For 100% response, the analysis model did not converge due to the small number of patients with 100% response. Open in a separate window Figure 2 Mean percentage of patients with 50% reduction from baseline in month to month migraine headache days. or used but not failed (no prior failure). Results In an integrated analysis of Bakuchiol EVOLVE studies, galcanezumab 120?mg/240?mg versus placebo led to larger overall mean (SE) reductions in month to month migraine headache days across 6?months in patients with prior preventive failures ((%)0672 (75.2)316 (71.2)331 (76.1)1319 (74.4)1222 (24.8)128 (28.8104 (23.9)454 (25.6)292 (10.3)51 (11.5)45 (10.3)188 (10.6)Age, years, mean (SD)041.8 (11.5)40.1 (11.7)40.1 (11.4)41.0 (11.5)142.0 (10.9)42.9 (10.9)41.9 (10.6)42.3 (10.8)243.8 (10.2)43.0 (11.6)43.8 (9.9)43.6 (10.5)Gender (female), %082.982.681.982.6189.291.491.490.3288.090.286.788.3Duration of migraine disease, years, mean (SD)020.3 (12.3)19.6 (12.2)19.0 (11.6)19.8 (12.1)121.3 (13.2)22.9 (12.5)21.8 (13.1)21.8 (13)222.9 (13.6)22.5 (12.9)24.8 (13.7)23.2 (13.4)Migraine headache days per month, mean (SD)09.1 (3.0)9.0 (3.0)9.0 Bakuchiol (2.9)9.1 (3.0)19.2 (2.9)9.5 (2.8)9.4 (2.9)9.3 (2.8)29.1 (3.0)9.3 (2.8)9.9 (2.8)9.3 (2.9)Migraine headache days per month with acute medication use, mean (SD)07.4 (3.5)7.2 (3.5)7.3 (3.3)7.3 (3.5)17.8 (3.2)8.0 (3.5)7.9 (3.1)7.9 (3.3)27.6 (3.4)8.2 (3.3)8.3 (3.1)7.9 (3.3)MSQ RF\R, imply (SD)a 052.8 (15.6)52.8 (15.4)49.7 (17.1)52.0 (16.0)150.1 (15.5)49.8 (15.4)52.1 (14.8)50.5 (15.3)249.7 (15.2)51.9 (14.5)55.1 (14.9)51.6 (15.0) Open in a separate windows GMB, galcanezumab; MSQ RF\R, Role Function\Restrictive domain score of the Migraine\Specific Quality of Life Questionnaire version 2.1; PBO, placebo. aFor MSQ RF\R domain name scores: PBO, (%) (%) (%) (%) /th /thead Antiepileptic199 (43.9)54 (11.9)46 (10.2)280 (61.8)Topiramate181 (40.0)39 (8.6)32 (7.1)246 (54.3)Valproate28 (6.2)10 (2.2)12 (2.6)49 Angpt1 (10.8)Gabapentin8 (1.8)4 (0.9)0 (0.0)12 (2.6)Zonisamide4 (0.9)3 (0.7)3 (0.7)10 (2.2)Pregabalin1 (0.2)3 (0.7)3 (0.7)6 (1.3)Ergenyl? chrono2 (0.4)1 (0.2)2 (0.4)5 (1.1)Beta blocker95 (21.0)32 (7.1)19 (4.2)145 (32.0)Propranolol64 (14.1)16 (3.5)14 (3.1)94 (20.8)Metoprolol15 (3.3)9 (2.0)6 (1.3)30 (6.6)Nadolol9 (2.0)4 (0.9)1 (0.2)14 (3.1)Antidepressant100 (22.1)25 (5.5)25 (5.5)140 (30.9)Amitriptyline67 (14.8)16 (3.5)12 (2.6)92 (20.3)Nortriptyline16 (3.5)4 (0.9)1 (0.2)21 (4.6)Venlafaxine7 (1.5)2 (0.4)6 (1.3)15 (3.3)Duloxetine2 (0.4)3 (0.7)2 (0.4)6 (1.3)Escitalopram2 (0.4)1 (0.2)3 (0.7)6 (1.3)Calcium channel blocker26 (5.7)13 (2.9)10 (2.2)48 (10.6)Flunarizine19 (4.2)9 (2.0)8 (1.8)35 (7.7)Verapamil3 (0.7)3 (0.7)1 (0.2)7 (1.5)Botulinum toxin type A16 (3.5)16 (3.5)031 (6.8)Angiotensin II antagonists10 (2.2)6 (1.3)2 (0.4)18 (4.0)Supplements16 (3.5)1 (0.2)0 (0.0)17 (3.8)Magnesium9 (2.0)1 (0.2)0 (0.0)10 (2.2)Riboflavin5 (1.1)0 (0.0)0 (0.0)5 (1.1)Antihistamines9 (2.0)0 (0.0)3 (0.7)12 (2.6)Pizotifen9 (2.0)0 (0.0)3 (0.7)12 (2.6)Muscle mass relaxant6 (1.3)2 (0.4)0 (0.0)8 (1.8)Tizanidine5 (1.1)1 (0.2)0 (0.0)6 (1.3)NSAIDs3 (0.7)3 (0.7)1 Bakuchiol (0.2)7 (1.5)Antipsychotic2 (0.4)0 (0.0)0 (0.0)2 (0.4)ACE inhibitors1 (0.2)0 (0.0)0 (0.0)1 (0.2)Ergot alkaloids0 (0.0)1 (0.2)0 (0.0)1 (0.2)Triptan1 (0.2)0 (0.0)0 (0.0)1 (0.2) Open in a separate windows ACE, angiotensin\converting enzyme; NSAID, non\steroidal anti\inflammatory drugs. A full list of drugs with reasons for failure is offered in Appendix S1. Individual medications included here are those that were failed by 1% of patients for efficacy and/or security/tolerability reasons. Medications identified in the treatment guidelines as having been investigated for preventive use 5, 15 were used to restrict the list of preventives reported by the investigative sites. Reductions in monthly migraine headache days In an integrated analysis of EVOLVE studies, amongst patients who failed 1 or 2 2 prior preventives, treatment with galcanezumab 120?mg/240?mg versus placebo led to significantly ( em P /em ? ?0.001) larger overall reductions from baseline in month to month migraine headache days over the 6\month period. Least squares (LS) mean switch (standard error, SE) in prior failure subgroups were as follows: 1 prior failure: galcanezumab 120?mg: ?4.04 (0.43); galcanezumab 240?mg: ?4.21 (0.46); placebo: ?1.30 (0.37); 2 prior failures: galcanezumab 120?mg: ?3.06 (0.74); galcanezumab 240?mg: ?3.83 (0.80); placebo: ?0.46 (0.64) (Fig. ?(Fig.1a,1a, b). Comparable results were observed in patients with no prior failures but the placebo response was larger [LS mean switch (SE): galcanezumab 120?mg: ?4.72 (0.24); galcanezumab 240 mg: ?4.46 (0.23); placebo: ?3.02 (0.20); Fig. ?Fig.1c].1c]. In all three subgroups, treatment with galcanezumab 120?mg/240?mg versus placebo led to significantly ( em P /em ? ?0.05) larger reductions from baseline in the number of monthly migraine headache days in each month (months 1C6) of the treatment period (Fig. ?(Fig.11aCc). Open in a separate window Physique 1 Monthly and overall LS mean changes from baseline in the number of migraine headache days per month during the treatment period. [Colour figure can be viewed at http://wileyonlinelibrary.com] Differences in overall reductions in migraine headache days between galcanezumab dose groups and placebo during the 6\month period were larger in patients.
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