Table 2.
Overview of safety and tolerability in the EQUIP, CONQUER and SEQUEL trials.
|
Placebo
(n = 513) |
PHEN/TPM ER 3.25/23
(n = 240) |
PHEN/TPM ER 15/92
(n = 511) |
|
|---|---|---|---|
| EQUIP: 56 weeks [26] | |||
| Change in HR, bpm | -0.2 | -0.3 | 1.2 |
| SAEs, % | 2.5 | 2.5 | 2.5 |
| Discontinuation due to AEs, % | 8.4 | 11.3 | 16.0 |
| Change in bicarbonate, mEq/l | -0.3 | -1.6 | -1.7 |
|
Placebo
(n = 979) |
PHEN/TPM ER 7.5/46
(n = 488) |
PHEN/TPM ER 15/92
(n = 981) |
|
| CONQUER: 56 weeks [27] | |||
| Change in HR, bpm | -0.1 | 0.1 | 1.7 |
| SAEs, % | 4.0 | 3.0 | 5.0 |
| Discontinuation due to AEs, % | 9.0 | 11.6 | 19.3 |
| Change in bicarbonate, mEq/l | 0.5 | -0.3 | -1.0 |
|
Placebo
(n = 227) |
PHEN/TPM ER 7.5/46
(n = 153) |
PHEN/TPM ER 15/92
(n = 295) |
|
| SEQUEL: 108 weeks [29] | |||
| Change in HR, bpm | 0.4 | 1.3 | 1.7 |
| SAEs, % | 6.2 | 5.9 | 8.1 |
| Discontinuation due to AEs, % | 3.1 | 4.5 | 4.4 |
| Change in bicarbonate, mEq/l | 2.2 | 0.7 | 0.2 |
AE: Adverse event; HR: Heart rate; PHEN/TPM ER: Phentermine/topiramate extended-release; SAE: Serious adverse event.