Randomized, controlled trial of telcagepant for the acute treatment of migraine
RachelNardin, Cambridge Health Alliance, 1493 Cambridge St. Macht 420, Cambridge MA 02139rnardin@challiance.org
Submitted November 20, 2009
Connor et al. report that the use of 150 mg of telcagepant results in pain relief at 2 hours in 54% of migraine patients compared to 33% of patients achieving this endpoint with placebo. [1] Merck Research Laboratories funded this study and all the authors were employees of Merck or had financial ties to Merck or other large pharmaceutical companies. The publication of this trial raises serious concerns.
Triptans are the standard care for moderate to severe migraine. Sumatriptan 50 mg, now available as a generic, results in pain relief at 2 hours in 50% to 59% of migraine patients compared to 17% to 26% for placebo. [2] The relevant question for patients and physicians is whether telcagepant offers any advantage over sumatriptan.
The authors justify comparing telcagepant to placebo—rather than to active treatment— because it may be used in patients with coronary artery or cerebrovascular disease, in whom triptans are contraindicated. However, if this is the population of interest for telcagepant, it should be tested in this population.
There is sufficient preliminary data supporting the superiority of telcagepant to placebo. A placebo-controlled trial in the population of patients eligible for triptan treatment before a trial in the clinically relevant population of migraineurs with coronary artery and cerebrovascular disease was not needed.[3]
The objective of this trial appears to be to bolster FDA drug approval and marketing efforts.
References
1. Connor KM, Shapiro RE, Diener H-C et al. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology 2009;73:970-977.
3. Tepper SJ, Cleves C. Telcagepant, a calcitonin gene-related peptide antagonist for the treatment of migraine. Curr Opin Investig Drugs 2009;10:711-720.
Disclosure: Dr. Nardin serves on the editorial board of Muscle & Nerve; has received honoraria from academic institutions for giving grand rounds; and receives royalties from UpToDate.
Connor et al. report that the use of 150 mg of telcagepant results in pain relief at 2 hours in 54% of migraine patients compared to 33% of patients achieving this endpoint with placebo. [1] Merck Research Laboratories funded this study and all the authors were employees of Merck or had financial ties to Merck or other large pharmaceutical companies. The publication of this trial raises serious concerns.
Triptans are the standard care for moderate to severe migraine. Sumatriptan 50 mg, now available as a generic, results in pain relief at 2 hours in 50% to 59% of migraine patients compared to 17% to 26% for placebo. [2] The relevant question for patients and physicians is whether telcagepant offers any advantage over sumatriptan.
The authors justify comparing telcagepant to placebo—rather than to active treatment— because it may be used in patients with coronary artery or cerebrovascular disease, in whom triptans are contraindicated. However, if this is the population of interest for telcagepant, it should be tested in this population.
There is sufficient preliminary data supporting the superiority of telcagepant to placebo. A placebo-controlled trial in the population of patients eligible for triptan treatment before a trial in the clinically relevant population of migraineurs with coronary artery and cerebrovascular disease was not needed.[3]
The objective of this trial appears to be to bolster FDA drug approval and marketing efforts.
References
1. Connor KM, Shapiro RE, Diener H-C et al. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology 2009;73:970-977.
2. McCrory DC, Gray RN. Oral sumatriptan for acute migraine. Cochrane Database Syst Rev 2003;CD002915.
3. Tepper SJ, Cleves C. Telcagepant, a calcitonin gene-related peptide antagonist for the treatment of migraine. Curr Opin Investig Drugs 2009;10:711-720.
Disclosure: Dr. Nardin serves on the editorial board of Muscle & Nerve; has received honoraria from academic institutions for giving grand rounds; and receives royalties from UpToDate.