AstraZeneca's angiotensin converting
enzyme (ACE) inhibitor, Zestril (lisinopril) 20 mg once daily demonstrated
a 21 percent reduction in the number of days with migraine attack and lowered
the headache severity index by 20 percent according to the Prophylactic
Treatment of Migraine with Lisinopril Study, published in the January 6
edition of the British Medical Journal. Zestril is not approved for the
prevention or treatment of migraine attacks.
About the Study
The twenty-four week, randomized, double-blind, placebo-controlled,
crossover study investigated the prophylactic effect of Zestril in 60 subjects
aged 19-59 years with frequent migraine attacks. Conducted by neurologists at
the Norwegian University of Science and Technology in Trondheim, Norway, the
study followed specific guidelines set forth by the International Committee on
Clinical Trials in Migraine.
The study involved two twelve-week treatment sequences with 30 subjects
participating in each sequence. For each twelve-week period, subjects received
one dose of Zestril 10 mg or a placebo once daily for the first week followed
by Zestril 20 mg or placebo once daily for the remaining eleven weeks. At the
end of the twelve-week sequence, a two-week washout period occurred, followed
by a crossover to the alternative sequence of treatment.
In both study sequences, the subjects treated with Zestril showed a
21 percent reduction in the number of days with migraine (p< 0.0003) and a
20 percent decrease in the headache severity index (p< 0.0003). In addition,
the mean blood pressure observed during the Zestril sequence was 121/78 mmHg
compared to 128/83 mmHg during the placebo sequence.
Both treatment regimens in the study were well tolerated. Three subjects
discontinued the study due to adverse events. The adverse events reported with
Zestril during this study include dizziness, dry cough, fatigue and tendency
About ACE Inhibitors and Zestril
Zestril is the most prescribed ACE inhibitor in the United States. A
once-daily, long-acting ACE inhibitor, Zestril is indicated for the treatment
of hypertension, adjunctive therapy in the management of heart failure in
patients not responding adequately to diuretics and digitalis, and as
treatment of hemodynamically stable patients within 24 hours of acute
myocardial infarction to improve survival.
Zestril interacts with the renin-angiotensin-aldosterone system to reduce
blood pressure. ACE inhibition limits the conversion of angiotensin I to
angiotensin II (AII), a peptide that increases blood pressure.
The most frequently reported adverse events in controlled clinical trials
occurring at an incidence of 2.5 percent or greater for hypertension included
fatigue, diarrhea, headache, dizziness and cough; for heart failure
(2.5 percent or greater) included chest pain, hypotension, dizziness, diarrhea
and headache; for acute myocardial infarction (2.0 percent or greater)
included hypotension and renal dysfunction. As with all ACE inhibitors,
Zestril should not be used by pregnant women and should be discontinued as
soon as possible when pregnancy is detected.