Effects of encapsulation on absorption of sumatriptan tablets: data from healthy volunteers and patients during a migraine

Fuseau, Eliane; Pétricoul, Olivier; Sabin, Antony; Pereira, Adrian; O’Quinn, Stephen; Thein, Stephen; Leibowitz, Mark; Purdon, Helen; McNeal, Scott; Salonen, R; Metz, Alan; Coates, P. E.

doi:10.1016/s0149-2918(01)80006-0

Cited by 37 publications

(38 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In vivo comparison of bioavailability was not performed. It was previously reported that encapsulation of sumatriptan delays absorption for up to two hours after intake, particularly during migraine (28). However, differences in efficacy of sumatriptan were found in clinical trials using encapsulated sumatriptan as active comparator (29)(30)(31).…”

Section: Discussionmentioning

confidence: 99%

BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: Results from a phase II study

Diener

Barbanti

Dahlöf³

et al. 2010

Cephalalgia

199

123

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: Results from a phase II study

Diener

Barbanti

Dahlöf³

et al. 2010

Cephalalgia

199

123

View full text Add to dashboard Cite

show abstract

“…Four of the studies have been published [6, 7, 8, 9]and one has not yet been published (Study 052, crossover comparison of rizatriptan 10 mg versus sumatriptan 50 mg, and rizatriptan 5 mg versus sumatriptan 25 mg). An early clinical trial in which rizatriptan 10 mg was compared with sumatriptan 100 mg using encapsulated clinical supplies [10]was not included in the analysis because of the concern that encapsulation may influence treatment response [11]. Similar study procedures were followed in all studies, allowing for pooling of the data.…”

Section: Methodsmentioning

confidence: 99%

Restoring Migraine Sufferers’ Ability to Function Normally: A Comparison of Rizatriptan and Other Triptans in Randomized Trials

Bussone¹,

D’Amico²,

McCarroll

et al. 2002

Eur Neurol

View full text Add to dashboard Cite

Background: Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers. Methods: Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale (‘normal’, ‘mild impairment’, ‘severe impairment’, ‘requires bedrest’) at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline. Results: Most patients in each trial and treatment group had some level of disability at baseline (range = 94–100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008). Conclusion: In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan.

show abstract

“…Patients rated sumatriptan (64%) and all doses of eletriptan (64%, 74% and 84% for the 20, 40 and 80 mg doses, respectively) more acceptable than placebo (32%), with the highest acceptability rate reported for eletriptan 80 mg. Sumatriptan, but not eletriptan was encapsulated for blinding purposes in the study, making the comparative groups asymmetric, a potential bias that was maximised by the parallel group design. Encapsulation of sumatriptan has been shown to negatively affect its pharmacokinetics and absorption [8].…”

Section: Sumatriptan Vs Zolmitriptanmentioning

confidence: 99%

Patients’ preference for triptans and other medications as a tool for assessing the efficacy of acute treatments for migraine

Dowson

Tepper

Dahlöf³

2005

J Headache Pain

View full text Add to dashboard Cite

Oral triptans are effective and well tolerated acute treatments for migraine, but clinical differences between them are small and difficult to measure in conventional clinical trials. Patient preference assesses a global measure of efficacy and tolerability, and may be a more sensitive means of distinguishing between these drugs. In a series of studies, patients consistently expressed a clear preference for triptans over their usual non–triptan acute medications, e.g., analgesics and ergotamine. Direct comparator studies of patient preference with oral triptans showed that patients could distinguish between different triptans, and between different formulations of the same triptan. Patients could even distinguish between the three oral doses of sumatriptan. The most frequently provided reasons for preference were speed of response and overall effectiveness. Patient preference is a sensitive clinical trial endpoint and physicians should consider using it when reviewing the efficacy of acute migraine medications.

show abstract

Effects of encapsulation on absorption of sumatriptan tablets: data from healthy volunteers and patients during a migraine

Cited by 37 publications

References 9 publications

BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: Results from a phase II study

BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: Results from a phase II study

Restoring Migraine Sufferers’ Ability to Function Normally: A Comparison of Rizatriptan and Other Triptans in Randomized Trials

Patients’ preference for triptans and other medications as a tool for assessing the efficacy of acute treatments for migraine

Contact Info

Product

Resources

About