Sumatriptan reduced pain and symptoms and was well tolerated for repeated episodes of migraine
ACP J Club. 1993 Nov-Dec;119:72. doi:10.7326/ACPJC-1993-119-3-072
Cady RK, Dexter J, Sargent JD, et al. Efficacy of subcutaneous sumatriptan in repeated episodes of migraine. Neurology. 1993 Jul;43:1363-8.
To study the efficacy and safety of and patient satisfaction with subcutaneous sumatriptan given for repeated episodes of migraine.
Randomized, double-blind, placebo-controlled, crossover trial.
10 clinical centers.
170 otherwise healthy adults (mean age 41 y, 91% women) with a history of migraine for > 1 year. Diagnosis was based on the International Headache Society criteria. Exclusion criteria were pregnancy, lactation, ergotamine or analgesics containing opioid derivatives within 24 hours of dosing, or simple analgesics or antiemetics within 6 hours of dosing.
Patients were treated for 4 episodes of moderate or severe migraine (3 active and 1 placebo treatment in random order). Treatment episodes were separated by ≥ 24 hours. A single 6-mg dose of subcutaneous sumatriptan or placebo was given in the thigh or upper arm. Rescue medication could be given 90 minutes after treatment.
Main outcome measures
Patients rated pain and clinical disability on a 4-point scale before dosing and 30, 60, and 90 minutes after dosing. Relief of nausea, vomiting, phonophobia, and photophobia was also assessed. Use of rescue medication, duration of migraine relief, and adverse events were monitored by patient diary for 24 hours.
The study was stopped when 120 people had completed their 4 treatments. 90 minutes after each attack 86% to 90% of patients taking sumatriptan reported pain relief (defined as reduction of moderate or severe pain to mild or no pain) compared with 9% to 38% of patients taking placebo ( P < 0.001). No difference was noted in pain relief with multiple episodes of sumatriptan use. Combining the 4 periods, the proportion of patients taking sumatriptan relieved of pain was 54% at 30 minutes, 80% at 60 minutes, and 85% at 90 minutes. For patients taking placebo, the corresponding proportions were 11%, 18%, and 20%. Compared with placebo, sumatriptan reduced nausea, photophobia, and phonophobia at 90 minutes and reduced clinical disability at all time periods ( P ≥ 0.001). 65% of patients receiving sumatriptan rated treatment as very good compared with 11% for patients receiving placebo (P < 0.001). More patients taking placebo used rescue medications for each of the 4 episodes ( P < 0.001). The groups did not differ in changes in vital signs or laboratory findings. More adverse effects were reported in patients taking sumatriptan, which caused 3 patients to withdraw from the study.
Single-dose, subcutaneous sumatriptan was effective for pain and other symptom relief and was well tolerated in repeated episodes of migraine in adults.
Source of funding: Glaxo Research Institute.
For article reprint: Dr. R.K. Cady, Headache Care Center, 1230 East Kingsley Street, Springfield, MO 65804, USA. FAX 417-890-8827.
The study by Cady and colleagues adds to the growing clinical evidence supporting sumatriptan's efficacy in the abortive treatment of migraine. This study supports the positive clinical impressions of physicians who treat headache that sumatriptan 1) is a very effective abortive agent; 2) is well perceived by patients because of its quick action; 3) is an advance in migraine therapy because it treats both pain and other migraine symptoms such as nausea, vomiting, photophobia, phonophobia, and visual affects, thus allowing for a return to near-normal functioning; 4) maintains its efficacy after several doses; and 5) treatment failure on one occasion does not prevent subsequent efficacy.
A treatment problem some patients have with sumatriptan is its relatively short duration of action. This study notes that 30% to 40% of patients taking sumatriptan still had maintained pain relief after 24 hours. Recurrence of migraine pain after successful treatment with sumatriptan was seen in most persons, although this was less common than with placebo.
Some important clinical issues in the use of sumatriptan were not resolved in this study. First, does frequent sumatriptan administration for several months produce drug-induced chronic daily headache ("rebound" or "transformed migraine") as does using most other symptomatic abortive headache medication (1)? Second, because migraine is a chronic disease, does sumatriptan maintain its efficacy after months and years? Third, is sumatriptan a better agent than other abortive agents commonly used, such as ergotamine or nonsteroidal anti-inflammatory drugs?
Prophylactic therapy was not reported, or tested, in this study. Primary care physicians should remember that prophylactic therapy, in addition to effective abortive therapy, is necessary for the optimal care of persons with chronic headache.
Bradley Galer, MD
University of WashingtonSeattle, Washington, USA