Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial

Made available in DSpace on 2022-04-28T19:29:26Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-02-01 Hospital de Clínicas de Porto Alegre Aims: To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of JNC 7 Stage I hypertension in patients with type 2 diabetes mellitus. Methods: In an a priori subgroup analysis of a randomized, double-blind, controlled trial, volunteers aged 30–70 years, with stage I hypertension and diabetes mellitus, were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 47) or 50 mg of losartan (N = 50), and followed for 18 months in 21 clinical centers. If BP remained uncontrolled after three months, study medication dose was doubled, and if uncontrolled after six months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg BID) were added as open label drugs in a progressive fashion. Results: Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001). After 18 months of follow-up, systolic BP was 128.4 ± 10.3 mmHg in the diuretic group versus 133.5 ± 8.0 in the losartan group (P < 0.01). In the diuretic group, 36 out of 43 participants (83.7%) had a JNC 7 normal BP, compared to 31/47 (66%) in the losartan group (P = 0.089). Serum cholesterol was higher in the diuretic arm at the end of the trial. Other biochemical parameters and reports of adverse events did not differ by treatment. Conclusions: Treatment of hypertension based on a combination of chlorthalidone and amiloride is more effective for BP lowering compared to losartan in patients with diabetes mellitus and hypertension. Trial registration: Clinical trials registration number: NCT00971165 Division of Cardiology Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande Do Sul INCT PREVER, CPC, 5º. and Ramiro Barcelos, 2350 Hospital Universitário Júlio Müller Universidade Federal de Mato Grosso Faculdade de Medicina São José Do Rio Preto Department of Epidemiology School of Public Health and Tropical Medicine Tulane University Faculdade de Medicina Hospital São Lucas PUCRS Hospital Universitário Walter Cantídio Universidade Federal do Ceará Faculdade de Medicina Instituto do Coração Universidade de São Paulo Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande Do Sul Faculdade de Ciências Farmacêuticas USP Ribeirão Preto Instituto de Cardiologia, Av. Princesa Isabel Hospital Universitário Universidade Federal do Maranhão Universidade Federal de Pernambuco Universidade Federal de Pelotas Instituto de Medicina Integral Prof Fernando Figueira Universidade Do Estado do Rio de Janeiro Hospital das Clínicas da Universidade Federal de Minas Gerais Hospital das Clínicas de Goiânia Universidade Federal de Goiás Faculdade de Medicina de Botucatu Hospital do Coração de Alagoas Anis Rassi Hospital Hospital Universitário Procape Hospital Universitário Antônio Pedro UFF Faculdade de Medicina de Ribeirão Preto USP Ribeirão Preto Instituto de Pesquisa Hospital Israelita Albert Einstein Faculdade de Medicina de Botucatu Hospital de Clínicas de Porto Alegre: GPPG: 08-621