Clinical characteristics and drug utilisation patterns in patients with chronic cough: a retrospective cohort study using a Japanese claims database.

BACKGROUND: Although unmet medical needs for better care of patients with chronic cough exist in Japan, epidemiological information about these patients and their treatments is very limited. OBJECTIVES: To describe patient characteristics, underlying cough-related diseases and drug utilisation patterns in patients with chronic cough, and their changes over time. METHODS: This large retrospective claims database study enrolled subjects with chronic cough, identified either by a specific diagnostic cough code for chronic cough (Population 1) or by multiple cough-related diagnostic codes spanning > 8 weeks (Population 2). Within Population 2, patients with each of the three most frequent diagnostic cough codes were analysed as subgroups. Patient characteristics, underlying cough-related diseases and utilisation patterns for drugs used for cough were documented at the index date, during the 6-month pre-index period and during the 12-month post-index period. RESULTS: 6,038 subjects were enrolled in the cohort (Population 1: N = 3,500; Population 2: N = 2,538). The mean age was 43.7 ± 12.2 years and 61.8% were women. The largest cough diagnosis subgroups in Population 2 were 'other coughs' (N = 1,444), 'cough-variant asthma' (N = 1,026) and 'atopic/allergic cough' (N = 105). At the index date, the most frequent underlying cough-related diseases were allergic rhinitis/nasal inflammation (N = 3,132; 51.9%), asthma (N = 2,517; 41.7%) and gastro-esophageal reflux disease (N = 829; 13.7%). At the index date, 4,860 participants (80.5%) were prescribed at least one cough-related treatment. 194 participants (4.0% of medication users) were prescribed central antitussives alone, principally in Population 1, and 2,331 (48.0%) were prescribed expectorants. Other frequently prescribed medications were antiallergic drugs (N = 2,588; 53.3%), antimicrobials (N = 1,627; 34.4%) and inhaled corticosteroids with long-acting beta-agonists (N = 1,404; 28.9%). Over time, cough diagnoses tended to be lost, with only 470 participants in Population 1 retaining a diagnostic code for chronic cough one year later. The frequency of underlying cough-related diseases was stable over time. CONCLUSIONS: Patients in this cohort with chronic cough are most frequently identified by a diagnostic cough code for chronic cough, followed by codes for other coughs, cough-variant asthma and atopic cough. Chronic cough frequently presents with an underlying cough-related disease, most frequently allergic rhinitis/nasal inflammation, asthma or GERD. Medication prescription for the underlying cough-related diseases was generally appropriate.

iStent inject® and cataract surgery for mild-to-moderate primary open angle glaucoma in Japan: a cost-utility analysis.

AIM: To evaluate the cost-utility of iStent inject® with cataract surgery vs cataract surgery alone in patients with mild-to-moderate primary open angle glaucoma (POAG) in the Japanese setting from a public payer's perspective. METHODS: A Markov model was adapted to estimate the cost-utility of iStent inject® plus cataract surgery vs cataract surgery alone in one eye in patients with mild-to-moderate POAG over lifetime horizon from the perspective of Japanese public payer. Japanese sources were used for patients' characteristics, clinical data, utility, and costs whenever available. Non-Japanese data were validated by Japanese clinical experts. RESULTS: In the probabilistic base case analysis, iStent inject® with cataract surgery was found to be cost-effective compared with cataract surgery alone over a lifetime horizon when using the ¥5 000 000/quality-adjusted life year (QALY) willingness-to-pay threshold. The incremental cost-utility ratio (ICUR) was estimated to be ¥1 430 647/QALY gained and the incremental cost-utility ratio (ICER) was estimated to be ¥12 845 154/blind eye avoided. iStent inject® with cataract surgery vs cataract surgery alone was found to increase costs (¥1 025 785 vs ¥933 759, respectively) but was more effective in increasing QALYs (12.80 vs 12.74) and avoiding blinded eyes (0.133 vs 0.141). The differences in costs were mainly driven by costs of primary surgery (¥279 903 vs ¥121 349). In the scenario analysis from a societal perspective, which included caregiver burden, iStent inject® with cataract surgery was found to dominate cataract surgery alone. CONCLUSION: The iStent inject® with cataract surgery is a cost-effective strategy over cataract surgery alone from the public payer's perspective and cost-saving from the societal perspective in patients with mild-to-moderate POAG in Japan.

