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In this international study, we examined the incidence of hip fractures, postfracture treatment, and all‐cause mortality following hip fractures, based on demographics, geography, and calendar year. We used patient‐level healthcare data from 19 countries and regions to identify patients aged 50 years and older hospitalized with a hip fracture from 2005 to 2018. The age‐ and sex‐standardized incidence rates of hip fractures, post‐hip fracture treatment (defined as the proportion of patients receiving anti‐osteoporosis medication with various mechanisms of action [bisphosphonates, denosumab, raloxifene, strontium ranelate, or teriparatide] following a hip fracture), and the all‐cause mortality rates after hip fractures were estimated using a standardized protocol and common data model. The number of hip fractures in 2050 was projected based on trends in the incidence and estimated future population demographics. In total, 4,115,046 hip fractures were identified from 20 databases. The reported age‐ and sex‐standardized incidence rates of hip fractures ranged from 95.1 (95% confidence interval [CI] 94.8–95.4) in Brazil to 315.9 (95% CI 314.0–317.7) in Denmark per 100,000 population. Incidence rates decreased over the study period in most countries; however, the estimated total annual number of hip fractures nearly doubled from 2018 to 2050. Within 1 year following a hip fracture, post‐hip fracture treatment ranged from 11.5% (95% CI 11.1% to 11.9%) in Germany to 50.3% (95% CI 50.0% to 50.7%) in the United Kingdom, and all‐cause mortality rates ranged from 14.4% (95% CI 14.0% to 14.8%) in Singapore to 28.3% (95% CI 28.0% to 28.6%) in the United Kingdom. Males had lower use of anti‐osteoporosis medication than females, higher rates of all‐cause mortality, and a larger increase in the projected number of hip fractures by 2050. Substantial variations exist in the global epidemiology of hip fractures and postfracture outcomes. Our findings inform possible actions to reduce the projected public health burden of osteoporotic fractures among the aging population. © 2023 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR). [ABSTRACT FROM AUTHOR]

Purpose The safety of nonsteroidal anti‐inflammatory drugs (NSAIDs) commonly used in Asia‐Pacific countries has had limited study. We assessed the risk of hospitalization for gastrointestinal events with loxoprofen and mefenamic acid compared with other NSAIDs in Asia‐Pacific populations. Methods: We conducted a cohort study using a distributed network with a common data model in Australia, Hong Kong, Japan, Korea, and Taiwan. We included patients who initiated diclofenac, loxoprofen, mefenamic acid, or celecoxib and followed them until their first gastrointestinal hospitalization, switch or discontinuation of medication, disenrollment, or end of database coverage. We used Cox proportional hazards models to assess hospitalization risk. Results: We identified 9879 patients in Japan, 70 492 in Taiwan, 263 741 in Korea, and 246 in Hong Kong who initiated an NSAID, and 44 013 patients in Australia, a predominantly Caucasian population. The incidence of gastrointestinal hospitalization was 25.6 per 1000 person‐years in Japan, 32.8 in Taiwan, 11.5 in Korea, 484.5 in Hong Kong, and 35.6 in Australia. Compared with diclofenac, the risk of gastrointestinal events with loxoprofen was significantly lower in Korea (hazards ratio, 0.37; 95% CI, 0.25‐0.54) but not in Japan (1.65; 95% CI, 0.47‐5.78). The risk of gastrointestinal events with mefenamic acid was significantly lower in Taiwan (0.45; 95% CI, 0.26‐0.78) and Korea (0.11; 95% CI, 0.05‐0.27) but not Hong Kong (2.16; 95% CI, 0.28‐16.87), compared with diclofenac. Conclusions: Compared with diclofenac, loxoprofen was associated with a lower risk of gastrointestinal hospitalizations in Korea and mefenamic acid with a lower risk in Taiwan and Korea. [ABSTRACT FROM AUTHOR]

