PS 14-33 DRUG EFFICACY AND SAFETY SURVEILLANCE OF TELMISARTAN/S-AMLODIPINE SINGLE-PILL COMBINATION IN KOREAN PATIENTS WITH HYPERTENSION

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Abstract

Objective:

To investigate the efficacy and safety surveillance of Telmisartan/S-Amlodipine single-pill combination.

Design and Method:

Hypertensive patients who took at least 1 dose of Telmisartan/S-Amlodipine single-pill were included in total 1,507 local clinics in Korea. Patients with 1 time point data regarding adverse effects and blood pressure were included in the study to find the unknown adverse effect in real word practice.

Results:

A total of 12,304 patients with both safety and efficacy data were included in the analysis. Fifty- five percents of patients were male and mean age was 59.6 ± 12.7 (range 19–98 yr). 31.1% of patients took a medicine for cardiovascular disease. The most common dose was T 40 mg/S-A 2.5 mg (62%), followed by T 80 mg/S-A 2.5 mg (20.5%), T 40 mg/S-A 5 mg (15.7%).

Results:

Blood pressure was significantly lowered from 144.0+16.5/89.1+11.8 mmHg to 129.9+11.3/81+8.8 mmHg after medication (difference −14.1 and −10.8 mmHg, P < 0.0001). Attainment rate to target blood pressure was 72.7%. The rate of SBP response (<140 mmHg or lowered 10 mmHg) or DBP response (<90 mmHg or lowered 10 mmHg) was 93.9%.

Results:

Total adverse events occurred in 1.23% (126 patients). The incidence of AEs was significantly higher in female group compared to male group (1.48% vs 1.02%, p = 0.037). The common AEs was headache (0.27%), dizziness (0.26%), and hypotension (0.2%). The incidence of peripheral edema was 0.1%. Drug related adverse events rate was 0.7% and no serious adverse event was reported. Drug discontinuation rate was 4.13% owing to 0.95% of adverse effect, 1.09% of low efficacy, and 2.09% others.

Conclusions:

Telmisartan/S-Amlodipine single-pill combination drug is an effective on lowering blood pressure and safe with drug-related adverse event rate 1.23%.

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