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Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial.

ABSTRACT: To determine the safety and efficacy of nebivolol in elderly heart failure (HF) patients with renal dysfunction.SENIORS recruited patients aged 70 years or older with symptomatic HF, irrespective of ejection fraction, and randomized them to nebivolol or placebo. Patients (n = 2112) were divided by tertile of estimated glomerular filtration rate (eGFR). Mean age of patients was 76.1 years, 35% of patients had an ejection fraction of >35%, and 37% were women resulting in a unique cohort, far more representative of clinical practice than previous trials. eGFR was strongly associated with outcomes and nebivolol was similarly efficacious across eGFR tertiles. The primary outcome rate (all-cause mortality or cardiovascular hospital admission) and adjusted hazard ratio for nebivolol use in those with low eGFR was 40% and 0.84 (95% CI 0.67-1.07), 31% and 0.79 (0.60-1.04) in the middle tertile, and 29% and 0.86 (0.65-1.14) in the highest eGFR tertile. There was no interaction noted between renal function and the treatment effect (P = 0.442). Nebivolol use in patients with moderate renal impairment (eGFR <60) was not associated with major safety concerns, apart from higher rates of drug-discontinuation due to bradycardia.Nebivolol is safe and has a similar effect in elderly HF patients with mild or moderate renal impairment.

SUBMITTER: Cohen-Solal A

PROVIDER: S-EPMC2729679 | biostudies-other | 2009 Sep

REPOSITORIES: biostudies-other

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Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial.

Cohen-Solal Alain A Kotecha Dipak D van Veldhuisen Dirk J DJ Babalis Daphne D Böhm Michael M Coats Andrew J AJ Roughton Michael M Poole-Wilson Philip P Tavazzi Luigi L Flather Marcus M

European journal of heart failure 20090801 9

<h4>Aim</h4>To determine the safety and efficacy of nebivolol in elderly heart failure (HF) patients with renal dysfunction.<h4>Methods and results</h4>SENIORS recruited patients aged 70 years or older with symptomatic HF, irrespective of ejection fraction, and randomized them to nebivolol or placebo. Patients (n = 2112) were divided by tertile of estimated glomerular filtration rate (eGFR). Mean age of patients was 76.1 years, 35% of patients had an ejection fraction of >35%, and 37% were women ...[more]

PMID: 19648605

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Project description:BackgroundElderly patients with metastatic renal cell carcinoma (mRCC) may require special treatment considerations, particularly when comorbidities are present. An understanding of the efficacy and safety of targeted agents in elderly patients with mRCC is essential to provide individualized therapy.ObjectiveTo evaluate the efficacy and safety of everolimus in elderly patients (those ≥ 65 and ≥ 70 yr of age) enrolled in RECORD-1.Design, setting, and participantsThe multicenter randomized RECORD-1 phase 3 trial (Clinicaltrials.gov identifier, NCT00410124; http://www.clinicaltrials.gov) enrolled patients with mRCC who progressed during or within 6 mo of stopping sunitinib and/or sorafenib treatment (n=416).InterventionEverolimus 10mg once daily (n=277) or placebo (n=139) plus best supportive care. Treatment was continued until disease progression or unacceptable toxicity.MeasurementsMedian progression-free survival (PFS), median overall survival (OS), and time to deterioration in Karnofsky performance status (TTD-KPS) were assessed using the Kaplan-Meier method; the log-rank test was used to compare treatment arms. Other outcomes evaluated included reduction in tumor burden, overall response rate (ORR), and safety.Results and limitationsIn RECORD-1, 36.8% of patients were ≥ 65 yr and 17.5% were ≥ 70 yr of age. PFS, OS, TTD-KPS, reduction in tumor burden, and ORR were similar in the elderly and the overall RECORD-1 population. Everolimus was generally well tolerated in elderly patients, and most adverse events were grade 1 or 2 in severity. The toxicity profile of everolimus was generally similar in older patients and the overall population; however, peripheral edema, cough, rash, and diarrhea were reported more frequently in the elderly regardless of treatment. The retrospective nature of the analyses was the major limitation.ConclusionsEverolimus is effective and tolerable in elderly patients with mRCC. When selecting targeted therapies in these patients, the specific toxicity profile of each agent and any patient comorbidities should be considered.

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Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial.

Publications

Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial.

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