Indication and drug | Active drug | Placebo | Therapeutic gain | Primary endpoint of the study | Literature reference |
---|---|---|---|---|---|
Migraine/ETTH fixed-dose combination of 500 mg ASA + 400 mg paracetamol + 100 mg caffeine | Secondary endpoints: PID at 2 h VAS: 44.7 mm ≥50% pain reduction at 2 h: 77% of patients | PID at 2 h VAS: 24.6 mm ≥50% pain reduction at 2 h: 47% of patients | Δ = 20.1 mm Δ = 30% | Kaplan–Meier estimator of the proportion of patients with 50% pain relief during the first 4 h after drug intake | |
Migraine fixed-dose combination of 500 mg ASA + 500 mg paracetamol + 130 mg caffeine | Primary endpoint: TOTPAR-2 at 2 h: 2.7 | TOTPAR-2 at 2 h: 2.0 | Δ = 0.7 | TOTPAR-2 sum of pain relief scores at 2 h postdose (5-point VRS) | Goldstein et al. [44] |
ETTH fixed-dose combination of 1,000 mg paracetamol + 130 mg caffeine | Primary endpoint: study 1: TOTPAR-4: 10.45 ± 0.20 study 2: TOTPAR-4: 10.54 ± 0.19 | study 1: TOTPAR-4: 8.82 ± 0.30 study 2: TOTPAR-4: 7.86 ± 0.32 | Δ = 1.63 Δ = 2.68 | TOTPAR-4 sum of pain relief scores at 4 h postdose (5-point VRS) | Migliardi et al. [56] |
Migraine 1,000 mg ASA | Primary endpoint: response rate at 2 h: 52.5% of patients | response rate at 2 h: 30.6% of patients | Δ = 21.9% | Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 2 h (4-point VRS) | Diener et al. [37] |
Migraine 1,000 mg ASA | Primary endpoint: response rate at 2 h: 52% of patients | response rate at 2 h: 34% of patients | Δ = 18% | Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 2 h (4-point VRS) | Lipton et al. [52] |
ETTH 1,000 mg ASA | Primary endpoint: response rate at 2 h: (7-point VRS): 75.7% | response rate at 2 h: (7-point VRS): 54.5% | Δ = 21.2% | Number of patients (in %) with headache relief to grade 1 or 0 at 2 h (7-point VRS) | Steiner et al. [63] |
ETTH 12.5 mg diclofenac-K | Primary endpoint: TOTPAR-3: 5.23 ± 2.71 secondary endpoint: complete pain relief at 2 h: 18.1% of patients | TOTPAR-3: 3.49 ± 3.02 complete pain relief at 2 h: 7.8% of patients | Δ = 1.74 Δ = 10.3% | TOTPAR-3 (time-weighted sum of pain relief scores at 3 h) | Kubitzek et al. [49] |
ETTH 25 mg diclofenac-K | Primary endpoint: TOTPAR-3: 5.55 ± 2.95 secondary endpoint: complete pain relief at 2 h: 22.6% of patients | TOTPAR-3: 3.49 ± 3.02 complete pain relief at 2 h: 7.8% of patients | Δ = 2.06 Δ = 14.8% | TOTPAR-3 (time-weighted sum of pain relief scores at 3 h) | Kubitzek et al. [49] |
ETTH 400 mg ibuprofen | Primary endpoint: TOTPAR-3: 5.37 ± 3.07 secondary endpoint: complete pain relief at 2 h: 21.9% of patients | TOTPAR-3: 3.49 ± 3.02 complete pain relief at 2 h: 7.8% of patients | Δ = 1.88 Δ = 14.1% | TOTPAR-3 (time-weighted sum of pain relief scores at 3 h) | Kubitzek et al. [49] |
Migraine 400 mg ibuprofen | Primary endpoint: response rate at 2 h: 72.3% of patients secondary endpoints: PID at 2 h VAS: 1.23 ± 0.97 pain free (cumulative): 27.7% of patients | response rate at 2 h: 50% of patients PID at 2 h VAS: 0.71 ± 0.87 pain free (cumulative): 13.4% of patients | Δ = 22.3% Δ = 0.52 Δ = 14.3% | Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 2 h (4-point VRS) | Kellstein et al. [110] |
Migraine 1,000 mg paracetamol | Primary endpoint: response rate at 2 h: 57.8% of patients secondary endpoint: pain free (cumulative): 22.4% of patients | response rate at 2 h: 38.7% of patients secondary endpoint: pain free (cumulative): 11.3% of patients | Δ = 19.1% Δ = 11.1% | Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 4 h (4-point VRS) | Lipton et al. [111] |
ETTH 1,000 mg paracetamol | Secondary endpoint: response rate at 2 h (7-point VRS): 71.2% | response rate at 2 h (7-point VRS): 54.5% | Δ = 16.7% | Number of patients (in %) with headache relief to grade 1 or 0 at 2 h (7-point VRS) | Steiner et al. [63] |
Migraine 1,000 mg phenazone | Primary endpoint: response rate at 2 h: 48.6% of patients secondary endpoint: pain free at 2 h postdose: 27.6% of patients | response rate at 2 h: 27.2% of patients secondary endpoint: pain free at 2 h postdose: 13.6% of patients | Δ = 21.4% Δ = 14% | Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 4 h (4-point VRS) | Göbel et al. [42] |
Migraine 2.5 mg nartriptan | Primary endpoint: response rate at 4 h: 41% of patients secondary endpoint: response rate at 2 h: 25% of patients | response rate at 4 h: 19% of patients response rate at 2 h: 10% of patients | Δ = 22% Δ = 15% | Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 4 h (4-point VRS) | Stark et al. [61] |