Efficacy and Tolerability of Telmisartan Plus Amlodipine in Asian Patients Not Adequately Controlled on Either Monotherapy or on Low-Dose Combination Therapy
Table 5
Safety results of 8 weeks’ treatment with T/A combination or the respective monotherapies.
Amlodipine monotherapy
Telmisartan monotherapy
T/A SPC therapy
Patients treated,
426
245
897
Total exposure (patient-years)
66.6
31.6
151.8
Patients with any AE, (%)
111 (26.1)
49 (20.0)
218 (24.3)
Patients with drug-related AEs, (%)
9 (2.1)
3 (1.2)
24 (2.7)
Patients with SAE, (%)
2 (0.5)
0 (0)
4 (0.4)
Patients with AEs leading to discontinuation, (%)
4 (0.9)
4 (1.6)
9 (1.0)
Most common AEs that occurred in more than one patient on at least one of the treatments, (%)
Nasopharyngitis
37 (8.7)
4 (1.6)
63 (7.0)
Gastroenteritis
4 (0.9)
5 (2.0)
4 (0.4)
Dizziness
4 (0.9)
0 (0)
8 (0.9)
Peripheral edema
2 (0.5)
0 (0)
6 (0.7)
Bronchitis
2 (0.5)
0 (0)
5 (0.6)
Back pain
2 (0.5)
1 (0.4)
3 (0.3)
AE: adverse event; SAE: serious adverse event; SPC: single-pill combination; T/A: telmisartan plus amlodipine. The number of patients included in this analysis may differ from those of the individual study publications, due to differences in statistical approach for the individual studies.
