Table 1.
Safety profile for telmisartan/amlodipine combination therapy: adverse event reporting
| TEAMSTA-5
|
TEAMSTA-10
|
Trial no 1235.16
|
||||
|---|---|---|---|---|---|---|
| T40/A5 n = 976 n (%) | T80/A5 n = 397 n (%) | T40/A10 n = 838 n (%) | T80/A10 n = 611 n (%) | T40/A5 n = 211 n (%) | T80/A5 n = 48 n (%) | |
| All-cause AEs | 381 (39) 95 per 100 PY |
201 (51) 97 per 100 PY |
102 (12) 50 per 100 PY |
157 (26) 46 per 100 PY |
163 (77) | 37 (77) |
| Discontinuations due to AEs | 12 (1.2) 3 per 100 PY |
4 (1.0) 2 per 100 PY |
6 (0.7) 3 per 100 PY |
9 (1.5) 3 per 100 PY |
– | – |
| SAE | 22 (2.3) 4 per 100 PY |
6 (1.5) 4 per 100 PY |
4 (0.5) 3 per 100 PY |
13 (2.1) 2 per 100 PY |
9 (4.3)a | 3 (6.3)a |
| Study-drug related AE | 51 (5.2) 13 per 100 PY |
30 (7.6) 14 per 100 PY |
28 (3.3) 14 per 100 PY |
38 (6.2) 11 per 100 PY |
4 (1.9) | 2 (4.2) |
| Treatment-related AE occurring in >1% of patients in any treatment group | ||||||
| Peripheral Edema | 23 (2.4) 6 per 100 PY |
11 (2.8) 5 per 100 PY |
16 (1.9) 8 per 100 PY |
24 (3.9) 7 per 100 PY |
– | – |
| Dizziness | 0 | 6 (1.5) 3 per 100 PY |
0 | 0 | – | – |
Notes: Number of participants (n) represents the number analyzed for the primary efficacy endpoints with the exception of TEAMSTA-10, which analyzed all participants exposed to study drug. An en-dash (–) indicates no data were provided. aNot considered related to study drug.
Abbreviations: T, telmisartan; A, amlodipine; TEAMSTA, TElmisartan plus AMlodipine Study–Amlodipine; AE, adverse event; PY, patient years; SAE, serious adverse event.