Stratified care vs step care strategies for migraine: The disability in strategies of care (DISC) study: A randomized trial

Richard B. Lipton, Walter F. Stewart, Andrew M. Stone, Miguel J A Láinez, James P C Sawyer

Research output: Contribution to journalArticle

288 Citations (Scopus)

Abstract

Context: Various guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated. Objective: To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine. Design and Setting: Randomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical centers in 13 countries. Patients: A total of 835 adult migraine patients with a Migraine Disability Assessment Scale (MIDAS) grade of II, III, or IV were analyzed as the efficacy population; the safety analysis included 930 patients. Interventions: Patients were randomly assigned to receive (1) stratified care (n=279), in which patients with MIDAS grade II treated up to 6 attacks with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg, and patients with MIDAS grade III and IV treated up to 6 attacks with zolmitriptan, 2.5 mg; (2) step care across attacks (n=271), in which initial treatment was with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg. Patients not responding in at least 2 of the first 3 attacks switched to zolmitriptan, 2.5 mg, to treat the remaining 3 attacks; and (3) step care within attacks (n=285), in which initial treatment for all attacks was with aspirin, 800 to 1000 mg, plus metoclopramide, 20 mg. Patients not responding to treatment after 2 hours in each attack escalated treatment to zolmitriptan, 2.5 mg. Main Outcome Measures: Headache response, achieved if pain intensity was reduced from severe or moderate at baseline to mild or no pain at 2 hours; and disability time per treated attack at 4 hours for all 6 attacks, compared among the 3 groups. Results: Headache response at 2 hours was significantly greater across 6 attacks in the stratified care treatment group (52.7%) than in either the step care across attacks group (40.6%; P<.001) or the step care within attacks group (36.4%; P<.001). Disability time (6 attacks) was significantly lower in the stratified care group (mean area under the curve [AUC], 185.0 mm·h) than in the step care across attacks group (mean AUC, 209.4 mm·h; P<.001) or the step care within attacks group (mean AUC, 199.7 mm·h; P<.001). The incidence of adverse events was higher in the stratified care group (321 events) vs both step care groups (159 events in across-attack group; 217 in within-attack group), although most events were of mild-to-moderate intensity. Conclusion: Our results indicate that as a treatment strategy, stratified care provides significantly better clinical outcomes than step care strategies within or across attacks as measured by headache response and disability time.

Original languageEnglish (US)
Pages (from-to)2599-2605
Number of pages7
JournalJournal of the American Medical Association
Volume284
Issue number20
StatePublished - 2000

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Migraine Disorders
zolmitriptan
Metoclopramide
Aspirin
Area Under Curve
Headache
Therapeutics
Pain
Outcome Assessment (Health Care)
Clinical Trials
Guidelines
Safety
Incidence
Population

ASJC Scopus subject areas

  • Medicine(all)

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Stratified care vs step care strategies for migraine : The disability in strategies of care (DISC) study: A randomized trial. / Lipton, Richard B.; Stewart, Walter F.; Stone, Andrew M.; Láinez, Miguel J A; Sawyer, James P C.

In: Journal of the American Medical Association, Vol. 284, No. 20, 2000, p. 2599-2605.

Research output: Contribution to journalArticle

Lipton, Richard B. ; Stewart, Walter F. ; Stone, Andrew M. ; Láinez, Miguel J A ; Sawyer, James P C. / Stratified care vs step care strategies for migraine : The disability in strategies of care (DISC) study: A randomized trial. In: Journal of the American Medical Association. 2000 ; Vol. 284, No. 20. pp. 2599-2605.
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abstract = "Context: Various guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated. Objective: To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine. Design and Setting: Randomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical centers in 13 countries. Patients: A total of 835 adult migraine patients with a Migraine Disability Assessment Scale (MIDAS) grade of II, III, or IV were analyzed as the efficacy population; the safety analysis included 930 patients. Interventions: Patients were randomly assigned to receive (1) stratified care (n=279), in which patients with MIDAS grade II treated up to 6 attacks with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg, and patients with MIDAS grade III and IV treated up to 6 attacks with zolmitriptan, 2.5 mg; (2) step care across attacks (n=271), in which initial treatment was with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg. Patients not responding in at least 2 of the first 3 attacks switched to zolmitriptan, 2.5 mg, to treat the remaining 3 attacks; and (3) step care within attacks (n=285), in which initial treatment for all attacks was with aspirin, 800 to 1000 mg, plus metoclopramide, 20 mg. Patients not responding to treatment after 2 hours in each attack escalated treatment to zolmitriptan, 2.5 mg. Main Outcome Measures: Headache response, achieved if pain intensity was reduced from severe or moderate at baseline to mild or no pain at 2 hours; and disability time per treated attack at 4 hours for all 6 attacks, compared among the 3 groups. Results: Headache response at 2 hours was significantly greater across 6 attacks in the stratified care treatment group (52.7{\%}) than in either the step care across attacks group (40.6{\%}; P<.001) or the step care within attacks group (36.4{\%}; P<.001). Disability time (6 attacks) was significantly lower in the stratified care group (mean area under the curve [AUC], 185.0 mm·h) than in the step care across attacks group (mean AUC, 209.4 mm·h; P<.001) or the step care within attacks group (mean AUC, 199.7 mm·h; P<.001). The incidence of adverse events was higher in the stratified care group (321 events) vs both step care groups (159 events in across-attack group; 217 in within-attack group), although most events were of mild-to-moderate intensity. Conclusion: Our results indicate that as a treatment strategy, stratified care provides significantly better clinical outcomes than step care strategies within or across attacks as measured by headache response and disability time.",
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T1 - Stratified care vs step care strategies for migraine

