.E.), Ankara, Turkey; Academisch Ziekenhuis Maastricht (P.W.D.L), Maastricht, Nederland; Fundaçao Oswaldo Cruz (A.R.), Sao Paulo, Brazil; Instituto de Cardiologia y Cirugia Cardiovascular (R.S.), Buenos Aires, Argentina; Hôpital La Rabta (R.M.), Tunis Jabbart, Tunisia; the Department of Endocrinology (J.N.), Dublin, Ireland; General Hospital (J.S.), Nitra, Slovakia; Hôpital Mohammed V (A.H.), Rabat, Morocco; CHU Sart Tilman (A.S.), Liege, Belgium; Inselspital Bern (B.H.), Bern, Switzerland; and Abt Endokrinologie (A.L.), Wien-Austria.

Correspondence to Carl Erik Mogensen, Medical Department M, Aarhus Komunehospital, Aarhus University Hospital, 8000 Aarhus, Denmark. E-mail carl.erik.mogensen{at}afdm.au.dk

Microalbuminuria in diabetes is a risk factor for early death and an indicator for aggressive blood pressure (BP) lowering. We compared a combination of 2 mg perindopril/0.625 mg indapamide with enalapril monotherapy on albumin excretion rate (AER) in patients with type 2 diabetes, albuminuria, and hypertension in a 12-month, randomized, double-blind, parallel-group international multicenter study. Four hundred eighty-one patients with type 2 diabetes and hypertension (systolic BP 140 mm Hg, <180 mm Hg, diastolic BP <110 mm Hg) were randomly assigned (age 59±9 years, 77% previously treated for hypertension). Results from 457 patients (intention-to-treat analysis) were available. After a 4-week placebo period, patients with albuminuria >20 and <500 µg/min were randomly assigned to a combination of 2 mg perindopril/0.625 mg indapamide or to 10 mg daily enalapril. After week 12, doses were adjusted on the basis of BP to a maximum of 8 mg perindopril/2.5 mg indapamide or 40 mg enalapril. The main outcome measures were overnight AER and supine BP. Both treatments reduced BP. Perindopril/indapamide treatment resulted in a statistically significant higher fall in both BP (-3.0 [95% CI -5.6, -0.4], P=0.012; systolic BP -1.5 [95% CI -3.0, -0.1] diastolic BP P=0.019) and AER -42% (95% CI -50%, -33%) versus -27% (95% CI -37%, -16%) with enalapril. The greater AER reduction remained significant after adjustment for mean BP. Adverse events were similar in the 2 groups. Thus, first-line treatment with low-dose combination perindopril/indapamide induces a greater decrease in albuminuria than enalapril, partially independent of BP reduction. A BP-independent effect of the combination may increase renal protection.

Key Words: albuminuria • microalbuminuria • hypertension, renal • diabetes mellitus • angiotensin-converting enzyme

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