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Cephalalgia. 2013 Sep;33(12):1026-34. doi: 10.1177/0333102413484989. Epub 2013 Apr 18.

Randomised trial on episodic cluster headache with an angiotensin II receptor blocker.

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  • 1Norwegian National Headache Centre, Trondheim University Hospital, Norway. erling.tronvik@ntnu.no

Abstract

OBJECTIVES:

The aim of this study was to evaluate the angiotensin II receptor antagonist candesartan as prophylactic medication in patients with episodic cluster headache.

METHODS:

This study comprised a prospective, placebo-controlled, double-blind, parallel-designed trial performed in seven centres in Scandinavia. Forty (40) patients with episodic cluster headache (ICHD-2) were recruited and randomised over a five-year period to placebo or 16 mg candesartan in the first week, and placebo or 32 mg candesartan in the second and third week.

RESULTS:

The number of cluster headache attacks (primary efficacy variable) during the three-week treatment period was reduced from 14.3 ± 9.2 attacks in week 1 to 5.6 ± 7.0 attacks in week 3 (-61%) in the candesartan group and from 16.8 ± 14.1 attacks in week 1 to 10.5 ± 11.3 attacks in week 3 (-38%) in the placebo group. The difference between the candesartan and placebo group was not significant with the pre-planned non-parametric ranking test, but a post-hoc exact Poisson test, which takes into account the temporal properties of the data, revealed a significant result ( P  < 0.0001).

CONCLUSIONS:

This was a negative trial. Post-hoc statistics suitable to describe the temporal changes in cluster headache indicate that conduction of future larger studies may be justified.

KEYWORDS:

Randomised controlled trial; angiotensin; candesartan; cluster headache; headache

[PubMed - indexed for MEDLINE]
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