Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment

Vikelis, Michail; Dermitzakis, Emmanouil V.; Spingos, Konstantinos C.; Makris, Nikolaos; Kararizou, Evangelia

doi:10.1186/s10194-018-0918-3

Cited by 30 publications

(39 citation statements)

References 23 publications

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“…Treatment with onabotulinumtoxinA was safe in our population. The most common side effects were in concordance with those reported in other long-term studies [20] with no differences between HFEM and CM.…”

Section: Discussionsupporting

confidence: 89%

“…OnabotulinumtoxinA is currently approved as a preventative treatment for CM in the USA and most European countries, including Spain , based on results of the PREEMPT clinical trial programme . Since then, consensus guidelines and a large number of real‐life clinical studies have been published with findings on clinical predictors of response , comparison to other current preventative treatments and endorsing its effectiveness and safety in different long‐term cohorts .…”

Section: Introductionmentioning

confidence: 99%

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Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Alpuente

Gallardo

Torres‐Ferrús

et al. 2019

Euro J of Neurology

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Background and purpose The aim was to analyse the clinical characteristics of a long‐term follow‐up of patients with chronic and high‐frequency episodic migraine in treatment with onabotulinumtoxinA. Methods Patients diagnosed with high‐frequency episodic migraine (HFEM) or chronic migraine (CM) according to the International Classification of Headache Disorders 3 beta were included. A comparative analysis was carried out at each study time point identifying outcome measures according to initial diagnosis and treatment duration. Results In all, 578 patients were recruited and after 24 months outcome data were collected from 100 patients: 84.0% CM and 16.0% HFEM. After 24 months, headache frequency was significantly reduced by 10.5 days from baseline, 64.0% reported a ≥50% reduction in pain intensity and 70.0% of patients had ≥50% reduction in analgesic use. Comparing baseline diagnoses, at month 6 CM patients presented higher mean reduction in frequency (CM 44.3% ± 32.6% vs. HFEM 34.6% ± 24.8%) and analgesic use (CM 53.6% ± 35.4% vs. HFEM 39.3% ± 33.2%). At month 12, the mean reduction in frequency was similar in CM and HFEM patients (CM 44.7% ± 33.4% vs. HFEM 41.2% ± 28.2%). Improvement in pain intensity, analgesic use and Migraine Disability Assessment were proportional in both diagnoses. Conclusions OnabotulinumtoxinA efficacy is significant at 6 months in frequency and analgesic intake and remains stable during follow‐up, whilst the intensity of pain decreases in a stepwise manner at each time point of the analysis. The improvement in CM and HFEM patients is proportional and significant after 1 year of treatment.

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Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Alpuente

Gallardo

Torres‐Ferrús

et al. 2019

Euro J of Neurology

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“…We proved the efficacy and safety of six quarterly cycles over a period of 18 months in 47 patients with CM, highlighting that efficacy significantly increases upon repeated administration [ 14 ]. Other real-life studies confirmed BoNT-A safety and effectiveness for periods of two [ 15 – 19 ] and three [ 20 , 21 ] years, evidencing the sustained therapeutic benefits associated with long-term treatment. Moreover, a general worsening of patient conditions was reported upon abrupt discontinuation of treatment [ 13 ] or prolongation of the inter-injection time interval [ 22 ].…”

Section: Introductionmentioning

confidence: 77%

“…"responders" (≥ 50 and ≤ 75% reduction) and consistently positive trend of improvement beyond the first year of treatment [13], over an 18-month period [14], and over 2 years [15][16][17][18][19]. Two real-life studies on a 3-year treatment [20,21] reported, on top of good tolerability, continuous improvements of headache frequency [20,21], migraine severity, headache days with acute medication use [20], pain and analgesics consumption [21], thus supporting the strategy of consistent BoNT-A administration over long time.…”

Section: Discussionmentioning

confidence: 99%

Chronic migraine long-term regular treatment with onabotulinumtoxinA: a retrospective real-life observational study up to 4 years of therapy

et al. 2020

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Introduction OnabotulinumtoxinA (BoNT-A) was proved effective and safe in chronic migraine (CM) prevention by the Phase III Research Evaluating Migraine Prophylaxis (PREEMPT) and Phase IV Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) trials over 1 and 2 years of treatment, respectively. Real-life studies highlighted BoNT-A sustained benefits up to 3 years of administration. Aim of this retrospective real-life study was observing within a 4-year timeframe the progress of a consecutive series of CM patients treated with BoNT-A and evaluating whether long-term quarterly treatment (up to 16 cycles) confirms the outcomes of previous studies over shorter periods of therapy. Methods One hundred nine chronic migraineurs were quarterly treated with BoNT-A according to the PREEMPT paradigm. Headache days and hours, analgesics intake and latency time together with disability were analysed at baseline, thereafter biannually up to 48 months. Patient responsiveness (improvement in monthly headache days and hours versus baseline) was computed at each study timepoint. Results A significant overall decrease from baseline to the 48-month assessment (p < 0.001) was evidenced for the mean number of monthly headache days and hours, analgesics intake and latency time. Severe disability cases significantly decreased at 6 months (p < 0.001), and a progressive shift towards lower degrees of disability was observed at each subsequent timepoint. A gradual percentage increase of responsive cases was observed as treatment was repeated over time. Transitory neck pain was reported in 6 cases.Conclusions This study appears to reconfirm the benefits of long-lasting CM prevention with BoNT-A, thus supporting quarterly treatment with BoNT-A over several year.

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“…8 In addition, many patients are noncompliant with these medications; unsatisfactory e cacy, safety or tolerability issues, and concerns about long-term safety are among the reasons. 9 As such, there is a growing therapeutic shift over the last years towards treatments with lower adverse event rate, including onabotulinum toxin-A, monoclonal antibodies, external neurostimulators [22][23][24] and nutraceuticals. Nutraceuticals is a non-pharmacological approach that includes vitamins, minerals, and herbs in the prevention of migraines.…”

Section: Discussionmentioning

confidence: 99%

Real world, open label prospective experience of supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) for episodic migraine prophylaxis

Vikelis

Dermitzakis

Vlachos³

et al. 2020

Preprint

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BackgroundTo investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention.MethodsAn observational, prospective, real-world study was conducted. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine who were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL) and the third month of supplementation (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥ 50% reduction in monthly migraine days at T3, compared to BL were considered Vivinor®-responders.ResultsMean number of migraine days was significantly decreased between BL and T3 (9.9 ± 5.0 vs 6.2 ± 4.0; P < 0.001). Likewise, days with peak headache intensity of > 4/10 (8.3 ± 3.8 vs 5.8 ± 4.0; P < 0.001) as well as days using acute headache medications per month (9.8 ± 5.6 vs 7.2 ± 5.4; P < 0.001) were significantly reduced. At final visit, 64 patients (56.6%) were classified as responders. The beneficial effect of Vivinor® supplementation was also associated with significant changes in HIT-6, MIDAS, MTAQ and MSQ-QOL scores between BL and Τ3. There were no safety concerns.ConclusionsVivinor® appears to be an effective and well-tolerated preventive treatment against episodic migraine.Trial registrationNCT04463875, Registered 9 July 2020- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04463875

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Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment

Cited by 30 publications

References 23 publications

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Chronic migraine long-term regular treatment with onabotulinumtoxinA: a retrospective real-life observational study up to 4 years of therapy

Real world, open label prospective experience of supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) for episodic migraine prophylaxis

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