Contact:
Rachel Bloom
Zeneca Pharmaceuticals
302-886-7858
[email protected]
EMBARGOED UNTIL WEDNESDAY, APRIL 29,1998, 7 A.M.
TWO NEW STUDIES SHOW HOW A DISEASE-SPECIFIC TOOL MEASURES QUALITY OF LIFE IN MIGRAINE PATIENTS
Tool Shows ZOMIG(TM) (zolmitriptan) Improves Well-Being of Patients Who Consistently Respond to the Migraine Treatment
MINNEAPOLIS-April 29, 1998-Results from two new studies demonstrate an advance in the medical community's ability to quantify what migraine sufferers have known for years-the disabling impact of migraine on sufferers' quality of life. These data may help migraine patients clearly communicate the social, physical, and emotional setbacks caused by the most common neurological condition in developed countries.1
The Migraine-Specific Quality-of-Life (MsQoL) instrument assesses the long-term effects of migraine treatment on life goals, values and expectations of migraine sufferers, according to research presented today at the 50th annual meeting of the American Academy of Neurology (AAN).2 The new tool also shows ZOMIG(TM) (zolmitriptan), a new migraine treatment from Zeneca Pharmaceuticals, improves quality of life for patients who consistently respond to migraine treatment.
"In the past, it was difficult to determine whether a new migraine treatment was successful in improving overall quality of life and patient functioning," said Dr. David B. Goodale, senior medical director, Zeneca Pharmaceuticals. "However, in testing the efficacy of the new migraine therapy ZOMIG(TM) (zolmitriptan), we developed a measurement tool to subjectively evaluate the effects of migraine and measure the success of this new treatment." STUDY OF GENERIC VERSUS SPECIFIC MEASURES
One of the MsQoL studies presented compared the performance of a widely used generic measure of quality of life (SF-36) with the MsQoL in evaluating migraine treatment.
Patients in six countries were given unrestricted access to ZOMIG(TM) (zolmitriptan), an oral medication for the treatment of acute migraine, on an open-label basis for up to one year. Generic and migraine-specific surveys were administered at all visits. Responsiveness was calculated after 180 days in the study. --more--
AAN MsQoL News Release/page 2 of 3
"The MsQoL demonstrated improved quality of life in the majority of patients who consistently respond (>90%) to ZOMIG(TM) (zolmitriptan)," said Donald L. Patrick, PhD, MSPH, of the Department of Health Services in Seattle and coauthor of both studies. "The generic instrument, however, was not as sensitive in detecting changes in how patients were able to function with this migraine therapy. For migraine patients who are unable to carry out normal daily activities, such as caring for children and continuing with work, it is critical that we have a tool to fully measure the impact of a new treatment." FURTHER TESTS OF THE MsQoL TOOL
Another study further developed and tested the MsQoL to report the measurement properties of the migraine-specific tool.
In this study, 1,383 patients from 11 countries also were given unrestricted access to ZOMIG 5 mg on an open-label basis for up to one year. The MsQoL was completed at all visits. After 180 days, patients were defined as responders, meaning those who consistently report headache response in more than 90 percent of attacks, or nonresponders, those with headache response less than 10 percent.
"This study confirmed the MsQoL's ability to measure a migraine patient's overall quality of life, with respect to avoidance, relationships, and feelings," said Bryan C. Hurst, Outcomes Research Adviser at Zeneca Pharmaceuticals in Macclesfield, United Kingdom, and coauthor of the study. "The instrument is sufficiently sensitive to changes in treatment to confirm the importance of consistency of response to treatment to the overall well-being of migraine sufferers." BACKGROUND ON ZOMIG(TM) (zolmitriptan)
ZOMIG 2.5-mg and 5.0-mg tablets were cleared for marketing by the US Food and Drug Administration in November 1997 for treatment of acute migraine with or without aura in adults. ZOMIG was made available by prescription in pharmacies nationwide in January.
ZOMIG(TM) (zolmitriptan) is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease. Patients with coronary heart disease, or those predisposed, should be fully evaluated by their physician prior to initiation of therapy with ZOMIG. In addition, ZOMIG should not be administered to patients who are hypersensitive to zolmitriptan or any of its inactive ingredients. ZOMIG should only be used where a clear diagnosis of migraine has been established. As with other serotonin agonists, sensations of tightness, pain, pressure, and heaviness have been reported after treatment with ZOMIG tablets in different regions of the body, including the chest.
In a safety database of more than 4,000 patients, ZOMIG(TM) (zolmitriptan) was well-tolerated. Adverse events reported by patients were mostly mild or of moderate intensity and the most common included asthenia (lack of energy), nausea, dizziness, somnolence (drowsiness), and paresthesia (feelings such as tingling, numbness or itching). --more--
AAN MsQoL News Release/page 3 of 3
In the US, Zeneca Inc. is a $3.4 billion bioscience business with approximately 7,500 employees. Zeneca Inc. is a wholly-owned subsidiary of the UK-based Zeneca Group PLC (NYSE:ZEN), a major $8.6 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services.
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1 P. Henry, Chapter 2, Migraine in General Practice: Basic concepts, Smith Gordon, 1993; page 15. 2 The MsQoL: A Quality of Life Measure for Persons with Migraine, User's Manual and Scoring Diskette; Medical Outcomes Trust; page 10.
NOTE: For full prescribing information, please call Rachel Bloom at 302-886-7858 or visit the ZOMIG web site at www.zomig.com.
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