Dataset Information

Drug Utilization Patterns in Patients with Diabetes Initiating Sodium Glucose Co-Transporter-2 Inhibitors (SGLT2i) in Japan: A Multi-Database Study (2014-2017).

ABSTRACT: INTRODUCTION:This study aimed to identify drug utilization patterns in patients initiating sodium glucose co-transporter-2 inhibitors (SGLT2i) in the first 3 years of their launch in Japan. METHODS:This was a retrospective study using three administrative databases in Japan: a pharmacy claims database, a hospital-based database, and an insurance claims database. Prescription data were extracted from adult outpatients with diabetes who started SGLT2i between April 2014 and March 2017 to evaluate pre-index and concomitant medications. For glimepiride and insulin co-users, dose at SGLT2i add-on was also assessed. RESULTS:Data from a total of 14,861 patients in the pharmacy dataset (P-dataset), 27,039 in the hospital dataset (H-dataset), and 12,408 in the insurance dataset (I-dataset) were analyzed. The majority of SGLT2i new users (ca. 70%) were taking one to three concomitant antidiabetic medications. Around half of SGLT2i initiators used dipeptidyl peptidase 4 inhibitors and/or biguanides before using SGLT2i or concomitantly with SGLT2i. The average daily glimepiride dose decreased from 2.1 mg/day during the pre-index period to 1.8 mg/day at SGLT2i add-on in the P-dataset and from 1.9 to 1.7 mg/day in the both H- and I-datasets, respectively, with a decreasing trend observed during the first 3 years of launch. The average daily insulin dose at SGLT2i add-on was higher during the first 15 months of launch and then decreased thereafter. Nearly 40% or more SGLT2i new users were taking at least five concomitant medications: cardiovascular agents were predominantly co-prescribed. CONCLUSION:SGLT2i were frequently used as second- or later-line treatment and as part of a dual, triple, or quadruple regimen, as well as co-prescribed with many other medications in the first 3 years of their launch. For SGLT2i users taking concomitant SU or insulin medications, the average daily doses of SU and insulin at SGLT2i add-on decreased slightly over the study period. FUNDING:Astellas Pharma Inc., Tokyo, Japan.

SUBMITTER: Ito Y

PROVIDER: S-EPMC6848432 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionSodium-glucose co-transporter 2 inhibitors (SGLT2is) are licensed for the treatment of type 2 diabetes (T2D) and more recently for heart failure with or without diabetes. They have been shown to be safe (from the cardiovascular (CV) perspective) and effective (in terms of glycaemia, and in some cases, in reducing CV events) in extensive randomised controlled trials (RCTs). However, there remain concerns regarding the generalisability of these findings (to those ineligible for RCT participation) and about non-CV safety. For effectiveness, population-based pharmacoepidemiology studies can confirm and extend the findings of RCTs to broader populations and explore safety, for which RCTs are not usually powered, in more detail.MethodsA pre-planned and registered ((International PROSPEctive Register Of Systematic Reviews) PROSPERO registration CRD42019160792) systematic review of population-based studies investigating SGLT2i effectiveness and safety, following Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines was conducted.ResultsA total of 37 studies were identified (total n = 1,300,184 adults; total follow-up 910,577 person-years; exposures: SGLT2i class, canagliflozin, dapagliflozin and empagliflozin) exploring CV disease (CVD) outcomes, acute kidney injury (AKI), lower limb amputation (LLA), diabetic ketoacidosis (DKA), bone fracture, urinary tract infection (UTI), genital mycotic infection (GMI), hypoglycaemia, pancreatitis and venous thromboembolism. For CV and mortality outcomes, studies confirmed the associated safety of these drugs and correlated closely with the findings from RCTs, which may extend to primary CVD prevention (major adverse cardiovascular events point estimate range (PER) hazard ratio (HR) 0.78-0.94; hospitalised heart failure PER HR 0.48-0.79). For safety outcomes, SGLT2i exposure was not associated with an increased risk of AKI (PER HR 0.40-0.96), fractures (PER HR 0.87-1.11), hypoglycaemia (PER HR 0.76-2.49) or UTI (PER HR 0.72-0.98). There was a signal for increased association for GMIs (PER HR 2.08-3.15), and possibly for LLA (PER HR 0.74-2.79) and DKA (PER HR 0.96-2.14), but with considerable uncertainty.ConclusionIn T2D, SGLT2is appear safe from the CV perspective and may have associated benefit in primary as well as secondary CVD prevention. For safety, they may be associated with an increased risk of GMI, LLA and DKA, although longer follow-up studies are needed.

Project description:BACKGROUND:To study patient physiology throughout a period of acute hospitalization, we sought to create accessible, standardized nationwide data at the level of the individual patient-facility-day. This methodology paper summarizes the development, organization, and characteristics of the Veterans Affairs Patient Database 2014-2017 (VAPD 2014-2017). The VAPD 2014-2017 contains acute hospitalizations from all parts of the nationwide VA healthcare system with daily physiology including clinical data (labs, vitals, medications, risk scores, etc.), intensive care unit (ICU) indicators, facility, patient, and hospitalization characteristics. METHODS:The VA data structure and database organization represents a complex multi-hospital system. We define a single-site hospitalization as one or more consecutive stays with an acute treating specialty at a single facility. The VAPD 2014-2017 is structured at the patient-facility-day level, where every patient-day in a hospital is a row with separate identification variables for facility, patient, and hospitalization. The VAPD 2014-2017 includes daily laboratory, vital signs, and inpatient medication. Such data were validated and verified through lab value range and comparison with patient charts. Sepsis, risk scores, and organ dysfunction definitions were standardized and calculated. RESULTS:We identified 565,242 single-site hospitalizations (SSHs) in 2014; 558,060 SSHs in 2015; 553,961 SSHs in 2016; and 550,236 SSHs in 2017 at 141 VA hospitals. The average length of stay was four days for all study years. In-hospital mortality decreased from 2014 to 2017 (1.7 to 1.4%), 30-day readmission rates increased from 15.3% in 2014 to 15.6% in 2017; 30-day mortality also decreased from 4.4% in 2014 to 4.1% in 2017. From 2014 to 2017, there were 107,512 (4.8%) of SSHs that met the Center for Disease Control and Prevention's Electronic Health Record-based retrospective definition of sepsis. CONCLUSION:The VAPD 2014-2017 represents a large, standardized collection of granular data from a heterogeneous nationwide healthcare system. It is also a direct resource for studying the evolution of inpatient physiology during both acute and critical illness.

Dataset Information

Drug Utilization Patterns in Patients with Diabetes Initiating Sodium Glucose Co-Transporter-2 Inhibitors (SGLT2i) in Japan: A Multi-Database Study (2014-2017).

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