Patient-Centered Treatment of Chronic Migraine With Medication Overuse: A Prospective, Randomized, Pragmatic Clinical Trial.

Adult Female Headache Disorders, Secondary / drug therapy Humans Migraine Disorders / drug therapy Patient-Centered Care Prescription Drug Overuse / prevention & control Prospective Studies Quality of Life

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
05 04 2022
Historique:
received: 01 09 2021
accepted: 11 01 2022
pubmed: 17 2 2022
medline: 7 4 2022
entrez: 16 2 2022
Statut: ppublish

Résumé

Overuse of symptomatic (i.e., acute) medications is common among those with chronic migraine. It is associated with developing frequent headaches, medication side effects, and reduced quality of life. The optimal treatment strategy for patients who have chronic migraine with medication overuse (CMMO) has long been debated. The study objective was to determine whether migraine preventive therapy without switching or limiting the frequency of the overused medication was noninferior to migraine preventive therapy with switching from the overused medication to an alternative medication that could be used on ≤2 d/wk. The Medication Overuse Treatment Strategy (MOTS) trial was an open-label, pragmatic clinical trial, randomizing adult participants 1:1 to migraine preventive medication and (1) switching from the overused medication to an alternative used ≤2 d/wk or (2) continuation of the overused medication with no maximum limit. Participants were enrolled between February 2017 and December 2020 from 34 clinics in the United States, including headache specialty, general neurology, and primary care clinics. The primary outcome was moderate to severe headache day frequency during weeks 9 to 12 and subsequently during weeks 1 to 2 after randomization. Seven hundred twenty participants were randomized; average age was 44 (SD 13) years; and 87.5% were female. At baseline, participants averaged 22.5 (SD 5.1) headache days over 4 weeks, including 12.8 (SD 6.7) moderate to severe headache days and 21.4 (SD 5.8) days of symptomatic medication use. Migraine preventive medication without switching of the overused medication was not inferior to preventive medication with switching for moderate to severe headache day frequency during weeks 9 to 12 (switching 9.3 [SD 7.2] vs no switching 9.1 [SD 6.8]; When reduction in moderate to severe headache days was used as the outcome of interest for the management of CMMO, migraine preventive medication without switching or limiting symptomatic medication is not inferior to migraine preventive medication with switching to a different symptomatic medication with a maximum limit of 2 treatment days per week. ClinicalTrials.gov identifier NCT02764320. This study provides Class III evidence that, for patients who have CMMO, migraine preventive medication without switching or limiting the overused medication is noninferior to migraine preventive medication with switching and limiting symptomatic medication.

Sections du résumé

BACKGROUND AND OBJECTIVES
Overuse of symptomatic (i.e., acute) medications is common among those with chronic migraine. It is associated with developing frequent headaches, medication side effects, and reduced quality of life. The optimal treatment strategy for patients who have chronic migraine with medication overuse (CMMO) has long been debated. The study objective was to determine whether migraine preventive therapy without switching or limiting the frequency of the overused medication was noninferior to migraine preventive therapy with switching from the overused medication to an alternative medication that could be used on ≤2 d/wk.
METHODS
The Medication Overuse Treatment Strategy (MOTS) trial was an open-label, pragmatic clinical trial, randomizing adult participants 1:1 to migraine preventive medication and (1) switching from the overused medication to an alternative used ≤2 d/wk or (2) continuation of the overused medication with no maximum limit. Participants were enrolled between February 2017 and December 2020 from 34 clinics in the United States, including headache specialty, general neurology, and primary care clinics. The primary outcome was moderate to severe headache day frequency during weeks 9 to 12 and subsequently during weeks 1 to 2 after randomization.
RESULTS
Seven hundred twenty participants were randomized; average age was 44 (SD 13) years; and 87.5% were female. At baseline, participants averaged 22.5 (SD 5.1) headache days over 4 weeks, including 12.8 (SD 6.7) moderate to severe headache days and 21.4 (SD 5.8) days of symptomatic medication use. Migraine preventive medication without switching of the overused medication was not inferior to preventive medication with switching for moderate to severe headache day frequency during weeks 9 to 12 (switching 9.3 [SD 7.2] vs no switching 9.1 [SD 6.8];
DISCUSSION
When reduction in moderate to severe headache days was used as the outcome of interest for the management of CMMO, migraine preventive medication without switching or limiting symptomatic medication is not inferior to migraine preventive medication with switching to a different symptomatic medication with a maximum limit of 2 treatment days per week.
TRIAL REGISTRATION INFORMATION
ClinicalTrials.gov identifier NCT02764320.
CLASSIFICATION OF EVIDENCE
This study provides Class III evidence that, for patients who have CMMO, migraine preventive medication without switching or limiting the overused medication is noninferior to migraine preventive medication with switching and limiting symptomatic medication.

