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Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information.

ABSTRACT: To estimate the incidence of muscle toxicity in patients receiving statin therapy by examining study populations, drug exposure status and outcome definitions.A retrospective cohort study.16 medical facilities in Japan providing information on laboratory tests performed in and claims received by their facilities between 1 April 2004 and 31 December 2010.A database representing a cohort of 35 903 adult statin (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin) users was studied. Use of interacting drugs (fibrates, triazoles, macrolides, amiodarone and ciclosporin) by these patients was determined.Statin-associated muscle toxicity (the 'event') was identified based on a diagnosis of muscle-related disorders (myopathy or rhabdomyolysis) and/or abnormal elevation of creatine kinase (CK) concentrations. Events were excluded if the patients had CK elevation-related conditions other than muscle toxicity. Incidence rates for muscle toxicity were determined per 1000 person-years, with 95% CI determined by Poisson regression.A total of 18 036 patients accounted for 42 193 person-years of statin therapy, and 43 events were identified. The incidence of muscle toxicity in the patients treated with statins was 1.02 (95% CI 0.76 to 1.37)/1000 person-years. The estimates varied when outcome definitions were modified from 0.09/1000 person-years, which met both diagnosis and CK 10× greater than the upper limit of normal range (ULN) criteria, to 2.06/1000 person-years, which met diagnosis or CK 5× ULN criterion. The incidence of muscle toxicity was also influenced by the statin therapies selected, but no significant differences were observed. Among 2430 patients (13.5%) received interacting drugs with statins, only three muscle toxicity cases were observed (incidence: 1.69/1000 person-years).This database study suggested that statin use is generally well tolerated and safe; however, the risk of muscle toxicity related to the use of interacting drugs requires further exploration.

SUBMITTER: Chang CH

PROVIDER: S-EPMC3641424 | biostudies-other | 2013

REPOSITORIES: biostudies-other

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Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information.

Chang Chia-Hsien CH Kusama Makiko M Ono Shunsuke S Sugiyama Yuichi Y Orii Takao T Akazawa Manabu M

BMJ open 20130411 4

<h4>Objective</h4>To estimate the incidence of muscle toxicity in patients receiving statin therapy by examining study populations, drug exposure status and outcome definitions.<h4>Design</h4>A retrospective cohort study.<h4>Setting</h4>16 medical facilities in Japan providing information on laboratory tests performed in and claims received by their facilities between 1 April 2004 and 31 December 2010.<h4>Participants</h4>A database representing a cohort of 35 903 adult statin (atorvastatin, flu ...[more]

PMID: 23585384

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Project description:BACKGROUND:Palmoplantar pustulosis (PPP) is a chronic, relapsing, inflammatory autoimmune condition, characterized by sterile pustules on the palms and soles. The treatment patterns of PPP and total health care resource utilization in Japan are not well described. Investigating these areas is needed to understand current PPP management in Japan. OBJECTIVE:To describe the characteristics, medication treatment and health care resource utilization patterns, and associated costs of PPP patients in Japan. METHODS:A retrospective analysis of insurance claims data was conducted using the Japan Medical Data Center database. Adult Patients with at least two claims with a PPP diagnosis from January 1, 2011 to March 30, 2017 and six months of follow-up after the first diagnosis were included. Patient characteristics described include age, gender, and comorbid conditions. Treatment patterns assessed include the types of treatment, sequence of treatment, and rates of discontinuation, switching, persistence and use of concomitant medications. RESULTS:A total of 5,162 adult patients met all inclusion criteria. Mean (SD) patient age was 49.7 (11.6) years and 43.2% were male. A total of 2441 patients (47.8%) received systemic non-biologic drugs during the entire follow up period, 2,366 (46.4%) were prescribed topical therapy, 273 (5.4%) were prescribed phototherapy, while 18 (0.4%) of patients with other autoimmune comorbidities were eligible for prescribed biologics. For treatment-naïve patients with mild PPP, topical therapy was most commonly (77.1%) prescribed, whereas in moderate to severe cases of PPP, systemic non-biologic drugs (65%) were most often used. The frequency of switching was similar (64.3% to 75.3%) across various therapies and treatment lines. CONCLUSION:This study describes the treatment patterns and health care resource utilization for Japanese PPP patients using a large claims database, and highlights an unmet need to derive better treatment strategies for PPP and address disease burden in Japan.

Project description:BackgroundLinking different sources of medical data is a promising approach to analyze care trajectories. The aim of the INSHARE (Integrating and Sharing Health Big Data for Research) project was to provide the blueprint for a technological platform that facilitates integration, sharing, and reuse of data from 2 sources: the clinical data warehouse (CDW) of the Rennes academic hospital, called eHOP (entrepôt Hôpital), and a data set extracted from the French national claim data warehouse (Système National des Données de Santé [SNDS]).ObjectiveThis study aims to demonstrate how the INSHARE platform can support big data analytic tasks in the health field using a pharmacovigilance use case based on statin consumption and statin-drug interactions.MethodsA Spark distributed cluster-computing framework was used for the record linkage procedure and all analyses. A semideterministic record linkage method based on the common variables between the chosen data sources was developed to identify all patients discharged after at least one hospital stay at the Rennes academic hospital between 2015 and 2017. The use-case study focused on a cohort of patients treated with statins prescribed by their general practitioner or during their hospital stay.ResultsThe whole process (record linkage procedure and use-case analyses) required 88 minutes. Of the 161,532 and 164,316 patients from the SNDS and eHOP CDW data sets, respectively, 159,495 patients were successfully linked (98.74% and 97.07% of patients from SNDS and eHOP CDW, respectively). Of the 16,806 patients with at least one statin delivery, 8293 patients started the consumption before and continued during the hospital stay, 6382 patients stopped statin consumption at hospital admission, and 2131 patients initiated statins in hospital. Statin-drug interactions occurred more frequently during hospitalization than in the community (3800/10,424, 36.45% and 3253/14,675, 22.17%, respectively; P<.001). Only 121 patients had the most severe level of statin-drug interaction. Hospital stay burden (length of stay and in-hospital mortality) was more severe in patients with statin-drug interactions during hospitalization.ConclusionsThis study demonstrates the added value of combining and reusing clinical and claim data to provide large-scale measures of drug-drug interaction prevalence and care pathways outside hospitals. It builds a path to move the current health care system toward a Learning Health System using knowledge generated from research on real-world health data.

Dataset Information

Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information.

Publications

Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information.

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