Abstract:Objectives: This retrospective analysis examined the efficacy and tolerability of nebivolol, a ß 1 -selective, vasodilatory β-blocker, in four different age groups of patients with hypertension. Methods: Data were pooled from three 12-week, randomized, placebo-controlled trials (placebo, n = 205; nebivolol [1.25-30/40 mg/day], n = 1811) and stratified into age quartiles (Group 1: 22-46 years; Group 2: 47-53 years; Group 3: 54-62 years; Group 4: 63-84 years). Only patients treated with placebo and the three commonly used nebivolol dosages (5, 10, and 20 mg/day) are presented. Baseline-to-endpoint changes in trough sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) were analyzed for each age quartile using an analysis of covariance (ANCOVA) model. Tolerability was assessed by means of adverse event (AE) rates. Results: The analysis comprised 205 placebo-treated patients and 1380 patients treated with nebivolol dosages of 5, 10, or 20 mg/day. Older age was associated with higher SBP values at baseline. In all age groups, each of the three most frequently used nebivolol dosages significantly reduced DBP, compared with placebo (-9.1 to -11.8 mmHg versus -3.4 to -5.9 mmHg; p ≤ 0.008 overall). For SBP, a statistically significant effect versus placebo was observed for all dosages and age groups except for 5 and 10 mg/day in Group 4. Within each group, treatment with nebivolol (all three dosages) and placebo resulted in similar AE rates (nebivolol: 26.1-36.6%; placebo: 36.2-42.6%) and AE-related discontinuation rates (1.8-3.8% versus 0-4.3%). In each age group, there were no significant nebivolol-placebo differences in the rates of patients who experienced clinically significant changes or abnormal endpoint levels of metabolic parameters. Conclusions: This retrospective analysis suggests that nebivolol monotherapy is efficacious and well tolerated across various age groups, with the efficacy in reducing SBP somewhat diminishing in patients over 62 years of age. The changes in hypertension type, severity, and prevalence across age groups pose notable challenges in clinical practice. For example, older age is also associated with an increased prevalence of comorbidities and polypharmacy, whereas younger age is a key determinant of poor therapy adherence [Briesacher et al. 2008;Fischer et al. 2010]. In addition, antihypertensive medication itself is independently associated with a higher risk of adverse events (AEs) such as erectile dysfunction (ED) [Cordero et al. 2010;Düsing, 2005;Ko et al. 2002;Shiri et al. 2007] and orthostatic hypotension (OH) [Cleophas and van Marum, 2003], which may affect quality of life and lead to treatment discontinuation in both younger and older patients [Fogari and Zoppi, 2004]. Therefore, patient age should be carefully taken into consideration when selecting antihypertensive therapy [Carlberg and Nilsson, 2010].
KeywordsNebivolol, a ß 1 -selective blocker with vasodilatory properties that are thought to be mediated by nitric oxide (NO) [Münze...