Background Prescription sequence symmetry analysis (PSSA) is a signal detection method for adverse drug events. Its capacity to consistently detect adverse drug events across different settings has not been tested. We aimed to determine the consistency of PSSA results for detecting positive and negative control adverse drug events across different settings. Methods Using a distributed network model, we analyzed prescription dispensing data using PSSA in Australia, Hong Kong, Japan, Korea, and Taiwan. Positive control was amiodarone and thyroxine, as a marker of amiodarone-induced hypothyroidism, a known adverse event with a clear temporal relationship to amiodarone initiation. Negative controls were amiodarone and allopurinol, as a marker of amiodarone-induced gout and thyroxine and allopurinol, as a marker of thyroxine-induced gout. Gout is not recorded as an adverse event in product information for either medicine. Adjusted sequence ratios (ASR) were calculated for each country. Pooled estimates were obtained by using the generic inverse variance method. Results A positive association was identified between amiodarone and thyroxine in all settings with a pooled ASR 2.63 (95% confidence interval (CI) 1.47-4.72). Temporal analysis showed the effect occurred within the first few weeks of treatment. No significant associations were found for the negative controls in any setting; pooled ASR were 0.76 (95%CI 0.62-0.93) and 0.98 (95%CI 0.85-1.12) for amiodarone-allopurinol and thyroxine-allopurinol, respectively. Conclusion Despite different health settings, different populations, and different patterns of medicine utilization, PSSA gave consistent estimates across countries for a well-known positive association and two negative control adverse events. © 2015 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Aim The risk factors for ischemic heart disease ( IHD) or cerebrovascular accident ( CVA) in elderly diabetic individuals with type IIb dyslipidemia are not fully known. Therefore, we investigated the relationship between lipid levels and IHD and CVA in diabetic individuals with type IIb dyslipidemia. Method The Japan Cholesterol and Diabetes Mellitus Study is a prospective cohort study of 4014 type 2 diabetic patients (1936 women; age 67.4 ± 9.5 years). The primary end-points were the onset of IHD or CVA. Lipid and glucose levels, and other factors were investigated in relation to the occurrence of IHD or CVA. A total of 462 participants were included in the group of patients with type IIb dyslipidemia. Results The 462 diabetic participants with type IIb dyslipidemia were divided into those who were aged <65 years, 65-74 years and >75 years ( n = 168, 190 and 104, respectively). High-density lipoprotein cholesterol ( HDL- C) and low-density lipoprotein cholesterol/ HDL- C were significantly associated with the risk of cardiovascular events in diabetic individuals with type IIb dyslipidemia who were aged <65 years, and HDL- C and diastolic blood pressure was significantly associated with cardiovascular events in patients aged 65-74 years. Non- HDL- C was not significantly associated with the risk of cardiovascular events. Multiple regression analysis showed that lower HDL- C was significantly associated with the risk of cardiovascular events in diabetic individuals with type IIb dyslipidemia who were aged <65 years and 65-74 years. Conclusions Lower HDL- C was an important risk factor for cardiovascular events in diabetic individuals with type IIb dyslipidemia who were aged <75 years. Geriatr Gerontol Int 2014; 14: 806-810. [ABSTRACT FROM AUTHOR]

ABSTRACT Purpose To undertake a multi-country study to investigate the risk of acute hyperglycaemia with antipsychotic use. Methods Using a distributed network model with a common minimal data set, we performed a prescription sequence symmetry analysis (PSSA) to investigate the risk of acute hyperglycaemia associated with antipsychotic initiation. Incident insulin prescriptions were used as a proxy indicator of acute hyperglycaemia. Participating countries and population datasets included Australia (300,000 persons), Japan I (300,000 persons), Japan II (200,000 persons), Korea (53 million persons) Taiwan (1 million persons), Sweden (9 million persons), USA-Public (87 million persons) and USA-Private (47 million persons). Results Olanzapine showed a trend towards increased risk in most databases, with a significant association observed in the USA-Public database (Adjusted sequence ratio (ASR) = 1.14; 95% Confidence Interval (CI) 1.10-1.17) and Sweden (ASR = 1.53; 95% CI 1.13-2.06). Null or negative associations were observed for haloperidol, quetiapine and risperidone. Conclusion Acute hyperglycaemia appears to be associated with olanzapine use, however, this effect was only observed in two large databases. Despite different patterns of utilization of both antipsychotics and insulin, PSSA analysis results for individual antipsychotic medicines were qualitatively similar across most countries. PSSA, used in conjunction with existing methods, may provide a simple and timely method further supporting multi-national drug safety monitoring. Copyright © 2013 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

