Abaloparatide in patients with mild or moderate renal impairment: results from the ACTIVE phase 3 trial.
Curr Med Res Opin
; 35(12): 2097-2102, 2019 12.
Article
en En
| MEDLINE
| ID: mdl-31418585
ABSTRACT
Objective:
To evaluate, post hoc, the efficacy and safety of abaloparatide by degree of renal impairment.Methods:
ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily. Patients with serum creatinine >2.0 mg/dL or 1.5-2.0 mg/dL with an estimated glomerular filtration rate (eGFR) <37 mL/min, calculated by Cockcroft-Gault formula, were excluded.Results:
At baseline, 660 patients had eGFR ≥90 mL/min, 1276 had 60 to Ë90 mL/min, and 527 had <60 mL/min. Older age and lower T-scores were associated with greater renal impairment. Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms. Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment. Hypercalcemia measured by albumin-adjusted serum calcium occurred significantly less frequently with abaloparatide than teriparatide in patients with eGFR <60 mL/min (3.6% versus 10.9%; p = .008) and in the overall ACTIVE safety population (3.4% versus 6.4%; p = .006). Computed tomography scans in 376 patients revealed no evidence of increased renal calcification.Conclusion:
Increased exposure to abaloparatide and teriparatide in patients with renal impairment led to no meaningful differences in efficacy or safety. These results support the use of abaloparatide without dosage adjustment in patients with renal impairment, provided those with severe renal impairments are monitored for adverse events.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Osteoporosis Posmenopáusica
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Proteína Relacionada con la Hormona Paratiroidea
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Insuficiencia Renal
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Tasa de Filtración Glomerular
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Riñón
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
Límite:
Aged
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Female
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Humans
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Middle aged
Idioma:
En
Año:
2019
Tipo del documento:
Article