Identifiants

DOI: 10.1212/WNL.0000000000200117 PMID: 35169011
pubmed: 35169011
pii: WNL.0000000000200117
doi: 10.1212/WNL.0000000000200117
doi:

Banques de données

ClinicalTrials.gov
['NCT02764320']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1409-e1421

Investigateurs

Zubair Ahmed (Z)
Nathan Bennett (N)
Maike Tiede Blaya (MT)
Melissa Cortez (M)
Michael Cutrer (M)
Paru David (P)
Justin Delange (J)
Lawrence Goldstick (L)
Christine Harter (C)
Susan Hutchinson (S)
Greg Kennebeck (G)
Judy Lane (J)
Laszlo Mechtler (L)
Tesha Monteith (T)
William Mullally (W)
Cumara O'Carroll (C)
Karly Pippitt (K)
Brian Plato (B)
Jill Rau (J)
Mitra Razzaghi (M)
Paul Rizzoli (P)
Howard Schecht (H)
Tim Smith (T)
David True (D)
John Wald (J)

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2022 American Academy of Neurology.

Auteurs

Todd J Schwedt (TJ)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV. schwedt.todd@mayo.edu.

Joseph G Hentz (JG)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Soma Sahai-Srivastava (S)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.
ORCID: 0000-0001-6693-9043

Natalia Murinova (N)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Nicole M Spare (NM)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Christina Treppendahl (C)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Vincent T Martin (VT)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Marius Birlea (M)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Kathleen Digre (K)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

David Watson (D)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Michael Leonard (M)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

Teri Robert (T)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

David W Dodick (DW)

From the Department of Neurology (T.J.S., J.G.H., M.L., D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.S.-S.), University of Southern California, Los Angeles; Department of Neurology (N.M.), University of Washington, Seattle; Department of Neurology (N.M.S.), Thomas Jefferson University, Philadelphia, PA; The Headache Center (C.T.), Ridgeland, MS; Department of Internal Medicine (V.T.M.), University of Cincinnati, OH; Department of Neurology (M.B.), University of Colorado, Denver; Department of Neurology (K.D.), University of Utah, Salt Lake City; Department of Neurology (D.W.), West Virginia University Rockefeller Neuroscience Institute, Morgantown; and patient advocate and educator (T.R.), Washington, WV.

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Classifications MeSH

Recherchemedicale.com › Personnes › Tranches d'âge › Adulte › Patient-Centered Treatment of Chronic Migraine...
Recherchemedicale.com › Maladies du système nerveux › Maladies du système nerveux central › Encéphalopathies › Céphalées › Céphalées secondaires › Patient-Centered Treatment of Chronic Migraine...
Recherchemedicale.com › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Patient-Centered Treatment of Chronic Migraine...
Recherchemedicale.com › Maladies du système nerveux › Maladies du système nerveux central › Encéphalopathies › Céphalées › Céphalées primitives › Migraines › Patient-Centered Treatment of Chronic Migraine...
Recherchemedicale.com › Administration des services de santé › Gestion des soins aux patients › Services de santé polyvalents › Soins de santé primaires › Soins centrés sur le patient › Patient-Centered Treatment of Chronic Migraine...
Recherchemedicale.com › Thérapeutique › Traitement médicamenteux › Mésusage de médicament › Surdose › Abus de médicaments sur ordonnance › Patient-Centered Treatment of Chronic Migraine...
Recherchemedicale.com › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Patient-Centered Treatment of Chronic Migraine...
Recherchemedicale.com › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Patient-Centered Treatment of Chronic Migraine...