BSTRACT Purpose In order to evaluate the incidence of an adverse event encountered when using a new therapeutic intervention, it is essential to know the background rate of this adverse event in the same patient population. Interstitial lung disease (ILD) often develops in Japanese patients receiving treatment with anti-neoplastic agents or other drugs. In our study, we estimated the background rate of ILD in patients with malignant mesothelioma (MM). Methods We conducted a retrospective cohort study of 328 Japanese patients diagnosed with MM during the period between 1996 and 2006. Results After the diagnosis of MM had been made, 21 (15 new and 6 exacerbation) of the 328 patients developed ILD. The crude baseline rate of ILD was estimated to be 0.023 (95%CI, 0.009-0.054) per patient-year, and the baseline rate using the Poisson regression model was estimated to be 0.032 (95%CI, 0.017-0.059) per patient-year where major therapeutic interventions were incorporated in the model. The risk of ILD was increased by surgical excision (rate ratio, 8.87; 95%CI, 2.39-33.0), pleurodesis with picibanil (rate ratio, 5.14; 95%CI, 1.63-16.3), and systemic chemotherapy using vinorelbine (rate ratio, 5.95; 95%CI, 1.22-29.0). Conclusions Our results have implications for evaluating the safety outcomes of future studies in patients receiving treatment for MM. The development of ILD in such studies at an incidence rate higher than 0.02-0.03 per patient-year might indicate an excess occurrence as a result of a therapeutic intervention. Copyright © 2011 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Purpose To know whether the reporting odds ratio (ROR) using 'control events' can detect signals hidden behind striking reports on one or more particular events. Methods We used data of 956 drug use investigations (DUIs) conducted between 1970 and 1998 in Japan and domestic spontaneous reports (SRs) between 1998 and 2008. The event terms in DUIs were converted to the preferred terms in Medical Dictionary for Regulatory Activities (MedDRA). We calculated the incidence proportion for various events and selected 20 'control events' with a relatively constant incidence proportion across DUIs and also reported regularly to the spontaneous reporting system. A 'signal' was generated for the drug-event combination when the lower limit of 95% confidence interval of the ROR exceeded 1. We also compared the ROR in SRs with the RR in DUIs. Results The 'control events' accounted for 18.2% of all reports. The ROR using 'control events' may detect some hidden signals for a drug with the proportion of 'control events' lower than the average. The median of the ratios of the ROR using 'control events' to RR was around the unity indicating that 'control events' roughly represented the exposure distribution though the range of the ratios was so diverse that the individual ROR might not be regarded as the estimate of RR. Conclusions The use of the ROR with 'control events' may give an adjunctive to the traditional signal detection methods to find a signal hidden behind some major events. Copyright © 2010 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Introduction A postmarketing study without a comparator group has been recognized as a problem as it provides no measure of association. Nevertheless, the design is sometimes used in company postmarketing studies particularly when the study involves the primary data collection. In this report, the 'Symmetry Analysis Cohort Design' without a comparator group but with a control period is proposed. Methods and Results In the proposed design, the rate ratio is estimated using the method of prescription sequence symmetry analysis with slight modification so that the rate ratio can be estimated using data on subjects who have started the drug during the study period but no data on other subjects. Discussion The proposed design has an advantage that it can provide the measure of association. Another advantage common to all self-controlled methods is that the effect of the measured and unmeasured confounders is automatically canceled out when the effect is stable over the study period. Compared with the standard design with a comparator group, the proposed design also has weaknesses. For example, adjustment of confounding by the indication may be difficult when the indication is an acute condition. In addition, the rate ratio is not valid when the probability of the prescription of the drug is dependent on the occurrence of the outcome in the unexposed (pre-dose) period. The design may be used to evaluate the need for further studies although its real usefulness is to be determined in the future. Copyright © 2015 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Purpose In hypertensive patients with diabetes, antihypertensive therapy is important in reducing the risk of macro- and microvascular complications. In contrast to the guidelines issued by the American Diabetes Association (ADA) in and after 2002, the guidelines issued by the Japanese Society of Hypertension (JSH) in 2000 and 2004 maintained the traditional view that β-blockers and thiazides should be rated as second-line drugs. However, both sets of guidelines recommended angiotensin converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) as first-line agents for such patients. Methods We examined the use of antihypertensives in hypertensive patients with and without diabetes using the prescription data for 1999, 2002 and 2005 from three Japanese university hospitals. Results When compared with 1999, the proportion of patients with and without diabetes using ARBs was dramatically increased in 2005 from 1.5 to 55% and from 1.5 to 40%, while that of angiotensin converting enzyme inhibitors decreased from 52 to 32% and 35 to 23%, respectively. A relatively stable proportion of patients (around 10% with and without diabetes) used β-blockers and around 60% of patients with and without diabetes used calcium channel blockers (CCBs) and very few (<5%) used thiazides. Conclusions The rapid increase in use of ARBs and under-use of thiazides may be explained by the fee schedule in the Japanese health insurance system. The paucity of large-scale clinical trials may also hinder evaluation of the traditional view of the role of β-blockers and thiazides in treatment of Japanese patients with diabetes. Copyright © 2008 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Three hundred Japanese patients with benign prostatic hyperplasia (BPH) who started an α1-adrenoceptor blocker, tamsulosin, between 1993 and 1996 were followed for 3.0 ± 3.3 years (mean ± SD) to determine whether an association existed between the disease severities measured prior to the tamsulosin treatment and the timing at which the invasive therapy was implemented. Patients with a lower quality of life (QOL) index or maximum urinary flow rate (Qmax) were transferred for invasive therapy earlier than those with less severe BPH. The International Prostate Symptom Score (I-PSS) was also associated, but apparently to a lesser extent, with the timing of the invasive therapy. Finally, the overall severity evaluated using all of the above three indices, I-PSS, QOL index, and Qmax, in accordance with the ‘Severity Criteria for BPH’ issued by the Japanese Urological Association, was found to be a good measure for predicting the prognosis of patients with BPH treated with tamsulosin. [ABSTRACT FROM AUTHOR]