Fracture risk associated with glucocorticoid-induced osteoporosis in Japan.

INTRODUCTION: Glucocorticoid-induced osteoporosis (GIOP) is associated with elevated fracture risk. Practice guidelines have been published to reduce this risk but are insufficiently followed in everyday practice. The objectives of this study were to estimate fracture incidence in patients exposed to oral glucocorticoids and to analyse the impact of glucocorticoid use on fracture incidence. MATERIALS AND METHODS: This retrospective cohort study was performed using the Medical Data Vision (MDV) claims database from Japan. All patients aged ≥ 18 years initiating oral glucocorticoids and fulfilling Japanese guideline criteria for starting prophylactic osteoporosis treatment between 2009 and 2019 were identified. These were matched to a cohort of unexposed controls using propensity score matching. Fracture incidence in the two cohorts were compared using a Fine-Gray proportional sub-distribution hazard model. RESULTS: 13,090 glucocorticoid-exposed cases were compared to 13,090 unexposed controls. The 1-year fracture rate (all sites) was 9.3 [95% CI 8.8-9.8] in cases and 5.8 [5.4-6.2] in controls. One-year vertebral fracture rates were 4.3 [4.0-4.7] and 2.3 [2.1-2.6] respectively. In the multivariate analysis, the use of glucocorticoids was associated with an increase in the incidence of osteoporotic fractures (hazard ratio: 1.63 [1.51-1.76]). The glucocorticoid-associated risk tended to be higher in subgroups of patients with rheumatoid arthritis, asthma, COPD and in those aged < 65 years. CONCLUSION: Oral glucocorticoid use is associated with an increase in fracture incidence. It is necessary to raise awareness of GIOP and to take public health measures to change the perceptions and behaviour of doctors prescribing glucocorticoids.

Drug Utilization and Medical Cost Study Focusing on Moisturizers in Cancer Patients Treated with Molecular Targeted Therapy: A Retrospective Observational Study Using Data from a Japanese Claims Database.

INTRODUCTION: Molecular targeted therapies (MTTs) cause skin disorders in patients with cancer, and moisturizers are useful treatments; however, their actual use and costs are unknown. Our purpose was to examine the use and costs of moisturizers prescribed for xerosis (asteatosis) in patients with cancer treated with MTTs. METHODS: We used data from a Japanese hospital-based claims database. The index date was the first date of MTT prescription from October 2011 to April 2018 (selection period), and the follow-up period was 1 year from the index date. Patients treated with MTTs during the selection period and who were not prescribed moisturizers in the 6 months before the index date were included as the study cohort. Timing, duration, amount, and costs of the prescribed moisturizers and total medical costs were analyzed. RESULTS: Among the 78,190 patients in the study cohort, 27,906 patients (35.7%) were prescribed moisturizers during follow-up. Moisturizer prescription timing, duration, and volume were inconsistent. The average annual total medical costs for treating patients with MTT who were prescribed moisturizers was JPY 6.165 million (USD 53,797) per patient, and the moisturizer costs were JPY 6033 (USD 53). The number of patients who used moisturizers showed an increasing trend. CONCLUSION: No consistent patterns were observed for the timing or duration of moisturizer use, which suggests various developmental patterns of skin disorders. Furthermore, medical costs for moisturizers accounted for only a small proportion of the total medical costs required for cancer treatment.

Cost-effectiveness of baloxavir marboxil compared with laninamivir for the treatment of influenza in patients at high risk for complications in Japan.

