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1.
Trends in Prescription Analgesic Use Among Adults With Musculoskeletal Conditions in the United States, 1999-2016.
Stokes, A, Berry, KM, Hempstead, K, Lundberg, DJ, Neogi, T
JAMA network open. 2019;(12):e1917228
Abstract
IMPORTANCE Monitoring trends in prescription analgesic use among adults with musculoskeletal conditions provides insight into how changing prescribing practices, guidelines, and policy measures may affect those who need pain management. OBJECTIVE To evaluate trends in prescription opioid use and nonopioid analgesic use among adults with functional limitations attributable to musculoskeletal conditions. DESIGN, SETTING, AND PARTICIPANTS This repeated cross-sectional study uses data from the National Health and Nutrition Examination Study from 1999 to 2016. Data were analyzed from January to July 2019. The participants were adults aged 30 to 79 years who reported functional limitations due to back or neck problems and/or arthritis or rheumatism. MAIN OUTCOMES AND MEASURES Any use of a prescription opioid or exclusive use of a prescription nonopioid analgesic. RESULTS In this population of 7256 adults with 1 or more functional limitations attributable to a musculoskeletal condition (4226 women [59.9%]; 3508 [74.4%] non-Hispanic white individuals; median [interquartile range] age, 63 [53-70] years), opioid use and exclusive nonopioid analgesic use exhibited approximately reciprocal patterns of change from 1999 to 2016. Opioid use increased significantly (difference in prevalence for 2015-2016 vs 1999-2000, 7.2%; 95% CI, 1.3% to 13%; P for trend = .002), and exclusive use of nonopioid analgesics decreased significantly (difference in prevalence for 2015-2016 vs 1999-2000, -13%; 95% CI, -19% to -7.5%; P for trend < .001) during this period. The increase in any opioid use was driven by long-term rather than short-term use. A crossover in the prevalence of opioid use and exclusive use of nonopioid analgesics occurred between 2003 and 2006, after which opioid use was more prevalent. Between 2013 and 2016, decreases in opioid use were observed among men (difference in prevalence for 2015-2016 vs 2013-2014, -11%; 95% CI, -21% to 1.8%) and participants with less than a high school education (difference, -15%; 95% CI, -24% to -6.1%). During this same period, exclusive nonopioid analgesic use also decreased markedly across the population (difference, -5.3%; 95% CI, -9.1% to -1.5%). CONCLUSIONS AND RELEVANCE The substitution of opioids for nonopioid analgesics between 2003 and 2006 may have occurred as evidence emerged on the cardiovascular risks associated with nonopioid analgesics. Reductions in opioid use between 2013 and 2016 were most substantial among those with low socioeconomic status, who may encounter barriers in accessing alternatives. Despite those decreases, opioid use remained more prevalent in 2015 to 2016 than in 1999 to 2000, suggesting a potentially long tail for the opioid epidemic.
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2.
Antithrombotic treatment in patients with atrial fibrillation and acute coronary syndromes: results of the European Heart Rhythm Association survey.
Lane, DA, Dagres, N, Dan, GA, García Seara, J, Iliodromitis, K, Lenarczyk, R, Lip, GYH, Mansourati, J, Marín, F, Scherr, D, et al
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2019;(7):1116-1125
Abstract
The management of an acute coronary syndrome (ACS) in a patient with existing atrial fibrillation (AF) often presents a management dilemma both in the acute phase and post-ACS, since the majority of AF patients will already be receiving oral anticoagulation (OAC) for stroke prevention and will require further antithrombotic treatment to reduce the risk of in-stent thrombosis or recurrent cardiac events. Current practice recommendations are based largely on consensus option as there is limited evidence from randomized controlled trials. Prior to the launch of the new European Heart Rhythm Association (EHRA) consensus document, a survey was undertaken to examine current clinical management of these patients across centres in Europe. Forty-seven centres submitted valid responses, with the majority (70.2%) being university hospitals. This EHRA survey demonstrated overall the management of ACS in AF patients is consistent with the available guidance. Most centres would use triple therapy for a short duration (4 weeks) and predominantly utilize a strategy of OAC (vitamin K antagonist, VKA or non-vitamin K antagonist oral anticoagulant, NOAC) plus aspirin and clopidogrel, followed by dual therapy [(N)OAC plus clopidogrel] until 12 months post-percutaneous coronary intervention, followed by (N)OAC monotherapy indefinitely. Where NOAC was used in combination with antiplatelet(s), the lower dose of the respective NOAC was preferred, in accordance with current recommendations.
