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Prescribing Trend of Inappropriate Medications in Outpatient Clinics for Older Adults With Heart Failure in the United States: NAMCS 2012 to 2016.
Kobayashi, M, Kwak, MJ, Aguilar, D, Goyal, P, Holmes, HM, Deshmukh, AA, Aparasu, RR
The American journal of cardiology. 2021;:168
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Loop Diuretics in Severe Bronchopulmonary Dysplasia: Cumulative Use and Associations with Mortality and Age at Discharge.
Bamat, NA, Nelin, TD, Eichenwald, EC, Kirpalani, H, Laughon, MM, Jackson, WM, Jensen, EA, Gibbs, KA, Lorch, SA
The Journal of pediatrics. 2021;:43-49.e3
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Abstract
OBJECTIVES To measure between-center variation in loop diuretic use in infants developing severe bronchopulmonary dysplasia (BPD) in US children's hospitals, and to compare mortality and age at discharge between infants from low-use centers and infants from high-use centers. STUDY DESIGN We performed a retrospective cohort study of preterm infants at <32 weeks of gestational age with severe BPD. The primary outcome was cumulative loop diuretic use, defined as the proportion of days with exposure between admission and discharge. Infant characteristics associated with loop diuretic use at P < .10 were included in multivariable models to adjust for center differences in case mix. Hospitals were ranked from lowest to highest in adjusted use and dichotomized into low-use centers and high-use centers. We then compared mortality and postmenstrual age at discharge between the groups through multivariable analyses. RESULTS We identified 3252 subjects from 43 centers. Significant variation between centers remained despite adjustment for infant characteristics, with use present in an adjusted mean range of 7.3% to 49.4% of days (P < .0001). Mortality did not differ significantly between the 2 groups (aOR, 0.98; 95% CI, 0.62-1.53; P = .92), nor did postmenstrual age at discharge (marginal mean, 47.3 weeks [95% CI, 46.8-47.9 weeks] in the low-use group vs 47.4 weeks [95% CI, 46.9-47.9 weeks] in the high-use group; P = .96). CONCLUSIONS A marked variation in loop diuretic use for infants developing severe BPD exists among US children's hospitals, without an observed difference in mortality or age at discharge. More research is needed to provide evidence-based guidance for this common exposure.
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Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus treated in real-world clinical practice: Results of a 36-month post-marketing surveillance study (J-STEP/LT).
Utsunomiya, K, Koshida, R, Kakiuchi, S, Senda, M, Fujii, S, Kurihara, Y, Gunji, R, Kaku, K
Journal of diabetes investigation. 2021;(2):184-199
Abstract
AIMS/INTRODUCTION Tofogliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that lowers plasma glucose levels by enhancing urinary glucose excretion. After its approval in Japan in 2014 for the treatment of type 2 diabetes mellitus, we carried out a 3-year prospective observational post-marketing surveillance study in Japanese patients (Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term [J-STEP/LT]). MATERIALS AND METHODS This surveillance was carried out between September 2014 and February 2019, and recorded safety in terms of adverse drug reactions (ADRs) and ADRs of special interest, and effectiveness in terms of changes in glycated hemoglobin and bodyweight from baseline to last observation carried forward. RESULTS Of 6,897 patients with type 2 diabetes mellitus registered, 6,711 and 6,451 were analyzed for safety and effectiveness, respectively. ADRs were reported in 846 patients (12.61%), with serious ADRs in 101 patients (1.5%). ADRs of special interest included hypoglycemia (62 patients [0.9%]), polyuria/pollakiuria (90 [1.3%]), volume depletion-related disorders (135 [2.0%]), urinary tract infections (91 [1.4%]), genital infections (117 [1.7%]) and skin diseases (53 [0.8%]). One case of diabetic ketoacidosis was reported. The mean ± standard deviation changes from baseline to last observation carried forward in glycated hemoglobin and bodyweight were -0.68 ± 1.34% (n = 6,158, P < 0.0001) and -3.13 ± 4.67 kg (n = 5,213, P < 0.0001), respectively. CONCLUSIONS J-STEP/LT, a 3-year, prospective, observational, post-marketing study in Japan, found no unprecedented ADRs, and consistent reductions from baseline in glycated hemoglobin and bodyweight over the observation period. The present results provide further evidence regarding the safety and tolerability of tofogliflozin in Japanese patients with type 2 diabetes mellitus.
