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    • The Irbesartan Diabetic Nephropathy Trial enrolled

    2023-11-16

    The Irbesartan Diabetic Nephropathy Trial enrolled patients with type 2 diabetes, proteinuria of at least 0.9 g/24 h, BP >135/85 mmHg and moderate kidney impairment (creatinine 88 to 265 µmol/L in women or 106 to 265 µmol/L in men). Patients were randomized to receive irbesartan (titrated from 75 to 300 mg daily), amlodipine (titrated from 2.5 to 10 mg daily) or placebo (7). Cardiovascular endpoints were monitored as secondary outcomes in this study and were reported separately (8). The composite cardiovascular endpoint included death from cardiovascular causes, nonfatal myocardial infarction, hospitalization for Vancomycin hydrochloride failure, cerebrovascular event with permanent neurologic deficit, or above-the-ankle lower-limb amputation. No significant difference was detected among the 3 treatment groups for this outcome. However, the study was not adequately powered for the cardiovascular endpoint. Irbesartan was superior to amlodipine for the heart failure component of the cardiovascular outcome (p=0.002). The reduction of endpoints in the Noninsulin-Dependent Diabetes Mellitus trial with the Angiotensin II Antagonist Losartan trial included patients with type 2 diabetes, albuminuria (albumin to creatinine ratio ≥ 300 mg/g or 24 h proteinuria of at least 0.5 g) and moderate kidney impairment (creatinine 115 to 265 µmol/L). They were randomized to receive losartan (titrated up to 100 mg daily) or placebo on the top of conventional antihypertensive medication. The BP target was <140/90 mmHg (9). The secondary outcome of the study was a composite of death from cardiovascular causes, myocardial infarction, stroke, first hospitalization for heart failure or unstable angina, and coronary or peripheral revascularization. It occurred in 32.9% of patients in the losartan group vs. 35.2% in the placebo group (p=0.26). However, the study was not adequately powered for the cardiovascular endpoint. Furthermore, a first hospitalization for heart failure was less commonly observed in the losartan group (11.9%) compared with the placebo group (16.7%; p<0.01). The Candesartan Antihypertensive Survival Evaluation in Japan trial enrolled hypertensive Japanese patients with 1 additional risk factor and randomized them to receive either candesartan at 4 to 8 mg daily (increasing up to 12 mg per day) or amlodipine at 2.5 to 5 mg per day (up to 10 mg daily). The primary outcome of the study was a composite of cardiovascular and renal events (sudden cardiac death; stroke or transient ischemic attack; heart failure, angina pectoris or acute myocardial infarction; dissecting aortic aneurysm or occlusion of a peripheral artery; creatinine ≥4 mg/dL; doubling creatinine; or end-stage renal disease). A posthoc analysis including 2,018 patients with diabetes at baseline was published separately (10). Although diabetes was an independent predictor of cardiovascular events, no difference was detected between patients taking candesartan or amlodipine for the outcomes of primary cardiovascular events, cerebrovascular events, cardiac events, all-cause mortality or cardiovascular mortality. The Olmesartan Reducing Incidence of Endstage renal disease in diabetic Nephropathy Trial (ORIENT) was designed to examine the renoprotective effect of olmesartan in patients with type 2 diabetes, urine albumin to creatinine ratio >33.9 mg/mmol, and serum creatinine of 1.0 to 2.5 mg/dL in women or 1.2 to 2.5 mg/dL in men (11). Patients were randomized to receive either 10 mg of olmesartan (titrated up to 40 mg daily if the BP target of <130/85 was not achieved) or placebo. The following cardiovascular events were combined in the secondary composite endpoint: cardiovascular death; hospital admission for heart failure or unstable angina; nonfatal myocardial infarction; nonfatal stroke; coronary, carotid or peripheral artery revascularization; or lower-extremity amputation. The composite cardiovascular outcome occurred in 14% of patients in the olmesartan group vs. 19% in the placebo group (adjusted HR 0.66, 95% CI 0.43 to 1.00).