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Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea

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Názov: Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea
Autori: Yumie Rhee, Dong-Gune Chang, Jeonghoon Ha, Sooa Kim, Yusun Lee, Euna Jo, Jung-Min Koh
Prispievatelia: Yumie Rhee, Dong-Gune Chang, Jeonghoon Ha, Sooa Kim, Yusun Lee, Euna Jo, Jung-Min Koh, Rhee, Yumie
Zdroj: Endocrinol Metab (Seoul)
Endocrinology and Metabolism, Vol 37, Iss 3, Pp 497-505 (2022)
Informácie o vydavateľovi: Korean Endocrine Society, 2022.
Rok vydania: 2022
Predmety: safety, Male, Bone Density Conservation Agents* / adverse effects, Osteoporosis* / chemically induced, Postmenopausal* / drug therapy, korea, Diseases of the endocrine glands. Clinical endocrinology, 03 medical and health sciences, 0302 clinical medicine, Postmarketing drug surveillance, Humans, Prospective Studies, Postmenopausal* / chemically induced, Osteoporosis, Postmenopausal, Denosumab / adverse effects, Aged, Korea, Bone Density Conservation Agents, bone density, Postmenopausal* / complications, denosumab, Middle Aged, RC648-665, osteoporosis, postmarketing drug surveillance, 3. Good health, Osteoporosis* / drug therapy, Osteoporosis, Original Article, Female, Safety, Denosumab, Bone density
Popis: Background: The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice.Methods: Patients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck.Results: Of the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean± standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively.Conclusion: The safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings.
Druh dokumentu: Article
Other literature type
Jazyk: English
ISSN: 2093-5978
2093-596X
DOI: 10.3803/enm.2022.1427
Prístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/35654577
https://doaj.org/article/d5b8568c8cbf484d94719850ef9c7fd6
Rights: CC BY NC
CC BY NC ND
Prístupové číslo: edsair.doi.dedup.....ef2bfc00afddb76f0fce2203ecf57825
Databáza: OpenAIRE
Popis
Abstrakt:Background: The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice.Methods: Patients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck.Results: Of the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean± standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively.Conclusion: The safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings.
ISSN:20935978
2093596X
DOI:10.3803/enm.2022.1427