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Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure.

ABSTRACT: The safety of once-daily (qd) dosing of valsartan in heart failure (HF) patients is not known.This 10-week, double-blind trial examined the relative safety and efficacy of valsartan administered qd versus twice-daily (bid).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.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.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.

SUBMITTER: Anand IS

PROVIDER: S-EPMC2922305 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

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Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure.

Anand Inder S IS Deswal Anita A Kereiakes Dean J DJ Purkayastha Das D Zappe Dion H DH

Vascular health and risk management 20100809

<h4>Background</h4>The safety of once-daily (qd) dosing of valsartan in heart failure (HF) patients is not known.<h4>Hypothesis</h4>This 10-week, double-blind trial examined the relative safety and efficacy of valsartan administered qd versus twice-daily (bid).<h4>Methods</h4>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) ...[more]

PMID: 20730060

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Project description:BackgroundPrevalence of immunosuppressant nonadherence in renal transplant recipients is high despite negative clinical outcomes associated with nonadherence. Simplification of dosing has been demonstrated to improve adherence in renal transplant recipients as measured through electronic monitoring and self-report.ObjectiveThe purpose of this study was to replicate and extend previous findings by measuring adherence with multiple methods in a Canadian sample.DesignThe study design was a randomized controlled medication dosing trial in adult renal transplant patients. The trial length was 4 months.SettingThis study was conducted within the Solid Organ Transplant (SOT) Clinic at Vancouver General Hospital (VGH; Vancouver, Canada).PatientsA total of 46 adult renal recipients (at least 1 year post-transplant) were recruited through the SOT clinic. With 8 withdrawals, 38 individuals completed all phases of the study.MeasurementsMedication adherence was measured for a period of 4 months using multiple methods, including electronic monitoring (MEMS [Medication Event Monitoring System]), pharmacy refill data (medication possession ratio [MPR]), and by self-report using the Adherence subscale of the Transplant Effects Questionnaire (TEQ).MethodsParticipants were randomized to twice-daily (n = 19) or once-daily tacrolimus dosing (n = 19) and followed over a 4-month period via monthly clinic study visits. Comparisons between the treatment groups were performed using the Mann-Whitney U and chi-square tests, for continuous and categorical variables, respectively.ResultsAs outlined in Table 3, the once-daily dosing group showed significantly better MEMS Dose Adherence (P = .001), whereas MEMS Timing Adherence showed a tendency toward better adherence for this group, but was not significant (P = .052). MEMS Days Adherent (P = .418), MPR% (P = .123), and self-reported adherence (P = .284) did not differ between the once- and twice-daily dosing groups when measured as continuous variables. The MPR% was significantly better for the once-daily dosing group when measured dichotomously but not continuously (P = .044). Notably, most of those exposed to once-daily dosing (63.2%) preferred this to the twice-daily regimen.LimitationsLimitations included small sample size and short follow-up period, precluding the examination of clinical outcome differences.ConclusionsResults for dose adherence replicate the finding that dose simplification increases adherence to immunosuppressants as measured through electronic monitoring. Such an advantage for the once-daily dosing group was not seen across the 2 other electronic monitoring measurement variables (days and timing adherence). This study extends previous research by examining adherence in once versus twice-daily dosing via prescription refill data in a Canadian sample. Given the gravity of potential health outcomes associated with nonadherence, although results indicate inconsistencies in significance testing across measurement methods, the medium to large effect sizes seen in the data favoring better adherence with once-daily dosing provide an indication of the potential clinical significance of these findings.Trial registrationThis study was registered with ClinicalTrials.gov (NCT01334333) on April 11, 2011.

Dataset Information

Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure.

Publications

Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure.

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