Evaluation of dosing time-related anti-hypertensive efficacy of valsartan in patients with type 2 diabetes.

The aim of this study was to evaluate which administration timing of valsartan provides satisfactory blood pressure (BP) control, once daily in the morning, once daily in the evening, or twice daily in total 160 mg. Hypertensive patients with mild-to-moderate diabetic nephropathy were enrolled, but those with more than three anti-hypertensive agents, renal insufficiency (serum creatinine ≥ 3 mg/ dL), or hepatic insufficiency were excluded. They were randomized to receive valsartan 160mg once daily in the morning, valsartan 160 mg once daily in the evening, or valsartan 80 mg twice daily for 12 weeks according to a three-period crossover design. Office blood pressure (OBP), home blood pressure (HBP) self-measured by patients, and urinary albumin excretion adjusted by creatinine excretion (UAE) were measured every 12 weeks. In 34 patients, (male: 18, mean age: 57.5 ± 10.3), valsartan with ether all administration timing demonstrated significant reductions in OBP and HBP compared to baseline: valsartan 160 mg once daily in the morning: -12.2/-9.5 mmHg (p < 0.01); valsartan 160 mg once daily in the evening: -14.2/-10.3 mmHg (p < 0.01); valsartan 80 mg twice daily: -15.0/-10.2 mmHg (p < 0.01) There was no statistically significant differences in a decrease in OBP and HBP, and reduction of UAE among three administration timing. In conclusion, these data indicate that the efficacy on BP-lowering does not depend on administration timing of valsartan in patients with diabetic nephropathy.