Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Sumatriptan nasal spray was effective and well tolerated for multiple migraine attacks

ACP J Club. 1999 Jan-Feb;130:12. doi:10.7326/ACPJC-1999-130-1-012


Source Citation

Diamond S, Elkind A, Jackson RT, et al. Multiple-attack efficacy and tolerability of sumatriptan nasal spray in the treatment of migraine. Arch Fam Med. 1998 May/Jun;7:234-40.


Abstract

Question

Is sumatriptan hemisulfate nasal spray effective and well tolerated for multiple migraine attacks?

Design

Randomized, double-blind, parallel-group, placebo-controlled trial.

Setting

56 U.S. outpatient clinical centers.

Patients

1086 patients who were 18 to 65 years of age (mean age 41 y, 88% women), met the International Headache Society diagnostic criteria for migraine with or without aura, and had 2 to 8 attacks/mo for ≥ 1 year that lasted ≤ 15 d/mo. Exclusion criteria included Raynaud syndrome, Prinzmetal angina, ischemic heart disease, uncontrolled hypertension, cerebrovascular disease, pregnancy, or lactation.

Intervention

Patients were allocated to self-administered sumatriptan hemisulfate nasal spray, 20 mg (n = 292), 10 mg (n = 296), 5 mg (n = 299), or to placebo (n = 199). Patients were instructed to treat up to 3 moderate or severe migraine attacks over 6 months with the same dose and to limit the use of rescue medication. Patients who had relief 120 minutes after initial dosing and did not take rescue medication were eligible to use a second identical dose for migraine recurrence within the same day.

Main outcome measures

Patients rated headache pain severity and clinical disability using two 4-point scales. Nausea, vomiting, photophobia, phonophobia, and adverse effects were also assessed.

Main results

1086, 904, and 698 patients were treated for 1, 2, and 3 attacks, respectively. For all attacks, pain relief after 120 minutes for treatment groups was higher than for the placebo group (P < 0.05 for treatment vs placebo [Table] and for 20 mg vs 5 mg). For all attacks, the ability to function normally after 120 minutes was 70% for 20 mg, 67% for 10 mg, and 57% for 5 mg for the treatment groups and 50% for the placebo group (P < 0.05 for 20 mg or 10 mg vs placebo and for 20 mg vs 5 mg). After 120 minutes, all treatment groups had less nausea and photophobia and the 20-mg and 10-mg groups had less phonophobia (P < 0.05) than the placebo group. Unpleasant taste, reported more among patients who received the treatment drug, was the most common adverse effect.

Conclusion

Sumatriptan hemisulfate nasal spray was an effective and well-tolerated treatment for multiple migraine attacks.

Source of funding: Glaxo Wellcome, Inc.

For correspondence: Dr. S. Diamond, Diamond Headache Clinic, 467 West Deming Place, Suite 500, Chicago, IL 60614, USA. FAX 773-477-9812.


Table. Sumatriptan nasal spray vs placebo for relief from migraine pain at 120 min*

Dose Sumatriptan Placebo RBI (95% CI) NNT (CI)
20 mg 60% 32% 88% (51 to 136) 4 (3 to 6)
10 mg 54% 32% 69% (35 to 113) 5 (4 to 8)
5 mg 44% 32% 38% (9 to 76) 9 (5 to 29)

*Abbreviations defined in Glossary; RBI, NNT, and CI calculated from data in article.


Commentary

Diamond and colleagues provide a straightforward trial of the efficacy of sumatriptan nasal spray for migraine. According to the percentages of patients with mild or no pain 2 hours after treatment, 2 of 3 patients with migraine will improve after treatment with 20 mg of sumatriptan nasal spray and 1 of 3 will improve on placebo.

Sumatriptan nasal spray has not been directly compared with other routes of sumatriptan administration. Although pain relief may occur faster with nasal administration than with oral administration, the rate of pain relief from nasal spray (60%) may be lower than that of oral (up to 71%) or subcutaneous administration (up to 77%) (1). Nasal sumatriptan is a convenient alternative for patients who are unable to take oral medication or those who do not wish to use the subcutaneous form.

The important issue, however, is not to compare the routes of sumatriptan administration but to compare sumatriptan with less expensive medications (2). Only 2 studies directly compared sumatriptan with a nonsteroidal anti-inflammatory drug (NSAID) (3, 4). In 1 study, the NSAID was combined with metoclopramide (4). Both studies found no difference in efficacy, and sumatriptan may be associated with increased side effects. Recent Canadian practice guidelines list sumatriptan as an option only for moderate migraine attacks (1). The guidelines list NSAIDs for mild attacks and dihydroergotamine for severe attacks.

Robert G. Badgett, MD
University of Texas Health Science CenterSan Antonio, Texas, USA


References

1. Pryse-Phillips WE, Dodick DW, Edmeads JG, et al. Guidelines for the diagnosis and management of migraine in clinical practice. Canadian Headache Society. CMAJ. 1997;156:1273-87.

2. Ilerisch L. Ottawa: Canadian Coordinating Office for Health Technology Assessment; 1997:13. (Abstract available through the NHS Centre for Reviews and Dissemination Web site, http://nhscrd.york.ac.uk/)

3. Myllyla VV, Havanka H, Herrala L, et al. Tolfenamic acid rapid release versus sumatriptan in the acute treatment of migraine: comparable effect in a double-blind, randomized, controlled, parallel-group study. Headache. 1998;38:201-7.

4. Tfelt-Hansen P, Henry P, Mulder LJ, et al. The effectiveness of combined oral lysine acetylsalicylate and metoclopramide compared with oral sumatriptan for migraine. Lancet. 1995;346:923-6.