Adverse and serious adverse events incidence of pharmacological interventions for managing chronic and episodic migraine in adults: a systematic review

被引:0
作者
Naghdi, Seyran [1 ]
Underwood, Martin [1 ,2 ]
Brown, Anna [3 ]
Matharu, Manjit [4 ,5 ]
Duncan, Callum [6 ]
Davies, Natasha [3 ]
Aksentyte, Aiva [3 ]
Mistry, Hema [1 ,2 ]
机构
[1] Univ Warwick, Warwick Med Sch, Warwick Clin Trials Unit, Coventry, England
[2] Univ Hosp Coventry, Warwickshire NHS Trust, Coventry, England
[3] Univ Warwick, Warwick Med Sch, Coventry, England
[4] UCL Inst Neurol, Headache Grp, London, England
[5] Natl Hosp Neurol & Neurosurg, London, England
[6] Aberdeen Royal Infirm, Dept Neurol, Aberdeen, Scotland
基金
美国国家卫生研究院;
关键词
MIGRAINE; SYSTEMATIC REVIEWS; PLACEBO-CONTROLLED PHASE; GENE-RELATED PEPTIDE; DOUBLE-BLIND; PREVENTIVE TREATMENT; SAFETY; EFFICACY; MULTICENTER; ERENUMAB; TRIAL; ONABOTULINUMTOXINA;
D O I
10.1136/bmjno-2023-000616
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background Migraine is the second most common prevalent disorder worldwide and is a top cause of disability with a substantial economic burden. Many preventive migraine medications have notable side effects that affect different body organs.Method We systematically searched for published randomised controlled trials (RCTs) using terms for migraine/headache and preventive medications. Using eligibility criteria, two reviewers independently assessed the articles. Cochrane risk-of-bias tool was applied to assess the quality of the studies. Data were classified by system organ class (SOC).Results Thirty-two RCTs with 21 780 participants met the eligibility criteria for the incidence of adverse events (AEs). Additionally, 33 RCTs with 22 615 participants were included to synthesise the incidence of serious AEs (SAEs). The percentage of attributed AEs and SAEs to each SOC for 10 preventive drugs with different dosing regimens was calculated. Amitriptyline and topiramate had a higher incidence of nervous system disorders; Topiramate was also associated with a higher incidence of psychiatric disorders. All drugs showed a certain incidence of infections and infestations, with Onabotulinumtoxin A (BTA) having the lowest rate. BTA had a higher incidence of musculoskeletal disorders than the other drugs. Calcitonin gene-related peptide (CGRP) monoclonal antibodies (MAbs) such as fremanezumab and galcanezumab were linked to more general disorders and administration site conditions than other drugs.Conclusion Notably, the observed harm to SOCs varies among these preventive drugs. We suggest conducting head-to-head RCTs to evaluate the safety profile of oral medications, BTA, and CGRP MAbs in episodic and/or chronic migraine populations.PROSPERO registration number CRD42021265993.
引用
收藏
页数:10
相关论文
共 61 条
  • [1] Atogepant for the Preventive Treatment of Migraine
    Ailani, Jessica
    Lipton, Richard B.
    Goadsby, Peter J.
    Guo, Hua
    Miceli, Rosa
    Severt, Lawrence
    Finnegan, Michelle
    Trugman, Joel M.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2021, 385 (08) : 695 - 706
  • [2] Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial
    Ashina, Messoud
    Tepper, Stewart J.
    Reuter, Uwe
    Blumenfeld, Andrew M.
    Hutchinson, Susan
    Xia, Jing
    Miceli, Rosa
    Severt, Lawrence
    Finnegan, Michelle
    Trugman, Joel M.
    [J]. HEADACHE, 2023, 63 (01): : 79 - 88
  • [3] Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial
    Ashina, Messoud
    Lanteri-Minet, Michel
    Pozo-Rosich, Patricia
    Ettrup, Anders
    Christoffersen, Cecilie Laurberg
    Josiassen, Mette Krog
    Phul, Ravinder
    Sperling, Bjorn
    [J]. LANCET NEUROLOGY, 2022, 21 (07) : 597 - 607
  • [4] Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)
    Ashina, Messoud
    Saper, Joel
    Cady, Roger
    Schaeffler, Barbara A.
    Biondi, David M.
    Hirman, Joe
    Pederson, Susan
    Allan, Brent
    Smith, Jeff
    [J]. CEPHALALGIA, 2020, 40 (03) : 241 - 254
  • [5] Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study
    Ashina, Messoud
    Tepper, Stewart
    Brandes, Jan Lewis
    Reuter, Uwe
    Boudreau, Guy
    Dolezil, David
    Cheng, Sunfa
    Zhang, Feng
    Lenz, Robert
    Klatt, Jan
    Mikol, Daniel D.
    [J]. CEPHALALGIA, 2018, 38 (10) : 1611 - 1621
  • [6] Aurora SK, 2010, CEPHALALGIA, V30, P793, DOI 10.1177/0333102410364676
  • [7] Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial
    Croop, Robert
    Lipton, Richard B.
    Kudrow, David
    Stock, David A.
    Kamen, Lisa
    Conway, Charles M.
    Stock, Elyse G.
    Coric, Vladimir
    Goadsby, Peter J.
    [J]. LANCET, 2021, 397 (10268) : 51 - 60
  • [8] Galcanezumab in chronic migraine The randomized, double-blind, placebo-controlled REGAIN study
    Detke, Holland C.
    Goadsby, Peter J.
    Wang, Shufang
    Friedman, Deborah I.
    Selzler, Katherine J.
    Aurora, Sheena K.
    [J]. NEUROLOGY, 2018, 91 (24) : E2211 - E2221
  • [9] OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial
    Diener, H. C.
    Dodick, D. W.
    Aurora, S. K.
    Turkel, C. C.
    DeGryse, R. E.
    Lipton, R. B.
    Silberstein, S. D.
    Brin, M. F.
    [J]. CEPHALALGIA, 2010, 30 (07) : 804 - 814
  • [10] Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication-overuse headache: Subgroup analysis of PROMISE-2
    Diener, Hans-Christoph
    Marmura, Michael J.
    Tepper, Stewart J.
    Cowan, Robert
    Starling, Amaal J.
    Diamond, Merle L.
    Hirman, Joe
    Mehta, Lahar
    Brevig, Thomas
    Sperling, Bjorn
    Cady, Roger
    [J]. HEADACHE, 2021, 61 (01): : 125 - 136