Abstract
Background: The safety of once-daily (qd) dosing of valsartan in heart failure (HF) patients is not known. Hypothesis: This 10-week, double-blind trial examined the relative safety and efficacy of valsartan administered qd versus twice-daily (bid). Methods: HF patients (NYHA class II-III) receiving diuretics (87%), angiotensin-converting enzyme inhibitors (98%), beta-blockers (92%), aldosterone antagonists (25%), or digoxin (32%) were randomized to valsartan 40 mg bid (n = 60) or 80 mg qd (n = 55) and titrated to a maximum dose of 320 mg/day; doubling the dose every 2 weeks. Clinical and biochemical parameters were measured at Weeks 2, 4, 6, and 10. Results: The average dose of valsartan at the end of study was 245 mg in the bid group vs 256 mg in the qd group (P = NS). Similar proportions of patients tolerated qd vs bid dosing (bid 67% vs qd 68%). Outcome measures including reduction in blood pressure, incidence of hypotension, renal impairment, orthostatic dizziness or fatigue, changes in serum K+, creatinine, cystatin-C, and estimated glomerular filtration rate were similar between the 2 groups at all time-points. Brain natriuretic peptide levels decreased and plasma renin activity increased from baseline by the same amount in both groups at all time-points. Conclusion: Valsartan administered qd has a similar safety and tolerability profile with comparable 24-hour RAAS blockade, as assessed by increases in PRA, as bid dosing in patients with moderate to severe (NYHA class II-III) heart failure.
Original language | English (US) |
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Pages (from-to) | 449-455 |
Number of pages | 7 |
Journal | Vascular Health and Risk Management |
Volume | 6 |
Issue number | 1 |
State | Published - 2010 |
Keywords
- Angiotensin receptor blocker
- Heart failure
- Valsartan
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Hematology
- Public Health, Environmental and Occupational Health
- Cardiology and Cardiovascular Medicine
- Pharmacology (medical)