Introduction
Methods
Study design
Patient selection
Treatment
Concomitant therapies
Ethics
Outcome measures
Statistical analyses and data management
Statistics
Data sets analyzed
Results
Baseline demographics, disease characteristics, and previous treatment
SAF | EFF | |
---|---|---|
N = 336 | N = 302 | |
Gender (N, %) | ||
Female | 292 (76.9) | 266 (88.1) |
Male | 44 (13.1) | 36 (11.9) |
Age (years) | ||
Mean ± SD | 41.8 ± 11.6 | 41.5 ± 11.4 |
Median (range) | 42 (18, 71) | 42 (18, 71) |
Height (cm) | ||
Mean ± SD | 168.6 ± 7.1 | 168.5 ± 7.0 |
Median (range) | 168 (150, 193) | 168 (150, 193) |
Weight (kg) | ||
Mean ± SD | 69.1 ± 11.6 | 68.6 ± 11.3 |
Median (range) | 68 (46, 110) | 67 (46, 107) |
BMI (kg/m2) | ||
Mean ± SD | 24.3 ± 3.7 | 24.2 ± 3.6 |
Median (range) | 23.5 (17.7, 41.3) | 23.4 (17.7, 38.2) |
SAF | EFF | |
---|---|---|
N = 336 | N = 302 | |
Age at first diagnosis of migraine (years) | ||
N | 328 | 295 |
Mean ± SD | 24.1 ± 9.0 | 24.0 ± 8.6 |
Median (range) | 22 (8, 53) | 22 (8, 53) |
Time since diagnosis (years) | ||
N | 328 | 295 |
Mean ± SD | 17.5 ± 11.0 | 17.4 ± 10.7 |
Median (range) | 17 (0, 52) | 17 (0, 52) |
Migraine associated with menstruation (women only) (N, %a) | ||
No | 183 (62.7) | 167 (62.8) |
Yes | 107 (36.6) | 98 (36.8) |
Aura (N, %b) | ||
No | 234 (69.6) | 213 (70.5) |
Yes | 102 (30.4) | 89 (29.5) |
Patients with preventive treatment | 139 (46.0) | ||||
Number of therapeutic trials/drugs used | 1–2 | 3–4 | 5–10 | >10 | |
Beta blockers | 115 (82.7) | 7 (5.0) | 1 (0.7) | 1 (0.7) | |
Ca2+-channel blockers | 37 (26.6) | 1 (0.7) | |||
Anticonvulsants | 23 (16.5) | ||||
Antidepressives | 43 (30.9) | 2 (1.4) | 1 (0.7) | ||
Other | 14 (10.1) | 3 (2.2) | 1 (0.7) |
Topiramate dose
Efficacy outcomes
Number of migraine attacks
Number of days with migraine
Responder rates
Pain intensity scores
Migraine with aura
Migraine and menstruation
Baseline | Week 12 | Month 6 | Month 9 | Month 12 | LOCF | |
---|---|---|---|---|---|---|
N = 302 | N = 272 | N = 261 | N = 203 | N = 183 | N = 235 | |
Patients N (%) | ||||||
Women with documented visitsa | 266 (88.1) | 240 (88.2) | 230 (88.1) | 180 (88.7) | 164 (89.6) | 235 (100) |
Women with migraine attacksb | 259 (97.4) | 177 (73.8) | 196 (85.2) | 134 (74.4) | 119 (72.6) | 187 (79.6) |
Association with menstruationc | ||||||
No | 165 (63.7) | 137 (77.4) | 145 (74.0) | 93 (69.4) | 88 (73.9) | |
Yes | 94 (36.3) | 35 (19.8) | 45 (23.0) | 40 (29.9) | 31 (26.1) | 42 (22.5)d |
Impairment of activities in daily life
Absenteeism
Quality of life (questionnaire HIT-6TM)
Therapy satisfaction (tolerability and prophylactic efficacy)
Acute medication
Tolerability
All patients N (%) | |
---|---|
Number of patients treated | 336 |
All adverse events | |
Number of adverse events | 101 |
Patients with adverse events | 46 (13.7) |
Patients with serious adverse events | 2 (0.6) |
Number of deaths | 0 (0.0) |
Related adverse events | |
Number of adverse events | 64 |
Patients with adverse events | 35 (10.4) |
Patients with serious adverse events | 1 (0.3) |
Number of deaths | 0 (0.0) |
Total | ||||
---|---|---|---|---|
All AEs | AEs with CRa | |||
N
| % |
N
| % | |
At least one AEb | 46 | 13.7 | 35 | 10.4 |
At least one AE from the following classb | ||||
Paraesthesia | 10 | 3.0 | 9 | 2.7 |
Dizziness | 4 | 1.2 | 4 | 1.2 |
Diarrhea | 5 | 1.5 | 4 | 1.2 |
Nausea | 14 | 4.2 | 8 | 2.4 |
Fatigue | 4 | 1.2 | 4 | 1.2 |
Vomiting | 4 | 1.2 | 1 | 0.3 |