Purpose Five data mining methodologies for detecting a possible signal from spontaneous reports on adverse drug reactions (ADRs) were compared. Methods The five methodologies, the Bayesian method using the Gamma Poissson Shrinker (GPS), the method employed in the UK Medicines Control Agency (MCA), the Bayesian Confidence Propagation Neural Network (BCPNN), the method using the 95% confidence interval (CI) for the reporting odds ratio (RORCI) and that using the 95% CI of the proportional reporting ratio (PRRCI) were compared using Japanese data obtained between 1998 and 2000. Results There were all in all 38 731 drug-ADR combinations. The count of drug-ADR pairs was equal to 1 or 2 for 31 230 combinations and none of them were identified as a possible signal with the MCA or BCPNN. Similarly, the GPS detected a possible signal in none of the combinations where the count was equal to 1 but in 7.5% of the combinations where the count was equal to 2. The RORCI and PRRCI detected a possible signal in more than half of the combinations where the count was equal to 1 or 2. When the pairwise agreement on whether or not a drug-ADR combination satisfied the criteria for a possible signal was assessed for the 38 731 combinations, the concordance measure kappa was greater than 0.9 between the MCA and BCPNN and between the RORCI and PRRCI. Kappa was around 0.6 between the GPS and MCA and between the GPS and BCPNN. Otherwise, kappa was smaller than 0.2. Conclusions The drug-ADR combinations detected as a possible signal vary between different methodologies. Copyright © 2004 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The safety of new drugs introduced into clinical practice in Britain is assessed by Prescription-Event Monitoring, a system complimentary to that of the Committee on Safety of Medicines. It is independent of studies carried out by the pharmaceutical industry. Data on 12692 patients treated with fluoxetine under the National Health Service were obtained from family practitioners throughout England. The main outcome measures were the rate of recorded events per 1000 patients during the first month of treatment and the mean rate of events during the following 5 months. The rates were compared with those for other selective serotonin reuptake inhibitors elicited by Prescription-Event Monitoring. Individual events, documented in the literature as unwanted effects of fluoxetine and other antidepressants and reported in the present study, were assessed with the help of information provided by the practitioners. All pregnancies were followed up to determine their outcome. Causes of death were established from patients' medical records and death certificates. Neuropsychiatric symptoms were the most frequently reported events, while the most commonly reported individual event was nausea. The rate of several events increased with increasing age. No hitherto unrecognized severe adverse drug-related events were reported. Fluoxetine was considered to be a safe drug, even when prescribed in family practice for a wide range of patients, many of them treated with other drugs for concomitant diseases. © 1997 by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

BSTRACT Rheological properties were studied with a tube viscometer. Emulsifying agents were soy lecithin and Tween 20. The volume concentration of dispersed phase, φ, ranged from 0.32-0.62. The emulsions behaved as pseudoplastic fluids. The flow behavior index, n, of the lecithin emulsions increased slightly with increasing φ and concentration of emulsifying agent, Ce. However, the n values of Tween 20 emulsions were nearly constant. Apparent viscosity of the emulsions increased with increase of φ and Ce. With φ constant the apparent viscosity was still strongly affected by Ce. [ABSTRACT FROM AUTHOR]

Agar gel spheres (diameter = 4.0, 7.2 and 12.5 cm) were dried in desiccated air flow at low temperatures near freezing point (from - 9.3 to 10.7°C) at atmospheric pressure. Air velocities ranged from 0.05 to 0.32 m/sec. The drying rates during the constant drying rate period were directly proportional to the moisture vapor pressure at the sample surface. A linear relationship between the drying rate and the square root of the air velocity was obtained at each air temperature. Further, the film coefficients of heat transfer were evaluated and arranged as a semi-empirical dimensionless equation. [ABSTRACT FROM AUTHOR]