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Cardiorenal end points in a trial of aliskiren for type 2 diabetes.
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Parving, H.H.; Brenner, B.M.; McMurray, J.J.; de Zeeuw, D.; Haffner, S.M.; Solomon, S.D.; Chaturvedi, N.; Persson, F.; Desai, A.S.; Nicolaides, M.; Richard, A.; Xiang, Z.; Brunel, P.; Pfeffer, M.A.
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In: New England Journal of Medicine, vol. 367, no. 23, pp. 2204-2213 (2012)
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Abstract:
BACKGROUND: This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both. METHODS: In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level. RESULTS: The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P=0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, ≥6 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P<0.001 for both comparisons). CONCLUSIONS: The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. (Funded by Novartis; ALTITUDE ClinicalTrials.gov number, NCT00549757.).
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Keyword:
Aged; Amides/adverse effects; Amides/therapeutic use; Angiotensin Receptor Antagonists/therapeutic use; Angiotensin-Converting Enzyme Inhibitors/therapeutic use; Antihypertensive Agents/adverse effects; Antihypertensive Agents/therapeutic use; Cardiovascular Diseases/epidemiology; Cardiovascular Diseases/mortality; Combination; Diabetes Mellitus; Double-Blind Method; Drug Therapy; Female; Follow-Up Studies; Fumarates/adverse effects; Fumarates/therapeutic use; Humans; Hyperkalemia/chemically induced; Hypokalemia; Kidney Diseases/epidemiology; Kidney Diseases/etiology; Male; Middle Aged; Patient Dropouts; Renin/antagonists & inhibitors; Treatment Failure; Type 2/complications; Type 2/drug therapy
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URL: https://serval.unil.ch/notice/serval:BIB_AA678180CBF9
https://doi.org/10.1056/NEJMoa1208799
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