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Meta-Analysis
. 2013 Jun 24;2013(6):CD010610.
doi: 10.1002/14651858.CD010610.

Topiramate for the prophylaxis of episodic migraine in adults

Mattias Linde  1 , Wim M Mulleners, Edward P Chronicle, Douglas C McCrory
Affiliations
Meta-Analysis

Topiramate for the prophylaxis of episodic migraine in adults

Mattias Linde et al. Cochrane Database Syst Rev. .

Abstract

Background: Some antiepileptic drugs but not others are useful in clinical practice for the prophylaxis of migraine. This might be explained by the variety of actions of these drugs in the central nervous system. The present review is part of an update of a Cochrane review first published in 2004, and previously updated (conclusions not changed) in 2007.

Objectives: To describe and assess the evidence from controlled trials on the efficacy and tolerability of topiramate for preventing migraine attacks in adult patients with episodic migraine.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2012, Issue 12), PubMed/MEDLINE (1966 to 15 January 2013), MEDLINE In-Process (current week, 15 January 2013), and EMBASE (1974 to 15 January 2013) and handsearched Headache and Cephalalgia through January 2013.

Selection criteria: Studies were required to be prospective, controlled trials of topiramate taken regularly to prevent the occurrence of migraine attacks, to improve migraine-related quality of life, or both.

Data collection and analysis: Two review authors independently selected studies and extracted data. For headache frequency data, we calculated mean differences (MDs) between topiramate and comparator (placebo, active control, or topiramate in a different dose) for individual studies and pooled these across studies. For dichotomous data on responders (patients with ≥ 50% reduction in headache frequency), we calculated odds ratios (ORs) and, in select cases, risk ratios (RRs); we also calculated numbers needed to treat (NNTs). We calculated MDs for selected quality of life instruments. Finally, we summarised data on adverse events from placebo-controlled trials and calculated risk differences (RDs) and numbers needed to harm (NNHs).

Main results: Twenty papers describing 17 unique trials met the inclusion criteria. Analysis of data from nine trials (1737 participants) showed that topiramate reduced headache frequency by about 1.2 attacks per 28 days as compared to placebo (MD -1.20; 95% confidence interval (CI) -1.59 to -0.80). Data from nine trials (1190 participants) show that topiramate approximately doubled the proportion of responders relative to placebo (RR 2.02; 95% CI 1.57 to 2.60; NNT 4; 95% CI 3 to 6). Separate analysis of different topiramate doses produced similar MDs versus placebo at 50 mg (-0.95; 95% CI -1.95 to 0.04; three studies; 520 participants), 100 mg (-1.15; 95% CI -1.58 to -0.71; six studies; 1620 participants), and 200 mg (-0.94; 95% CI -1.53 to -0.36; five studies; 804 participants). All three doses significantly increased the proportion of responders relative to placebo; ORs were as follows: for 50 mg, 2.35 (95% CI 1.60 to 3.44; three studies; 519 participants); for 100 mg, 3.49 (95% CI 2.23 to 5.45; five studies; 852 participants); and for 200 mg, 2.49 (95% CI 1.61 to 3.87; six studies; 1025 participants). All three doses also significantly improved three or more domains of quality of life as compared to placebo. Meta-analysis of the three studies that included more than one dose of topiramate suggests that 200 mg is no more effective than 100 mg. With regard to mean headache frequency and/or responder rate, seven trials using active comparators found (a) no significant difference between topiramate and amitriptyline (one study, 330 participants); (b) no significant difference between topiramate and flunarizine (one study, 83 participants); (c) no significant difference between topiramate and propranolol (two studies, 342 participants); (d) no significant difference between topiramate and relaxation (one study, 61 participants); but (e) a slight significant advantage of topiramate over valproate (two studies, 120 participants). Relaxation improved migraine-specific quality of life significantly more than topiramate. In trials of topiramate against placebo, seven adverse events (AEs) were reported by at least three studies. These were usually mild and of a non-serious nature. Except for taste disturbance and weight loss, there were no significant differences in the frequency of AEs in general, or of the seven specific AEs, between placebo and topiramate 50 mg. AEs in general and all of the specific AEs except nausea were significantly more common on topiramate 100 mg than on placebo, with NNHs varying from 3 to 25, and the RDs versus placebo were even higher for topiramate 200 mg, with NNHs varying from 2 to 17.

Authors' conclusions: Meta-analysis demonstrates that topiramate in a 100 mg/day dosage is effective in reducing headache frequency and reasonably well-tolerated in adult patients with episodic migraine. This provides good evidence to support its use in routine clinical management. More studies designed specifically to compare the efficacy or safety of topiramate versus other interventions with proven efficacy in the prophylaxis of migraine are needed.

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Conflict of interest statement

Prof Linde: During the process of preparing this review the author received a travel grant from Allergan in Sweden and was involved as an investigator in a clinical trial in Norway sponsored by AstraZeneca and comparing candesartan, propranolol, and placebo in the prophylaxis of migraine. He was senior investigator in one of the included studies (Varkey 2011).

Dr Mulleners: The author was a paid consultant for the Merck Dutch Migraine Advisory Board and received a speaker's fee from Merck Sharp & Dohme Corp.

Prof Chronicle: Author deceased. During the process of preparing the original review the author was a paid consultant for Johnson & Johnson and NPS Pharmaceuticals in the USA.

