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Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Problematic presentation and use of efficacy measures in current trials of CGRP monoclonal antibodies for episodic migraine prevention: A mini-review

Publikation: Bidrag til tidsskriftReviewForskningpeer review

DOI

  1. Erenumab prevents the occurrence of migraine attacks and not just migraine days: Post-hoc analyses of a phase III study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Twenty-five years of triptans - a nationwide population study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Prevalence of pre-cluster symptoms in episodic cluster headache: Is it possible to predict an upcoming bout?

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Erenumab prevents the occurrence of migraine attacks and not just migraine days: Post-hoc analyses of a phase III study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Can tendon reflexes be elicited by both stretch and vibration in man?

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  4. Pharmacological strategies to treat attacks of episodic migraine in adults

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

Vis graf over relationer

BACKGROUND: In trials of monoclonal antibodies against calcitonin gene-related peptide or its receptor for prevention of episodic migraine, we observed two problematic aspects: a) The graphic presentations; b) the methods of calculating "response rates" (≥50% decrease of monthly migraine days from baseline).

OBSERVATIONS: Decrease in monthly migraine days is presented, over time, in figures on a downward (negative) scale from zero at baseline, with the ordinate stopped just beyond the maximum effect of the active drugs. In one trial, decreases in monthly migraine days were -1.8 after placebo, -3.2 after erenumab 70 mg and -3.7 after erenumab 140 mg, with the ordinate stopped at -4.5. The reader can perceive only a relative 2-fold benefit of erenumab versus placebo. If, however, treatment periods are compared with baseline in bar charts, MMDs persisting after treatment in the same trial can be illustrated as follows, creating a different perception: 78% for placebo, 61% for erenumab 70 mg, and 55% for erenumab 140 mg. In the nine trials, "response rates" defined as above were calculated in five different ways, taking different numbers of treatment months into account in comparisons with the one-month baseline. This makes comparisons impossible.

SUGGESTIONS FOR IMPROVEMENTS: Mean monthly migraine days before and after treatment should be presented in a bar chart. Such figures, presenting persisting MMDs, are more clinically relevant and less misleading than decreases from baseline. The definition and methods of calculating and presenting "50% response rates" should be standardized by the Drug Trial Committee of the International Headache Society.

OriginalsprogEngelsk
TidsskriftCephalalgia : an international journal of headache
Vol/bind40
Udgave nummer1
Sider (fra-til)122-126
Antal sider5
ISSN0333-1024
DOI
StatusUdgivet - 1 jan. 2020

ID: 60054776