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3.
Evaluation of ranibizumab and aflibercept for the treatment of diabetic macular edema in daily clinical practice.
Plaza-Ramos, P, Borque, E, García-Layana, A
PloS one. 2019;(10):e0223793
Abstract
PURPOSE To evaluate the efficacy and safety of ranibizumab and aflibercept in the treatment of diabetic macular edema in a real world study, and to compare the two treatments with each other. METHODS Retrospective observational study of 213 eyes from 141 patients with diabetic macular edema was completed between June 2014 and June 2016. 122 were treated with ranibizumab intravitreal injection and 91 with aflibercept intravitreal injection, with a loading phase of 3 injections and a Pro Re Nata protocol. The drug was selected by the physician and fluorescein angiography was performed by physician`s criteria. Re-treatment was performed when a decline in BCVA, an increase of central macular thickness or an increase or persistence of intraretinal fluid in OCT was observed. The primary outcome was the mean change in best corrected visual acuity at 1 year, while central macular thickness, central macular volume, the number of injections and visits were evaluated as secondary outcomes. The correlation between BCVA at 4th month visit and BCVA at 12th month visit was also evaluated. RESULTS The mean baseline best corrected visual acuity for the eyes treated with ranibizumab was 0.55 (+/- 0.35) logMAR, and with aflibercept it was 0.48 (+/- 0.29) (P = 0.109). Best corrected visual acuity improved in both groups, and at the end of the follow-up was 0.40 (+/- 0.35) in the ranibizumab group and 0.40 (+/- 0.29) in the aflibercept group (P = 0.864). Best corrected visual acuity at 4th month visit is correlated at a high value (R = 0.789) with the one at the end of the study. No differences were found in central macular thickness, central macular volume and glycosylated hemoglobin when adjusting with baseline values. The overall number of injections was 5.77 (+/- 2.01), being 5.56 (+/- 2.0) in the ranibizumab group and 6.07 (+/- 1.99) in the aflibercept group (P = 0.069). The main outcome determining final best corrected visual acuity was the baseline best corrected visual acuity (P<0.001). CONCLUSION There are no differences in efficacy between ranibizumab and aflibercept in diabetic macular edema treatment in this real world study.
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4.
Development of Quality Indicators of Stroke Centers and Feasibility of Their Measurement Using a Nationwide Insurance Claims Database in Japan ― J-ASPECT Study ―.
Nishimura, A, Nishimura, K, Onozuka, D, Matsuo, R, Kada, A, Kamitani, S, Higashi, T, Ogasawara, K, Shimodozono, M, Harada, M, et al
Circulation journal : official journal of the Japanese Circulation Society. 2019;(11):2292-2302
Abstract
BACKGROUND We aimed to develop quality indicators (QIs) related to primary and comprehensive stroke care and examine the feasibility of their measurement using the existing Diagnosis Procedure Combination (DPC) database. METHODS AND RESULTS We conducted a systematic review of domestic and international studies using the modified Delphi method. Feasibility of measuring the QI adherence rates was examined using a DPC-based nationwide stroke database (396,350 patients admitted during 2013-2015 to 558 hospitals participating in the J-ASPECT study). Associations between adherence rates of these QIs and hospital characteristics were analyzed using hierarchical logistic regression analysis. We developed 17 and 12 measures as QIs for primary and comprehensive stroke care, respectively. We found that measurement of the adherence rates of the developed QIs using the existing DPC database was feasible for the 6 QIs (primary stroke care: early and discharge antithrombotic drugs, mean 54.6% and 58.7%; discharge anticoagulation for atrial fibrillation, 64.4%; discharge antihypertensive agents, 51.7%; comprehensive stroke care: fasudil hydrochloride or ozagrel sodium for vasospasm prevention, 86.9%; death complications of diagnostic neuroangiography, 0.4%). We found wide inter-hospital variation in QI adherence rates based on hospital characteristics. CONCLUSIONS We developed QIs for primary and comprehensive stroke care. The DPC database may allow efficient data collection at low cost and decreased burden to evaluate the developed QIs.
