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ABSTRACT
BACKGROUND: Six selective serotonin 5-HT1B/1D agonists (triptans) are currently approved and available in the United States; 1 more may eventually be approved. Although clinicians need evidence of the differences in efficacy and safety of these agents to assist in their prescribing decisions, a lack of head-to-head comparison trials makes this assessment difficult. The authors performed a meta-analysis of multiple trials of oral triptans to determine their relative effectiveness in treating acute migraine.
POPULATION STUDIED: Patients eligible for the studies were aged 18 to 65 years, had moderate to severe migraine, and had pain rated on a 4-point scale (0 = no pain; 3 = most severe pain). A total of 24,000 patients from 53 clinical trials met the criteria. The authors selected 100 mg sumatriptan, the most widely prescribed agent, as the reference dose.
STUDY DESIGN AND VALIDITY: The authors performed a systematic review of published English-language trials and asked the 6 pharmaceutical companies for raw data from published and unpublished trials. Five companies provided data on 6 drugs; the makers of frovatriptan did not. The investigators included studies that (1) were randomized double-blind controlled clinical trials (placebo or active comparison); (2) treated moderate or severe migraine attacks (by International Headache Society criteria) within 8 hours of migraine onset; (3) used an oral triptan at a recommended clinical dose; and (4) evaluated the headache on the 4-point pain scale. The authors excluded 23 studies that lacked a control group, used nonrecommended dosages, or studied special populations. Of the 53 trials reviewed, 31 were placebo-controlled trials and 22 were direct-comparison trials.
OUTCOMES MEASURED: Four outcomes were measured: (1) proportion of patients with a headache response (improvement to mild or no pain 2 hours post dose); (2) sustained pain-free response (2 hours post dose and no recurrence of moderate or severe migraine 2 to 24 hours post dose); (3) consistent effect of a medication over recurrent attacks in the same person; and (4) adverse reactions.
RESULTS: In placebo trials, 100 mg sumatriptan showed a mean absolute and therapeutic gain of 59% and 29% for 2-hour headache response and 29% and 10% for sustained pain-free rate. The mean therapeutic harm rate was 13% for at least 1 adverse event, 6% for 1 central nervous system event, and 2% for 1 chest event. On average, patients obtained relief for 2 of 3 consecutive migraines. Only 80 mg eletriptan had a statistically significant advantage over 100 mg sumatriptan for therapeutic gain in 2-hour headache response (number needed to treat [NNT] = 8). For therapeutic gain in 2-hour pain-free response, both 10 mg rizatriptan (NNT = 8) and 80 mg eletriptan (NNT = 13) had a statistically significant advantage. Adverse reaction rates were similar for most triptans but lower for 2.5 mg naratriptan and 12.5 mg almotriptan.
This meta-analysis demonstrates that oral triptans are effective in relieving acute migraine headache with acceptable adverse effect rates and non-clinically relevant degrees of relief among the agents. The meta-analysis also showed that only approximately 60% of patients respond to a specific triptan. In the few consistency trials, the triptans were effective in treating an average of 2 of 3 consecutive acute migraines in the same patient. Research supports nonsteroidal anti-inflammatory drugs as first-line therapy for mild to moderate migraine; triptans should be considered first-line therapy for moderate to severe migraine. We suggest that clinicians become familiar with several triptans and recognize that a given agent will not always relieve the same person’s migraine and that the failure of 1 triptan to help a patient does not predict failure with another triptan.
ABSTRACT
BACKGROUND: Six selective serotonin 5-HT1B/1D agonists (triptans) are currently approved and available in the United States; 1 more may eventually be approved. Although clinicians need evidence of the differences in efficacy and safety of these agents to assist in their prescribing decisions, a lack of head-to-head comparison trials makes this assessment difficult. The authors performed a meta-analysis of multiple trials of oral triptans to determine their relative effectiveness in treating acute migraine.
POPULATION STUDIED: Patients eligible for the studies were aged 18 to 65 years, had moderate to severe migraine, and had pain rated on a 4-point scale (0 = no pain; 3 = most severe pain). A total of 24,000 patients from 53 clinical trials met the criteria. The authors selected 100 mg sumatriptan, the most widely prescribed agent, as the reference dose.
STUDY DESIGN AND VALIDITY: The authors performed a systematic review of published English-language trials and asked the 6 pharmaceutical companies for raw data from published and unpublished trials. Five companies provided data on 6 drugs; the makers of frovatriptan did not. The investigators included studies that (1) were randomized double-blind controlled clinical trials (placebo or active comparison); (2) treated moderate or severe migraine attacks (by International Headache Society criteria) within 8 hours of migraine onset; (3) used an oral triptan at a recommended clinical dose; and (4) evaluated the headache on the 4-point pain scale. The authors excluded 23 studies that lacked a control group, used nonrecommended dosages, or studied special populations. Of the 53 trials reviewed, 31 were placebo-controlled trials and 22 were direct-comparison trials.
OUTCOMES MEASURED: Four outcomes were measured: (1) proportion of patients with a headache response (improvement to mild or no pain 2 hours post dose); (2) sustained pain-free response (2 hours post dose and no recurrence of moderate or severe migraine 2 to 24 hours post dose); (3) consistent effect of a medication over recurrent attacks in the same person; and (4) adverse reactions.
