Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine

David J. Hewitt, Vincent Martin, Richard B. Lipton, Jan Brandes, Paulette Ceesay, Regina Gottwald, Eleanor Schaefer, Christopher Lines, Tony W. Ho

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Objective. - To evaluate the efficacy and tolerability of telcagepant when co-administered with ibuprofen or acetaminophen for the acute treatment of migraine. Background. - Telcagepant is an oral calcitonin gene-related peptide receptor antagonist which is being evaluated for the acute treatment of migraine. Combining telcagepant with analgesics that have a different mechanism of action could produce greater efficacy. Methods. - Randomized, double-blind, placebo-controlled study. Patients were randomized to treat a moderate or severe migraine headache with either telcagepant 280 mg + ibuprofen 400 mg (N = 171), telcagepant 280 mg + acetaminophen 1000 mg (N = 171), telcagepant 280 mg (N = 170), or placebo (N = 171). The primary efficacy endpoint was 2-hour pain freedom. The study had approximately 88% power to detect an additive effect of at least 15 percentage points (telcagepant combination vs telcagepant monotherapy) and 48% power to detect an additive effect of at least 10 percentage points. Safety and tolerability were assessed by adverse events and laboratory tests. Results. - The percentages of patients with 2-hour pain freedom were greater in each active treatment group compared to placebo (P < .001): telcagepant + ibuprofen = 35.2%, telcagepant + acetaminophen = 38.3%, telcagepant = 31.2%, placebo = 10.9%. No significant differences were seen for either of the combination groups vs telcagepant monotherapy, but both were numerically larger than telcagepant monotherapy. All the active treatments were generally well tolerated. The percentage of patients reporting any adverse event within 48 hours was higher in the active treatment groups than placebo: telcagepant + ibuprofen = 30.3%, telcagepant + acetaminophen = 31.6%, telcagepant = 24.8%, placebo = 18.2%. The most common adverse events reported by ≥4 patients in one or more of the treatment groups that included telcagepant were fatigue, nausea, dizziness, somnolence, dry mouth, and tremor. Conclusions. - The combination of telcagepant 280 mg with either ibuprofen 400 mg or acetaminophen 1000 mg did not show a statistically significant difference from telcagepant alone. Numerically greater treatment effects in the combination treatment groups over the telcagepant 280 mg monotherapy suggest that telcagepant combination treatments may merit further evaluation in studies powered to detect smaller additive benefits. (Clinicaltrials.gov; NCT00758836).

Original languageEnglish (US)
Pages (from-to)533-543
Number of pages11
JournalHeadache
Volume51
Issue number4
DOIs
StatePublished - Apr 2011

Fingerprint

Ibuprofen
Acetaminophen
Migraine Disorders
Placebos
telcagepant
Therapeutics
Calcitonin Gene-Related Peptide Receptors
Pain

Keywords

  • Acetaminophen
  • Calcitonin gene-related peptide
  • Combination
  • Ibuprofen
  • Nonsteroidal anti-inflammatory drug
  • Telcagepant

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Hewitt, D. J., Martin, V., Lipton, R. B., Brandes, J., Ceesay, P., Gottwald, R., ... Ho, T. W. (2011). Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache, 51(4), 533-543. https://doi.org/10.1111/j.1526-4610.2011.01860.x

Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. / Hewitt, David J.; Martin, Vincent; Lipton, Richard B.; Brandes, Jan; Ceesay, Paulette; Gottwald, Regina; Schaefer, Eleanor; Lines, Christopher; Ho, Tony W.

In: Headache, Vol. 51, No. 4, 04.2011, p. 533-543.

