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Results tables
Results tables
Table 5 Ferreira J et al. 2016 (BIPARK I)
Placebo |
Opicapone 50 mg |
Entacapone 200 mg |
Analysis |
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n (full analysis set) a |
120 |
115 |
120 |
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Primary outcome |
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Adjusted least squares mean change from baseline in absolute time (mins) in the off state |
−56.0 (from a baseline of 6.2 hours) |
−116.8 (from a baseline of 6.2 hours) |
−96.3 (from a baseline of 6.5 hours) |
Mean difference vs placebo (95% CI)b Opicapone 50 mg: −60.8 mins (−97.2 to −24.4), p=0.0015 Entacapone 200 mg: −40.3 mins (−76.2 to −4.3), p=0.014 |
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Mean difference between entacapone 200 mg vs opicapone 50 mg (95% CI)c, d −26.2 mins (−63.8 to 11.4), p=0.0051 |
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Selected secondary outcomes |
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Number of participants achieving a 1 hour or more reduction in absolute time in the off state |
57/120 (48%) |
80/115 |
Comparison with placebo OR (95% CI) Opicapone 50 mg: 2.5 (1.5 to 4.3), p=0.001 Entacapone 200 mg: 1.6 (0.9 to 2.6), p=0.094, NS |
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Number of participants achieving a 1 hour or more increase in the absolute time in the on state |
55/120 (46%) |
75/115 (65%) |
69/120 (58%) |
Comparison with placebo OR (95% CI) Opicapone 50 mg: 2.2 (1.3 to 3.8), p=0.003 Entacapone 200 mg: 1.6 (1.0 to 2.7), p=0.067, NS |
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Least squares mean change in total time (mins) in the on state to study end |
47.1 (from a baseline of 10 hours) |
119.0 (from a baseline of 9.9 hours) |
99.7 (from a baseline of 9.6 hours) |
Mean difference vs placebo (95% CI) Opicapone 50 mg: 71.9 (35.0 to 108.8), p=0.0001 Entacapone 200 mg: 52.6 (16.1 to 89.1), p=0.005 |
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Least squares mean change in time (mins) in the on state without troublesome dyskinesia |
46.5 |
109.1 |
94.1 |
Mean difference vs placebo (95% CI) Opicapone 50 mg: 62.6 (23.8 to 101.4), p=0.002 Entacapone 200 mg: 47.6 (9.3 to 6.0), p=0.02 |
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Least squares mean change in the UPDRS total score from baseline to study ende |
−5.4 |
−6.1 |
−6.1 |
p value vs placebof Opicapone 50 mg, p=0.56, NS Entacapone 200 mg, p=0.56, NS |
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Least squares mean change in the PDSS score from baseline to study endg |
1.0 |
2.9 |
2.9 |
p value vs placebof Opicapone 50 mg, p=0.45, NS Entacapone 200 mg, p=0.45, NS |
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Least squares mean change in the PDQ-39 total score from baseline to study endh |
−2.6 |
−2.8 |
−4.0 |
p value vs placebof Opicapone 50 mg, p=0.90, NS Entacapone 200 mg, p=0.28, NS |
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Least squares mean change in the NMSS score from baseline to study endi |
−5.7 |
−2.0 |
−4.7 |
p value vs placebof Opicapone 50 mg, p=0.06, NS Entacapone 200 mg, p=0.63, NS |
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CGI-C (% of patients with improvement)j |
49.9 |
73 |
50.9 |
p value vs placebof Opicapone 50 mg, p=0.0005 Entacapone 200 mg, p=0.61, NS |
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PGI-C (% of patients with improvement)j |
50.9 |
72.1 |
52.5 |
p value vs placebof Opicapone 50 mg, p=0.0008 Entacapone 200 mg, p=0.47, NS |
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Safety and tolerability outcomes |
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n (safety set) |
121 |
115 |
122 |
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Number of participants with at least 1 TEAEs |
60/121 (50%) |
62/115 (54%) |
69/122 (57%) |
Not reported |
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Number of participants with TEAEs leading to study medicine discontinuation |
8/121 (7%) |
5/115 (4%) |
8/122 (7%) |
Not reported |
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Number of participants with TEAEs |
6/121 (5%) |
4/115 (3%) |
8/122 (7%) |
Not reported |
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Number of participants with dyskinesia |
5/121 (4%) |
18/115 (16%) |
10/122 (8%) |
Not reported |
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a Intention-to-treat analysis (full analysis set) b Superiority test vs placebo c Non-inferiority test vs entacapone (non-inferiority margin of 30 minutes) d Per protocol set: entacapone 200 mg, n=104; opicapone 50 mg, n=106, see EPAR for details. e Analysed in 114 participants in the placebo group, 109 in the opicapone 50 mg group and 111 in the entacapone group f Effect size not reported in the paper g Analysed in 117 participants in the placebo group, 112 in the opicapone 50 mg group and 118 in the entacapone group h Analysed in 120 patients in the placebo group, 113 in the opicapone 50 mg group and 117 in the entacapone group i Analysed in 118 patients in the placebo group, 112 in the opicapone 50 mg group and 116 in the entacapone group J Data for 3 participants in the entacapone group and for 2 participants in the opicapone group were missing or they were not assessed |
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Abbreviations: CGI‑C, clinician global impression of change; CI, confidence interval; NS, not statistically significant; OR, odds ratio; PGI‑C, patient global impression of change; TEAE, treatment-emergent adverse event. |