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5.
X-linked hypophosphatemic rickets: an Italian experts' opinion survey.
Emma, F, Cappa, M, Antoniazzi, F, Bianchi, ML, Chiodini, I, Eller Vainicher, C, Di Iorgi, N, Maghnie, M, Cassio, A, Balsamo, A, et al
Italian journal of pediatrics. 2019;(1):67
Abstract
BACKGROUND X-linked hypophosphatemic rickets (XLH) is the first cause of inherited hypophosphatemia and is caused by mutation in the PHEX gene, resulting in excessive expression of the phosphaturic factor FGF23. Symptoms are mainly related to rickets in children and osteomalacia in adults and cause several complications that can be highly invalidating. Due to its rarity, XLH is poorly known and diagnosis is frequently delayed. Conventional treatment is based on oral phosphate salts supplementation and activated vitamin D analogs, which however, cannot cure the disease in most cases. OBJECTIVE Due to the low prevalence of XLH, an experts' opinion survey was conducted across Italian centers to collect data on XLH and on its management. METHODS A questionnaire was developed by a group of experts to collect data on XLH epidemiology, diagnosis and treatment in Italy. RESULTS Data from 10 Italian centers (nine of which pediatric) on 175 patients, followed between 1998 and 2017, were included in the survey. Most patients were followed since childhood and 63 children became adults during the investigated period. The diagnosis was made before the age of 1 and between 1 and 5 years in 11 and 50% of cases, respectively. Clinically apparent bone deformities were present in 95% of patients. These were ranked moderate/severe in 75% of subjects and caused growth stunting in 67% of patients. Other frequent complications included bone pain (40%), dental abscesses (33%), and dental malpositions (53%). Treatment protocols varied substantially among centers. Nephrocalcinosis was observed in 34% of patients. Tertiary hyperparathyroidism developed in 6% of patients. CONCLUSIONS XLH remains a severe condition with significant morbidities.
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6.
Challenges in IBD Research: Pragmatic Clinical Research.
Scott, FI, Rubin, DT, Kugathasan, S, Bousvaros, A, Elson, CO, Newberry, RD, Melmed, GY, Pekow, J, Fleshman, JW, Boyle, BM, et al
Inflammatory bowel diseases. 2019;(Suppl 2):S40-S47
Abstract
Pragmatic clinical research is part of five focus areas of the Challenges in IBD research document, which also includes preclinical human IBD mechanisms, environmental triggers, novel technologies, and precision medicine. The Challenges in IBD research document provides a comprehensive overview of current gaps in inflammatory bowel diseases (IBD) research and delivers actionable approaches to address them. It is the result of multidisciplinary input from scientists, clinicians, patients, and funders, and represents a valuable resource for patient centric research prioritization. In particular, the pragmatic clinical research section is focused on highlighting gaps that need to be addressed in order to optimize and standardize IBD care. Identified gaps include: 1) understanding the incidence and prevalence of IBD; 2) evaluating medication positioning to increase therapeutic effectiveness; 3) understanding the utility of therapeutic drug monitoring (TDM); 4) studying pain management; and 5) understanding healthcare economics and resources utilization. To address these gaps, there is a need to emphasize the use of emerging data sources and real-world evidence to better understand epidemiologic and therapeutic trends in IBD, expanding on existing data to better understand how and where we should improve care. Proposed approaches include epidemiological studies in ethnically and geographically diverse cohorts to estimate incidence and prevalence of IBD and impact of diversity on treatment patterns and outcomes. The implementation of new clinical trial design and methodologies will be essential to evaluate optimal medication positioning, appropriate use of TDM in adults and children, and multidisciplinary approaches to IBD pain management and its impact on healthcare resources.
