Tolerability of sumatriptan: Clinical trials and post-marketing experience

University of Kansas School of Medicine, Kansas City, Kansas, USA.
Cephalalgia (Impact Factor: 4.12). 11/2000; 20(8):687-95. DOI: 10.1046/j.1468-2982.2000.00116.x
Source: PubMed

ABSTRACT Through December 1998, sumatriptan had been used to treat more than 236 million migraine attacks world-wide. In clinical trials alone, more than 88000 migraine patients had treated more than 300000 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.

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    • "The development (Humphrey et al., 1990) and clinical use of sumatriptan (Ferrari, 1998) initiated a cascade of mechanistic and therapeutic advances that has included several other triptans that all share the property of being serotonin (5-HT 1B/1D ) agonists (Goadsby, 2000). The search for novel non-vasoconstrictor treatments of acute migraine continues because of the potential safety bene®ts (Welch et al., 2000) such a strategy would offer, and the considerable mechanistic insight that would be generated if it were clear that non-vascular medicines were effective. "
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