OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial

Hc, Diener; Dodick, DW; Aurora, SK; Turkel, Catherine C.; DeGryse, Ronald; Lipton, RB; Silberstein, SD; Brin, MF

doi:10.1177/0333102410364677

Cited by 847 publications

(928 citation statements)

References 45 publications

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“…The two largest multicentre RCTs were those of the PREEMPT programme sponsored by Allergan [69] [70,71]. PREEMPT 1 and 2 comprised 1,384 CM patients randomized either to BoNT-A (n = 688) or to saline injections (n = 696) and followed up for 24 weeks during which they received two injection cycles.…”

Section: Other Agentsmentioning

confidence: 99%

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society

Paemeleire

Louis²,

Magis

et al. 2014

Acta Neurol Belg

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Chronic migraine (CM) is a disabling neurological condition affecting 0.5-2 % of the population. In the current third edition of the International Classification of Headache Disorders, medication overuse is no longer an exclusion criterion and CM is diagnosed in patients suffering from at least 15 headache days per month of which at least eight are related to migraine. CM is difficult to treat, and preventive treatment options are limited. We provide a pathogenetic model for CM, integrating the latest findings from neurophysiological and neuroimaging studies. On behalf of the Belgian Headache Society, we present a management algorithm for CM based on the international literature and adapted to the Belgian situation. Pharmacological treatment options are discussed, and recent data on transcranial and invasive neuromodulation studies in CM are reviewed. An integrated multimodal treatment programme may be beneficial to refractory patients, but at present, this approach is only supported by a limited number of observational studies and quite variable between centres

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Section: Other Agentsmentioning

confidence: 99%

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society

Paemeleire

Louis²,

Magis

et al. 2014

Acta Neurol Belg

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“…In questo studio, la coorte simulata è quella estratta dal database della ex ASL Roma A. Il modello, la cui struttura è riportata in Figura 1, utilizza probabilità di transizione tra sei stati di salute, sulla base della frequenza con cui si presenta il mal di testa nell'arco di un mese (0-3, 4-9, 10-14, 15-19, 20-23, 24-28 giorni al mese) e una transizione supplementare per l'interruzione della terapia, derivate dagli studi clinici PREEMPT su un totale di 1.384 soggetti [17,18]. La frequenza di mal di testa è un criterio utilizzato per la classificazione di emicrania cronica, pertanto può essere ritenuta una misura chiave per definire gli stati di salute del modello.…”

Section: Struttura Del Modellounclassified

“…I dati di efficacia inseriti nel modello provengono dai due studi registrativi PREEMPT di onabotulinumtoxinA di Fase III, randomizzati, controllati con placebo, in doppio cieco, della durata di 24 settimane seguite da una fase in aperto di 32 settimane [17,18] e i cui risultati sono stati aggregati e pubblicati [10]. L'endpoint primario dell'analisi dei dati aggregati è la variazione rispetto al basale dei giorni di emicrania dopo 24 settimane di trattamento.…”

Section: Dati DI Efficaciaunclassified

[Organizational and financial aspects of the introduction of Botox® in the clinical diagnostic therapeutic process of chronic migraine at a Local Health Unit in Italy]

Cioffi

Oradei

Cerbo³

et al. 2016

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ma cronica è caratterizzata da una frequenza di cefalee maggiore di 15 giorni al mese per almeno 3 mesi consecutivi con o senza aura. L'emicrania cronica rimane ancora una condizione sotto-diagnosticata e sotto-trattata e generalmente esiste una scarsa consapevolezza del burden of disease [2] . A livello glo- IntroduzIoneSecondo l'International Classification of Headache Disorders, terza edizione (ICHD 3-beta) [1] si distinguono, rispetto alla frequenza degli attacchi, due forme di emicrania, quella episodica e quella cronica. La for- Corresponding authorFrancesca Cioffi cioffi_francesca@allergan.com DisclosureThe publication fee was sponsored by Allergan Spa AbstrAct BACKGROUND: Existing literature shows that the use of Botox

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“…Two double-blind, randomized, placebocontrolled clinical trials for the treatment of CM with onabotulinumtoxinA, the Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) 1 and 2, as well as the pooled data from the two trials were recently published [12,44,45]. Pooled analyses demonstrate a mean decrease from baseline in frequency of headache days, with statistically significant between-group differences favouring onabotulinumtoxinA over placebo (-8.4 vs. -6.6; P \ 0.001).…”

Section: Role Of Long-acting Opioids In Chronic Migrainementioning

confidence: 99%

“…While the options for prophylaxis therapy of migraine have expanded and improved considerably over recent years, CM remains very difficult to treat. The medical literature contains relatively few reports of randomized controlled trials about treatment of CM [12][13][14] and relatively few patients receive a benefit from the proposed therapies. A further hope for patients with CM might come from the neurostimulation techniques [15].…”

Section: Introductionmentioning

confidence: 99%

Opioids can be useful in the treatment of headache

Finocchi

Viani

2013

Neurol Sci

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The use of opioids in headache treatment is very controversial. In the migraine acute attack use of short-acting opioids is not recommended by the principal guidelines but is frequent in North American emergency departments. Their efficacy in migraine acute attack has not been extensively studied but seems to be similar to nonsteroidal anti-inflammatory drugs and metoclopramide. Opioids have been never compared to triptans. The principal concerns about the use of opioids regard the possible association with an increased risk of medication-overuse headache and chronic migraine and the risk of abuse and dependence. These risks have to be considered but not overestimated. The association between frequent use and increased risk of chronic migraine has been observed for almost all categories of acute migraine attack drugs. Compared to the reference category of acetaminophen, risk of chronic migraine for opioid use is only moderately higher (with an OR = 1.48). In some cases, when treatment with triptans, non-steroidal anti-inflammatory drugs, or ergotamines is contraindicated or simply ineffective, a judicious prescription of a short-acting opioid for severe migraine attacks can be considered. Chronic migraine is a highly disabling condition. Although the options for prophylaxis therapy of migraine have expanded and improved considerably over recent years, chronic migraine remains very difficult to treat. The results coming from small clinical series are described, suggesting that in expert hands daily long-acting opioids provide an option for the treatment of some individuals with chronic intractable headaches.

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OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial

Abstract: The results of PREEMPT 2 demonstrate that onabotulinumtoxinA is effective for prophylaxis of headache in adults with chronic migraine. Repeated onabotulinumtoxinA treatments were safe and well tolerated.

Cited by 847 publications

References 45 publications

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society

[Organizational and financial aspects of the introduction of Botox® in the clinical diagnostic therapeutic process of chronic migraine at a Local Health Unit in Italy]

Opioids can be useful in the treatment of headache

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