OBJECTIVE: Baloxavir marboxil (baloxavir) is a single-dose antiviral which was previously found to be a cost-effective alternative to laninamivir in otherwise healthy adults in Japan. This study aimed at investigating the cost-effectiveness of baloxavir versus laninamivir in patients with influenza at high risk for complications. METHODS: A decision tree was utilized to estimate costs and health gains associated with the use of antivirals. A lifetime horizon was applied to capture the long-term impact of influenza complications, and other events with associated costs and health outcomes were accounted for one influenza season. The study population was stratified into three categories: adolescents and non-elderly adults with high-risk conditions (HRC), elderly without other HRC, and elderly with other HRC. The cost-effectiveness was assessed from a public healthcare payer's perspective. The duration of influenza symptoms, probabilities of complications and probabilities of adverse events were obtained from a clinical trial and network meta-analysis. The costs of influenza and adverse events management were derived from the JammNet claims database. Utility values were informed by the clinical trial data and literature. Sensitivity analyses were also performed. RESULTS: The baloxavir strategy was associated with higher costs (+¥144) and higher quality-adjusted life-years (QALYs) in adults with HRC, elderly without HRC and elderly with HRC (+0.00078, +0.00183 and +0.00350 respectively). The overall incremental cost/QALY for baloxavir versus laninamivir was ¥68,855, which was below the willingness-to-pay threshold of ¥5 million/QALY gained. Key drivers of the model results were the probability of pneumonia and bronchitis. The probability of baloxavir being cost-effective was 72%. CONCLUSIONS: This study suggests that influenza treatment with baloxavir is cost-effective compared with laninamivir in the adult high-risk population in Japan.

Cost-effectiveness of baloxavir marboxil compared to laninamivir for the treatment of influenza in Japan.

BACKGROUND: Baloxavir marboxil (baloxavir) is a new oral antiviral for influenza types A and B. OBJECTIVES: To determine the cost-effectiveness of baloxavir versus laninamivir in otherwise healthy (OwH) adults in Japan. METHODS: A decision tree was utilized to describe the course of influenza and predict associated costs and quality-adjusted life-years (QALYs) over one year by antiviral. Costs were valued from the public healthcare payer perspective, including influenza test, antiviral acquisition, other medications, physician visits, other outpatient costs associated with influenza or drug-related adverse events (DRAEs), and hospitalizations. Resource utilization and unit costs were obtained from the analysis of the JammNet claims database. Health state utilities were obtained from a clinical trial of baloxavir and previous models, and were driven by influenza symptoms, DRAEs, and complications caused by influenza. Sensitivity analyses were also performed. RESULTS: The total payer expenditure per patient for baloxavir versus laninamivir was ¥9383 versus ¥9132. The additional acquisition costs of baloxavir were partly offset by the DRAE costs avoided. Baloxavir showed a small gain in QALYs versus laninamivir and the incremental cost per QALY gained (¥2,231,260) was lower than the considered willingness-to-pay threshold (¥5,000,000/QALY). Key model drivers were the probability of DRAEs and the duration of symptoms. The probability of baloxavir being cost-effective was 64%. CONCLUSION: This cost-effectiveness study on baloxavir suggests that it would be cost-effective compared to laninamivir in OwH adults in Japan. Further studies are needed in different settings such as high-risk population and with different comparators.

Family caregiving in dementia and its impact on quality of life and economic burden in Japan-web based survey.

Background: Dementia has become a growing health-care problem in the rapidly ageing Japanese population. This study assesses the impact of dementia on quality of life, economic burden, and productivity loss. Objective: The objective of this study was to assess the impact of dementia on the Quality of Life (QoL), economic burden, and productivity loss among families living with dementia. Methods: An online survey was conducted among families who lived with relatives with dementia. Demographic data and information about health condition and costs of long-term care and treatment were collected. Participants were asked to answer the EuroQol (EQ-5D-5L) questionnaire, Zarit Burden Interview (ZARIT-8), and Work Productivity and Activity Impairment Questionnaire (WPAI). Multivariate analyses were conducted to assess factors associated with burden by families living with dementia. Results: Six hundred and thirty-five participants completed the survey. Of these participants, 50.5% were primary caregivers. Overall, 78.7% of dementia patients suffered from Alzheimer, and 43.9% needed long-term care. Compared to non-primary caregivers, primary caregivers had lower health utility scores (0.896 vs 0.873; p = 0.02), higher burden of caregiving (ZARIT-8: 21.1 vs 24.5; p < 0.0001), and higher overall work impairment (40.2% vs 20.8%; p < 0.0001), absenteeism (15.3% vs 5.7%; p < 0.0001), and presenteeism-related impairment (33.2% vs 17.3%; p < 0.0001). Conclusion: Families living with dementia caring for a person with dementia experience increased burden. Health policies related to dementia need to be considered not only for patients, but also for their families living with dementia to improve their QoL.