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7.
Low-Value Transthoracic Echocardiography, Healthcare Utilization, and Clinical Outcomes in Patients With Coronary Artery Disease.
Tharmaratnam, T, Bouck, Z, Sivaswamy, A, Wijeysundera, HC, Chu, C, Yin, CX, Nesbitt, GC, Edwards, J, Yared, K, Wong, B, et al
Circulation. Cardiovascular quality and outcomes. 2019;(11):e006123
Abstract
BACKGROUND The relationship between ordering frequency of rarely appropriate transthoracic echocardiograms on healthcare utilization and patient outcomes in coronary artery disease (CAD) is not known. Our objective was to investigate practice patterns of cardiologists who order a high frequency of low-value transthoracic echocardiograms in patients with CAD and whether practice behavior influences patient outcomes. METHODS AND RESULTS A retrospective cohort of outpatient CAD patients was accrued by identifying patients with at least 1 visit to 1 of 35 Ontario-based cardiologists in the EchoWISELY randomized clinical trial (Will Inappropriate Scenarios for Echocardiography Lessen Significantly) control group. The main outcomes of interest were patient-level receipt of diagnostic tests, physician visits, medication prescriptions, and clinical outcomes at 1 year. Our cohort consisted of 3966 patients with CAD (mean [SD] age, 67.8 [12.0] years; 72% men), with an outpatient visit to 1 of 35 eligible cardiologists, stratified into 3 ordering tertiles. Patients of cardiologists in the top ordering tertile of rarely appropriate transthoracic echocardiograms had significantly lower odds of receiving the following services at 1 year compared with patients in the low ordering group: cholesterol assessment (odds ratio [OR], 0.77 [95% CI, 0.65-0.91]); hemoglobin A1c assessment (OR, 0.79 [95% CI, 0.66-0.94]); β-blocker prescription (OR, 0.70 [95% CI, 0.55-0.90]); and aldosterone receptor antagonist prescription (OR, 0.46 [95% CI, 0.22-0.98]). Patients of high ordering cardiologists had greater odds of all-cause mortality at 1 year (OR, 1.54 [95% CI, 1.04-2.28]), although all other outcomes were similar. CONCLUSIONS Patients with CAD seen by cardiologist who ordered a high rate of rarely appropriate transthoracic echocardiograms were less likely to receive potentially high-value screening tests and evidence-based medications than low ordering cardiologists. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02038101.
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8.
International, multicentre, observational study of fluid bolus therapy in neonates.
Keir, AK, Karam, O, Hodyl, N, Stark, MJ, Liley, HG, Shah, PS, Stanworth, SJ, ,
Journal of paediatrics and child health. 2019;(6):632-639
Abstract
AIM: To assess the prevalence, types and indications for fluid bolus therapy in neonates with haemodynamic compromise. METHODS This was a pragmatic, international, multicentre observational study in neonatal units across Australasia, Europe and North America with a predefined study period of 10-15 study days per participating neonatal unit between December 2015 and March 2017. Infants ≤28 days of age who received a fluid bolus for the management of haemodynamic compromise (≥10 mL/kg given at ≤6 h) were included. RESULTS A total of 163 neonates received a bolus over 8479 eligible patient days in 41 neonatal units. Prevalence of fluid bolus therapy varied between centres from 0 to 28.6% of admitted neonates per day, with a pooled prevalence rate of 1.5% (95% confidence interval 1.1-1.9%). The most common fluid used was 0.9% sodium chloride (129/163; 79%), and the volume of fluid administered was most commonly 10 mL/kg (115/163; 71%) over a median of 30 min (interquartile range 20-60). The most frequent indications were hypotension (n = 56; 34%), poor perfusion (n = 20; 12%) and metabolic acidosis (n = 20; 12%). Minimal or no clinical improvement was reported by clinicians in 66 of 163 cases (40%). CONCLUSIONS Wide international variations in types, indications and effects of fluid bolus administration in haemodynamically compromised neonates suggest uncertainty in the risk-benefit profile. This is likely to reflect the lack of robust evidence to support the efficacy of different fluid types, doses and appropriate indications. Together, these highlight a need for further clinically relevant studies.
