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.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Malacco
E
E
III Division of Internal Medicine, "L. Sacco" Hospital, Milan, Italy. ettore.malacco@tiscali.it
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001578:Benzopyrans / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D003920:Diabetes Mellitus / Q000503:physiopathology; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D006852:Hydrochlorothiazide / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068577:Nebivolol; D011358:Product Surveillance, Postmarketing / Q000379:methods; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D001578:Benzopyrans; D004338:Drug Combinations; D004983:Ethanolamines; D000068577:Nebivolol; D006852:Hydrochlorothiazide