Research output: Contribution to journalArticle

Hewitt, DJ, Martin, V, Lipton, RB, Brandes, J, Ceesay, P, Gottwald, R, Schaefer, E, Lines, C & Ho, TW 2011, 'Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine', Headache, vol. 51, no. 4, pp. 533-543. https://doi.org/10.1111/j.1526-4610.2011.01860.x
Hewitt, David J. ; Martin, Vincent ; Lipton, Richard B. ; Brandes, Jan ; Ceesay, Paulette ; Gottwald, Regina ; Schaefer, Eleanor ; Lines, Christopher ; Ho, Tony W. / Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. In: Headache. 2011 ; Vol. 51, No. 4. pp. 533-543.
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abstract = "Objective. - To evaluate the efficacy and tolerability of telcagepant when co-administered with ibuprofen or acetaminophen for the acute treatment of migraine. Background. - Telcagepant is an oral calcitonin gene-related peptide receptor antagonist which is being evaluated for the acute treatment of migraine. Combining telcagepant with analgesics that have a different mechanism of action could produce greater efficacy. Methods. - Randomized, double-blind, placebo-controlled study. Patients were randomized to treat a moderate or severe migraine headache with either telcagepant 280 mg + ibuprofen 400 mg (N = 171), telcagepant 280 mg + acetaminophen 1000 mg (N = 171), telcagepant 280 mg (N = 170), or placebo (N = 171). The primary efficacy endpoint was 2-hour pain freedom. The study had approximately 88{\%} power to detect an additive effect of at least 15 percentage points (telcagepant combination vs telcagepant monotherapy) and 48{\%} power to detect an additive effect of at least 10 percentage points. Safety and tolerability were assessed by adverse events and laboratory tests. Results. - The percentages of patients with 2-hour pain freedom were greater in each active treatment group compared to placebo (P < .001): telcagepant + ibuprofen = 35.2{\%}, telcagepant + acetaminophen = 38.3{\%}, telcagepant = 31.2{\%}, placebo = 10.9{\%}. No significant differences were seen for either of the combination groups vs telcagepant monotherapy, but both were numerically larger than telcagepant monotherapy. All the active treatments were generally well tolerated. The percentage of patients reporting any adverse event within 48 hours was higher in the active treatment groups than placebo: telcagepant + ibuprofen = 30.3{\%}, telcagepant + acetaminophen = 31.6{\%}, telcagepant = 24.8{\%}, placebo = 18.2{\%}. The most common adverse events reported by ≥4 patients in one or more of the treatment groups that included telcagepant were fatigue, nausea, dizziness, somnolence, dry mouth, and tremor. Conclusions. - The combination of telcagepant 280 mg with either ibuprofen 400 mg or acetaminophen 1000 mg did not show a statistically significant difference from telcagepant alone. Numerically greater treatment effects in the combination treatment groups over the telcagepant 280 mg monotherapy suggest that telcagepant combination treatments may merit further evaluation in studies powered to detect smaller additive benefits. (Clinicaltrials.gov; NCT00758836).",
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AU - Hewitt, David J.

AU - Martin, Vincent

AU - Lipton, Richard B.

AU - Brandes, Jan

AU - Ceesay, Paulette

AU - Gottwald, Regina

AU - Schaefer, Eleanor

AU - Lines, Christopher

AU - Ho, Tony W.