Treatment patterns, persistence and adherence rates in patients with type 2 diabetes mellitus in Japan: a claims-based cohort study.

OBJECTIVE: To determine real-world trends in antidiabetic drug use, and persistence and adherence, in Japanese patients with type 2 diabetes mellitus (T2DM). DESIGN: Retrospective evaluation of administrative claims data (2011-2015) using the Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases. SETTING: Analysis of two administrative claims databases for Japanese patients with T2DM. PARTICIPANTS: Adults (aged ≥18 years) with an International Classification of Diseases, 10th Revision code of T2DM and at least one antidiabetic drug prescription. MAIN OUTCOME MEASURES: Treatment patterns in untreated (UT) or previously treated (PT) patients receiving antidiabetic therapy; persistence with treatment at 12 months; adherence to treatment at 12 months. RESULTS: 40 908 and 90 421 patients were included from the JMDC and MDV databases, respectively. The most frequently prescribed therapy at the index (first prescription) date was dipeptidyl peptidase-4 inhibitor (DPP-4i) in UT patients (JMDC: 44.0%, MDV: 54.8%) and combination therapy in PT patients (74.6%, 81.1%). Most common combinations were DPP-4i plus: biguanide (BG; 11.4%, 10.9%), sulfonylurea (SU; 8.4%, 11.0%) or BG+SU (7.8%, 9.1%). In UT or PT patients from either database whose index prescription was for any antidiabetic drug class(es) other than DPP-4i, the most frequent add-on or switch was to DPP-4i. 12-month persistence with index monotherapy was highest with DPP-4i and BG. Adherence was high (≥80%) for all monotherapy schedules, except insulin and glucagon-like peptide-1 agonist, and for the five most frequent two-drug and three-drug combinations. Persistence was greater in elderly UT patients and in those receiving ≤5 medications, but comparatively worse in UT patients with ≥3 index antidiabetic drug classes. CONCLUSIONS: The findings indicate that DPP-4i is the most commonly used antidiabetic drug class in Japanese patients with T2DM, and persistence and adherence to this antidiabetic drug class are high.

Adherence and persistence to hyperlipidemia medications in patients with atherosclerotic cardiovascular disease and those with diabetes mellitus based on administrative claims data in Japan.

BACKGROUND AND AIMS: Real-world data on treatment patterns in Japanese hyperlipidemia patients with diabetes mellitus (DM) or prior atherosclerotic cardiovascular diseases (ASCVD) are lacking. METHODS: This is a retrospective, longitudinal cohort analysis of administrative claims data (Japan Medical Data Center [JMDC] and Medical Data Vision [MDV] databases) for patients prescribed a new hyperlipidemia medication between 2014 and 2015. Patients were followed for ≥12 months. Outcomes included prescribing patterns, persistence (discontinuations), and adherence (proportion of days covered). RESULTS: Data were analyzed for 11,718 and 27,746 DM, and 4101 and 14,356 ASCVD patients from the JMDC and MDV databases, respectively. Among previously-untreated patients, index prescriptions were primarily for moderate statins in the DM (JMDC: 74.7%, MDV: 77.5%) and ASCVD (JMDC: 75.4%, MDV: 78.5%) sub-cohorts. Combinations were rarely prescribed (≤2.5%). Previously-treated patients were most frequently prescribed combinations in the DM (JMDC: 46.7%, MDV: 53.6%) and ASCVD (JMDC: 49.3%, MDV: 53.3%) sub-cohorts. Intensive statins were rarely used by previously-untreated (≤1%) or previously-treated (≤8%) patients in either sub-cohort. Approximately half of previously-untreated patients discontinued hyperlipidemia therapy within 12 months. Adherence was ≥80% across most drug classes. CONCLUSIONS: Many Japanese hyperlipidemia patients with DM or ASCVD are prescribed single-agent lipid-lowering therapy. Use of intensive therapy is lower than expected, and is suggestive of under-treatment. The low persistence rates are concerning, and warrant further study.

Impact of Hypertension on Hospitalizations for Cardiovascular Diseases in a Worksite Population: An Epidemiologic Study Using Claims Data for Workers.