RESULTS: In placebo trials, 100 mg sumatriptan showed a mean absolute and therapeutic gain of 59% and 29% for 2-hour headache response and 29% and 10% for sustained pain-free rate. The mean therapeutic harm rate was 13% for at least 1 adverse event, 6% for 1 central nervous system event, and 2% for 1 chest event. On average, patients obtained relief for 2 of 3 consecutive migraines. Only 80 mg eletriptan had a statistically significant advantage over 100 mg sumatriptan for therapeutic gain in 2-hour headache response (number needed to treat [NNT] = 8). For therapeutic gain in 2-hour pain-free response, both 10 mg rizatriptan (NNT = 8) and 80 mg eletriptan (NNT = 13) had a statistically significant advantage. Adverse reaction rates were similar for most triptans but lower for 2.5 mg naratriptan and 12.5 mg almotriptan.
This meta-analysis demonstrates that oral triptans are effective in relieving acute migraine headache with acceptable adverse effect rates and non-clinically relevant degrees of relief among the agents. The meta-analysis also showed that only approximately 60% of patients respond to a specific triptan. In the few consistency trials, the triptans were effective in treating an average of 2 of 3 consecutive acute migraines in the same patient. Research supports nonsteroidal anti-inflammatory drugs as first-line therapy for mild to moderate migraine; triptans should be considered first-line therapy for moderate to severe migraine. We suggest that clinicians become familiar with several triptans and recognize that a given agent will not always relieve the same person’s migraine and that the failure of 1 triptan to help a patient does not predict failure with another triptan.
ABSTRACT
BACKGROUND: Six selective serotonin 5-HT1B/1D agonists (triptans) are currently approved and available in the United States; 1 more may eventually be approved. Although clinicians need evidence of the differences in efficacy and safety of these agents to assist in their prescribing decisions, a lack of head-to-head comparison trials makes this assessment difficult. The authors performed a meta-analysis of multiple trials of oral triptans to determine their relative effectiveness in treating acute migraine.
POPULATION STUDIED: Patients eligible for the studies were aged 18 to 65 years, had moderate to severe migraine, and had pain rated on a 4-point scale (0 = no pain; 3 = most severe pain). A total of 24,000 patients from 53 clinical trials met the criteria. The authors selected 100 mg sumatriptan, the most widely prescribed agent, as the reference dose.
STUDY DESIGN AND VALIDITY: The authors performed a systematic review of published English-language trials and asked the 6 pharmaceutical companies for raw data from published and unpublished trials. Five companies provided data on 6 drugs; the makers of frovatriptan did not. The investigators included studies that (1) were randomized double-blind controlled clinical trials (placebo or active comparison); (2) treated moderate or severe migraine attacks (by International Headache Society criteria) within 8 hours of migraine onset; (3) used an oral triptan at a recommended clinical dose; and (4) evaluated the headache on the 4-point pain scale. The authors excluded 23 studies that lacked a control group, used nonrecommended dosages, or studied special populations. Of the 53 trials reviewed, 31 were placebo-controlled trials and 22 were direct-comparison trials.
OUTCOMES MEASURED: Four outcomes were measured: (1) proportion of patients with a headache response (improvement to mild or no pain 2 hours post dose); (2) sustained pain-free response (2 hours post dose and no recurrence of moderate or severe migraine 2 to 24 hours post dose); (3) consistent effect of a medication over recurrent attacks in the same person; and (4) adverse reactions.
RESULTS: In placebo trials, 100 mg sumatriptan showed a mean absolute and therapeutic gain of 59% and 29% for 2-hour headache response and 29% and 10% for sustained pain-free rate. The mean therapeutic harm rate was 13% for at least 1 adverse event, 6% for 1 central nervous system event, and 2% for 1 chest event. On average, patients obtained relief for 2 of 3 consecutive migraines. Only 80 mg eletriptan had a statistically significant advantage over 100 mg sumatriptan for therapeutic gain in 2-hour headache response (number needed to treat [NNT] = 8). For therapeutic gain in 2-hour pain-free response, both 10 mg rizatriptan (NNT = 8) and 80 mg eletriptan (NNT = 13) had a statistically significant advantage. Adverse reaction rates were similar for most triptans but lower for 2.5 mg naratriptan and 12.5 mg almotriptan.
This meta-analysis demonstrates that oral triptans are effective in relieving acute migraine headache with acceptable adverse effect rates and non-clinically relevant degrees of relief among the agents. The meta-analysis also showed that only approximately 60% of patients respond to a specific triptan. In the few consistency trials, the triptans were effective in treating an average of 2 of 3 consecutive acute migraines in the same patient. Research supports nonsteroidal anti-inflammatory drugs as first-line therapy for mild to moderate migraine; triptans should be considered first-line therapy for moderate to severe migraine. We suggest that clinicians become familiar with several triptans and recognize that a given agent will not always relieve the same person’s migraine and that the failure of 1 triptan to help a patient does not predict failure with another triptan.