Clinical Drug Investigation

, Volume 22, Issue 11, pp 719–729 | Cite as

Metoprolol Succinate SR plus Hydrochlorothiazide (Beloc-Zok® Comp) in Patients with Essential Hypertension in General Practice

A Prospective, Observational Trial in 14 964 Patients
  • S. K. Hildemann
  • H. Fischer
  • D. Pittrow
  • V. Bohlscheid
Original Research Article

Abstract

Objective

Low-dose combination treatment for patients with essential hypertension has received growing interest since the introduction of recent guidelines. We investigated the efficacy and tolerability of a fixed low-dose combination of once-daily metoprolol succinate 95mg (slow-release Zok) plus hydrochlorothiazide (HCTZ) 12.5mg in daily practice.

Design

This was an open-label, multicentre, prospective, observational phase IV study in 14 964 patients with hypertension at 2 808 general practitioners’ offices throughout Germany.

Main outcome measure

Decrease in systolic and diastolic blood pressure (BP) and heart rate from baseline after 8 weeks, and analysis of adverse events.

Results

54% of the patients were male; the mean age was 57 years (range 16 to 99 years), and the mean body mass index was 27 +- 4 kg/m2. Of the study patients, 74.9% had essential hypertension only, and 23.7% also had coronary artery disease. The drug combination reduced mean systolic and diastolic BP by 24.5/13.6mm Hg from baseline (166.7/97.3mm Hg) after 8 weeks (p < 0.0001 for systolic and diastolic BP); 92.2% of patients had a ≥10mm Hg reduction in systolic BP. Mean heart rate was reduced by 10.2 beats/min (from 81.4 beats/min; p < 0.0001). The BP-lowering effect was consistent in patients who received metoprolol succinate/HCTZ as first-line treatment and those who received it in addition to other antihypertensive therapies. Tolerability of the combination was excellent: 98.6% of patients remained free of adverse events during the study.

Conclusion

This 8-week non-interventional study carried out under daily routine practice conditions in a large heterogeneous sample of patients with multiple concomitant diseases and taking various co-medications confirmed the efficacy and tolerability of the metoprolol succinate/HCTZ combination in the treatment of patients with essential hypertension.

Notes

Acknowledgements

We would like to acknowledge the cooperation and commitment of all the local general physicians and their staff without whom the present study would not have been possible. We are indebted to Prof. Kohnen, Mr Windisch and Mr Hylla, Imerem, Nürnberg, Germany, for their excellent assistance with the statistical work. The study was supported by a grant from Searle GmbH, Nürnberg and Pharmacia, Nürnberg, Germany.

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Copyright information

© Adis International Limited 2002

Authors and Affiliations

  • S. K. Hildemann
    • 1
  • H. Fischer
    • 2
  • D. Pittrow
    • 3
  • V. Bohlscheid
    • 4
  1. 1.Pharmacia GmbHErlangenGermany
  2. 2.Medical Department IIKrankenhaus VincentinumRuhpoldingGermany
  3. 3.Department of Clinical Pharmacology, Medical FacultyUniversity of DresdenDresdenGermany
  4. 4.Medical Department IIIDietrich Bonhoeffer KlinikumNeubrandenburgGermany

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