Effectiveness and safety of high-dose valsartan monotherapy in hypertension treatment: the ValTop study

Abstract

Early combination therapy is increasingly recommended in hypertension management because of increased risk of adverse effects with high-dose monotherapy. However, this risk is not necessarily increased for high doses of angiotensin receptor blockers (ARB). ValTop study compared efficacy and safety of high vs. conventional dose of valsartan in hypertensive patients. ValTop was a controlled, randomized, double-blind trial. Of 6035 screened subjects, 4004 mild-to-moderate hypertensive patients (mean seated diastolic blood pressure (MSDBP) 90-109 mm Hg) started 4-week open-label treatment with valsartan 160 mg. Of them, 3776 were randomized to receive valsartan 160 mg (N¼1900) or 320 mg (N¼1876) o.d. for 4 weeks. In 28-week open-label extension study, all participating patients (N¼642) received valsartan 320 mg. Valsartan 160 mg reduced MSDBP by 10.0 mm Hg in the initial open-label phase. Further BP reductions in the double-blind phase were significantly (Po0.0001) greater in the 320 mg group than in the 160 mg group for MSDBP (1.6 ± 0.18 mm Hg vs. 0.5 ± 0.18 mm Hg) and mean seated systolic BP (3.3 ± 0.31 mm Hg vs. 0.7 ± 0.31 mm Hg). The size of the additional effect of the 320 mg dose on BP was similar in subjects controlled or not by the initial 160 mg dose. Adverse event (AE) rates were similar in both treatment groups, drug-related AEs occurring in o5% of subjects in each phase. High-dose valsartan is safe and effective in uncomplicated mild-to-moderate hypertension independently of the initial response to a moderate dose. High-dose ARB monotherapy may thus be a viable option in hypertension management.

Efficacy and tolerability of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension

“…The results of the present study demonstrated the antihypertensive efficacy of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension. The blood pressure reductions observed in the current study (15.6/11.1 mmHg for office SBP/DBP following 10 weeks treatment) were comparable to those obtained in previous studies (7,11,(19)(20)(21)(22)(23), which examined single-drug or combination valsartan therapy in patients with mild to moderate hypertension over a similar time frame. In the latter studies, mean SBP reductions between 10.2 and 16.5 mmHg were observed, whereas mean DBP reductions were between 5.3 and 10.3 mmHg.…”

“…Antihypertensive efficacy of valsartan has been established over a range of doses, up to 320 mg/day, in North American and European hypertensive patient populations (7,8,18). The results of the present study demonstrated the antihypertensive efficacy of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension.…”

“…Valsartan is widely used alone and in combination with other antihypertensive drugs (6). Dose-dependent antihypertensive efficacy has been demonstrated for valsartan at doses up to 320 mg, with 80 or 160 mg as the recommended starting dose in Europe and North America (7,8). The antihypertensive efficacy of 160 mg valsartan has been demonstrated in several large controlled clinical trials, including VALUE and NAVIGATOR (9,10).…”

Use of automated blood pressure measurements in clinical trials and registration studies: data from the VALTOP Study

“…This allowed the identification of statistically significant differences between the effects of valsartan 160 and 320 mg. These observations clearly show that eBPM can safely and effectively be used in clinical research as an alternative to AuscBPM [17].…”

Therapeutic implications of high-dose angiotensin receptor blocker monotherapy in mild-to-moderate hypertensive patients

“…This notion is strengthened by the results of the ValTop study published in the present issue of Hypertension Research. 11 The ValTop study was a controlled, randomized, double-blind trial. A total of 4004 patients with uncomplicated mild-tomoderate hypertension (mean diastolic BP: 95-109 mm Hg) were started on a 4-week open-label treatment with valsartan 160 mg.…”