Safety of telmisartan in patients with arterial hypertension - An open-label observational study

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.