PMID: 18705533Aug 19, 2008Paper

The safety profile of telmisartan as monotherapy or combined with hydrochlorothiazide: a retrospective analysis of 50 studies

Blood Pressure. Supplement
Helmut Schumacher, Giuseppe Mancia

Abstract

To compare the tolerability and safety of telmisartan +/- hydrochlorothiazide (HCTZ). This retrospective analysis was performed on all hypertensive patients that were enrolled in telmisartan studies. A total of 30 double-blind (n=8023) and 20 open-label (n=8393) studies were available at the time of this analysis, and were included. Treatments investigated were placebo, telmisartan 10-160 mg, or telmisartan 10-160 mg plus HCTZ 6.25-25 mg. The incidence and causality of all adverse events (AEs) and laboratory abnormalities occurring during treatment were recorded. The incidences of all-cause AEs in the double-blind studies were: 2.73 per patient-year (PY) (36.1%; placebo); 2.03/PY (37.4%; telmisartan monotherapy) and 2.09/PY (44.8%; telmisartan plus HCTZ). The respective numbers in the open-label studies were: 0.65/PY (49.6%; telmisartan monotherapy) and 0.70/PY (40.3%; telmisartan plus HCTZ). The most frequent suspected adverse reactions were dizziness and headache, which were comparable across groups and studies. The overall incidence of drug-related laboratory abnormalities was low in all treatment groups. Treatment-related hyperuricaemia and hypokalaemia occurred in less than 0.1% of patients, respectively, treated with telm...Continue Reading

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Citations

Jan 10, 2012·Expert Opinion on Pharmacotherapy·Sripal Bangalore, Ludwin Ley
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