OBJECTIVES: To assess the efficacy and tolerability of rizatriptan (RI), dexamethasone (DE), and RI combined with DE (RI+DE) in the acute treatment of menstrually related migraine (MRM). METHODS: This was a randomized, double-blind, 6-attack crossover study comparing RI 10 mg, DE 4 mg, and RI+DE (2 attacks each). The primary endpoint was 24-hour sustained-relief. The secondary endpoint was 24-hour sustained pain-free. We treated the primary and secondary endpoint as dichotomous outcomes and used matched nonparametric statistics to assess proportions. We used logistic regression to determine the effect of treatment order and if response to previous treatment influenced treatment response. RESULTS: A total of 35 patients treated 190 attacks (mean of 5.4 per participant). For the primary endpoint, RI was significantly superior to DE (62.7% vs 33.3%, P = .001). RI+DE was superior to RI (81.5% vs 62.7%, P < .05) and to DE (81.5% vs 33.3%%, P < .001). For the secondary endpoint RI was also superior to DE (32.2% vs 12.1%, P < .05). RI+DE was superior to RI (50.7% vs 32.2%, P < .05) and DE (P < .01, RR). Similar findings were seen for the other endpoints. More attacks treated with DE+RI (33.8%) were associated with side effects, compared to RI (18.6%) and DE (15.2%). CONCLUSIONS:Rizatriptan is an effective treatment for MRM. RI+DE is significantly more effective than RI alone, although is associated with higher rate of adverse events.The combination should be considered for subjects with high disability, incomplete relief, or recurrence of pain with triptan monotherapy.The use of DE alone in the treatment ofMRMis not justified based on our data.
RCT Entities:
OBJECTIVES: To assess the efficacy and tolerability of rizatriptan (RI), dexamethasone (DE), and RI combined with DE (RI+DE) in the acute treatment of menstrually related migraine (MRM). METHODS: This was a randomized, double-blind, 6-attack crossover study comparing RI 10 mg, DE 4 mg, and RI+DE (2 attacks each). The primary endpoint was 24-hour sustained-relief. The secondary endpoint was 24-hour sustained pain-free. We treated the primary and secondary endpoint as dichotomous outcomes and used matched nonparametric statistics to assess proportions. We used logistic regression to determine the effect of treatment order and if response to previous treatment influenced treatment response. RESULTS: A total of 35 patients treated 190 attacks (mean of 5.4 per participant). For the primary endpoint, RI was significantly superior to DE (62.7% vs 33.3%, P = .001). RI+DE was superior to RI (81.5% vs 62.7%, P < .05) and to DE (81.5% vs 33.3%%, P < .001). For the secondary endpoint RI was also superior to DE (32.2% vs 12.1%, P < .05). RI+DE was superior to RI (50.7% vs 32.2%, P < .05) and DE (P < .01, RR). Similar findings were seen for the other endpoints. More attacks treated with DE+RI (33.8%) were associated with side effects, compared to RI (18.6%) and DE (15.2%). CONCLUSIONS:Rizatriptan is an effective treatment for MRM. RI+DE is significantly more effective than RI alone, although is associated with higher rate of adverse events.The combination should be considered for subjects with high disability, incomplete relief, or recurrence of pain with triptan monotherapy.The use of DE alone in the treatment ofMRMis not justified based on our data.
Authors: Lidia Savi; Stefano Omboni; Carlo Lisotto; Giorgio Zanchin; Michel D Ferrari; Dario Zava; Lorenzo Pinessi Journal: J Headache Pain Date: 2011-08-13 Impact factor: 7.277
Authors: Marco Bartolini; Maria Adelaide Giamberardino; Carlo Lisotto; Paolo Martelletti; Davide Moscato; Biagio Panascia; Lidia Savi; Luigi Alberto Pini; Grazia Sances; Patrizia Santoro; Giorgio Zanchin; Stefano Omboni; Michel D Ferrari; Brigida Fierro; Filippo Brighina Journal: J Headache Pain Date: 2012-05-17 Impact factor: 7.277
Authors: Paola Sarchielli; Franco Granella; Maria Pia Prudenzano; Luigi Alberto Pini; Vincenzo Guidetti; Giorgio Bono; Lorenzo Pinessi; Massimo Alessandri; Fabio Antonaci; Marcello Fanciullacci; Anna Ferrari; Mario Guazzelli; Giuseppe Nappi; Grazia Sances; Giorgio Sandrini; Lidia Savi; Cristina Tassorelli; Giorgio Zanchin Journal: J Headache Pain Date: 2012-05 Impact factor: 7.277