Key result
Abaloparatide caused transient heart rate increases (7.9 vs 1.2 bpm for placebo) but prolonged time to first incidence of MACE or heart failure compared to placebo (P=0.02).
Why the study?
Abaloparatide is approved for osteoporosis in postmenopausal women at high risk of fracture, but its cardiovascular safety profile warranted assessment.
Does abaloparatide increase the risk of adverse cardiovascular events in postmenopausal women with osteoporosis?
Population
2463 postmenopausal women with osteoporosis and 55 healthy adults
Comparison
Abaloparatide vs teriparatide vs placebo
Design
Review of randomized phase 3 trial, extension study, and pharmacology study data
Follow-up
18 months in ACTIVE and 2 years in ACTIVExtend
Authors
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Supports abaloparatide CV safety in osteoporosis; extends randomized data showing no MACE+HF increase despite transient hemodynamics.
RCT (n=2,463)
randomized
Does abaloparatide increase the risk of adverse cardiovascular events in postmenopausal women with osteoporosis?
Absolute Event Rate: 7.9% vs 1.2%
Abaloparatide demonstrates a favorable cardiovascular safety profile in postmenopausal women with osteoporosis, causing only transient hemodynamic changes without increasing the risk of MACE or heart failure.
Cosman et al. (2020) conducted an RCT in Osteoporosis (n=2,463). Abaloparatide vs. Placebo and teriparatide was evaluated on Mean heart rate change from pretreatment to 1 hour posttreatment (bpm). Abaloparatide caused transient heart rate increases (7.9 vs 1.2 bpm for placebo) but prolonged time to first incidence of MACE or heart failure compared to placebo (P=0.02).
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