Objective: To evaluate the efficacy and safety of 80 or 160 mg/day valsartan in Chinese adult patients with essential hypertension and albuminuria.
Methods: A multicenter prospective open-label observational study was conducted. Adult hypertensive patients with albuminuria were treated with 80 or 160 mg/day valsartan. Blood pressure (BP) was recorded at weeks 4, 8 and 12. Albuminuria was selectively measured at week 12.
Results: The intent-to-treat (ITT) population included 1180 patients. Mean sitting systolic BP (MSSBP) and diastolic BP (MSDBP) at baseline was 153.5 [14.41] (mean [SD]) and 88.2 [11.99] (mean [SD]) mmHg. MSSBP and MSDBP at week 4 (mean [SD]: 139.1 [12.02] and 82.2 [8.54] mmHg), week 8 (mean [SD]: 135.3 [10.46] and 80.2 [7.55] mmHg) and week 12 (mean [SD]: 132.1 [9.80] and 78.1 [6.88] mmHg) were significantly lower than baseline (p < 0.001). The BP control rate of ITT patients at week 12 was 17.8%. Diabetic patients exhibited lower BP control rate than non-diabetic patients (14.0 vs. 22.4%, p < 0.001). A total of 904 patients had albuminuria assessed at week 12. UACR and UAER at week 12 were lower compared with baseline (p < 0.05). In all, 171 patients (18.9%) returned to normal albuminuria and albuminuria normalization percentage in diabetic patients exceeded that of non-diabetic patients (26.3 vs. 12.1%, p < 0.001). Albuminuria declined by more than 50% in 340 patients (37.6%) and more diabetic patients exhibited such decline in albuminuria than non-diabetic patients (41.7 vs. 33.8%, p < 0.05). No serious drug-related adverse effects (AEs) were observed.
Limitations: Prior antihypertensive treatment before valsartan administration may interfere with the efficacy of subsequent treatment. The discrepancy between 80 and 160 mg may affect patient outcomes and occurrence of AEs.
Conclusions: Valsartan can safely and effectively reduce BP and albuminuria in Chinese adult patients with essential hypertension and albuminuria. Valsartan has the more dramatic effect on albuminuria in diabetic patients than non-diabetic patients.