T2 - The disability in strategies of care (DISC) study: A randomized trial

AU - Lipton, Richard B.

AU - Stewart, Walter F.

AU - Stone, Andrew M.

AU - Láinez, Miguel J A

AU - Sawyer, James P C

PY - 2000

Y1 - 2000

N2 - Context: Various guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated. Objective: To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine. Design and Setting: Randomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical centers in 13 countries. Patients: A total of 835 adult migraine patients with a Migraine Disability Assessment Scale (MIDAS) grade of II, III, or IV were analyzed as the efficacy population; the safety analysis included 930 patients. Interventions: Patients were randomly assigned to receive (1) stratified care (n=279), in which patients with MIDAS grade II treated up to 6 attacks with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg, and patients with MIDAS grade III and IV treated up to 6 attacks with zolmitriptan, 2.5 mg; (2) step care across attacks (n=271), in which initial treatment was with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg. Patients not responding in at least 2 of the first 3 attacks switched to zolmitriptan, 2.5 mg, to treat the remaining 3 attacks; and (3) step care within attacks (n=285), in which initial treatment for all attacks was with aspirin, 800 to 1000 mg, plus metoclopramide, 20 mg. Patients not responding to treatment after 2 hours in each attack escalated treatment to zolmitriptan, 2.5 mg. Main Outcome Measures: Headache response, achieved if pain intensity was reduced from severe or moderate at baseline to mild or no pain at 2 hours; and disability time per treated attack at 4 hours for all 6 attacks, compared among the 3 groups. Results: Headache response at 2 hours was significantly greater across 6 attacks in the stratified care treatment group (52.7%) than in either the step care across attacks group (40.6%; P<.001) or the step care within attacks group (36.4%; P<.001). Disability time (6 attacks) was significantly lower in the stratified care group (mean area under the curve [AUC], 185.0 mm·h) than in the step care across attacks group (mean AUC, 209.4 mm·h; P<.001) or the step care within attacks group (mean AUC, 199.7 mm·h; P<.001). The incidence of adverse events was higher in the stratified care group (321 events) vs both step care groups (159 events in across-attack group; 217 in within-attack group), although most events were of mild-to-moderate intensity. Conclusion: Our results indicate that as a treatment strategy, stratified care provides significantly better clinical outcomes than step care strategies within or across attacks as measured by headache response and disability time.

AB - Context: Various guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated. Objective: To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine. Design and Setting: Randomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical centers in 13 countries. Patients: A total of 835 adult migraine patients with a Migraine Disability Assessment Scale (MIDAS) grade of II, III, or IV were analyzed as the efficacy population; the safety analysis included 930 patients. Interventions: Patients were randomly assigned to receive (1) stratified care (n=279), in which patients with MIDAS grade II treated up to 6 attacks with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg, and patients with MIDAS grade III and IV treated up to 6 attacks with zolmitriptan, 2.5 mg; (2) step care across attacks (n=271), in which initial treatment was with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg. Patients not responding in at least 2 of the first 3 attacks switched to zolmitriptan, 2.5 mg, to treat the remaining 3 attacks; and (3) step care within attacks (n=285), in which initial treatment for all attacks was with aspirin, 800 to 1000 mg, plus metoclopramide, 20 mg. Patients not responding to treatment after 2 hours in each attack escalated treatment to zolmitriptan, 2.5 mg. Main Outcome Measures: Headache response, achieved if pain intensity was reduced from severe or moderate at baseline to mild or no pain at 2 hours; and disability time per treated attack at 4 hours for all 6 attacks, compared among the 3 groups. Results: Headache response at 2 hours was significantly greater across 6 attacks in the stratified care treatment group (52.7%) than in either the step care across attacks group (40.6%; P<.001) or the step care within attacks group (36.4%; P<.001). Disability time (6 attacks) was significantly lower in the stratified care group (mean area under the curve [AUC], 185.0 mm·h) than in the step care across attacks group (mean AUC, 209.4 mm·h; P<.001) or the step care within attacks group (mean AUC, 199.7 mm·h; P<.001). The incidence of adverse events was higher in the stratified care group (321 events) vs both step care groups (159 events in across-attack group; 217 in within-attack group), although most events were of mild-to-moderate intensity. Conclusion: Our results indicate that as a treatment strategy, stratified care provides significantly better clinical outcomes than step care strategies within or across attacks as measured by headache response and disability time.

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