BACKGROUND: Few of studies investigated the effect of antihypertensives among working population. We aimed to describe the impact of hypertension with and without antihypertensives on hospitalizations because of cardiovascular diseases (CVDs) in the Japanese working population. METHODS: This retrospective study included adults aged 40-64 years whose systolic and diastolic blood pressure (BP) readings taken between 2008 and 2015 were available in the Japanese claims database. Individuals were categorized as treated (T) or untreated (UT) depending on their hypertension treatment history. Time to first CVD-related hospitalization was compared among individuals with different BP levels using Cox models that included baseline characteristics with either baseline BP level or a time-dependent variable reflecting BP changes over time. RESULTS: Of 740,784 UT individuals (male: 61.9%, mean age: 47.9 years), 2,121 individuals were hospitalized due to a CVD over a 957.3-day average follow-up. Among 72,828 T individuals (male: 74.3%, mean age: 53.7 years), the corresponding figure was 470 individuals over an 813.4-day average follow-up. The risk of hospitalization increased with baseline hypertension severity among UT (hazard ratios [HRs] = 1.93, 2.82, and 6.32 for grade 1, grade 2, and grade 3, respectively; P < 0.0001, reference: optimal) but not among T individuals. UT individuals with hypertension at any given time had a significantly higher probability of hospitalization compared to nonhypertensive individuals (HR = 1.74, P < 0.0001). CONCLUSIONS: This study adds quantitative evidence on the impact of hypertension on the risk of CVD-related hospitalization in the Japanese working population. It suggests that antihypertensive treatment had beneficial effects in this relatively young, working population aged 40-64 years.

Comparison of persistence and adherence between fixed-dose combinations and two-pill combinations in Japanese patients with type 2 diabetes.

OBJECTIVE: To compare treatment patterns, persistence and adherence between fixed-dose combinations (FDCs) and two-pill combinations (TPCs) of oral antidiabetic drug (OAD) classes in Japanese patients with type 2 diabetes mellitus (T2DM) using administrative claims databases (Japan Medical Data Center [JMDC] and Medical Data Vision [MDV]). METHODS: This was a retrospective, longitudinal cohort analysis conducted between 2011 and 2015, in patients with T2DM receiving OADs as FDC or TPC. Outcomes included prescribing patterns, treatment persistence and adherence. RESULTS: Data from 3474 and 3066 patients receiving FDCs, and 4325 and 5192 patients receiving TPCs from the JMDC and MDV databases, respectively, was extracted. The most common OAD combination received by over half of all patients was dipeptidyl peptidase-4 inhibitor (DPP-4i) + thiazolidinediones (TZDs) (64.1% [JMDC] and 70.5% [MDV]). Overall, 12-month persistence rates were higher in patients receiving FDCs compared with TPCs (70.4 vs. 66.2% [JMDC], 75.6 vs. 55.7% [MDV]). In the JMDC population receiving FDCs or TPCs, persistence rates were highest with DPP-4i schedules (67.5-83.5%). Median time to discontinuation was significantly longer with biguanide + TZD, and DPP-4i + TZD FDC schedules (p < .05) than TPC; adherence rates were ≥80% across all antidiabetic drug classes in both database populations. CONCLUSIONS: Persistence with and adherence to OADs in Japanese patients with T2DM were greater with FDCs than with TPCs, which may suggest increased patient satisfaction due to reduced treatment burden. Further studies are warranted to investigate the impact of adherence and persistence of FDCs of OADs on glycemic control.

Treatment patterns and healthcare resource utilization and costs in heavy menstrual bleeding: a Japanese claims database analysis.

