Safety of Telmisartan in Patients with Arterial Hypertension
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ORIGINAL RESEARCH ARTICLE
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Safety of Telmisartan in Patients with Arterial Hypertension An Open-Label Observational Study ¨ Martin C. Michel,1 Herbert Bohner,2 Jurgen K¨oster,2 Rafael Sch¨afers3 and 4 Uwe Heemann 1
Department of Pharmacology and Pharmacotherapy, University of Amsterdam, Amsterdam, The Netherlands 2 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany ¨ Nieren- und Hochdruckkrankheiten, Essen, Germany 3 Praxis fur 4 Department of Nephrology, Klinikum rechts der Isar, Technical University, Munich, Germany
Abstract
Objective: To determine whether age, gender, concomitant disease and/or previous or present antihypertensive medication affect the safety or antihypertensive efficacy of telmisartan in the treatment of arterial hypertension. Study Design and Methods: In this large-scale, open-label postmarketing surveillance study, German physicians systematically documented their observations concerning patients with essential hypertension on case report forms. Patients were treated for 6 months with telmisartan (40–80mg once daily). Data were analysed using direct group comparisons and multiple linear regression analysis. Results: A total of 19 870 patients (52.3% males, mean age 59.1 years) were evaluated, of whom 47.6, 18.3, 13.2 and 2.1%, respectively, had concomitant hypercholesterolaemia, diabetes mellitus, congestive heart failure and renal insufficiency. In the overall group, adverse events were reported in 1.9% of patients. Global tolerability was rated as very good, good, moderate or poor, respectively, in 74.7, 22.1, 0.7 and 0.5% of patients; tolerability was similar across all subgroups of patients. Telmisartan treatment did not increase serum creatinine or potassium in any subgroup, including >400 patients with impaired renal function (basal creatinine 1.73 mg/dL). Telmisartan had no adverse effects on glucose, triglyceride or cholesterol levels. In the overall group, telmisartan reduced mean ± SD systolic blood pressure from 171.3 ± 16.4mm Hg to 141.3 ± 12.0mm Hg and diastolic blood pressure from 99.0 ± 9.4mm Hg to 83.4 ± 6.9mm Hg. Reductions were very similar between genders, age groups and patients with and without comorbidities, and not dependent on prior or concomitant treatment with other antihypertensive drugs. Conclusion: The safety and efficacy of telmisartan found in controlled studies is maintained in a large postmarketing population that included sizeable patient subgroups potentially at higher risk for adverse events.
Chronically elevated blood pressure causes major morbidity and mortality, and a variety of drug classes are now available to treat arterial hyperten-
sion and at least partly normalise that risk.[1] With all drug classes, the extent of blood pressure lowering appears to be the most important contributor to the
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reduction of hypertension-associated morbidity and mortality.[2-5] However, the hypertensive population is heterogeneous with regard to age, gender, concomitant morbidity and concurrent
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