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Shifting from vitamin K antagonists to non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: predictors, patterns and temporal trends.
Shiyovich, A, Shalev, V, Chodick, G, Tirosh, M, Katz, A, Klar, MM, Shuvy, M, Pereg, D, Minha, S
BMC cardiovascular disorders. 2021;(1):493
Abstract
BACKGROUND Non-Vitamin K antagonist oral anticoagulants (NOACs) emerged as an alternative with comparable or superior efficacy and safety to vitamin K antagonists (VKAs) for stroke prevention in patients with non-valvular atrial fibrillation (AF). OBJECTIVES The aim of the current study was to investigate the patterns, predictors, timelines and temporal trends of shifting from VKAs to NOACs. METHODS In this retrospective observational study, the computerized database of a large healthcare provider in Israel, Maccabi Healthcare Services, was searched to identify patients with AF for whom either a VKA or NOAC was prescribed between 2012 and 2015. Time from diagnosis to therapy initiation and to shifting between therapies was evaluated. RESULTS Out of 6987 eligible AF incident patients, 2338 (33.4%) initiated treatment with a VKA and 2221 (31.7%) with a NOAC. In addition, 5259 prevalent patients were analyzed. During the study period, NOAC prescriptions proportion among the newly diagnosed cases increased from 32 to 68.4% (p for trend < 0.001). The median time from diagnosis to first dispensing was greater in NOAC than VKA and decreased among patients treated with NOAC during the study period (2012: 1.9 and 0.3 months, 2015: 0.7 and 0.2 months, respectively). During follow-up, 3737 (49%) patients (54.3% and 47.1% of the incident and prevalent cases, respectively), shifted from a VKA to a NOAC, after a median of 22 months and 39 months in the incident and prevalent cases, respectively, decreasing throughout the study period. Female gender, younger age, southern district, higher CHADS2 and CHA2DS2-VASC score, non-smoking, and treatment with antiplatelets were associated with a greater likelihood for therapy shift. Shifting from a NOAC to a VKA decreased over time from 8 to 4.5% in 2012 to 0.5% and 0.7% in 2015 in the incident and prevalent groups, p < 0.001 respectively. CONCLUSIONS Shifting from VKA to NOAC occurred in 50% of the cases, more frequently among incident cases, and younger patients with greater stroke risk. Shifting from a NOAC to a VKA was much less frequent, yet it occurred more often in incident cases and decreased over time. A socially and economically sensitive program to optimize the initiation of OAC therapy upon diagnosis is warranted.
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Impact of changing reimbursement criteria on statin treatment patterns among patients with atherosclerotic cardiovascular disease or cardiovascular risk factors.
Hsu, CY, Chen, WJ, Chen, HM, Tsai, HY, Hsiao, FY
Journal of clinical pharmacy and therapeutics. 2021;(2):415-423
Abstract
WHAT IS KNOWN AND OBJECTIVE Starting 1 August 2013, the eligible cholesterol level for statin reimbursement in patients with atherosclerotic cardiovascular disease (ASCVD) or cardiovascular disease (CVD)-related risk factors changed from LDL-C ≥ 130 mg/dl (or TC ≥ 200 mg/dl) to LDL-C ≥ 100 mg/dl (or TC ≥ 160 mg/dl) in Taiwan, which may modify clinician prescribing behaviours. We aimed to evaluate the impact of changing reimbursement criteria on statin treatment patterns. METHODS A before-after cohort design was conducted using Taiwan's National Health Insurance Research Database. Differences in statin treatment patterns between the pre- and postregulation periods were compared. Two prespecified study cohorts were identified to examine the impacts of this change on those who need statins for "secondary prevention" (patients newly diagnosed with ASCVD) and those who need statins for "primary prevention" (patients newly diagnosed with CVD-related risk factors, such as diabetes mellitus [DM]). Treatment patterns measured in this study included initiation, discontinuation, switching, dose increase, dose decrease and dose maximization. RESULTS The proportion of patients who initiated statins during the postregulation period was higher than that of patients who initiated statins during the preregulation period (eg coronary heart disease (CHD) patients, pre- vs. postregulation: 41.23% vs. 48.25%). Notably, only 30%-40% of patients initiated statin use in the postregulation period across different conditions. In addition, the proportion of patients who discontinued statins remained very high. Even in the postregulation period, more than half of CHD patients discontinued statins during the 1-year follow-up period (eg CHD patients, pre- vs. postregulation: 59.07% vs. 52.75%). WHAT IS NEW AND CONCLUSION The new reimbursement criteria started on 1 August 2013 seemed to lower the barriers of access to the first statin prescription among patients with CHD, cerebrovascular disease (CBVD) and DM. Nevertheless, the proportion of patients who initiated statin use was suboptimal, and the proportion of patients who discontinued statins was very high in the postregulation period.
