Tolerability of sumatriptan: clinical trials and post-marketing experience


Donna Gutterman, Neurology & Psychiatry Therapeutic Development Group, Glaxo Wellcome, Five Moore Drive, Research Triangle Park, NC 27709 USA. Tel. + 1919 4835251, fax + 1919 4830645, e-mail: Received 27 September 1999, accepted 23 September 2000


Through December 1998, sumatriptan had been used to treat more than 236 million migraine attacks world-wide. In clinical trials alone, more than 88 000 migraine patients had treated more than 300 000 migraine attacks with sumatriptan, and 2000 normal healthy volunteers had been exposed to the drug. This paper describes the safety and tolerability profile of sumatriptan in three sections: adverse events reported in clinical trials, special issues, and spontaneous post-marketing reports of adverse reactions. Data from the extensive clinical trials programme coupled with information from nearly 10 years of experience in clinical practice demonstrate that sumatriptan is generally well-tolerated, with an acceptable benefit–risk ratio when used properly. Significant cardiovascular and cerebrovascular events are rare but have been observed. This fact highlights the need for careful patient selection and vigilant adherence to the prescribing recommendations for sumatriptan. The wealth of clinical trials and post-marketing information for sumatriptan may be useful in guiding prescribing decisions for members of this class of drugs.