Background Sleep disturbance in Alzheimer’s disease (AD) patients may have a negative impact not only on patients themselves but also on the physical and mental health of their caregivers. Detailed analysis of these issues is lacking. Objective This study investigated the association between sleep disturbance in AD patients and the burden on, and health status of, their caregivers in Japan. Methods We conducted a cross-sectional web-based questionnaire survey among caregivers of AD patients with insomnia symptoms in Japan. Demographic data and Sleep Disorders Inventory (SDI) scores for patients, caregiver burden (Burden Index of Caregivers-11 [BIC-11]) and health status, including Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, and 12-Item Short Form Health Survey v2, were collected. Multivariate analysis was used to examine the association between the burden and health status of caregivers and sleep disturbance in their care recipients with AD. Results A total of 496 caregivers of AD patients with insomnia symptoms were examined in this study. We found that the BIC-11 total score increased as the SDI score increased, indicating a significant positive association, even after adjusting for confounding factors. We also found an association between sleep disturbances of AD patients and health of caregivers (sleep quality, depression, and physical/mental quality of life). Conclusion This study demonstrated that sleep disturbance in AD patients was associated with an increased burden and poorer health status of caregivers. Our findings highlight the importance of sleep management in AD patients. Electronic supplementary material The online version of this article (10.1007/s00415-019-09286-0) contains supplementary material, which is available to authorized users.
BackgroundDirect-acting anti-viral agents have improved the treatment of chronic hepatitis C virus (HCV) infection, but this treatment is challenging for patients using co-medications because of potential drug–drug interactions. This study aimed to examine the comorbidities and co-medications of Japanese chronic HCV patients by age group, compared with a non-HCV patient population.MethodsThis was a retrospective observational study using a hospital-based medical claims database. We extracted data of patients with chronic HCV aged ≥18 years, and age-, sex-, and hospital-matched patients without HCV, for the period from January 2015 to November 2016, and then examined chronic comorbidities, long-term co-medications, and medications prescribed at least once during the study period.ResultsWe analysed data from 128,967 chronic HCV patients and 515,868 non-HCV patients. The median age was 70 years, and 51.0% of patients were male. More chronic HCV patients than non-HCV patients (70.5% vs. 47.1%) had at least one comorbidity, and older patients had more comorbidities than younger patients. The most common comorbidities in chronic HCV patients were diseases of oesophagus, stomach and duodenum (41.7%), followed by hypertensive diseases (31.4%). Chronic HCV patients used co-medications more commonly than non-HCV patients, and older patients used more co-medications. The most common long-term co-medications in chronic HCV patients were proton pump inhibitors (14.0%), which were prescribed to 31.9% of chronic HCV patients at least once during the study period.ConclusionsPatients with chronic HCV in Japan had more comorbidities than patients without chronic HCV regardless of age. Particularly older patients, who constitute the majority of the HCV patient population in Japan, commonly had multiple comorbidities and used co-medications. To optimise HCV treatment, physicians need to know the exact medication profiles of patients and take appropriate action to manage drug–drug interactions.Electronic supplementary materialThe online version of this article (10.1186/s12879-018-3148-z) contains supplementary material, which is available to authorized users.
To investigate the prevalence of comorbid conditions/complications among Japanese patients with type 2 diabetes mellitus (T2DM) in a real-world setting. Methods: We performed retrospective analyses of a large-scale database directly linked to electronic medical records, J-DREAMS (Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System), to determine the prevalence of clinically significant comorbid conditions/complications among Japanese patients with T2DM aged ! 20 years with ! 1 clinical encounter at a referral center between April 1, 2017 and March 31, 2019.Results: Data were available for 10,151 patients (39.2% female). The mean age and T2DM duration were 66.0 years and 16.1 years, respectively. Only 0.5% had isolated T2DM, 6.6% had one comorbid condition/complication, and the remainder had multiple comorbid conditions/complications. Dyslipidemia (84.7%) and hypertension (75.1%) were the most common, followed by chronic kidney disease (35.4%), retinopathy (23.1%), and cardiovascular diseases (22.1%). Overall, 36.0% of patients were overweight/obese (body mass index ! 25 kg/m 2 ) and 18.6% had a history of neoplasms. The prevalence of comorbid conditions/complications tended to increase with advancing age and duration of T2DM. Conclusions:We revealed a high prevalence of comorbid conditions/complications, including chronic kidney and cardiovascular diseases, in Japanese patients with T2DM.
