Oral zolmitriptan for acute migraine

Clinical bottom line:

Oral zolmitriptan 5 mg has been fully tested in four randomised trials with about 1200 patients. The NNT for two hour headache response was 3.1 (2.6 to 3.9). The NNT for two hour pain free was 3.9 (3.4 to 4.6) in 1,228 patients in four trials. In one trial the two hour headache response sustained for 24 hours with no additional analgesic was not significantly different between zolmitriptan 5 mg and placebo.

Oral zolmitriptan 2.5 mg has been fully tested in two randomised trials with about 600 patients. The NNT for two hour headache response was 3.5 (2.7 to 4.7). The NNT for two hour pain free was 5.9 (4.5 to 8.7) in 651 patients in two trials. There was no information headache response sustained for 24 hours with no additional analgesic.


Reference

AD Oldman, LA Smith, HJ McQuay, RA Moore. A systematic review of treatments for acute migraine. Pain 2002 97: 247-257.

Inclusion criteria were: treatment of acute migraine with dihydroergotamine by any route; randomised allocation to treatment groups; double-blind design; adult population and headache outcomes.

Search

Comprehensive searches of the following databases were made: MEDLINE (1966 - July 2001), EMBASE (1980 - June 2001), Cochrane Library (Issue 3, 2001), PubMed (to September 2001) and the Oxford Pain Relief Database (1950 - 1994). A series of free text searches were undertaken, using generic and trade names. There was no restriction to language. Retrieved reports were searched for additional trials. Neither individual authors nor pharmaceutical companies were contacted for unpublished data.

Findings

Tables with all included trials and excluded trials are available.

Oral zolmitriptan 5 mg

The results for the four trials for oral zolmitriptan 5 mg were consistent for all outcomes, and those for two hour headache response are shown in Figure 1.

Figure 1: Headache response at two hours for oral zolmitriptan 5 mg

Table 1: Results for oral zolmitriptan 5 mg

Number/total with outcome (%)

Outcome

Number of trials

Treatment

Placebo

NNT
(95%CI)

Two hour headache response

4

583/943
(62)

85/285
(30)

3.1 (2.6 to 3.9)

Two hour pain free

4

298/943
(32)

17/285
(6)

3.9 (3.4 to 4.6)

Headache response at 2 hours sustained to 24 hours

1

180/498
(36)

14/56
(25)

no significant benefit

 

For oral zolmitriptan 5 mg in four trials, 583/943 patients (62%) had a headache response at two hours compared with 85/285 (30%) with placebo. The NNT was 3.1 (2.6 to 3.9). The NNT for two hour pain free was 3.9 (3.4 to 4.6) in 1,228 patients in four trials. In one trial the two hour headache response sustained for 24 hours with no additional analgesic was not significantly different between zolmitriptan 5 mg and placebo.

Oral zolmitriptan 2.5 mg

Table 2: Results for oral zolmitriptan 2.5 mg

Number/total with outcome (%)

Outcome

Number of trials

Treatment

Placebo

NNT
(95%CI)

Two hour headache response

2

279/438
(64)

74/213
(35)

3.5 (2.7 to 4.7)

Two hour pain free

2

109/438
(25)

17/213
(8)

5.9 (4.5 to 8.7)

Headache response at 2 hours sustained to 24 hours

no data

For oral zolmitriptan 2.5 mg in two trials, 279/438 patients (64%) had a headache response at two hours compared with 74/213 (35%) with placebo. The NNT was 3.5 (2.7 to 4.7). The NNT for two hour pain free was 5.9 (4.5 to 8.7) in 651 patients in two trials. There was no information headache response sustained for 24 hours with no additional analgesic.

Adverse effects

Adverse effects are not reported in any way that makes obvious sense because efficacy was measured over 24 hours and adverse events for up to 10 days.

Comment


Zolmitriptan is clearly effective in the treatment of acute migraine.