AIMS: Heavy menstrual bleeding (HMB) is a highly prevalent condition, characterized by excessive menstrual blood loss and cramping, that interferes with activities of daily life. The aim of this study was to investigate treatment patterns in HMB in Japan, and to assess healthcare resource utilization and costs among women newly-diagnosed with the condition. MATERIALS AND METHODS: This study retrospectively analyzed health insurance data available in the Japan Medical Data Center (JMDC) database on women aged 18-49 years who were newly-diagnosed with primary or secondary HMB. Treatment patterns were analyzed, and healthcare utilization and costs were evaluated and compared to matched controls. RESULTS: The study included a total of 635 patients, 210 with primary HMB and 425 with secondary HMB. In the primary HMB cohort, 60.0% of patients received one or more pharmacological or surgical treatments, compared with 76.2% in the secondary HMB cohort. The most commonly prescribed medications in all patients were hemostatic agents (28.7%), traditional Chinese medicine (TCM) (12.1%), and low-dose estrogen progestins (LEPs) (10.1%). After adjustment for patient baseline characteristics, healthcare costs were 1.93-times higher in primary HMB cases (p < .0001) and 4.44-times higher in secondary HMB cases (p < .0001) vs healthy controls. Outpatient care was the main cost driver. LIMITATIONS: The main limitations of this study are related to its retrospective nature, and the fact that only reimbursed medications were captured in the source database. CONCLUSIONS: A substantial proportion of HMB patients did not receive the recommended treatments. Healthcare costs were considerably increased in the presence of an HMB diagnosis.

Treatment patterns in hyperlipidaemia patients based on administrative claim databases in Japan.

BACKGROUND AND AIMS: Real-world evidence on treatment of hyperlipidaemia (HLD) in Japan is limited. We aimed to describe treatment patterns, persistence with, and adherence to treatment in Japanese patients with HLD. METHODS: Retrospective analyses of adult HLD patients receiving drug therapy in 2014-2015 were conducted using the Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases. Depending on their HLD treatment history, individuals were categorised as untreated (UT) or previously treated (PT), and were followed for at least 12 months. Outcomes of interest included prescribing patterns of HLD drug classes, persistence with treatment at 12 months, and adherence to treatment. RESULTS: Data for 49,582 and 53,865 patients from the JMDC and MDV databases, respectively, were analysed. First-line HLD prescriptions for UT patients were predominantly for moderate statins (JMDC: 75.9%, MDV: 77.0%). PT patients most commonly received combination therapy (JMDC: 43.9%, MDV: 52.6%). Approximately half of the UT patients discontinued treatment during observation. Within each cohort, persistence rates were lower in UT patients than in PT patients (JMDC: 45.0% vs. 77.5%; MDV: 51.9% vs. 85.3%). Adherence was ≥80% across almost all HLD drug classes, and was slightly lower in the JMDC cohort than MDV cohort. CONCLUSIONS: Most common prescriptions were moderate statins in UT patients and combination therapy in PT patients. The high discontinuation rate of HLD therapy in UT patients warrants further investigation and identification of methods to encourage and support long-term persistence.

Evaluation of the treatment patterns and economic burden of dysmenorrhea in Japanese women, using a claims database.

PURPOSE: This study aimed to describe treatment patterns and estimate health care resource utilization and associated costs among Japanese women with dysmenorrhea, using a claims database. METHODS: This was a retrospective analysis using health insurance data from the Japan Medical Data Center, assessing female patients aged 18-49 years with newly diagnosed primary or secondary dysmenorrhea. Treatment pattern analyses focused on hormonal medications, analgesics, hemostatic agents, traditional Chinese medicine (TCM), and gynecological surgeries. Data were collected on health care resource utilization and costs associated with medications, imaging procedures, and inpatient and outpatient care in both patients and matched controls. RESULTS: The analysis included 6,315 women with dysmenorrhea (3,441 primary; 2,874 secondary). The most commonly prescribed initial therapies were low-dose estrogen progestins (LEPs, 37.7%) and TCM (30.0%), with substantial differences between primary (LEPs: 27.4%, TCM: 38.8%) and secondary (LEPs: 50.2%, TCM: 19.5%) dysmenorrhea cohorts. Surgery was conducted in <5% of all patients. Both primary and secondary cohorts of dysmenorrhea had significantly higher mean total health care costs compared to controls within the 1-year period following diagnosis (Case-primary: 191,680 JPY [1,916 USD]; secondary: 246,488 JPY [2,465 USD], Control-primary: 83,615 JPY [836 USD]; secondary: 90,711 JPY [907 USD]) (p<0.0001). After adjusting for baseline characteristics, these costs were 2.2 and 2.9 times higher for primary and secondary dysmenorrhea cohorts, respectively, compared with matched controls, (both p<0.0001). The main driver of these excess costs was outpatient care, with eight additional physician visits per year among dysmenorrhea patients compared to controls (p<0.0001). CONCLUSION: Considerable heterogeneity in treatment patterns was observed, with relatively low utilization of LEPs in patients with primary dysmenorrhea and those treated by internal medicine physicians. Total annual health care costs were approximately 2-3 times higher in patients with dysmenorrhea compared to women without the condition.

