Schmitz Natalie, Artz Margaret, Walsh Karen, Gaudana Sandeep, Cloyd James, Schrogie John, Kriel Robert
Department of Experimental and Clinical Pharmacology, College of Pharmacy, Center for Orphan Drug Research, University of Minnesota, Minneapolis, MN, USA.
School of Pharmacy, University of Wisconsin, 1037 Rennebohm, Hall 777 Highland Ave, Madison, WI, 53705, USA.
Drugs Real World Outcomes. 2022 Jun;9(2):307-314. doi: 10.1007/s40801-022-00293-8. Epub 2022 Mar 31.
Baclofen is an effective treatment for spasticity. Abrupt cessation of intrathecal (IT) or oral baclofen risks the development of withdrawal symptoms; however, the magnitude of the problem is unknown.
The aims for this study were as follows: (1) using an administrative claims database, estimate the number of patients in the United States on baclofen, and (2) estimate the annual percent hospitalized pediatric and adult populations consequently at risk for interruption of chronic baclofen therapy.
Using 2011-2014 data representing commercially insured individuals, patients were selected based on insurance coverage; evidence of a baclofen claim; and hospitalization. All patients hospitalized while receiving chronic baclofen were assumed to be at risk for baclofen discontinuation. Yearly counts were determined and then extrapolated to national estimates using census data.
Extrapolating from the claims database, oral or IT baclofen was prescribed annually to 33,061 or 1486 patients ≤ 18 years, and 654,294 or 7084 patients 19-64 years, respectively. The estimated national mean number of at-risk hospitalizations per year for patients aged 19-64 years on chronic oral or IT baclofen was 31,116 and 3774, respectively; patients ≤ 18 years numbered 4691 and 959, respectively. The mean percent of patients hospitalized per year was 42% in those ≤ 18 years receiving IT baclofen compared with 30% in adults, and 3-10% in the populations receiving oral baclofen.
Extrapolation from an administrative claims database was used to estimate the national number and demographics of hospitalized chronic baclofen users. Patients ≤ 18 years receiving IT baclofen were at highest risk of withdrawal due to a high occurrence of hospitalization.
巴氯芬是治疗痉挛的有效药物。鞘内注射(IT)或口服巴氯芬突然停药有出现戒断症状的风险;然而,该问题的严重程度尚不清楚。
本研究的目的如下:(1)利用管理索赔数据库,估计美国使用巴氯芬的患者数量,以及(2)估计因慢性巴氯芬治疗中断而住院的儿科和成人患者的年百分比。
使用2011 - 2014年代表商业保险个体的数据,根据保险覆盖范围、巴氯芬索赔证据和住院情况选择患者。所有在接受慢性巴氯芬治疗期间住院的患者均被认为有巴氯芬停药的风险。确定每年的病例数,然后使用人口普查数据外推至全国估计数。
从索赔数据库推断,口服或IT巴氯芬每年分别用于≤18岁的患者33061例或1486例,19 - 64岁的患者654294例或7084例。估计19 - 64岁接受慢性口服或IT巴氯芬治疗的患者每年因风险住院的全国平均人数分别为31116例和3774例;≤18岁的患者分别为4691例和959例。接受IT巴氯芬治疗的≤18岁患者每年住院的平均百分比为42%,而成人患者为30%,接受口服巴氯芬治疗的人群为3 - 10%。
利用管理索赔数据库进行推断,以估计住院慢性巴氯芬使用者的全国数量和人口统计学特征。接受IT巴氯芬治疗的≤18岁患者因住院发生率高,戒断风险最高。