Donna L. Gutterman

Sumatriptan for the Range of Headaches in Migraine Sufferers: Results of the Spectrum Study

Background.—Migraineurs experience a spectrum of headaches: migraine, migrainous, and episodic tension‐type as defined by the International Headache Society (IHS).

Treatment of Mild Headache in Disabled Migraine Sufferers: Results of the Spectrum Study

Objective.—To evaluate the effectiveness of sumatriptan, 50‐mg tablets, versus placebo for early intervention while head pain was mild in patients with disabling migraine.

Analgesic rebound headache in clinical practice: data from a physician survey.

Background: Frequent, excessive use of over‐the‐counter or prescription analgesics may lead to analgesic rebound headache. Little is known about the magnitude of the health problem posed by analgesic rebound headache, its epidemiology, the characteristics of analgesic rebound headache sufferers, or about physicians’ approaches to treatment.

Tolerability of sumatriptan: clinical trials and post‐marketing experience

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.

Impact of sumatriptan on workplace productivity, nonwork activities, and health-related quality of life among hospital employees with migraine.

This prospective, open‐label study evaluated the effects of subcutaneous sumatriptan versus usual therapy on workplace productivity, activity time outside of work, and health‐related quality of life in 43 men or women who were hospital employees diagnosed with migraine according to International Headache Society criteria. Patients treated migraines with their usual therapy for 12 to 18 weeks followed by subcutaneous sumatriptan for 6 months. Health‐related quality of life measurements obtained at baseline, after usual therapy, and after sumatriptan therapy included the Short Form‐36 Health Surveyº and the Migraine‐Specific Quality of Life Questionnaireº . Patient daily diaries were used to capture data on migraine symptoms and on Lost Workplace Productivity and Non‐workplace Activity Time. Traditional clinical efficacy measures were obtained to support the pharmacoeconomic data. Clinical data showed that the percentage of treated migraine days per patient on which the patient experienced relief (moderate or severe pain reduced to mild or none) was 75% with sumatriptan and 25% with usual therapy. The mean time to meaningful relief was 1.1 hours during the sumatriptan phase and 4.2 hours during the usual therapy phase. Lost Workplace Productivity and Nonworkplace Activity Time was 35% lower with sumatriptan therapy (1.5 hours) compared with usual therapy (2.3 hours). Time missed from work due to symptoms time worked with symptoms, and time normal activities were carried on with symptoms were each lower during sumatriptan therapy compared with usual therapy. Scores on each of the three Migraine‐Specific Quality of Life Questionnaire dimensions and on the Role‐Emotional dimension of the Short Form‐36 were significantly more favorable after sumatriptan than after usual therapy (P<0.05). These data demonstrate that treatment of migraines with sumatriptan for 6 months following usual therapy for 12 to 18 weeks was associated with improvement in clinical efficacy, reduction in lost workplace productivity and nonworkplace activity time, and enhancement of key dimensions of health‐related quality of life among employees of a large university hospital.

Pregnancy and perinatal outcomes in migraineurs using sumatriptan: a prospective study

Background: Sumatriptan is an acute treatment for migraine which is often used by women in their child-bearing years, and who become unexpectedly pregnant. Within the context of the post-marketing use of sumatriptan injection for the acute treatment of migraine, and in compliance with approved labeling, we wished to compare perinatal pregnancy outcomes in women who did and did not use the drug after conception. Methods: Open-label, prospective study conducted in 12,339 migraineurs (including 9,861 women) whose demography and consumption pattern of sumatriptan injections were typical, and were predicted to include 150 pregnancies. Outcome of pregnancy was the end-point. Results: There were 168 of 173 pregnancies that were well-documented. Sumatriptan was only used prior to conception in 92 cases. There were 76 first trimester exposures to sumatriptan. There were no differences in pregnancy outcome between the two groups. Conclusions: Perinatal and pregnancy outcome did not differ between patients who had and had not used sumatriptan after conception, at the resolution of these sample sizes. This study design complements the ongoing pregnancy registry, which is now widened to patients exposed to all formulations of sumatriptan.

Efficacy and tolerability of subcutaneous sumatriptan administered using the IMITREX® STATdose™ System

The efficacy and tolerability of subcutaneous (SC) sumatriptan administered with the IMITREX (sumatriptan succinate) STATdose System, which circumvents the need for patients or health care professionals to handle a syringe, were evaluated in two randomized, double-masked, parallel-group, placebo-controlled, multicenter studies. In the clinic, 158 adults with migraine diagnosed according to International Headache Society criteria received SC sumatriptan (6 mg) or placebo delivered with the IMITREX STATdose System for treatment of a migraine attack. By 120 minutes after SC dosing, 73% and 79% of sumatriptan-treated patients, compared with 28% and 37% of placebo-treated patients in studies 1 and 2, respectively, experienced headache relief (a statistically significant difference). Clinical disability scores 120 minutes after dosing showed that 75% and 85% of sumatriptan-treated patients, compared with 30% and 42% of placebo-treated patients, were normal or only mildly impaired (a statistically significant difference). Similar efficacy rates were observed for nausea, phonophobia, and photophobia. No serious or unusual adverse events occurred, and no clinically relevant abnormalities in laboratory test values were reported. Based on these results, we concluded that SC sumatriptan (6 mg) administered using the IMITREX STATdose System is effective for the treatment of migraine. The efficacy and tolerability profiles of SC sumatriptan administered with this device are similar to those reported for SC sumatriptan administered with a conventional syringe.

Response From Cady et al

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