International Journal of Hypertension / 2014 / Article / Tab 5

Research Article

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 monotherapyTelmisartan monotherapyT/A SPC therapy

Patients treated, 426245897
Total exposure (patient-years)66.631.6151.8
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, (%)
Nasopharyngitis37 (8.7)4 (1.6)63 (7.0)
Gastroenteritis4 (0.9)5 (2.0)4 (0.4)
Dizziness4 (0.9)0 (0)8 (0.9)
Peripheral edema 2 (0.5)0 (0)6 (0.7)
Bronchitis2 (0.5)0 (0)5 (0.6)
Back pain2 (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.