Evidence map›Paper›PMID 37695442›Full record

ArticleNeurology and therapy2023

Effects of Fremanezumab on Medication Overuse in Japanese Chronic Migraine Patients: Post Hoc Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Noboru Imai, Yuki Isogai, Yoshiyuki Shibasaki, Masami Nakai, Miki Ishida, Xiaoping Ning, Nobuyuki Koga

Open access · goldAbstract read
In one paragraph

Article in Neurology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 5 pooled it
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Noboru ImaiJapanese Red Cross Shizuoka Hospital, Shizuoka, Japan.
Yuki IsogaiMedical Affairs, Otsuka Pharmaceutical Co., Ltd, 16-4 Kounan 2-Chome, Minatoku, Tokyo, 108-8242, Japan. isogai@otsuka.jp.
Yoshiyuki ShibasakiMedical Affairs, Otsuka Pharmaceutical Co., Ltd, 16-4 Kounan 2-Chome, Minatoku, Tokyo, 108-8242, Japan.
Masami NakaiOtsuka Pharmaceutical Co., Ltd, Osaka, Japan.
Miki IshidaOtsuka Pharmaceutical Co., Ltd, Osaka, Japan.
Xiaoping NingTeva Branded Pharmaceutical Products R&D, Inc, West Chester, PA, USA.
Nobuyuki KogaOtsuka Pharmaceutical Co., Ltd, Tokushima, Japan.
Otsuka (Japan) · JPShizuoka Red Cross Hospital · JPTeva Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic migraine (CM) patients commonly take acute headache medications, often resulting in medication overuse (MO). This post hoc analysis evaluated the efficacy of fremanezumab in CM patients from Japan with and without MO, which is not yet established.

methodsA multicenter, double-blind, parallel-group, phase 2b/3 trial randomized patients (1:1:1) to monthly fremanezumab via subcutaneous injection (initial dose: 675 mg, second/third doses: 225 mg), quarterly fremanezumab (initial dose: 675 mg, second/third doses: placebo), or placebo for 3 months. This post hoc analysis analyzed data from Japanese patients with and without MO (monthly use of acute headache medication ≥ 15 days, migraine-specific acute medication ≥ 10 days, or combination medication ≥ 10 days). Outcomes included the original primary endpoint of average headache days of moderate or greater severity per month (HDs), the proportion of patients with ≥ 50% reduction in HDs and the proportion of patients changing status from with to without MO.

resultsOf 479 patients enrolled, 320 (66.8%) had baseline MO. Monthly average HDs were significantly reduced versus placebo with fremanezumab in both patients with MO (mean [standard error] difference vs. placebo: monthly - 2.0 [0.6], p = 0.0012; quarterly - 1.8 [0.6], p = 0.0042) and without MO (- 1.6 [0.8], p = 0.0437; - 1.5 [0.8], p = 0.0441). Significantly more fremanezumab-treated patients with MO (monthly 28/108 [25.9%], p = 0.0040 quarterly 25/99 [25.3%], p = 0.0070) or without MO (18/50 [36.0%], p = 0.0132; and 21/60 [35.0%], p = 0.0126) had ≥ 50% reduction in HDs versus placebo (12/111 [10.8%] and 7/49 [14.3%], respectively). A significantly greater proportion of fremanezumab-treated patients reverted to no MO (monthly 50/108 [46.3%], p = 0.0115; quarterly 44/99 [44.4%], p = 0.0272) vs. placebo (33/111 [29.7%]).

conclusionFremanezumab appears effective as preventive migraine treatment in Japanese CM patients with or without MO while also being beneficial in reducing MO.

Indexed as

Calcitonin gene-related peptideChronic migraineFremanezumabJapaneseMedication overuse

Identifiers

PMID37695442
PMCPMC10630291
OpenAlexW4386591841

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.