Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis
We aimed to provide insights on the role of the circadian time of administration in influencing the efficacy and tolerability/safety profile of OnabotulinumtoxinA (BoNTA) for chronic migraine (CM) prophylaxis. Methods: We retrospectively reviewed the medical files of BoNTA-naïve patients with CM who...
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MDPI AG
2022-04-01
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| Series: | Toxins |
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| Online Access: | https://www.mdpi.com/2072-6651/14/5/296 |
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| author | Emmanouil V. Dermitzakis Michail Vikelis George S. Vlachos Andreas A. Argyriou |
| author_facet | Emmanouil V. Dermitzakis Michail Vikelis George S. Vlachos Andreas A. Argyriou |
| author_sort | Emmanouil V. Dermitzakis |
| collection | DOAJ |
| description | We aimed to provide insights on the role of the circadian time of administration in influencing the efficacy and tolerability/safety profile of OnabotulinumtoxinA (BoNTA) for chronic migraine (CM) prophylaxis. Methods: We retrospectively reviewed the medical files of BoNTA-naïve patients with CM who completed three consecutive cycles of treatment, according to the standard PREEMPT paradigm. Participants were classified to those scheduled to be treated in the morning hours from 8:00 to 12:00 (AM) or afternoon hours from 13:00 to 18:00 (PM). We then assessed and compared between groups the changes from baseline (T0—trimester before BoNTA’s first administration) to the period after its third administration (T3) in the following efficacy outcomes: (i) mean number of headache days/month, (ii) mean number of days/month with peak headache intensity of >4/10, (iii) mean number of days/month with consumption of any abortive treatment. Safety–tolerability was also compared between groups. Results: A total of 50 AM and 50 PM-treated patients were evaluated. The within-group analysis in both groups showed a significant decrease in all efficacy variables between T0 and T3. However, the between-group comparisons of all BoNTA-related efficacy outcomes at T3 vs. T0 documented comparable improvements between AM vs. PM-treated patients. Safety/tolerability was also similar between groups. Conclusions: We were not able to identify significant differences between patients treated in the AM vs. PM, so as to demonstrate that the circadian time of administration should be considered before initiating BoNTA in CM patients. |
| first_indexed | 2024-03-10T01:42:35Z |
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| id | doaj.art-b8dec0ee59604329a25e9d5450cc8278 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-03-10T01:42:35Z |
| publishDate | 2022-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-b8dec0ee59604329a25e9d5450cc82782023-11-23T13:22:27ZengMDPI AGToxins2072-66512022-04-0114529610.3390/toxins14050296Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine ProphylaxisEmmanouil V. Dermitzakis0Michail Vikelis1George S. Vlachos2Andreas A. Argyriou3Department of Neurology, “Geniki Kliniki” Euromedica, 54645 Thessaloniki, GreeceHeadache Clinic, Mediterraneo Hospital, 16675 Glyfada, GreeceHeadache Clinic, Mediterraneo Hospital, 16675 Glyfada, GreeceNeurology Department of the “Agios Andreas” State General Hospital of Patras, Headache Outpatient Clinic, 26335 Patras, GreeceWe aimed to provide insights on the role of the circadian time of administration in influencing the efficacy and tolerability/safety profile of OnabotulinumtoxinA (BoNTA) for chronic migraine (CM) prophylaxis. Methods: We retrospectively reviewed the medical files of BoNTA-naïve patients with CM who completed three consecutive cycles of treatment, according to the standard PREEMPT paradigm. Participants were classified to those scheduled to be treated in the morning hours from 8:00 to 12:00 (AM) or afternoon hours from 13:00 to 18:00 (PM). We then assessed and compared between groups the changes from baseline (T0—trimester before BoNTA’s first administration) to the period after its third administration (T3) in the following efficacy outcomes: (i) mean number of headache days/month, (ii) mean number of days/month with peak headache intensity of >4/10, (iii) mean number of days/month with consumption of any abortive treatment. Safety–tolerability was also compared between groups. Results: A total of 50 AM and 50 PM-treated patients were evaluated. The within-group analysis in both groups showed a significant decrease in all efficacy variables between T0 and T3. However, the between-group comparisons of all BoNTA-related efficacy outcomes at T3 vs. T0 documented comparable improvements between AM vs. PM-treated patients. Safety/tolerability was also similar between groups. Conclusions: We were not able to identify significant differences between patients treated in the AM vs. PM, so as to demonstrate that the circadian time of administration should be considered before initiating BoNTA in CM patients.https://www.mdpi.com/2072-6651/14/5/296OnabotulinumtoxinAchronic migraineefficacytolerability/safetycircadian time |
| spellingShingle | Emmanouil V. Dermitzakis Michail Vikelis George S. Vlachos Andreas A. Argyriou Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis Toxins OnabotulinumtoxinA chronic migraine efficacy tolerability/safety circadian time |
| title | Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis |
| title_full | Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis |
| title_fullStr | Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis |
| title_full_unstemmed | Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis |
| title_short | Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis |
| title_sort | assessing the significance of the circadian time of administration on the effectiveness and tolerability of onabotulinumtoxina for chronic migraine prophylaxis |
| topic | OnabotulinumtoxinA chronic migraine efficacy tolerability/safety circadian time |
| url | https://www.mdpi.com/2072-6651/14/5/296 |
| work_keys_str_mv | AT emmanouilvdermitzakis assessingthesignificanceofthecircadiantimeofadministrationontheeffectivenessandtolerabilityofonabotulinumtoxinaforchronicmigraineprophylaxis AT michailvikelis assessingthesignificanceofthecircadiantimeofadministrationontheeffectivenessandtolerabilityofonabotulinumtoxinaforchronicmigraineprophylaxis AT georgesvlachos assessingthesignificanceofthecircadiantimeofadministrationontheeffectivenessandtolerabilityofonabotulinumtoxinaforchronicmigraineprophylaxis AT andreasaargyriou assessingthesignificanceofthecircadiantimeofadministrationontheeffectivenessandtolerabilityofonabotulinumtoxinaforchronicmigraineprophylaxis |