Clinical and economic burden in patients with diagnosis of peripheral arterial disease in a claims database in Japan.

PURPOSE: The effect of peripheral arterial disease (PAD) among young and middle-aged adults can be significant, but no previous study has examined the prognosis and the associated health care cost of the disease in this population. We evaluated the clinical and economic burden of PAD in patients from a large claims database to clarify the effect of the disease on a relatively young working Japanese population. METHODS: Patients aged ≥45 and ≤64 years with first PAD diagnosis between 2005 and 2011 comprised the PAD cohort (n = 362); an age- and sex-matched non-PAD comparison cohort (n = 362) was also identified. Rates of cardiovascular events/interventions, health care utilization, and costs were compared. FINDINGS: The mean (SD) age of the cohort was 52.8 (5.6) years and 40.8% were women. Baseline Charlson comorbidity index was significantly higher in the PAD cohort than in the non-PAD cohort (1.90 [2.19] vs 1.16 [1.99]; P < 0.001). The PAD cohort had significantly higher first-year event rates than did the non-PAD cohort for myocardial infarction (2.2% vs 0.2%; P = 0.019) and ischemic stroke (4.1% vs 0.5%; P = 0.001). Health care utilization was significantly greater for the PAD cohort for all parameters assessed (number of hospitalization, inpatient days, and outpatient visits) in the first year (all, P < 0.001). Total annual costs for health care were significantly higher in the PAD cohort than in the non-PAD cohort in the first year (P < 0.001). Among patients with diabetes, patients with PAD (n = 98) had significantly greater first-year event rates (myocardial infarction, ischemic stroke, coronary artery bypass surgery, peripheral arterial revascularization, percutaneous coronary intervention, and limb amputation; all, P < 0.001), significantly greater number of clinic visits (P = 0.023), and total cost burden than did patients without PAD (n = 63). IMPLICATIONS: Even in a relatively young working Japanese population, PAD is associated with substantial clinical and economic burden.

Psychotropic prescription patterns among patients diagnosed with depressive disorder based on claims database in Japan.

BACKGROUND AND OBJECTIVE: Clinical guidelines recommend monotherapy with antidepressants for the treatment of major depression. This study examined prescription patterns with regard to both duration and type of treatment used among patients with newly diagnosed non-psychotic major depression based on a claims database from health insurance societies between 2008 and 2011 in Japan. METHODS: A retrospective cohort (N = 600,000) followed up for 4 years was used to identify patients (age ≥18 years) with newly diagnosed non-psychotic major depression. The prescription patterns and polypharmacy were examined. Four different types of pharmaceutical drugs were defined as possible psychotropic agents for major depression: (1) first- and/or second-generation antidepressants; (2) benzodiazepines; (3) sulpiride; and (4) antipsychotics. The data were analyzed by an intent-to-treat approach at months 0, 1, 3, 6, and 12 from the date of diagnosis. RESULTS: A total of 7,338 patients (3,684 males and 3,654 females, mean age 36.8 ± 10.9 years) with newly diagnosed non-psychotic major depression were identified. The median duration of treatment was 122 days. The proportion of patients in the cohort prescribed at least one type of defined psychotropic agents was 75.6 % (month 0), 47.3 % (month 1), 36.0 % (month 3), 26.8 % (month 6), and 17.4 % (month 12). The proportion of patients in the cohort prescribed at least one first- and/or second-generation antidepressant was 50.2 % (month 0), 34.9 % (month 1), 27.5 % (month 3), 20.3 % (month 6), and 12.5 % (month 12). The proportion of patients receiving at least one benzodiazepine was 58.0 % (month 0), 36.7 % (month 1), 27.1 % (month 3), 20.0 % (month 6), and 12.0 % (month 12). The proportion of patients receiving an antidepressant as monotherapy was only 12.0 % (month 0), 7.8 % (month 1), 6.5 % (month 3), 4.8 % (month 6), and 2.9 % (month 12), whereas the proportion of patients treated with a benzodiazepine alone was 13.5 % (month 0), 6.9 % (month 1), 4.6 % (month 3), 3.5 % (month 6), and 2.7 % (month 12). Various combinations of polypharmacy were observed. The most common was a combination of at least one antidepressant and benzodiazepine, which was prescribed to 36.7 % (month 0), 25.8 % (month 1), 19.9 % (month 3), 14.9 % (month 6), and 9.2 % (month 12) of the cohort. CONCLUSIONS: Based on analysis of prescription patterns and type of treatment used for treating non-psychotic major depression, a majority of patients were not treated according to the recommended guidelines in Japan. Various patterns of prescription and use of polypharmacy were observed over time. The median duration of treatment was shorter than the recommendation (6 months) in the guidelines.

