In a randomized, placebo-controlled study, 1021 healthy women 45 years of age or

Question

In a randomized, placebo-controlled study, 1021 healthy women 45 years of age or older were randomly divided into two groups. The women in group 1 received 100 mg of a drug every other day; the women in group 2 received a placebo every other day. The women were monitored for 10 years to determine if they experienced a cardiovascular event (such as a heart attack or stroke). Of the 505 in the drug group,11 experienced a heart attack. Of the 516 women in the placebo group,16 experienced a heart attack. Complete parts (a) through (c) below.

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Explanation / Answer

Migraine is a very common disorder characterized by the combination of typical headache with associated autonomic symptoms and/or the presence of aura. Considerable advances have been made in recent years to understand the pathophysiology of migraine, which has led to improved treatment options for the acute migraine attack as well as migraine prophylaxis. Unfortunately, preventive treatment is often insufficient to decrease migraine frequency substantially or is not well tolerated. Topiramate is an antipileptic drug with a complex mode of action which has proven its efficacy and safety in the prophylactic treatment of episodic migraine in a number of randomized controlled clinical trials. Topiramate is also effective in treating patients with chronic migraine. It has little pharmacological interaction with other drugs and is generally well tolerated by patients.

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