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Profile of patients diagnosed with acute venous thromboembolism in routine practice according to age and renal function: RE-COVERY DVT/PE study.
Ageno, W, Casella, IB, Chee, KH, Schellong, S, Schulman, S, Singer, DE, Desch, M, Tang, W, Voccia, I, Zint, K, et al
Journal of thrombosis and thrombolysis. 2021;(3):561-570
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Abstract
In randomized clinical trials (RCTs) of nonvitamin K antagonist oral anticoagulants (NOACs) for acute venous thromboembolism (VTE), ~ 12-13% of patients were elderly and ~ 26% had mild-to-moderate renal impairment. Observational studies are not restricted by the selection and treatment criteria of RCTs. In this ancillary analysis of the RE-COVERY DVT/PE global observational study, we aimed to describe patient characteristics, comorbidities, and anticoagulant therapy for subgroups of age (< or ≥ 75 years) and renal impairment (creatinine clearance [CrCl; estimated with Cockcroft-Gault formula] < 30 [severe], 30 to < 50 [moderate], 50 to < 80 [mild], ≥ 80 [normal] mL/min). Of 6095 eligible patients, 25.3% were aged ≥ 75 years; 38.2% (1605/4203 with CrCl values) had mild-to-moderate renal impairment. Comorbidities were more common in older patients (73.9% aged ≥ 75 vs. 58.1% < 75 years) and in those with mild or moderate versus no renal impairment (75.9%, 80.9%, and 59.3%, respectively). At hospital discharge or 14 days after diagnosis (whichever was later), most patients (53.7% and 55.1%, respectively) in both age groups received NOACs; 20.8% and 23.4%, respectively, received vitamin K antagonists, 19.0% and 21.8% parenteral therapy, 2.3% and 3.8% other anticoagulant treatments. Use of NOACs decreased with worsening renal impairment (none 58.5%, moderate 49.6%, severe 25.7%) and, in younger versus older patients with moderate renal impairment (33.1% vs. 56.1%). In routine practice, there are more elderly and renally impaired patients with VTE than represented in RCTs. Decreasing renal function, but not older age, was associated with less NOAC use. Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT02596230. Decreasing renal function, particularly in the subgroup with CrCl < 30 mL/min, but not older age, was associated with less use of nonvitamin K antagonist oral anticoagulants (NOACs). Nevertheless, more than half of the older patients with moderate renal impairment received a NOAC as their oral anticoagulant.
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The NSW Pathology Atlas of Variation: Part I-Identifying Emergency Departments With Outlying Laboratory Test-Ordering Practices.