Assoc Prof McCrory: During 2008, the author was a paid expert witness for the plaintiffs in a legal action against the manufacturer of Neurontin (gabapentin). In this capacity, he prepared a systematic review examining previously confidential research reports obtained from the manufacturer (through discovery), along with published trial reports of gabapentin for migraine prophylaxis, and testified at trial.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Topiramate (combined analyses based on most relevant dose in each study) versus placebo, outcome: 1.1 Headache frequency (change from baseline to post‐treatment, or post‐treatment alone).
4
4
Forest plot of comparison: 2 Topiramate (separate analyses of various doses) versus placebo, outcome: 2.1 Headache frequency (change from baseline to post‐treatment, or post‐treatment alone).
5
5
Forest plot of comparison: 1 Topiramate (combined analyses based on most relevant dose in each study) versus placebo, outcome: 1.3 RRs for responders (patients with ≥ 50% reduction in headache frequency).
1.1
1.1. Analysis
Comparison 1 Topiramate (combined analyses based on most relevant dose in each study) versus placebo, Outcome 1 Headache frequency (change from baseline to post‐treatment, or post‐treatment alone).
1.2
1.2. Analysis
Comparison 1 Topiramate (combined analyses based on most relevant dose in each study) versus placebo, Outcome 2 ORs for responders (patients with ≥ 50% reduction in headache frequency).
1.3
1.3. Analysis
Comparison 1 Topiramate (combined analyses based on most relevant dose in each study) versus placebo, Outcome 3 RRs for responders (patients with ≥ 50% reduction in headache frequency).
2.1
2.1. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 1 Headache frequency (change from baseline to post‐treatment, or post‐treatment alone).
2.2
2.2. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 2 Responders (patients with ≥ 50% reduction in headache frequency).
2.3
2.3. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 3 Any adverse event.
2.4
2.4. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 4 Anorexia.
2.5
2.5. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 5 Fatigue.
2.6
2.6. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 6 Memory problems.
2.7
2.7. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 7 Nausea.
2.8
2.8. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 8 Paresthesia.
2.9
2.9. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 9 Taste disturbance.
2.10
2.10. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 10 Weight loss.
2.11
2.11. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 11 MSQ‐role function restrictive.
2.12
2.12. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 12 MSQ‐role function prevention.
2.13
2.13. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 13 MSQ‐emotional function.
2.14
2.14. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 14 SF‐36 role physical.
2.15
2.15. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 15 SF‐36 vitality.
2.16
2.16. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 16 SF‐36 physical functioning.
2.17
2.17. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 17 SF‐36 bodily pain.
2.18
2.18. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 18 SF‐36 general health.
2.19
2.19. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 19 SF‐36 social functioning.
2.20
2.20. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 20 SF‐36 role emotional.
2.21
2.21. Analysis
Comparison 2 Topiramate (separate analyses of various doses) versus placebo, Outcome 21 SF‐36 mental health.
3.1
3.1. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 1 Headache frequency (change from baseline to post‐treatment, or post‐treatment alone).
3.2
3.2. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 2 Responders (patients with ≥ 50% reduction in headache frequency).
3.3
3.3. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 3 MSQ‐role function restrictive.
3.4
3.4. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 4 MSQ‐role function prevention.
3.5
3.5. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 5 MSQ‐emotional function.
3.6
3.6. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 6 SF‐36 role physical.
3.7
3.7. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 7 SF‐36 vitality.
3.8
3.8. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 8 SF‐36 physical functioning.
3.9
3.9. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 9 SF‐36 bodily pain.
3.10
3.10. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 10 SF‐36 general health.
3.11
3.11. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 11 SF‐36 social functioning.
3.12
3.12. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 12 SF‐36 role emotional.
3.13
3.13. Analysis
Comparison 3 Topiramate direct dose comparisons, Outcome 13 SF‐36 mental health.
4.1
4.1. Analysis
Comparison 4 Topiramate versus amitriptyline, Outcome 1 Responders (patients with ≥ 50% reduction in headache frequency).
4.2
4.2. Analysis
Comparison 4 Topiramate versus amitriptyline, Outcome 2 MIDAS score.
5.1
5.1. Analysis
Comparison 5 Topiramate versus flunarizine, Outcome 1 Headache frequency (post‐treatment).
5.2
5.2. Analysis
Comparison 5 Topiramate versus flunarizine, Outcome 2 Responders (patients with ≥ 50% reduction in headache frequency).
6.1
6.1. Analysis
Comparison 6 Topiramate versus propranolol, Outcome 1 Headache frequency (change from baseline to post‐treatment, or post‐treatment alone).
6.2
6.2. Analysis
Comparison 6 Topiramate versus propranolol, Outcome 2 Responders (patients with ≥ 50% reduction in headache frequency).
7.1
7.1. Analysis
Comparison 7 Topiramate versus sodium valproate, Outcome 1 Headache frequency (post‐treatment).
7.2
7.2. Analysis
Comparison 7 Topiramate versus sodium valproate, Outcome 2 MIDAS score.
8.1
8.1. Analysis
Comparison 8 Topiramate versus relaxation, Outcome 1 Headache frequency (change from baseline to post‐treatment).
8.2
8.2. Analysis
Comparison 8 Topiramate versus relaxation, Outcome 2 Responders (patients with ≥ 50% reduction in headache frequency).
8.3
8.3. Analysis
Comparison 8 Topiramate versus relaxation, Outcome 3 Change from baseline in MSQoL.
See this image and copyright information in PMC

Comment in

References

References to studies included in this review

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Bartolini 2005 {published data only}
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