Utilization, adherence, and outcomes of 17-alpha hydroxyprogesterone caproate for recurrent spontaneous preterm birth prevention. (2nd September 2021)

• Record Type: Journal Article
• Authors: Zhang, Shiyu; Rascati, Karen L.
• Is Part Of: Current medical research and opinion. Volume 37:Number 9(2021)
• Page Start: 1667
• Page End: 1675
• Publication Date: 2021-09-02
• Subjects: Preterm birth -- 17 alpha-hydroxyprogesterone caproate -- drug utilization -- adherence -- real-world outcome; Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1080/03007995.2021.1933928
• Languages: English
• ISSNs: 0300-7995

Abstract

Abstract: Objective: To describe the use of and adherence to 17-alpha hydroxyprogesterone caproate (17-OHPC), explore factors associated with its utilization and adherence, and to investigate the outcomes of 17-OHPC in a real-world setting. Methods: The Decision Resources Group (DRG) database (1 January 2012–31 December 2017) was used to identify women with diagnosis of "history of preterm labor", aged 16–50 years old, had a singleton gestation, were continuously enrolled for at least 6 months and 9 months before and after the index date, respectively, and had a delivery outcome recorded. Adequate adherence was defined and compared using two approaches: (1) patients receiving at least 10 injections of 17-OHPC; (2) number of received injections/eligible number of injections ≥0.7. The outcome of 17-OHPC was evaluated by the incidence rate of preterm birth (PTB). Bivariate tests compared patients' characteristics with their use of and adherence to 17-OHPC, and examined the associations between 17-OHPC utilization and incidence of diabetes or hypertension. Stepwise logistic regression was conducted to assess the effect of adherence on the delivery outcome. Results: Of 28, 339 patients meeting study criteria, 2585 (9.1%) had ≥1 claim for 17-OHPC. An increasing trend of utilization was observed from 2012 to 2017 (7.6–13.1%). The utilization rate was highest in the Southwest US (13.8%) ( p < .001). Commercial insurance patients (9.6%) were more likely to use 17-OHPC than Medicaid patients (7.9%) ( p < .001). Patients with higher Charlson Comorbidity Index (CCI) scores were less likely to use 17-OHPC. Of women prescribed 17-OHPC, 792 (30.6%) and 424 (16.4%) were adherent using two definitions, respectively. No difference in PTB rate was observed between adherers and non-adherers (definition 1: aOR = 0.97, 95% CI = 0.81–1.16; definition 2: aOR = 1.18, 95% CI = 0.95–1.48). No association was found between 17-OHPC and incidence of diabetes ( p = .96); however, use of 17-OHPC was associated with a lower incidence rate of hypertension ( p = .002). Conclusions: 17-OHPC utilization and adherence rates remain low. Insurance type and geographic region were associated with both utilization and adherence. There was no association between 17-OHPC adherence and effectiveness. More evidence is needed to determine if the use of 17-OHPC is advantageous in a sub-group of patients.