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Evaluation of Cardiovascular Outcomes in Adult Patients With Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Double-Blind, Placebo-Controlled EVOLVE-1, EVOLVE-2, and REGAIN Studies

Plain-language guide to PMID 31721185 (2020): placebo-controlled randomized controlled trial study of CGRP (Calcitonin Gene-Related Peptide), migraine.

Key Facts

PMID
31721185
Journal
Headache
Year
2020
Study type
Randomized Controlled Trial
Authors
Oakes TM et al. (7 authors)
DOI
10.1111/head.13684

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of CGRP (Calcitonin Gene-Related Peptide) in the context of migraine, published as a randomized controlled trial.

Calcitonin gene-related peptide, a potent microvascular vasodilator, has a hypothesized protective role in CV health.

Who Took Part

PubMed indexes the participants as adults and middle-aged adults, both men and women.

Treatment comparisons for cardiovascular treatment-emergent adverse events (CV TEAE) and categorical and mean changes in BP, pulse, and ECG were evaluated using the Cochran-Mantel-Haenszel test.

How the Study Was Run

The design is described as randomized and placebo-controlled.

Random assignment meant chance, not the researchers, decided who got CGRP (Calcitonin Gene-Related Peptide) and who got the comparison, which limits bias.

The comparison arm used a placebo, so changes seen with CGRP (Calcitonin Gene-Related Peptide) could be set against what happens without it.

Mean changes from baseline in BP, pulse, and ECG were evaluated using the analysis of covariance model.

What Was Measured

The subject headings attached to it are Antibodies, Monoclonal, Humanized, Blood Pressure, Calcitonin Gene-Related Peptide, Cardiovascular Diseases, Chronic Disease, Electrocardiography and Heart Rate.

The authors tagged it with the keywords cardiovascular risks, galcanezumab, hypertension, ischemia and migraine.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of CGRP (Calcitonin Gene-Related Peptide) in people with migraine.

Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2020 (Headache), a journal based in United States.

More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.

Our Notes on the Compound

CGRP (Calcitonin Gene-Related Peptide): A 37-amino-acid neuropeptide that widens blood vessels and is involved in migraine; given in research provocation studies.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.