TWYNSTA Safety

Review safety data for TWYNSTA—A fixed-dose ARB/CCB combining telmisartan and amlodipine for the treatment of hypertension

The concomitant use of telmisartan and amlodipine has been evaluated for safety in more than 3700 patients with hypertension; approximately 1900 of these patients were exposed for at least 6 months and over 160 of these patients were exposed for at least 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.

In the placebo-controlled factorial design study, the population treated with a telmisartan and amlodipine combination had a mean age of 53 years and included approximately 50% males; 79% were Caucasian, 17% Black, and 4% Asian. Patients received doses ranging from 20/2.5 mg to 80/10 mg orally, once daily.

The frequency of adverse reactions was not related to gender, age, or race.

PERIPHERAL EDEMA

Peripheral edema is a known, dose-dependent adverse reaction of amlodipine, but not of telmisartan. In the factorial design study, the incidence of peripheral edema during the 8-week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy. The incidence was notably lower when telmisartan was used in combination with amlodipine 10 mg.

The incidence of peripheral edema during the 8-week treatment period is presented in the following table.


ADVERSE REACTIONS

The adverse reactions that occurred in the placebo-controlled factorial design trial in ≥2% of patients treated with Twynsta^® (telmisartan/amlodipine) Tablets and at a higher incidence in TWYNSTA-treated patients (n=789) than placebo-treated patients (n=46) are presented in the following table.


In addition, other adverse reactions that occurred in more than 1% of the patients treated with TWYNSTA tablets (n=789) were dizziness (2.0% vs 2.2% on placebo) and headache (1.4% vs 4.3% on placebo).

In the placebo-controlled factorial design trial, discontinuation due to adverse events occurred in 2.2% of all treatment cells of patients in the telmisartan/amlodipine-treated patients and in 4.3% in the placebo-treated group. The most common reasons for discontinuation of therapy with TWYNSTA tablets were peripheral edema, dizziness, and hypotension (each ≤0.5%).

NOTE: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.