Wabe, N, Thomas, J, Scowen, C, Eigenstetter, A, Lindeman, R, Georgiou, A
Annals of emergency medicine. 2021;(1):150-162
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Abstract
STUDY OBJECTIVE Abdominal pain and chest pain are leading reasons for emergency department (ED) presentations, with laboratory tests frequently ordered to aid the diagnostic process. Our study aims to identify EDs with outlying laboratory ordering practices for patients presenting with undifferentiated abdominal pain and chest pain. METHODS This was a retrospective observational study of 519,597 patients who presented with the complaint of abdominal or chest pain at 44 major hospital EDs across New South Wales, Australia, from January 2017 to September 2018. For each condition, we evaluated the risk-adjusted rate of ordering at least 1 laboratory test and of each of the top 15 ordered tests. We used funnel plots to graph variations in test ordering and identify EDs with outlying test-ordering practices. EDs lying above or below the 99.8% funnel control limits were regarded as outliers. RESULTS From 3,360,152 unplanned presentations, abdominal pain and chest pain represented 8.8% (n=296,809) and 6.6% (n=222,788) of all cases, respectively. No major outliers were observed for ordering at least one laboratory test; however, variations were observed for individual tests. For abdominal pain, the top 3 tests with the highest ordering variation included glucose (20 outlier EDs), C-reactive protein (10 outliers), and calcium-magnesium-phosphate (7 outliers). For chest pain, the top 3 tests with the highest ordering variation were glucose (21 outlier EDs), C-reactive protein (17 outliers), and liver function test (14 outliers). CONCLUSION Identifying EDs with outlying laboratory-ordering practices is the first step in initiating context-specific evaluation of whether outlying variations are unwarranted.
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Prescribing sodium-glucose co-transporter-2 inhibitors for type 2 diabetes in primary care: influence of renal function and heart failure diagnosis.
Hinton, W, Feher, MD, Munro, N, Joy, M, de Lusignan, S
Cardiovascular diabetology. 2021;(1):130
Abstract
BACKGROUND Sodium-glucose co-transporter-2 inhibitors (SGLT-2is) are licenced for initiation for glucose lowering in people with type 2 diabetes (T2DM) with an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2). However, recent trial data have shown that these medications have renal and cardio-protective effects, even for impaired kidney function. The extent to which trial evidence and updated guidelines have influenced real-world prescribing of SGLT-2is is not known, particularly with co-administration of diuretics. METHODS We performed a cross-sectional analysis of people with T2DM registered with practices in the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database on the 31st July 2019. We calculated the percentage of people prescribed SGLT-2is according to eGFR categories (< 45, 45-59, and ≥ 60 mL/min/1.73m2), with a heart failure diagnosis and stratified by body mass index categories (underweight, normal weight, overweight, obese), and with concomitant prescription of a diuretic. Multilevel logistic regression analysis was performed to determine whether heart failure diagnosis and renal function were associated with SGLT-2i prescribing. RESULTS From a population of 242,624 people with T2DM across 419 practices, 11.0% (n = 26,700) had been prescribed SGLT-2is. The majority of people initiated SGLT-2is had an eGFR ≥ 60 mL/min/1.73m2 (93.2%), and 4.3% had a heart failure diagnosis. 9,226 (3.8%) people were prescribed SGLT-2is as an add-on to their diuretic prescription. People in the highest eGFR category (≥ 60 mL/min/1.73m2) were more likely to be prescribed SGLT-2is than those in eGFR lower categories. Overweight (OR 2.05, 95% CI 1.841-2.274) and obese people (OR 3.84, 95% CI 3.472-4.250) were also more likely to be prescribed these medications, whilst use of diuretics (OR 0.74, 95% CI 0.682-0.804) and heart failure (OR 0.81, 95% CI 0.653-0.998) were associated with lower odds of being prescribed SGLT-2is. CONCLUSIONS Prescribing patterns of SGLT-2is for glucose lowering in T2DM in primary care generally concur with licenced indications according to recommended renal thresholds. A small percentage of people with heart failure were prescribed SGLT-2is for T2DM. An updated analysis is merited should UK National Institute for Health Care and Excellence prescribing guidelines for T2DM be revised to incorporate new data on the benefits for those with reduced renal function or with heart failure.
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Blood Pressure Targets Achievement According to 2018 ESC/ESH Guidelines in Three European Excellence Centers for Hypertension.