Prescription patterns following first-line new generation antidepressants for depression in Japan: a naturalistic cohort study based on a large claims database.

BACKGROUND: Several studies have described real-world prescription patterns of first-line antidepressants for depression but little is known about their fate in terms of duration, intensity and changes. METHODS: An inception cohort of new onset non-psychotic depression initiating antidepressant treatment with a new generation antidpressive agent was identified in a large health insurance claims database in Japan between 2009 and 2010. The duration and intensity of first-line antidepressants, the timing and kind of second-line antidepressants and the total duration of antidepressant treatment were examined. RESULTS: We identified 1592 patients. The starting dose and the maximum dose attained with the first-line agent appeared to be largely in line with the guideline recommendations although the latter tended toward the minimum of the recommended range. The continuity of the first-line antidepressant was far below the guideline recommendations, with 28% never returning after the initial prescription and 55% dropping out within 3 months. Of all the first-line antidepressants, 14% were subsequently augmented by another psychotropic agent while 17% were switched to another antidepressant after a median of 3 or 2 months, respectively. The choice of the second-line agents varied extremely widely. The total duration of antidepressant therapy was as short as a median of 4 months, with 68% stopping treatment by 6 months. LIMITATIONS: The diagnosis of non-psychotic unipolar depression in the claims database analyses remains approximate. CONCLUSIONS: The current guidelines are grossly out of touch with the clinical realities. On the one hand, guidelines need to reflect the real-world practices; on the other hand clinicians should limit their treatment options and allow evidence-based comparative effectiveness research among them so that patients shall no longer be given less effective and more effective treatments without being able to distinguish among them.

Economic Evaluation of Pravastatin for Primary Prevention of Coronary Artery Disease Based on Risk Prediction from JALS-ECC in Japan.

OBJECTIVES: The clinical efficacy of 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitor (statin) therapy in cardiovascular disease has been established in clinical trials. Nonetheless, it is unclear to whom and when statin treatment should be initiated for patients without cardiovascular disease with regard to overall absolute risk reduction of cardiovascular disease and the cost-effectiveness of long-term statin therapy. The objective of this study was to examine the cost-effectiveness of pravastatin 10 mg/d compared with no-drug therapy for primary prevention of coronary artery disease (CAD), using cardiac risk factors from risk predictions for CAD from Japanese cohort studies. METHODS: A Markov transition model was used to evaluate the cost-effectiveness of pravastatin compared with no-drug therapy. The incidence of acute myocardial infarction was estimated by using risk predictions for CAD in Japan. A hypothetical population from 45 to 75 years old was examined by using the cardiac risk factors. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio over a lifetime horizon were estimated from a perspective of payers. RESULTS: Incremental cost-effectiveness ratios of pravastatin therapy compared with no-drug therapy were 9,677,000 yen per QALY in 55-year-old men and 8,648,000 yen per QALY in 65-year-old men with diabetes mellitus, hypertension (grade II), and smoking as cardiac risk factors. Pravastatin therapy was not cost-effective compared with no-drug therapy in all subgroups evaluated. CONCLUSIONS: Using risk prediction for CAD based on a Japanese cohort with no history of cardiovascular events, the cost-effectiveness of pravastatin for primary prevention of CAD may not be cost-effective in populations at both low and high cardiac risk.