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N2 - Objective. - To evaluate the efficacy and tolerability of telcagepant when co-administered with ibuprofen or acetaminophen for the acute treatment of migraine. Background. - Telcagepant is an oral calcitonin gene-related peptide receptor antagonist which is being evaluated for the acute treatment of migraine. Combining telcagepant with analgesics that have a different mechanism of action could produce greater efficacy. Methods. - Randomized, double-blind, placebo-controlled study. Patients were randomized to treat a moderate or severe migraine headache with either telcagepant 280 mg + ibuprofen 400 mg (N = 171), telcagepant 280 mg + acetaminophen 1000 mg (N = 171), telcagepant 280 mg (N = 170), or placebo (N = 171). The primary efficacy endpoint was 2-hour pain freedom. The study had approximately 88% power to detect an additive effect of at least 15 percentage points (telcagepant combination vs telcagepant monotherapy) and 48% power to detect an additive effect of at least 10 percentage points. Safety and tolerability were assessed by adverse events and laboratory tests. Results. - The percentages of patients with 2-hour pain freedom were greater in each active treatment group compared to placebo (P < .001): telcagepant + ibuprofen = 35.2%, telcagepant + acetaminophen = 38.3%, telcagepant = 31.2%, placebo = 10.9%. No significant differences were seen for either of the combination groups vs telcagepant monotherapy, but both were numerically larger than telcagepant monotherapy. All the active treatments were generally well tolerated. The percentage of patients reporting any adverse event within 48 hours was higher in the active treatment groups than placebo: telcagepant + ibuprofen = 30.3%, telcagepant + acetaminophen = 31.6%, telcagepant = 24.8%, placebo = 18.2%. The most common adverse events reported by ≥4 patients in one or more of the treatment groups that included telcagepant were fatigue, nausea, dizziness, somnolence, dry mouth, and tremor. Conclusions. - The combination of telcagepant 280 mg with either ibuprofen 400 mg or acetaminophen 1000 mg did not show a statistically significant difference from telcagepant alone. Numerically greater treatment effects in the combination treatment groups over the telcagepant 280 mg monotherapy suggest that telcagepant combination treatments may merit further evaluation in studies powered to detect smaller additive benefits. (Clinicaltrials.gov; NCT00758836).

AB - Objective. - To evaluate the efficacy and tolerability of telcagepant when co-administered with ibuprofen or acetaminophen for the acute treatment of migraine. Background. - Telcagepant is an oral calcitonin gene-related peptide receptor antagonist which is being evaluated for the acute treatment of migraine. Combining telcagepant with analgesics that have a different mechanism of action could produce greater efficacy. Methods. - Randomized, double-blind, placebo-controlled study. Patients were randomized to treat a moderate or severe migraine headache with either telcagepant 280 mg + ibuprofen 400 mg (N = 171), telcagepant 280 mg + acetaminophen 1000 mg (N = 171), telcagepant 280 mg (N = 170), or placebo (N = 171). The primary efficacy endpoint was 2-hour pain freedom. The study had approximately 88% power to detect an additive effect of at least 15 percentage points (telcagepant combination vs telcagepant monotherapy) and 48% power to detect an additive effect of at least 10 percentage points. Safety and tolerability were assessed by adverse events and laboratory tests. Results. - The percentages of patients with 2-hour pain freedom were greater in each active treatment group compared to placebo (P < .001): telcagepant + ibuprofen = 35.2%, telcagepant + acetaminophen = 38.3%, telcagepant = 31.2%, placebo = 10.9%. No significant differences were seen for either of the combination groups vs telcagepant monotherapy, but both were numerically larger than telcagepant monotherapy. All the active treatments were generally well tolerated. The percentage of patients reporting any adverse event within 48 hours was higher in the active treatment groups than placebo: telcagepant + ibuprofen = 30.3%, telcagepant + acetaminophen = 31.6%, telcagepant = 24.8%, placebo = 18.2%. The most common adverse events reported by ≥4 patients in one or more of the treatment groups that included telcagepant were fatigue, nausea, dizziness, somnolence, dry mouth, and tremor. Conclusions. - The combination of telcagepant 280 mg with either ibuprofen 400 mg or acetaminophen 1000 mg did not show a statistically significant difference from telcagepant alone. Numerically greater treatment effects in the combination treatment groups over the telcagepant 280 mg monotherapy suggest that telcagepant combination treatments may merit further evaluation in studies powered to detect smaller additive benefits. (Clinicaltrials.gov; NCT00758836).

KW - Acetaminophen

KW - Calcitonin gene-related peptide

KW - Combination

KW - Ibuprofen

KW - Nonsteroidal anti-inflammatory drug

KW - Telcagepant

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