Martín-Merino Elisa, Huerta-Álvarez Consuelo, Prieto-Alhambra Daniel, Montero-Corominas Dolores
Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Arch Osteoporos. 2017 Dec;12(1):39. doi: 10.1007/s11657-017-0331-6. Epub 2017 Apr 11.
Among 95,057 patients ≥50 years with new anti-osteoporosis medications (AOM) (2001-2013) in primary care, 1-year cessation was 51% (28%-68%), higher in men, smokers, patients with missing lifestyle data, and out normal BMI, and lower in those aged 60-79, with recent fractures or other anti-osteoporotics, suggesting non-severe osteoporosis and less risk awareness.
Low compliance to anti-osteoporosis medications (AOM) has been previously reported. We aimed to estimate 1-year cessation rates of different AOMs as used in Spanish healthcare settings, and to identify associated risk factors.
A cohort study was performed using primary care records data (BIFAP). Patients entered the cohort when aged 50 years in 2001-2013, with ≥1 year of data available, and identified as incident users of AOM (1-year washout). Participants were divided into six cohorts: alendronate, other oral bisphosphonates, selective oestrogen receptor modulators, strontium ranelate, teriparatide, and denosumab. Patients were followed from therapy initiation to the earliest of cessation (90-day refill gap), switching (to alternative AOM), loss to follow-up, death, or end of 2013. One-year therapy cessation was estimated using life tables. Hazard ratios (of cessation) according to age, sex, lifestyle factors, morbidity, and co-medication were estimated after stepwise backwards selection.
A total of 95,057 AOM users were identified (91% women; mean age 68). One-year cessation was 51% overall, highest for strontium ranelate (68%), and lowest for denosumab (28%). Cessation probability was higher in men (14% to 2.1-fold), smokers (>6%), and patients with missing BMI (19-28%) or smoking (6-20%) data, and overweight/obese/underweight (7% to 2.6-fold increase compared to normal weight). Patients aged 60-79 years, with a recent fracture or other drugs used for osteoporosis, had better persistence.
Over half of the patients initiating AOM stopped therapy within the first year after initiation. The described risk factors for cessation could be proxies for non-severe osteoporosis, and/or disease/risk awareness, which could inform the targeting of high-risk patients for monitoring and/or interventions aimed at improving persistence.
在基层医疗中95057例年龄≥50岁且使用新型抗骨质疏松药物（AOM）（2001 - 2013年）的患者中，1年停药率为51%（28% - 68%），男性、吸烟者、生活方式数据缺失的患者以及BMI不在正常范围的患者停药率较高，而60 - 79岁、近期有骨折或正在使用其他抗骨质疏松药物的患者停药率较低，提示骨质疏松病情不严重且风险意识较低。
此前已有报道抗骨质疏松药物（AOM）依从性较低。我们旨在估算西班牙医疗环境中不同AOM的1年停药率，并确定相关风险因素。
使用基层医疗记录数据（BIFAP）进行队列研究。患者在2001 - 2013年年龄达到50岁时进入队列，有≥1年可用数据，并被确定为AOM的新使用者（1年洗脱期）。参与者被分为六个队列：阿仑膦酸钠、其他口服双膦酸盐、选择性雌激素受体调节剂、雷奈酸锶、特立帕肽和地诺单抗。对患者从治疗开始进行随访，直至最早出现停药（90天的药物 refill 间隔）、换药（换用其他AOM）、失访、死亡或2013年底。使用生命表估算1年治疗停药率。在逐步向后选择后，估算根据年龄、性别、生活方式因素、发病率和联合用药情况（停药）的风险比。
共确定95057例AOM使用者（91%为女性；平均年龄68岁）。总体1年停药率为51%，雷奈酸锶最高（68%），地诺单抗最低（28%）。男性（高14%至2.1倍）、吸烟者（>6%）、BMI数据缺失（19% - 28%）或吸烟数据缺失（6% - 20%）以及超重/肥胖/体重过轻（与正常体重相比增加7%至2.6倍）的患者停药可能性更高。60 - 79岁、近期有骨折或正在使用其他骨质疏松药物的患者持续性更好。
开始使用AOM的患者中超过一半在开始后的第一年内停止治疗。所描述的停药风险因素可能是骨质疏松病情不严重和/或疾病/风险意识的替代指标，这可为针对高危患者进行监测和/或旨在提高持续性的干预措施提供依据。
