[Antihypertensive first-line and add-on treatment with a fixed controlled release combination of metoprololsuccinate/hydrochlorothiazide. Prospective doctor's office observational study in 14,964 patients].

AIM: To evaluate the efficacy and tolerability of a single daily dose of a fixed combination of 95 mg metoprololsuccinate (MS) and 12.5 mg hydrochlorothiazide (HCTZ) in the first-line treatment of non-pretreated hypertensives, or additional (add-on) to ongoing antihypertensive medication. METHOD: 14,964 patients aged 18 years or older treated by 2808 family doctors in Germany were included in a noncontrolled observational study. Most patients had at least one concurrent disease or concomitant medication of one kind or another. The primary target parameters for efficacy was the lowering of the systolic blood pressure (SBP) and diastolic blood pressure (DBP) after 8 weeks and for tolerability the number of patients reporting adverse events (AE). RESULTS: 65.4% of the patients received MS/HCTZ in the form of first-line treatment, the remainder as add-on therapy. The mean blood pressure decrease for the overall group by the end of the study was -24.5/-13.6 mmHg (baseline: 166.7/97.3 mmHg; p < 0.0001 for SBP and DBP). 92.2% of the patients experienced a decrease in SBP of > or = 10 mmHg. The mean heart rate decreased by 10.2 beats (baseline 81.4; p < 0.0001). The blood pressure decreased both in patients receiving MS/HCTZ alone and in those receiving it as an add-on to other antihypertensives. Only 1.4 of the patients reported AE. CONCLUSION: The MS/HCTZ controlled release combination was safe, efficacious and well-tolerated both as first-line and add-on therapy for essential hypertension.