Pfizer Ltd., Tadworth, UK.
Pfizer Inc., Collegeville, PA, USA.
Curr Med Res Opin. 2022 Jun;38(6):917-925. doi: 10.1080/03007995.2022.2070378. Epub 2022 May 13.
The objective of this retrospective cohort study was to describe the adherence and discontinuation patterns of somatropin over 3 years among children with pGHD insured by Medicaid across the United States.
Eligible children were aged ≥3 and <16 years with Medicaid coverage, diagnosed with pGHD, and had ≥2 new prescriptions for somatropin between 1 July 2014 and 31 December 2018. Four non-exclusive patient cohorts were constructed (≥3, 12, 24, and 36 months of continuous enrollment after initial prescription). Suboptimal adherence was defined as medication possession ratio <0.80, and discontinuation as a gap of >60 days between somatropin fills. Logistic and proportional hazards regression methods were used to estimate odds of suboptimal adherence and time to discontinuation, respectively.
In the 12-month cohort ( = 3623), mean age was 10.5 ± 3.2 years, 70.8% were male, 44.4% White, 29.1% Hispanic, 7.1% Black, and 1.7% Asian. At months 12, 24, and 36, the proportion with suboptimal adherence was 40.9, 50.4, 54.4%, respectively, and 49.2% of patients with ≥3 months of follow-up discontinued therapy. At 12 months, lower age and race/ethnicity (Black vs. White referent) had greater odds of suboptimal adherence. Discontinuation was associated with Black (vs. White referent) race and geographic region.
Sociodemographic characteristics may be risk factors for suboptimal adherence and/or discontinuation of prescribed somatropin therapy. Improving GH regimen adherence among this at-risk population, and specifically among subgroups at highest risk, is warranted to improve clinical outcomes.
本回顾性队列研究的目的是描述 3 年来,美国医疗补助计划(Medicaid)覆盖的生长激素缺乏症(pGHD)患儿使用生长激素的依从性和停药模式。
符合条件的患儿年龄≥3 岁且<16 岁,有 Medicaid 保险,诊断为 pGHD,并且在 2014 年 7 月 1 日至 2018 年 12 月 31 日期间有≥2 次新的生长激素处方。构建了四个非排他性患者队列(初始处方后连续 3、12、24 和 36 个月的≥3 个月的连续入组)。药物使用不依从定义为药物使用剂量比<0.80,停药定义为生长激素剂量之间的间隔>60 天。使用逻辑和比例风险回归方法分别估计药物使用不依从的可能性和停药时间。
在 12 个月的队列(n=3623)中,平均年龄为 10.5±3.2 岁,70.8%为男性,44.4%为白人,29.1%为西班牙裔,7.1%为黑人,1.7%为亚洲人。在第 12、24 和 36 个月时,药物使用不依从的比例分别为 40.9%、50.4%和 54.4%,有≥3 个月随访的 49.2%患者停止了治疗。在 12 个月时,年龄较小和种族/民族(黑人与白人参考)与药物使用不依从的可能性更高相关。停药与黑人(与白人参考)种族和地理位置有关。
社会人口统计学特征可能是药物使用不依从和/或处方生长激素治疗停药的风险因素。改善高危人群(尤其是风险最高的亚组)的 GH 治疗方案依从性,对于改善临床结局是必要的。