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Volume 7
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10.1080/20016689.2019.1603538
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Journal of Market Access & Health Policy (JMAHP) is published by MDPI from Volume 12 Issue 1 (2024). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Taylor & Francis.
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Article

From Investigational Product to Active Reference: Evolution of Oral Aumatriptan Efficacy versus Placebo for the Treatment of Acute Migraine Episodes and Potential Impact in Comparative Analyses

by
Katia Thokagevistk
1,
Clément François
1,2,*,
Mélanie Brignone
3 and
Mondher Toumi
1,2
1
Health Economics and Outcomes Research, Creativ-Ceutical, Paris, France
2
Public Health Department-Research Unit, Aix-Marseille University, Marseille, France
3
Health Economics and Outcomes Research, Lundbeck SAS, Paris, France
*
Author to whom correspondence should be addressed.
J. Mark. Access Health Policy 2019, 7(1), 1603538; https://doi.org/10.1080/20016689.2019.1603538
Submission received: 3 August 2018 / Revised: 28 March 2019 / Accepted: 29 March 2019 / Published: 15 April 2019

Abstract

Background: The relative efficacy and safety can vary among drugs over time. Sumatriptan, a first choice drug for acute migraine, can illustrate this phenomenon. Objective: To assess the evolution of the relative efficacy and tolerability of oral sumatriptan against placebo between its approval in 1991 and 2006. Methods: A systematic literature review of randomized controlled trials (RCTs) of adults suffering from acute migraine episodes was performed using Medline. Meta-analyses estimated odds ratios of the occurrence of pain-free at 2 hours and of any adverse event. Results: Out of the 67 RCTs identi.fied, pain-free at 2 hours and adverse events were reported in 25 and 28 studies, respectively. For pain-free, the relative effect of sumatriptan increases considerably over time, despite an increase in the absolute placebo effect. The odds ratio (95% CI) equaled 3.13 (1.67–5.86) around approval (1991–1994) and increased up to 4.14 (3.67–4.67) on the following decade. No specific variation was observed in the relative tolerability effect of sumatriptan over placebo over time. Conclusions: The relative effect of sumatriptan evolved substantially over time. This phenomenon may impact the results of network meta-analysis and indirect comparisons performed to evaluate the potential of a new drug, compared to widely prescribed older drugs.
Keywords: comparative evidence; meta-analysis; acute migraine episodes; sumatriptan comparative evidence; meta-analysis; acute migraine episodes; sumatriptan

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MDPI and ACS Style

Thokagevistk, K.; François, C.; Brignone, M.; Toumi, M. From Investigational Product to Active Reference: Evolution of Oral Aumatriptan Efficacy versus Placebo for the Treatment of Acute Migraine Episodes and Potential Impact in Comparative Analyses. J. Mark. Access Health Policy 2019, 7, 1603538. https://doi.org/10.1080/20016689.2019.1603538

AMA Style

Thokagevistk K, François C, Brignone M, Toumi M. From Investigational Product to Active Reference: Evolution of Oral Aumatriptan Efficacy versus Placebo for the Treatment of Acute Migraine Episodes and Potential Impact in Comparative Analyses. Journal of Market Access & Health Policy. 2019; 7(1):1603538. https://doi.org/10.1080/20016689.2019.1603538

Chicago/Turabian Style

Thokagevistk, Katia, Clément François, Mélanie Brignone, and Mondher Toumi. 2019. "From Investigational Product to Active Reference: Evolution of Oral Aumatriptan Efficacy versus Placebo for the Treatment of Acute Migraine Episodes and Potential Impact in Comparative Analyses" Journal of Market Access & Health Policy 7, no. 1: 1603538. https://doi.org/10.1080/20016689.2019.1603538

APA Style

Thokagevistk, K., François, C., Brignone, M., & Toumi, M. (2019). From Investigational Product to Active Reference: Evolution of Oral Aumatriptan Efficacy versus Placebo for the Treatment of Acute Migraine Episodes and Potential Impact in Comparative Analyses. Journal of Market Access & Health Policy, 7(1), 1603538. https://doi.org/10.1080/20016689.2019.1603538

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