Division of Gastroenterology, Hepatology and Nutrition, University of Texas Health Science Center at Houston.
Takeda Pharmaceuticals USA, Inc., Lexington, MA.
J Manag Care Spec Pharm. 2024 Oct;30(10):1136-1148. doi: 10.18553/jmcp.2024.30.10.1136.
At present, 4 prescription therapies have been approved by the US Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults.
To compare persistence with and adherence to prucalopride vs 3 other prescription medications for CIC in a US population.
This retrospective, observational cohort study used data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases (January 2015-June 2020). Inclusion criteria were patients (aged ≥18 years) with at least 1 prescription fill for prucalopride, lubiprostone, linaclotide, or plecanatide on or after April 2, 2019 (commercial availability of prucalopride), and at least 1 constipation-related diagnosis code. Persistence was assessed by time to discontinuation, and adherence was assessed by the proportion of days covered (PDC) and the proportion of patients who achieved PDC of at least 80%. Adjusted hazard ratios (HRs) for discontinuation and odds ratios for adherence were calculated.
A total of 14,700 patients (mean age = 48.3 years; female = 81.9%) were included (prucalopride, n = 675; lubiprostone, n = 1,591; linaclotide, n = 11,105; plecanatide, n = 1,329). After adjusting for confounding factors, the HRs for discontinuation were significantly higher for all comparator medications compared with prucalopride after 2 months (HR [95% CI]: lubiprostone, 1.70 [1.48-1.95]; linaclotide, 1.25 [1.10-1.41]; plecanatide, 1.31 [1.13-1.51], all < 0.001). The unadjusted mean (SD) PDC was 0.53 (0.32) with prucalopride compared with 0.41 (0.31); less than 0.001 with lubiprostone, 0.48 (0.31), less than 0.05 with linaclotide, and 0.48 (0.29), = 0.98 with plecanatide. The comparator medications were all associated with lower odds of achieving PDC of at least 80% relative to prucalopride (odds ratio [95% CI]: lubiprostone, 0.52 [0.40-0.69], < 0.001; linaclotide, 0.73 [0.58-0.93], = 0.009; plecanatide, 0.70 [0.53-0.93], = 0.015).
The findings of this study indicate that prucalopride has higher treatment persistence and adherence compared with other CIC prescription medications. This research represents the first instance of a real-world claims study showcasing such outcomes.
目前，美国食品和药物管理局已批准 4 种处方疗法用于治疗成人慢性特发性便秘（CIC）。
比较普芦卡必利与其他 3 种 CIC 处方药物在美国家庭中的持久性和依从性。
这是一项回顾性、观察性队列研究，使用了 IBM MarketScan 商业索赔和就诊数据库以及 Medicare 补充数据库的数据（2015 年 1 月至 2020 年 6 月）。纳入标准为至少有 1 次在 2019 年 4 月 2 日（普芦卡必利上市）后开具普芦卡必利、鲁比前列酮、利那洛肽或培可尼肽处方的患者（年龄≥18 岁），且至少有 1 次便秘相关的诊断代码。通过停药时间评估持久性，通过比例天数覆盖（PDC）和达到 PDC 至少 80%的患者比例评估依从性。计算了调整后的停药风险比（HR）和达到 PDC 的依从性比值比（OR）。
共纳入 14700 名患者（平均年龄=48.3 岁；女性=81.9%）（普芦卡必利组 n=675；鲁比前列酮组 n=1591；利那洛肽组 n=11105；培可尼肽组 n=1329）。调整混杂因素后，与普芦卡必利相比，所有对照药物在 2 个月时的停药 HR 均显著升高（HR [95%CI]：鲁比前列酮，1.70 [1.48-1.95]；利那洛肽，1.25 [1.10-1.41]；培可尼肽，1.31 [1.13-1.51]，均<0.001）。普芦卡必利的未调整平均（SD）PDC 为 0.53（0.32），而鲁比前列酮为 0.41（0.31）；利那洛肽为 0.48（0.31），均<0.05；培可尼肽为 0.48（0.29），=0.98。与普芦卡必利相比，对照药物均与较低的达到 PDC 至少 80%的可能性相关（OR [95%CI]：鲁比前列酮，0.52 [0.40-0.69]，<0.001；利那洛肽，0.73 [0.58-0.93]，=0.009；培可尼肽，0.70 [0.53-0.93]，=0.015）。
这项研究的结果表明，与其他 CIC 处方药物相比，普芦卡必利的治疗持久性和依从性更高。这是首次在真实世界的索赔研究中展示此类结果的实例。