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9.
Safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world clinical practice: Results of 3-month interim analysis of a long-term post-marketing surveillance study (J-STEP/LT).
Utsunomiya, K, Senda, M, Kakiuchi, S, Kameda, H, Tamura, M, Kurihara, Y, Gunji, R, Fujii, S, Fujiwara, H, Kaku, K
Journal of diabetes investigation. 2019;(5):1272-1283
Abstract
AIMS/INTRODUCTION The present study analysis was carried out to evaluate the safety and efficacy of tofogliflozin, a sodium-glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus in real-world clinical practice. MATERIALS AND METHODS This was a 3-year non-interventional observational study of patients with type 2 diabetes mellitus newly administered tofogliflozin who were uncontrolled on current therapy. We carried out a 12-week interim analysis of tofogliflozin as part of 3-year post-marketing surveillance study. The incidence of adverse drug reactions was evaluated as a safety end-point. As efficacy end-points, glycated hemoglobin and bodyweight were evaluated. RESULTS A total of 6,897 patients were enrolled. Tofogliflozin significantly reduced mean changes from baseline glycated hemoglobin (-0.63%, P < 0.0001) and bodyweight (-2.02 kg, P < 0.0001). The change in glycated hemoglobin and bodyweight reductions in response to tofogliflozin was consistently observed in all body mass index subgroups. Adverse drug reactions occurred in 345 of 6,712 patients (5.14%). There was a low incidence of adverse drug reactions known to be associated with sodium-glucose cotransporter 2 inhibitors, and they were reported as non-serious. The incidences of polyuria/pollakiuria were higher in patients aged ≥65 years than <65 years, and were significantly different among estimated glomerular filtration rate subgroups. Urinary tract and genital infections occurred more frequently in women than in men. CONCLUSIONS Tofogliflozin was well tolerated, and no emerging new safety concerns were observed. Tofogliflozin significantly improved glycemic control with no impact on bodyweight gain. The short-term administration of tofogliflozin is considered to have a favorable benefit-risk profile in Japanese patients with type 2 diabetes mellitus.
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10.
Trends in Atrial Fibrillation and Prescription of Oral Anticoagulants and Embolic Strokes in Germany.
Guelker, JE, Bufe, A, Klues, H, Shin, DI, Blockhaus, C, Gabriel, NH, Haverkamp, W, Kroeger, K
Cardiovascular revascularization medicine : including molecular interventions. 2019;(5):399-402
Abstract
BACKGROUND The aim of the study was to compare trends in frequency of atrial fibrillation (AF) with the prescription rates of oral anticoagulants (OAC) and the incidence of embolic stroke (ES) from 2005 through 2014. METHODS Annual numbers of hospitalized patients with AF and ES were extracted from the Federal Bureau of Statistics. Defined daily doses (DDD) of prescribed OAC among outpatients were extracted from the insurance drug information system. RESULTS The number of cases hospitalized with the diagnosis AF increased continuously by 78.3% (1.25 Million in 2005 to 2.19 Million in 2014, p < 0.001), likewise frequency of ES increased by 89.0% (from 46,068 to 87,050, p < 0.001) and the number of prescribed DDD of OAC almost doubled by 105.4% (from 271,328 to 557,281, p < 0.001). There is an almost linear correlation between occurrence of AF and ES (R2 = 0.9683). In contrast association between prescription rate of OAC and incidence of ES is not linear as there was a disproportional increase in OAC prescriptions beginning in the year 2010 that is not accompanied by a reduction of cases hospitalized with ES. CONCLUSIONS Our analysis of drug treatment rates for OAC in outpatients and hospitalization rates for ES revealed a disproportional increase in prescription of OAC beginning in the year 2010 that does not affect the number of cases hospitalized with ES.