Candesartan Equivalent to Propranolol in Migraine Prevention

Pauline Anderson

July 05, 2013

BOSTON — The angiotensin receptor blocker candesartan (Atacand, AstraZeneca Pharmaceuticals LP) is safe and as effective as the beta blocker propranolol in preventing migraine headaches, according to a new study.

The results of the randomized, placebo-controlled study suggest that candesartan, often used to treat hypertension, should be part of the arsenal of agents for the prevention of migraine in adult patients, said Lars Jacob Stovner, PhD, Norwegian National Headache Center, Norwegian University of Science and Technology, Trondheim, Norway.

Dr. Stovner presented the study findings at the 2013 International Headache Congress (IHC).

Crossover Design

The study randomly assigned 72 adult patients who were experiencing 2 or more migraine attacks per month, with our without aura (so both episodic and chronic). At baseline, the mean number of migraine days per 4 weeks was 4.82.

The study included 3 periods, each with a washout and 12-week treatment period. According to the double crossover design, patients starting on candesartan crossed over to propranolol and then to placebo, and those starting on propranolol crossed over to placebo and then to candesartan.

During week 1 of the treatment period, patients received 80 mg of propranolol or placebo, or candesartan 8 mg or placebo. During weeks 2 to 11, doses were increased to 160 mg propranolol and 16 mg candesartan, and in week 12, the doses were 80 mg and 8 mg, respectively.

Patients, investigators, and staff analyzing data were all blinded.

The study found that the number of migraine-free days per 4 weeks was 3.53 for placebo, 2.95 for candesartan, and 2.91 for propranolol (P = .02 for both agents vs placebo).

Use of candesartan was associated with a statistically significant reduction in headache days compared with placebo (P = .01), whereas propranolol did not reduce headache days (P = .16).

Triptan doses per 4 weeks were also reduced from baseline for both drugs (P = .04 for propranolol vs placebo; P = .001 for candesartan vs placebo), as were analgesic doses per 4 weeks.

In 55 patients who were evaluable, 23% on placebo had a 50% or greater reduction in frequency of moderate to severe migraine headache days compared with 43% for candesartan and 40% for propranolol.

The total number of adverse events (including bodily pain, tiredness, paresthesia, and low heart rate with exercise), were as follows: 90 for placebo; 133 for candesartan, and 143 for propranolol.

The study confirms that candesartan 16 mg is superior to placebo, that it is probably not inferior to propranolol 160 mg, and that if one of these agents is not effective or well tolerated, the other should be tried, concluded Dr. Stovner.

"Clinical Immediacy"

According to David Dodick, MD, professor, Department of Neurology, Mayo Clinic, Phoenix, Arizona, candesartan has never been "top of mind" for migraine treatment, even though there has already been a published placebo-controlled study showing it to be effective.

On the basis of that study and the results of the current "very rigorous" research, Dr. Dodick said he would agree that candesartan should be a first-line preventive therapy.

"This is an example of where I think this might have clinical immediacy for when you go back to your clinics on Monday."

The study received an unconditional grant from AstraZeneca Pharmaceuticals LP. Dr. Stovner has received speaker's fees from GSK; honoraria to participate in meetings with Pfizer; and research grants and support from Allergen and AstraZeneca.

2013 International Headache Congress (IHC). Abstract OR21. Presented June 29, 2013.

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