Dataset Information

Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study.

ABSTRACT: Objective: Pegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.

Methods: We conducted a retrospective descriptive study using data from two US commercial insurance claims databases (2010-2018). We identified new initiators of pegloticase with ?1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. We measured the number and duration of pegloticase infusions. We assessed the risk of anaphylaxis or anaphylactoid reactions, cardiovascular events, including myocardial infarction or stroke, and hospitalisation for heart failure (new onset or exacerbations) while undergoing pegloticase therapy.

Results: Among 2.9 million patients with ?1 diagnosis of gout, we identified only 483 (179 in Optum and 304 in MarketScan) pegloticase initiators. The mean age and % female was 55.6 years, 10.9% for MarketScan and 60.6 years and 17.3% for Optum. Hypertension was present in up to 85%, diabetes mellitus in 38%, chronic kidney disease in 46% and heart failure in 21% of the patients. The median number of infusions was four and the duration of therapy was 3 months. During the mean 0.5-year follow-up time on pegloticase, there were 3 (0.6%) anaphylaxis, 7 (1.4%) composite cardiovascular, 31 (6.4%) heart failure hospitalisations and 3 (0.6%) deaths.

Conclusion: Pegloticase is rarely used in gout, and the median duration of pegloticase therapy was 3 months. There were few anaphylaxis events captured in this claims-based study, while heart failure hospitalisations were common.

SUBMITTER: Chen SK

PROVIDER: S-EPMC7722814 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study.

Chen Sarah K SK Liu Jun J Kim Seoyoung C SC

BMJ open 20201207 12

<h4>Objective</h4>Pegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.<h4>Methods</h4>We conducted a retrospective descriptive study using data from two US commercial insurance claims databases (2010-2018). We identified new initiators of pegloticase with ≥1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. ...[more]

PMID: 33293318

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Project description:BackgroundKetamine has emerged as a promising pharmacotherapy for depression and other mental illnesses, and the intramuscular (IM) administration of ketamine is now offered at many North American outpatient psychiatric clinics. However, a characterization of the outpatient population receiving IM ketamine treatment and an evaluation of the real-world depression, anxiety, and safety outcomes of long-term psychiatric IM ketamine treatment has not been reported. This study aimed to evaluate the clinical characteristics, treatment patterns, clinical outcomes, and adverse events of patients receiving IM ketamine treatment.MethodsPatient data from the electronic health records of a private outpatient psychiatric clinic network in the United States were collected and analyzed retrospectively. Adults with any psychiatric diagnosis who received ketamine treatment only by IM administration from January 2018 to June 2021 were included. A total of 452 patients were included in the cohort.ResultsPatients receiving IM ketamine treatment had a mean of 2.8 (SD 1.4) psychiatric diagnoses. 420 (93%) patients had a diagnosis of major depressive disorder, 243 (54%) patients had a diagnosis of generalized anxiety disorder, and 126 (28%) patients had a diagnosis of post-traumatic stress disorder. Patients received a median of 4 (range 1-48) IM ketamine treatments. Median depression scores (PHQ-9) improved 38% from 16.0 (IQR 11.3-21.8) at baseline to 10.0 (IQR 6.0-15.0) at last treatment (p < .001). Median anxiety scores (GAD-7) improved 50% from 14.0 (IQR 8.0-17.0) at baseline to 7.0 (IQR 4.3-11.8) at last treatment (p < .001). With maintenance ketamine treatments, average improvements in depression (PHQ-9) and anxiety (GAD-7) scores of at least 4.7 and 4.9 points were maintained for over 7 months. An adverse event occurred during 59 of 2532 treatments (2.3%).ConclusionsIM ketamine is being utilized to treat psychiatric outpatients with multiple mental illnesses not limited to depression. Average depression and anxiety levels significantly improve throughout IM ketamine treatment and do not regress to baseline during patients' maintenance treatment phase. Prospective studies are recommended to confirm the long-term effectiveness and safety of IM ketamine.

Project description:BackgroundTrends in off-label postpartum use of domperidone and the impact of safety advisories on its use remain unknown. Our objectives were to describe postpartum use of domperidone in Canada, to evaluate the impact of Health Canada advisories on prescribing patterns, and to describe the association between domperidone use and a composite end point of sudden cardiac death or ventricular tachycardia (VT) among postpartum patients.MethodsWe conducted a multidatabase cohort study involving pregnant patients with live births between 2004 and 2017 using administrative health databases from 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba and Ontario). We excluded patients with less than 1 year of prepregnancy database history and with approved indications for domperidone. We assessed domperidone use in the 6 months postpartum and the impact of the 2012 and 2015 Health Canada advisories on prescribing via interrupted time series analysis. We estimated crude rates of VT and sudden cardiac death.ResultsWe included 1 190 987 live births. Mean maternal age was 28.6 (standard error 0.6) years. Domperidone use increased over time, from 7% in 2003-2005 to 12% in 2009-2011, when it plateaued. The 2012 advisory was followed by a drop in use and a reduction in slope, and the 2015 advisory had a more modest impact. Crude analysis suggests that domperidone may be associated with increased VT or sudden cardiac death (0.74 v. 0.37 per 10 000 person-years; difference per 10 000 person-years: 0.37, 95% confidence interval -0.67 to 1.41).InterpretationPostpartum domperidone use increased between 2004 and 2017, with prescribing attenuated after Health Canada advisories and a very low absolute rate of VT or sudden cardiac death. These findings suggest that Health Canada advisories affected prescribing; any potential increase in VT or sudden cardiac death with use of domperidone is small and could not be confirmed in this large study STUDY REGISTRATION: ClinicalTrials.gov, no. NCT04024865.

Dataset Information

Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study.

Publications

Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study.

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