medwireNews: The use of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) for treating migraine in older individuals and those with disability does not increase the risk for cardiovascular disease (CVD) compared with onabotulinumtoxinA, says a study published in JAMA Neurology.
The investigators explain that since “[c]ardiovascular safety concerns for anti-CGRP mAbs have been raised due to the cardioprotective role of CGRP observed in animal and human studies,” they assessed for the possible association using real-world Medicare beneficiary data including for “populations under-represented in [randomized controlled trials], such as older patients and patients with multiple comorbidities.”
Wei-Hsuan Lo-Ciganic (University of Pittsburgh, Pennsylvania, USA) and colleagues say they found no statistically significant difference in the incidence of the study’s composite primary outcome of stroke or myocardial infarction in patients receiving anti-CGRP mAbs compared with onabotulinumtoxinA.
Their study included US patients with at least one inpatient or two outpatient migraine diagnoses, and at least one prescription fill or administration for anti-CGRP mABs or onabotulinumtoxinA. To rule out patients who were receiving onabotulinumtoxinA for conditions other than migraine, the researchers only included those who had a migraine diagnosis on the first day they were prescribed the drug or in the 30 days prior.
The team analyzed data from 2018–2020 on 5153 patients who received anti-CGRP mAbs (mean age 57.8 years; 83.6% women; 82.2% White) and 4000 patients who received onabotulinumtoxinA (mean age 61.9 years; 83.8% women; 83.8% White).
The patients in the anti-CGRP mAbs group primarily took ereunamb (60.4%), followed by galcanezumab (29.5%), fremanezumab (9.8%), and eptinezumab (0.4%). These patients were more likely than those receiving onabotulinumtoxinA to have disability status (67.6 vs 56.0%) and obesity (37.0 vs 30.4%), and to be receiving low-income subsidies under Medicare (54.9 vs 39.7%).
Lo-Ciganic and team report that 17 composite CVD events occurred in both treatment groups, over a median follow-up of 4.3 months among those in the anti-CGRP mAbs group and 4.4 months in the onabotulinumtoxinA group. This translated to respective incidence rates per 1000 person–years of 5.83 and 6.81, and a nonsignificant propensity-score adjusted hazard ratio (aHR) of 0.88. In addition, they found no significant difference between the treatments when comparing the risk for myocardial infarction (aHR=0.86) and stroke (aHR=0.90) separately.
The results were consistent for exploratory endpoints, namely hypertensive crisis, peripheral revascularization, and Reynaud phenomenon, and there was a comparable risk in subgroup analyses stratifying by age and the presence of established CVD.
Lo-Ciganic and team say that their findings suggest that “anti-CGRP mAbs can be considered a viable option for preventing migraine in older adults and patients at high risk of CVD.”
They add: “Given that many other migraine medications, such as triptans, have CVD contraindications and that the off-label use of oral preventive medications often results in significant adverse effects and tolerability issues, demonstrating the CVD safety of anti-CGRP mAbs, despite their theoretical risk, is crucial.”
The authors conclude: “Future studies should leverage more recent data to assess the long-term safety of anti-CGRP mAbs in larger samples.”
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