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Back To Vidyya ACE Inhibitors Studied For Role In Migraine Prevention

Zestril (Lisinopril) 20 mg Once Daily Demonstrated A 21 Percent Reduction In The Number Of Days With Migraine Attack

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 to faint.

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.

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Editor: Susan K. Boyer, RN
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