Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial.
OBJECTIVE
To determine the safety and efficacy of nebivolol in elderly heart failure (HF) patients with renal dysfunction.


RESULTS
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.


CONCLUSIONS
Nebivolol is safe and has a similar effect in elderly HF patients with mild or moderate renal impairment.
Cohen-Solal
Alain
A
Hôpital Lariboisiere, Assistance Publique-Hopitaux de Paris, Université Paris Diderot, INSERM U942, 2 Rue Ambroise Paré, 75475 Paris Cedex 10, France.
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
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001578:Benzopyrans / Q000627:therapeutic use*; D016001:Confidence Intervals; D003404:Creatinine / Q000097:blood / Q000652:urine; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate; D006339:Heart Rate; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D007674:Kidney Diseases; D008297:Male; D015999:Multivariate Analysis; D000068577:Nebivolol; D013318:Stroke Volume / Q000187:drug effects; D014665:Vasodilator Agents / Q000627:therapeutic use*; D016277:Ventricular Function, Left / Q000187:drug effects
D000319:Adrenergic beta-Antagonists; D001578:Benzopyrans; D004983:Ethanolamines; D014665:Vasodilator Agents; D000068577:Nebivolol; D003404:Creatinine