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  • The Nagoya Heart Study enrolled patients

    2024-06-05

    The Nagoya Heart Study enrolled patients with hypertension and type 2 diabetes or impaired BX-912 tolerance (12). Patients were randomized to valsartan- or amlodipine-based regimens with a BP target of ≤130/80 mmHg. The primary outcome was a composite of sudden cardiac death, myocardial infarction, stroke, heart failure admission or coronary revascularization. It occurred in 9.4% of patients in the valsartan group and in 9.7% in the amlodipine group (HR 0.97, 95% CI 0.66 to 1.40). When each component of the primary outcome was assessed separately, the incidence of heart failure admission was lower in patients taking valsartan (p=0.01).
    Renal Outcomes with ARBs in Patients with Diabetes In 2001, 3 hallmark trials were published demonstrating the efficacy of the ARBs to prevent the occurrence or delay the progression of nephropathy in patients with diabetes. The Irbesartan Diabetic Nephropathy Trial, which was briefly presented previously, aimed to identify whether irbesartan, as compared with amlodipine or placebo, was associated with a lower incidence of a composite outcome of death from any cause, doubling serum creatinine or progression to end-stage renal disease. After a mean follow up of 2.6 years, the composite primary outcome occurred in 32.6% of patients in the irbesartan group, 39.0% in the placebo group (p=0.02 vs. irbesartan) and 41.1% in the amlodipine group (p=0.006 vs. irbesartan) (7). Mean BP was significantly higher in the placebo group but was similar in the 2 active treatment groups. Median proteinuria was 2.9 g at baseline for all groups. In patients treated with irbesartan, proteinuria decreased by 1.1±1.7 g/24 h compared with 0.1±2.9 g/24 h in the amlodipine group and 0.3±4.3 g/24 h in the placebo group. The Angiotensin II Antagonist Losartan trial compared losartan to placebo in patients with diabetic nephropathy. After a mean follow up of 3.4 years, the primary composite endpoint of death from any cause, doubling of serum creatinine or end-stage renal disease was reached in 43.5% of patients in the losartan group vs. 47.1% of patients in the placebo group (p=0.02) (9). Losartan also reduced the urine albumin-to-creatinine ratio by 35%, whereas it tended to increase in the placebo group (p<0.001). BP declined progressively throughout the study in both groups without any significant difference between them at baseline or at the end of the trial. The Irbesartan Diabetic Nephropathy Trial and Angiotensin II Antagonist Losartan trials were conducted in patients with relatively advanced diabetic nephropathy at baseline. The Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria study evaluated whether irbesartan could prevent or delay progression to advanced diabetic nephropathy in patients with type 2 diabetes, hypertension (>135/85 mmHg), persistent microalbuminuria (20 to 200 µg/min) and serum creatinine levels of ≤97 µmol/L for women or 133 µmol/L for men (13). Study patients were randomized to receive irbesartan 150 mg once daily, 300 mg once daily or matching BX-912 placebo. The primary outcome was development of overt nephropathy, defined as urine albumin excretion >200 µg/min with at least a 30% increase from baseline. After a median follow up of 2 years, 14.9% of patients in the placebo group developed the primary outcome vs. 9.7% of patients in the irbesartan 150 mg group (p=0.08) and 5.2% in the irbesartan 300 mg group (p<0.001 vs. placebo). Irbesartan reduced urinary albumin excretion by 24% in the 150 mg group and by 38% in the 300 mg group, and there was a 2% decrease in the placebo group. ORIENT evaluated the nephroprotective effect of olmesartan in patients with diabetic nephropathy (11). The primary outcome was composite of death from any cause, doubling of serum creatinine, reaching a creatinine level of 442 µmol/L, chronic dialysis or transplantation. It occurred in 41% of patients in the olmesartan group and 45% of patients in the placebo group (adjusted HR 1.02, 95% CI 0.79 to 1.32). Proteinuria decreased from baseline in the olmesartan but not in the placebo group (p=0.005) (10).