[Botulinum toxin type A (Relatox) in transition from medication overuse to non-overuse status in patients with chronic migraine: a subgroup analysis of phase IIIb randomized single-blind multicenter active-controlled parallel-group trial].

Autor:	Artemenko AR; Sechenov First Moscow State Medical University of (Sechenov University), Moscow, Russia.; LLC «Medical Center «Practical Neurology», Moscow, Russia., Abramov VG; Federal Siberian Scientific and Clinical Center, Krasnoyarsk, Russia., Bozhenkina TV; Federal Siberian Scientific and Clinical Center, Krasnoyarsk, Russia., Konovalova ZN; LLC «Central Institute of Botulinotherapy and Actual Neurology», Moscow, Russia., Korenko AN; LLC «Professorial Clinic «Oda», St. Petersburg, Russia.; Academian I.P. Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia., Krasavina DA; LLC «Professorial Clinic «Oda», St. Petersburg, Russia.; Staint Petersburg State Pediatric Medical University, St. Petersburg, Russia., Kurenkov AL; LLC «Medical Center «Practical Neurology», Moscow, Russia.; National Medical Research Center for Children's Health, Moscow, Russia., Latysheva NV; Sechenov First Moscow State Medical University of (Sechenov University), Moscow, Russia.; LLC «Cephalgologist», Moscow, Russia., Naprienko MV; Sechenov First Moscow State Medical University of (Sechenov University), Moscow, Russia.; LLC «Cephalgologist», Moscow, Russia., Orlova OR; Sechenov First Moscow State Medical University of (Sechenov University), Moscow, Russia.; LLC «Central Institute of Botulinotherapy and Actual Neurology», Moscow, Russia., Filatova EG; Sechenov First Moscow State Medical University of (Sechenov University), Moscow, Russia.; LLC «Cephalgologist», Moscow, Russia., Shevchenko VS; LLC «Medical Center «Practical Neurology», Moscow, Russia.; Treatment and Rehabilitation Center, Moscow, Russia., Iakovleva PN; LLC «Central Institute of Botulinotherapy and Actual Neurology», Moscow, Russia.
Jazyk:	ruština
Zdroj:	Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova [Zh Nevrol Psikhiatr Im S S Korsakova] 2023; Vol. 123 (11), pp. 64-74.
DOI:	10.17116/jnevro202312311164
Abstrakt:	Objective: To access the effect of Relatox, the first Russian botulinum toxin type A, in patients with chronic migraine (CM) and medication overuse (MO). Material and Methods: In phase IIIb single-blind randomized multicenter active-controlled parallel-group study, patients with CM were randomized to once intramuscular injections of Relatox ( n= 101) or onabotulinumtoxin A injections - Botox ( n= 108). This subgroup analysis evaluated the percentage of patients who transition from medication overuse to non overuse status from baseline; mean changes in the number of headache days, migraine headache days, acute headache medication intakes days, headache intensity, proportion of patients who had a ≥50% reduction in headache days, proportion of the patients with severe (≥60) Headache Impact Test-6 score and with a severe (≥21) MIDAS score in a 28-day periods in each treatment among patients with baseline acute medication overuse via repeated measures. Results: Of 209 patients with CM, 100% met medication overuse criteria. Relatox and Botox demonstrated significant improvement for overall least squares mean change in headache days, migraine headache days, headache intensity; and headache-related disability and quality of life in CM patients with baseline MO, without differences between the groups. 75% and 70% patients in the Relatox and Botox groups, respectively, achieved ≥50% reduction in headache days from baseline (OR 1.58, CI 95% 0.84; 3.02, p =0.155). Furthermore, Relatox and Botox significant reduced average medication overuse rates in patient with CM and MO at baseline. 62% of patients in the Relatox group and 48% of patients in the Botox group transitioned from medication overuse to non overuse status compared from baseline (OR 2.07, CI 95% 0.91; 4.62, p =0.044). Relatox group had greater reductions than the Botox group in the percentage of patients with acute migraine-specific medication (triptan) overuse ( p =0.050). Conclusion: The results demonstrate highly prevalent of medication overuse among individuals with CM. This analysis provides evidence that the Russian botulinum toxin type A Relatox significantly improves measures of headache symptoms, quality of life and headache-related disability, and also significantly greater, compared to Botox, reduces migraine-specific medication consumption in patients with chronic migraine who overuse acute medications.
Databáze:	MEDLINE
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