The study* demonstrates that candesartan cilexetil (Atacand®), an angiotensin II receptor blocker, is potentially effective as a migraine prevention drug by reducing headache incidence among migraine sufferers by 26% compared to placebo. The mean number of days with headaches in the 12 week placebo period was 18.5, versus 13.6 in the 12 week candesartan period (p=0.001).
These data also show significance (p<0.001) for key secondary endpoints including: hours with headache; days with migraine; hours with migraine; headache severity; and level of disability. Days with sick leave were also significantly reduced by 64% (p=0.01). Importantly, these benefits were associated with good tolerability as adverse events were few with candesartan treatment and not significantly different from placebo.1
"These exciting results provide the first evidence for the potential of candesartan to provide effective prevention for migraine sufferers, with an improved tolerability over currently prescribed therapies. These patients could gain a degree of protection from migraine attacks, without having to bear the additional burden of unpleasant side-effects," commented Dr Erling Tronvik, study principal investigator, Norwegian National Headache Centre, St Olavs Hospital, Trondheim, Norway.
"Any patient will tell you that they would prefer to prevent, rather than treat, an attack", Dr Tronvik continued, "but clinicians are currently faced with an increasing number of medications for migraine prevention, all of which differ in efficacy and are associated with various side effects. Further investigation is needed, but a treatment with proven efficacy and good tolerability would have obvious benefits for both clinician and patient."
Migraine prevention aims to restore normality to patients' lives. Preventative therapy should only be considered if more than two attacks occur per month, acute medications prove ineffective, severity justifies prevention, or if there is a need to improve the efficacy of symptomatic treatments.
Recommended treatments for migraine prevention vary from country to country. Common treatment options include beta-blockers, serotonin antagonists and anticonvulsants, however, these treatments are often associated with side effects. Beta-blockers, such as propranolol and timolol, are associated with fatigue, depression and nightmares, and should not be used in patients with asthma, diabetes or low blood pressure. Treatment with the serotonin antagonist methysergide, can lead to vasoconstriction, cramping and fibrotic changes. Divalproex sodium, an anticonvulsant, has been linked with tremor, transient male hair loss and liver toxicity.
Migraine is a disease characterised by recurrent severe headaches in addition to nausea, vomiting and aversion to light and/or sound. More than 10% of the adult population in Western countries are affected with the highest prevalence between the ages of 25 and 55 with females more susceptible than males. Attacks in adults normally last between four and 72 hours and result in an estimated annual loss of almost six days per 1000 working people.
Alleviating the burden of migraine allows sufferers to live normal lives, unhindered by the incapacity and considerable discomfort associated with the condition and it also offers important socioeconomic benefits by reducing related absenteeism from the workplace. Efficacy and tolerability in the field of migraine prevention are extremely desirable characteristics and any novel treatment option that can deliver these offers both patients and prescribers an exciting alternative to current therapies.
* Notes to editors:
The study was a randomised, double blind, placebo-controlled crossover study performed in Norway to determine whether treatment with an angiotensin II receptor blocker is as effective as a migraine prophylactic. Sixty patients between the ages of 18 to 65, who suffer two to six migraine attacks per month, were treated in the study.
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Stephen Morgan
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Ross Wilkie
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References:
1. Tronvik E, Stovner LJ, Helde G, Sand T and Bovim G. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomised, placebo controlled, cross over study. JAMA 2003
2. Mathew NT. Abortive vs prophylactic treatment of migraine: a reappraisal. Headache 1990;30:238-239
3. National Headache Foundation 2001. Advances in migraine prophylaxis: current state of the art and future prospects
4. Lipton RB. Stewart WF and Scher AI. Epidemiology and economic impact of migraine. Curr Med Res Opin 2001;17(1s):s4-s12
5. European Agency for the Evaluation of Medicinal Products (EMEA). Committee for proprietary medicinal products (CPMP). Notes for guidance on clinical investigation of medicinal products for the treatment of migraine; Draft, 19 September 2002
Journal
JAMA