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Efficacy and tolerability of a fixed-dose combination of telmisartan plus hydrochlorothiazide in patients uncontrolled with telmisartan monotherapy

Journal of Human Hypertension volume 15, pages 763–770 (2001)Cite this article

Abstract

The antihypertensive effects of a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination and telmisartan 80 mg monotherapy were compared in patients with a history of mild-to-moderate essential hypertension and inadequate BP control (DBP ⩾90 mm Hg) following 8 weeks of telmisartan monotherapy. At the end of this period, 491 patients (62.9% men; mean age 55.3 years) whose DBP was ⩾90 mm Hg were double-blind randomised to once-daily telmisartan 80 mg/HCTZ 12.5 mg (n = 246) or telmisartan 80 mg (n = 245). Trough (24 h post-dose) clinic BP was measured after 4 and 8 weeks of double-blind therapy. At the end of double-blind treatment, patients receiving telmisartan 80 mg/HCTZ 12.5 mg had significant additional decrements in clinic SBP/DBP over telmisartan 80 mg of −5.7/−3.1 mm Hg (P < 0.01). Most of the additional effect occurred during the first 4 weeks of treatment. The proportion of patients with normalised BP (SBP <140 mm Hg and DBP <90 mm Hg) was significantly greater in the telmisartan 80 mg/HCTZ 12.5 mg group than the telmisartan 80 mg group (41.5%vs 26.1%;P < 0.05). Both treatments were well tolerated. The incidence of adverse events was similar except for diarrhoea, which occurred more frequently in the telmisartan 80 mg/HCTZ 12.5 mg group, and oedema, which occurred more frequently in the telmisartan group. Our results indicate that a telmisartan 80 mg/HCTZ 12.5 mg fixed-dose combination confers significant additional BP reductions compared with continuation of telmisartan monotherapy in non-responders.

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Acknowledgements

The authors would like to extend their thanks to the following principal investigators, and their staff, who participated in the trial: W Booth (Antigonish, Nova Scotia); D Cavanaugh (London, Ontario); H Conter (Halifax, Nova Scotia); J Daiter (Richmond Hill, Ontario); ID Dattani (Saskatoon, Saskatchewan); J Ennett (Stratford, Ontario); B Lasko (Weston, Ontario); J-P Ouellet (Sherbrooke, Québec); V Senikas (Montreal, Québec); D Taylor (Charlottetown, Prince Edward Island). Financial support for this work was provided by Boehringer Ingelheim (Canada) Ltd.

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Authors and Affiliations

  1. Hypertension Research Unit, Centre Hospitalier Universitaire de Québec, Québec, Canada

    Y Lacourcière

  2. Hamilton Medical Research Group, Hamilton, Ontario, Canada

    R Tytus

  3. Commonwealth Medical Centre, Mount Pearl, Newfoundland, Canada

    D O’Keefe

  4. Invascor, Longueuil, Québec, Canada

    J Lenis

  5. Midtown Medical Centre, Saskatoon, Saskatchewan, Canada

    R Orchard

  6. Boehringer Ingelheim (Canada) Ltd, Burlington, Ontario, Canada

    K Martin

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  1. Y Lacourcière
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Correspondence to Y Lacourcière.

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Lacourcière, Y., Tytus, R., O’Keefe, D. et al. Efficacy and tolerability of a fixed-dose combination of telmisartan plus hydrochlorothiazide in patients uncontrolled with telmisartan monotherapy. J Hum Hypertens 15, 763–770 (2001). https://doi.org/10.1038/sj.jhh.1001267

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