A study published in the
November 22 issue of the Journal of the American Medical Association (JAMA)
suggests that stratified care which included Zomig® (zolmitripan) Tablets is a more effective migraine treatment strategy than step care approaches.(1)
The Disability in Strategies of Care (DISC) study, which compared the clinical benefits of stratified care with two
variants of step care, demonstrated that patients achieve greater headache
response and have less disability time when using a stratified care
"This study is great news for migraine patients, many of whom may suffer
through a lengthy and painful process of identifying the appropriate medicine
needed to effectively treat their illness," said study lead author Richard B.
Lipton, MD, of the Albert Einstein College of Medicine in Bronx, NY and
Innovative Medical Research. "By determining the severity of a patient's
illness using the Migraine Disability Assessment tool (MIDAS), the treatment
process becomes more efficient. Stratifying care according to disability
allows patients to be more confident that their pain will be more efficiently
A stratified care approach to treatment matches treatment to illness
severity or other factors. In the DISC study, initial stratified care
treatment of migraine attacks was based on the degree of headache-related
disability, as measured by the MIDAS questionnaire.(1) The MIDAS
questionnaire measures the severity of disability according to lost time in
different activities.(2) Patients having a lower level of disability, as
measured by MIDAS, were treated with aspirin plus metoclopramide; patients
with more serious disability were treated with Zomig.
Step care is a trial and error approach in which treatment is escalated
after non-specific medications fail.(1) In the DISC study, patients were
asked to treat six migraine attacks using either a step care within or step
care across attacks approach. Initial treatment for step care within attacks
was a combination of aspirin and metoclopramide. If headache relief was not
achieved within two hours, treatment was escalated to Zomig® (zolmitripan),
a widely used oral triptan.(1) Initial treatment for step care across attacks
was the combination of aspirin plus metoclopramide for the first three
migraine attacks. If analgesic treatment was inadequate, patients received
Zomig for the next three attacks.
This international, open-label, randomized, three-arm, controlled,
multiple attack study involved 88 clinical centers in 13 countries.(1) During
the course of the 15-month clinical trial (December 1997 to March 1999), 835
patients treated 4,945 migraine attacks.(1) Eligible patients ranged in age
from 18 to 65 years, and had onset of their first migraine before age 50.(1)
Patients recorded details of their migraine attacks and pain intensity (0=no
pain, 1=mild pain, 2=moderate pain, and 3=severe pain) two hours after an
initial dose of study medication; functional status (0=inability to do any
activity, 100=normal function) was recorded four hours after the initial
dose.(1) Based on their MIDAS scores, patients following stratified care
guidelines received either the migraine-specific therapy Zomig or aspirin plus
metoclopramide for six migraine attacks. Initial treatment for patients
following the step care approaches was aspirin plus metoclopramide,
irrespective of their MIDAS score. Treatment was escalated to Zomig for
patients who had inadequate headache response.
"I believe this is the first randomized trial to compare strategies of
selecting and sequencing migraine medications," said study co-author Walter F.
Stewart, PhD, of Innovative Medical Research and Johns Hopkins University.
"The results show that if doctors consider headache-related disability as
measured by MIDAS in selecting migraine therapies, patient outcomes improve.
The DISC study suggests that patients achieve faster headache response and
experience less disability time when treated using a stratified care
Headache response at two hours was significantly greater across six
attacks when using stratified care versus both step care approaches.(1)
Similar results were evident for headache response at one hour. Further,
disability time averaged across six attacks was significantly lower for
stratified care compared with both step care approaches.(1) Adverse events
for all treatment arms were predominantly mild to moderate and are consistent
with other 5-HT1B/1D agonists. Most common were weakness, nausea, dizziness,
tingling and drowsiness.
Zomig® (zolmitriptan) conventional tablets are indicated for the acute
treatment of migraine with or without aura in adults. Zomig is not intended
to prevent migraine. Zomig is intended to relieve migraine pain at any time
during a migraine attack. Zomig is contraindicated for patients with
uncontrolled hypertension, ischemic heart disease, or other significant
underlying heart disease. In addition, Zomig should not be administered to
patients who are hypersensitive to zolmitriptan or any of the inactive
ingredients of Zomig Tablets. Zomig should not be taken by patients who have
certain types of heart disease or uncontrolled high blood pressure. Very
rarely, some people without recognized heart disease may have serious
heart-related problems. Also, if patients think they may have risk factors
for heart disease such as smoking, high blood pressure, high cholesterol, or a
family history of heart disease, or if they are pregnant, nursing, or taking
medications, patients should talk to their healthcare provider. The most
common side effects associated with taking Zomig include dizziness; tightness,
pressure or pain in the neck, throat, or jaw; fatigue; tingling sensations;
drowsiness; or nausea.
- (1) Lipton RB, Stewart W, Stone A, et al. Stratified Care is More
Effective than Step Care Strategies for Migraine: Results of the
Disability in Strategies of Care (DISC) Study.
Journal of the American Medical Association. November 22, 2000.
- (2) Migraine Disability Assessment Questionnaire.
Innovative Medical Research 1999.