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

BACKGROUND To compare the tolerability and safety of telmisartan +/- hydrochlorothiazide (HCTZ). METHODS 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. RESULTS 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 telmisartan plus HCTZ. Incidences of discontinuation due to an AE were 4.6%, 4.5% and 4.7%, respectively, for the placebo, telmisartan and telmisartan plus HCTZ treatment groups. CONCLUSION The consolidated data show that telmisartan +/- HCTZ are well tolerated in patients of all ages and have placebo-like tolerabilities.