Tocci, G, Presta, V, Ferri, C, Redon, J, Volpe, M
High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension. 2020;(1):51-59
Abstract
INTRODUCTION The most recent European guidelines on hypertension redefined office blood pressure (BP) treatment targets according to age strata and cardiovascular (CV) risk profile. AIM: To evaluate proportions of adult outpatients achieving office BP treatment targets recommended by current compared to previous hypertension guidelines. METHODS We extracted data from medical databases of adult outpatients followed in three excellence centers in hypertension (Rome, Italy; L'Aquila, Italy; Valencia, Spain). Office BP treatment targets were defined according to either 2013 ESH/ESC guidelines (< 140/90 mmHg in non-diabetic individuals aged 18-80 years, < 150/90 mmHg in those aged ≥ 80 years, and < 140/85 mmHg in diabetic individuals), or 2018 ESC/ESH guidelines: (< 130/80 mmHg in individuals aged 18-65 years, < 140/80 mmHg in those aged 65-79 and ≥ 80 years). SCORE risk was assessed in all patients. RESULTS From an overall sample of 14,229 adult subjects, 4049 (28.5%) resulted normotensive individuals, 3088 (21.7%) were untreated and 7092 (49.8%) treated hypertensive outpatients. Treated hypertensives showed significantly higher ESC score risk (8.3 ± 13.0% vs. 3.9 ± 8.4%; P < 0.001) and lower systolic/diastolic BP (140.6 ± 18.8/83.9 ± 11.5 vs. 148.3 ± 14.2/94.7 ± 10.1 mmHg; P < 0.001) than untreated hypertensives. Compared to previous guidelines, BP control significantly lowered in non-diabetic outpatients (n = 5847) of all age groups [18-65 years: (13.1% vs. 42.9%), 65-79 years (25.8% vs. 42.5%) and ≥ 80 years (29.1% vs. 66.0%); P < 0.001 for all comparisons]; similar reductions were observed in diabetic outpatients (n = 1245) [18-65 years (32.7% vs. 14.8%), 65-79 years (37.3% vs. 24.7%) and ≥ 80 years (47.1% vs. 27.9%); P < 0.001]. CONCLUSIONS According to the recommended new office BP treatment targets, the proportions of treated uncontrolled hypertensive patients substantially increased. These findings should prompt a tighter application of therapeutic recommendations and, thus, highlight the need for improving hypertension management and control strategies.
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Conditional prescriptions of oral antihypertensive drugs for the management of hypertension urgencies in the inpatient setting: An observational study.
Pieragostini, R, Perrin, G, Nevoret, C, Amar, L, Jannot, AS, Sabatier, P, Korb-Savoldelli, V, Sabatier, B
Journal of clinical pharmacy and therapeutics. 2020;(2):282-289
Abstract
WHAT IS KNOWN AND OBJECTIVES The management of hypertension urgencies during hospitalization may generally not necessitate urgent care. However, physicians frequently prescribe 'as needed' antihypertensive drugs for which administration is triggered by blood pressure thresholds. The lack of rationale for this hospital practice led us to study oral conditional antihypertensive (OCA) prescriptions. We aimed to estimate the prevalence of OCA prescriptions and to establish their characteristics. METHODS In our institution, prescriptions are computerized. The study was retrospectively performed using a hospital clinical data warehouse over a 5-year period. RESULTS AND DISCUSSION The prevalence of OCA prescriptions was 6.9% among subjects treated with an antihypertensive drug. The median duration of these prescriptions was 4 days, until the day of the patient discharge in 78.8% stays. The calcium channel inhibitors were the main (79.9%) pharmacological class prescribed, with mostly prescriptions of nicardipine. OCA prescriptions were associated with another antihypertensive medication in 58.8% of the prescriptions; for 19.3%, it was a medication belonging to the same pharmacological class than the OCA drug prescribed. Regarding the computerized drafting, 39.6% of the conditional prescriptions were considered uninterpretable. At least one administration by nurses concerned 65.1% of the OCA prescriptions. The mean SBP and DBP before the initiation of an OCA drug was 142.9 ± 28.2 and 75.8 ± 24.5 mm Hg, respectively, relative to 143.0 ± 24.9 and 77.6 ± 19.9 mm Hg after the initiation (P = .8 for SBP and P = .06 for DBP). WHAT IS NEW AND CONCLUSION The originality of this study lies in the use of a clinical data warehouse to evaluate OCA prescriptions in hospital. These prescriptions are current, often uninterpretable and mostly ordered until patient discharge. Such drug orders could be associated with an increased risk of iatrogenic events and/or administration errors. This underlies the need for developing decision support tools and computerized protocols to manage hypertension urgencies.