BIFAP, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
BIFAP, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
Bone. 2017 Dec;105:292-298. doi: 10.1016/j.bone.2017.08.031. Epub 2017 Sep 8.
Different regulatory actions for anti-osteoporotic medication (AOM) were taken during the last years, including marketing of new drugs, safety warnings, or restrictions on the indications. We aimed to characterise the secular trends of AOM use in Spain from 2001 to 2013.
A cohort study using the Spanish Database for Pharmacoepidemiological Research in Primary Care (BIFAP), was performed. BIFAP includes anonym records for 4million patients. Participants entered the study when aged ≥50years in 2001-2013 and after 1year of data available, and were followed to an AOM prescription (including alendronate, other bisphosphonates, SERM (selective estrogen receptor modulators), strontium ranelate, teriparatide or denosumab), death, lost or the end of December 2013. Prevalence (%) and incidence rate (IR/1000person-years (py)) of AOM users were computed by years and sex.
Out of 1.5million participants, 135,410 received AOM treatment during 2001-2013. Prevalence was 6.1% (women) and 1.1% (men), that increased from 2001 (2.0%) to 2009 (7.6%) to decrease thereafter. Out of them, 95,057 were incident. The IR was 24.90 (women) and 2.77 (men), that increased from 2001 (21.25 and 1.96) to 2007 (35.84 and 3.64), and decreased to 12.48 and 1.81 (2013). IRs were highest for bisphosphonates along the years (ranging 3.70-14.73 and 0.57-1.75 in women and men respectively), followed by SERM up to 2005 (6.51-9.02 and 0.06-0.07), and strontium ranelate from 2006 (4.66 and 0.45) to 2012 (2.05 and 0.26). IR for teriparatide increased from marketing in 2004 (0.10-1.01 and 0.02-0.29), as was denosumab from marketing in 2011 (0.03-2.64 and 0.09-0.15).
Population-based estimates of AOM use in Spain peaked in 2007-2009 and decreased thereafter, irrespective of age and sex. New treatments were ten times higher in women than men. Bisphosphonates were the most frequently prescribed class, followed by SERM in women before 2006, strontium otherwise till 2012, and denosumab in women or teriparatide in men in 2013. Changes in the osteoporosis criteria, fracture risk assessment strategies, and regulatory actions for AOM around the time, may explain that trend.
近年来，针对抗骨质疏松药物（AOM）采取了不同的监管措施，包括新药上市、安全警示或限制适应证等。本研究旨在描述 2001 年至 2013 年西班牙 AOM 应用的趋势。
采用西班牙初级保健药物流行病学研究数据库（BIFAP）进行了一项队列研究。BIFAP 包含了 400 万患者的匿名记录。参与者在 2001-2013 年年龄≥50 岁时进入研究，并在有 1 年的数据可用后进行随访，直至开具 AOM 处方（包括阿仑膦酸盐、其他双膦酸盐、选择性雌激素受体调节剂（SERM）、雷奈酸锶、特立帕肽或地舒单抗）、死亡、失访或 2013 年 12 月 31 日。根据年份和性别计算 AOM 使用者的患病率（%）和发病率（IR/1000 人年（py））。
在 150 万名参与者中，有 135410 人在 2001-2013 年期间接受了 AOM 治疗。女性患病率为 6.1%，男性为 1.1%，从 2001 年（2.0%）增加到 2009 年（7.6%），然后下降。其中，95057 人是新发病例。IR 为 24.90（女性）和 2.77（男性），从 2001 年（21.25 和 1.96）增加到 2007 年（35.84 和 3.64），然后在 2013 年下降到 12.48 和 1.81。多年来，双膦酸盐的 IR 一直最高（女性分别为 3.70-14.73 和 0.57-1.75，男性分别为 0.70-1.44 和 0.06-0.07），其次是 SERM，直到 2005 年（6.51-9.02 和 0.06-0.07），雷奈酸锶从 2006 年（4.66 和 0.45）到 2012 年（2.05 和 0.26）。特立帕肽的 IR 从 2004 年上市开始增加（0.10-1.01 和 0.02-0.29），地舒单抗从 2011 年上市开始增加（0.03-2.64 和 0.09-0.15）。
西班牙基于人群的 AOM 使用估计值在 2007-2009 年达到峰值，此后有所下降，与年龄和性别无关。女性新发病例是男性的 10 倍。最常开的药物是双膦酸盐，其次是女性在 2006 年前的 SERM，雷奈酸锶在其他情况下直到 2012 年，女性的地舒单抗或男性的特立帕肽在 2013 年。在这段时间内，骨质疏松症标准、骨折风险评估策略和 AOM 的监管措施发生了变化，这可能解释了这一趋势。
