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Data on safety and tolerability of telmisartan (T) and T hydrochlorothiazide (HCTZ) in comparison with placebo (P) was consolidated from clinical trials. Safety data were collected from 34 randomized multicenter trials. Patients had a minimum of mild-to-moderate hypertension (supine DBP 90-114 mmHg). Treatment (P, T 10-160 mg or T 10-160 mg HCTZ 6.25-25 mg) was given for 7 days to more than 2 years. Uptitration was performed in some studies, with an increase of the T dose or the addition of HCTZ. The incidence and causality of adverse events and laboratory abnormalities were recorded. 819 patients received P, 6575 T and 2180 T HCTZ; 23.5% were 65 years of age or older and 4.5% were 75 years or older. Patient-years of treatment were P 106, T 4018 and T HCTZ 1568. Incidences of allcausality adverse events were P 38.2%, T 52.0% and T HCTZ 59.5%. Incidences of treatment-related adverse events were P 10.5%, T 12.0% and T HCTZ 12.8%, amounting to for P 1.02, T 0.20 and T HCTZ 0.18 such events per patient per treatment year. The most frequent treatment-related adverse events were dizziness and headache; incidences were similar in P, T and T HCTZ treatment groups. Incidences were also similar in younger patients (less than 65 years) and the elderly (65 years or older). Events were mainly mild or moderate in intensity. Incidences of serious adverse events were P 1.1%, T 4.3% and T HCTZ 5.6%, which amounts to 0.08 such events per patient per treatment year for P, 0.07 for T and 0.08 for T HCTZ. The overall incidence of drug-related laboratory abnormalities was low in all treatment groups. Hyperuricemia and hypokalemia considered related to treatment occurred in 5 and 6 patients, respectively, treated with T HCTZ. Incidences of discontinuation due to an adverse event were P 4.6%, T 4.5% and T HCTZ 4.7%. In conclusion, T and T HCTZ are both well tolerated in patients of all ages and have placebo-like tolerabilities.

Tolerability and safety of telmisartan as monotherapy or combined with hydrochlorothiazide compared with placebo