Nebivolol/hydrochlorothiazide (HCTZ) combination in patients with essential hypertension: a pooled analysis from five non-interventional studies with a focus on diabetic and elderly patients.

BACKGROUND AND OBJECTIVES: Nebivolol is a third-generation beta-blocker, characterized by unique pharmacological properties. The combination of nebivolol and hydrochlorothiazide (HCTZ) has been evaluated in large-scale clinical trials. This post-marketing surveillance analysis evaluated the effectiveness of the nebivolol/HCTZ combination in a "real-life" setting that included diabetic and elderly patients. PATIENTS AND METHODS: The analysis was based on data from five non-interventional studies conducted in Germany, which lasted up to 12 weeks. Data from patients treated with nebivolol/HCTZ 5/12.5 mg/day in combination were pooled. The following parameters were calculated at the final visit, in the whole population and in elderly (>70 years) and diabetic subgroups: (1) difference from baseline in diastolic blood pressure (DBP) and in systolic blood pressure (SBP); (2) percentage of responder patients (reduction in DBP or SBP of 10 or 20 mmHg, respectively). Alterations in laboratory parameters were also monitored.
RESULTS: In total, 86 patients (mean age 58.9 +/- 10.8 years) were included in the analysis. Nebivolol/HCTZ significantly reduced both DBP (-11.8 +/- 7.9 mmHg; p<0.0001 vs baseline) and SBP (-22.5 +/- 13.5 mmHg; p<0.0001 vs baseline). In total, 81.4% of patients were responders (75% and 83.3% in elderly and diabetic patients, respectively). No clinically significant alterations in laboratory parameters were observed. DISCUSSION: This study confirms that nebivolol/HCTZ is an effective and well tolerated therapeutic strategy in a real-life setting as well as in clinical trials. Therefore, this combination may represent a first-choice therapy in the management of hypertension.