Variation in Endpoints in FDA Medication Approvals: A Review of Acute and Preventive Migraine Medications.
Leigh K SharplessAaron S KesselheimSerena Laura OrrJonathan J DarrowPublished in: Neurology (2023)
Migraine medication trial endpoints were inconsistent within the same indication (episodic or chronic), mechanistic class, and route of administration, frustrating direct comparison among these medications. Further, inconsistent definitions for the indications "episodic" and "chronic" migraine were also observed. Consistent endpoint selection for medications approved for preventive and acute migraine treatment would enhance the ability of patients, physicians, and payers to make informed choices among these medications.
Keyphrases
- liver failure
- drug induced
- end stage renal disease
- respiratory failure
- healthcare
- ejection fraction
- newly diagnosed
- primary care
- chronic kidney disease
- aortic dissection
- clinical trial
- prognostic factors
- peritoneal dialysis
- emergency department
- randomized controlled trial
- intensive care unit
- patient reported outcomes
- extracorporeal membrane oxygenation
- smoking cessation
- open label
- combination therapy
- clinical evaluation
- double blind
- drug administration