Valsartan 320 mg provided equally effective 24-hour blood pressure reduction whether administered in the morning or evening in patients with hypertension and cardiovascular risk factors.
RCT (n=1,093)
Double-blind
1:1:1
Yes
Does evening dosing of valsartan improve 24-hour blood pressure control compared to morning dosing of valsartan or lisinopril in patients with grade 1-2 hypertension?
Evening dosing of valsartan does not provide superior 24-hour blood pressure control compared to morning dosing of valsartan or lisinopril in patients with hypertension.
Absolute Event Rate: -10.6% vs -9.8%
p-value: p=0.4219
OBJECTIVE: Studies suggest that bedtime dosing of an angiotensin-converting enzyme (ACE)-inhibitor or angiotensin receptor blocker shows a more sustained and consistent 24-h antihypertensive profile, including greater night-time blood pressure (BP) reduction. We compared the antihypertensive effects of morning (a.m.) and evening (p.m.) dosing of valsartan on 24-h BP. METHODS: This 26-week, multicentre, randomized, double-blind study evaluated the efficacy and safety of valsartan 320 mg, dosed a.m. or p.m., versus lisinopril 40 mg (a.m.), a long-acting ACE-inhibitor, in patients with grade 1-2 hypertension and at least one additional cardiovascular risk factor. Patients (n = 1093; BP = 156 ± 11/91 ± 8 mmHg; 62 years, 56% male, 99% white) received (1 : 1 : 1) valsartan 160 mg a.m. or p.m. or lisinopril 20 mg a.m. for 4 weeks, then force-titrated to double the initial dose for 8 weeks. At Week 12, hydrochlorothiazide (HCTZ) 12.5 mg was added for 14 weeks if office BP was more than 140/90 mmHg and/or ambulatory BP more than 130/80 mmHg. RESULTS: Mean 24-h ambulatory SBP change from baseline to Weeks 12 and 26 was comparable between valsartan a.m. (-10.6 and -13.3 mmHg) and p.m. (-9.8 and -12.3 mmHg) and lisinopril (-10.7 and -13.7 mmHg). There was no benefit of valsartan p.m. versus a.m. on night-time BP, early morning BP and morning BP surge. Evening dosing also did not improve BP lowering in patients requiring add-on HCTZ or in nondippers at baseline. All treatments were well tolerated. CONCLUSION: Once-daily dosing of valsartan 320 mg results in equally effective 24-h BP efficacy, regardless of dosing time. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00241124.
Zappe et al. (Thu,) conducted a rct in Grade 1-2 hypertension with additional cardiovascular risk factors (n=1,093). Valsartan (morning dosing) vs. Valsartan (evening dosing) was evaluated on Change in 24-h mean ambulatory SBP from baseline to Week 12 (95% CI -2.30 to 0.96, p=0.4219). Valsartan 320 mg provided equally effective 24-hour blood pressure reduction whether administered in the morning or evening in patients with hypertension and cardiovascular risk factors.