Table 1.
Overview of phentermine/topiramate ER Phase II and III clinical trials*.
| Placebo (n = 55) |
PHEN/TPM ER 15/92
(n = 75) |
p-value vs placebo | |||
|---|---|---|---|---|---|
| Diabetes: 56 weeks [21] | |||||
| HbA1c, % | -1.2 | -1.6 | 0.0381 | ||
| Weight loss, % | -2.7 | -9.4 | < 0.0001 | ||
| SBP, mm Hg | -2.4 | -7.2 | < 0.05 | ||
| DBP, mm Hg | -1.7 | -2.6 | NS | ||
| Fasting glucose, mg/dl | -27.4 | -42.1 | < 0.05 | ||
| Fasting insulin, μIU/ml | 5.9 | 2.1 | < 0.05 | ||
| Placebo (n = 23) |
PHEN/TPM ER 15/92
(n = 22) |
p-value vs placebo | |||
| Obstructive sleep apnea: 28 weeks [22] | |||||
| AHI, events/h | -16.6 | -31.5 | 0.0084 | ||
| Weight loss, % | -4.2 | -10.3 | 0.0006 | ||
| Weight loss, kg | -4.7 | -10.8 | 0.0006 | ||
| SBP, mm Hg | -7.3 | -15.0 | 0.0431 | ||
| DBP, mm Hg | -5.6 | -6.3 | 0.7991 | ||
|
Placebo
(n = 103) |
PHEN/TPM ER 7.5/46 (n = 103) | p-value vs placebo |
PHEN/TPM ER 15/92
(n = 103) |
p-value vs placebo | |
| EQUATE: 28 weeks [25] | |||||
| Weight loss, % | -1.7 | -8.5 | < 0.0001 | -9.2 | < 0.0001 |
| SBP, mm Hg | -1.8 | -7.0 | < 0.05 | -5.2 | < 0.05 |
| DBP, mm Hg | -0.7 | -2.2 | NS | -2.0 | NS |
|
Placebo
(n = 498) |
PHEN/TPM ER 3.25/23 (n = 234) | p-value vs placebo |
PHEN/TPM ER 15/92
(n = 498) |
p-value vs placebo | |
| EQUIP: 56 weeks [26,52] | |||||
| Weight loss, % | -1.6 | -5.1 | < 0.0001 | -10.9 | < 0.0001 |
| Weight loss, kg | -1.9 | -5.9 | < 0.0001 | -12.6 | < 0.0001 |
| SBP, mm Hg | 0.9 | -1.8 | 0.0019 | -2.9 | < 0.0001 |
| DBP, mm Hg | 0.4 | -0.1 | NS | -1.5 | 0.0002 |
| Fasting glucose, mg/dl | 1.9 | 0.8 | NS | -0.6 | < 0.0001 |
| Triglycerides, % | 9.1 | 5.2 | NS | -5.2 | < 0.0001 |
| LDL-C, % | -5.5 | -7.7 | NS | -8.4 | 0.0157 |
| HDL-C, % | 0 | 0.5 | NS | 3.5 | 0.0005 |
|
Placebo
(n = 979) |
PHEN/TPM ER 7.5/46
(n = 488) |
p-value vs placebo |
PHEN/TPM ER 15/92
(n = 981) |
p-value vs placebo | |
| CONQUER: 56 weeks [27] | |||||
| Weight loss, % | -1.2 | -7.8 | < 0.0001 | -9.8 | < 0.0001 |
| Weight loss, kg | -1.4 | -8.1 | < 0.0001 | -10.2 | < 0.0001 |
| SBP, mm Hg | -2.4 | -4.7 | 0.0008 | -5.6 | < 0.0001 |
| DBP, mm Hg | -2.7 | -3.4 | NS | -3.8 | 0.0031 |
| Fasting glucose, mmol/l | 0.13 | -0.01 | 0.0047 | -0.07 | < 0.0001 |
| HbA1c, % | 0.1 | 0 | < 0.0001 | -0.1 | < 0.0001 |
| Fasting insulin, ρmol/l | 5.1 | -24.0 | 0.0004 | -27.6 | < 0.0001 |
| Triglycerides, % | 4.7 | -8.6 | < 0.0001 | -10.6 | < 0.0001 |
| LDL-C, % | -4.1 | -3.7 | NS | -6.9 | 0.0069 |
| HDL-C, % | 1.2 | 5.2 | < 0.0001 | 6.8 | < 0.0001 |
|
Placebo
(n = 227) |
PHEN/TPM ER 7.5/46 (n = 153) | p-value vs placebo |
PHEN/TPM ER 15/92
(n = 295) |
p-value vs placebo | |
| SEQUEL: 108 weeks [29] | |||||
| Weight loss, % | -1.8 | -9.3 | < 0.0001 | -10.5 | < 0.0001 |
| Weight loss, kg | -2.1 | -9.6 | < 0.0001 | -10.9 | < 0.0001 |
| SBP, mm Hg | -3.2 | -4.7 | NS | -4.3 | NS |
| DBP, mm Hg | -3.9 | -3.7 | NS | -3.5 | NS |
| Fasting glucose, mg/dl | 3.7 | 0.1 | NS | -1.2 | 0.0048 |
| HbA1c, % | 0.2 | 0.01 | 0.0042 | 0.00 | 0.0003 |
| Fasting insulin, μIU/ml | -2.6 | -5.3 | 0.0051 | -5.2 | 0.0012 |
| Triglycerides, % | 0.4 | -12.5 | < 0.01 | -13.7 | < 0.0001 |
| LDL-C, % | -10.7 | -4.6 | < 0.01 | -5.6 | < 0.01 |
| HDL-C, % | 4.7 | 7.3 | NS | 11.9 | < 0.0001 |
*All subjects in all treatment arms received standardized lifestyle and management to standard of care.
AHI: Apnea–hypopnea index; DBP: Diastolic blood pressure; HDL-C, high-density lipoprotein cholesterol; LDL-C: Low-density lipoprotein cholesterol; PHEN/TPM ER: Phentermine/topiramate extended-release; SBP: Systolic blood pressure.