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 (40-80 mg 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 +/- 16.4 mm Hg to 141.3 +/- 12.0 mm Hg and diastolic blood pressure from 99.0 +/- 9.4 mm Hg to 83.4 +/- 6.9 mm 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.