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

Abstract

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.

• Angiotensin II receptor blockers
• hydrochlorothiazide
• safety, telmisartan
• thiazide diuretic
• tolerability