Introduction Dasatinib is a BCR-ABL kinase inhibitor that was approved in Japan in January 2009 for the treatment of chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). This study was aimed to acquire the background information on the patients treated with dasatinib and early data related to safety and efficacy, which would provide important information to ensure the appropriate use of dasatinib. Methods We conducted the nation-wide surveillance for all the patients who used dasatinib for 3 years after starting this medicine. The target number of patients was 800. The principal aims of the survey were to identify: (1) unknown adverse drug reactions, (2) the circumstances under which adverse drug reactions occur in real-world use of the drug, and (3) the factors that may affect safety and efficacy. Especially, we focused on the circumstances of development and incidences of bone marrow depression/cytopenia, hemorrhage, fluid retention, cardiovascular events and abnormal electrocardiogram (QT prolongation), hepatobiliary disorders, and interstitial lung diseases. Results This survey included 903 evaluable subjects for whom survey sheets have been returned to date, June 27, 2012. The composition of the registered cases was: chronic-phase CML 375, accelerated-phase CML 80, blastic-phase CML 133, Ph+ ALL 312, and others 3. Median age was 62 years (range, 7-92) in the chronic-phase CML group, 63.5 years (range, 9-84) in the accelerated-phase group, 63 years (range, 18-86) in the blastic-phase CML group, and 60 years (range, 5-92) in the Ph+ ALL group. 879 patients were previously treated with imatinib. The proportion of imatinib resistant to imatinib intolerant (resistant/ intolerant) in chronic-phase CML was 57.6%/42.4%, in accelerated-phase CML was 84.0%/16.0%, in blastic-phase CML was 78.4%/21.6%, and in Ph+ ALL was 65.1%/34.9%. The median treatment duration (days) was 414 in the chronic-phase CML group, 303.5 in the accelerated-phase CML group, 81 in the blastic-phase CML group, and 96.5 in the Ph+ ALL group. The frequent adverse drug reactions (10% or more) were thrombocytopenia 45.7%, anemia 36.7%, leucopenia 30.7%, pleural effusion 28.0%, and neutropenia 23.8% (all grades). The incidence of bone marrow depression/cytopenia was 56.1%, hemorrhage 10.7%, fluid retention 37.1%, cardiovascular events and abnormal electrocardiogram 4.5%, hepatobiliary disorders 20.4%, and interstitial lung diseases 3.5%. The incidences of bone marrow depression/cytopenia, hemorrhage, and fluid retention in chronic-phase CML were 49.6%, 5.9%, and 28.8%, respectively, and tended to be lower than in the other phases (accelerated phase and blastic phase CML and Ph+ ALL). Additionally, we will report the intervals before the onset of adverse drug reactions, the circumstances of continuation of administration, and factors that appear to affect safety or efficacy based on the latest data update. Conclusions The information in this all-case drug use results survey will be useful to ensure the appropriate use of dasatinib in real-world patients. Disclosures: Kurokawa: Novartis: Consultancy, Research Funding; Bristol-Myers Squibb: Research Funding; Celgene: Consultancy, Research Funding. Nishizawa:Bristol-Myers K.K.: Employment. Tetsuka:Bristol-Myers K.K.: Employment. Meiji:Bristol-Myers K.K.: Employment. Hiroshi:Bristol-Myers K.K.: Employment.
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