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1.
Medicine (Baltimore) ; 103(18): e37935, 2024 May 03.
Article En | MEDLINE | ID: mdl-38701304

BACKGROUND: Inappropriate medication utilization among older adults is a pressing concern in the United States, owing to its high prevalence and the consequential detrimental impact it engenders. The adverse effects stemming from the inappropriate use of medication may be unequally borne by racial/ethnic minority populations, calling for greater efforts towards promoting equity in healthcare. The study objective was to assess the cost-effectiveness of Medication Therapy Management (MTM) services among Medicare beneficiaries and across racial/ethnic groups. METHODS: Medicare administrative data from 2016 to 2017 linked to Area Health Resources Files were used to analyze Medicare fee-for-service patients aged 65 or above with continuous Parts A/B/D coverage. The intervention group included new MTM enrollees in 2017; the control group referred to patients who met the general MTM eligible criteria but did not enroll in 2016 or 2017. The 2 groups were matched using a propensity score method. Effectiveness was evaluated as the proportion of appropriate medication utilization based on performance measures developed by the Pharmacy Quality Alliance. Costs were computed as total healthcare costs from Medicare perspective. A multivariable net benefit regressions with a classic linear model and Bayesian analysis were utilized. Net benefit was calculated based on willingness-to-pay thresholds at various multiples of the gross domestic product in 2017. Three-way interaction terms among dummy variables for MTM enrollment, 2017, and racial/ethnic minority groups were incorporated in a difference-in-differences study design. RESULTS: After adjusting for patient characteristics, the findings indicate that MTM receipt was associated with incremental net benefit among each race and ethnicity. For instance, the net benefit of MTM among the non-Hispanic White patients was $2498 (95% confidence interval = $1609, $3386) at a willingness-to-pay value of $59,908. The study found no significant difference in net benefits for MTM services between minority and White patients. CONCLUSION: The study provides evidence that MTM is a cost-effective tool for managing medication utilization among the Medicare population. However, MTM may not be cost-effective in reducing racial/ethnic disparities in medication utilization in the short term. Further research is needed to understand the long-term cost-effectiveness of MTM on racial/ethnic disparities.


Cost-Benefit Analysis , Medicare , Medication Therapy Management , Humans , United States , Medication Therapy Management/economics , Medication Therapy Management/statistics & numerical data , Aged , Medicare/economics , Male , Female , Aged, 80 and over , Ethnicity/statistics & numerical data , Racial Groups/statistics & numerical data
2.
Hepatology ; 75(3): 673-689, 2022 03.
Article En | MEDLINE | ID: mdl-34537985

BACKGROUND AND AIMS: The global burden of viral hepatitis B is substantial, and monitoring infections across the care cascade is important for elimination efforts. There is little information on care disparities by immigration status, and we aimed to quantify disease burden among immigrant subgroups. APPROACH AND RESULTS: In this population-based, retrospective cohort study, we used linked laboratory and health administrative records to describe the HBV care cascade in five distinct stages: (1) lifetime prevalence; (2) diagnosis; (3) engagement with care; (4) treatment initiation; and (5) treatment continuation. Infections were identified based on at least one reactive antigen or nucleic acid test, and lifetime prevalence was estimated as the sum of diagnosed and estimated undiagnosed cases. Care cascades were compared between long-term residents and immigrant groups, including subgroups born in hepatitis B endemic countries. Stratified analyses and multivariable Poisson regression were used to identify drivers for cascade progression. Between January 1997 and December 2014, 2,014,470 persons were included, 50,475 with infections, of whom 30,118 were engaged with care, 11,450 initiated treatment, and 6554 continued treatment >1 year. Lifetime prevalence was estimated as 163,309 (1.34%) overall, 115,722 (3.42%) among all immigrants, and 50,876 (9.37%) among those from highly endemic countries. Compared to long-term residents, immigrants were more likely to be diagnosed (adjusted rate ratio [aRR], 4.55; 95% CI, 4.46, 4.63), engaged with care (aRR, 1.07; 95% CI, 1.04, 1.09), and initiate treatment (aRR, 1.09; 95% CI, 1.03, 1.16). CONCLUSIONS: In conclusion, immigrants fared well compared to long-term residents along the care cascade, having higher rates of diagnosis and slightly better measures in subsequent cascade stages, although intensified screening efforts and better strategies to facilitate linkage to care are still needed.


Continuity of Patient Care/organization & administration , Emigrants and Immigrants/statistics & numerical data , Hepatitis B Surface Antigens/isolation & purification , Hepatitis B e Antigens/isolation & purification , Hepatitis B , Mass Screening , Medication Therapy Management/statistics & numerical data , Cohort Studies , Epidemiological Monitoring , Female , Health Services Needs and Demand , Hepatitis B/diagnosis , Hepatitis B/epidemiology , Hepatitis B/therapy , Humans , Male , Mass Screening/methods , Mass Screening/statistics & numerical data , Middle Aged , Ontario/epidemiology , Prevalence , Retrospective Studies
3.
J Clin Psychiatry ; 82(6)2021 11 02.
Article En | MEDLINE | ID: mdl-34727421

Objective: To determine the proportion of adults treated for depression in the US who achieve remission and, among those not achieving remission, the proportion receiving augmentation treatment.Methods: Using data from the US National Health and Nutrition Examination Survey (NHANES) for years 2013-2014, 2015-2016, and 2017-2018, we identified 869 adults who reported using antidepressant medications for depression for at least 3 months. This sample was partitioned into remitted (score < 5) and non-remitted (score ≥ 5) respondents based on 9-item Patient Health Questionnaire (PHQ-9) score-a questionnaire based on the DSM-IV criteria for major depressive disorder. Among the non-remitted group, the proportion receiving antidepressant augmentation with another antidepressant medication of a different class or other medications was also assessed.Results: An estimated 43.5% of adults receiving antidepressant medications for depression were in remission when assessed. Among those not in remission, 28.1% were using augmentation treatment, which in most cases was another antidepressant medication from a different class. As compared to depressed adults without any mental health contact in the past year, those with such contact had significantly higher odds of using augmentation treatment (adjusted odds ratio = 2.72; 95% CI, 1.56-4.76; P = .001).Conclusions: The low percentage of US adults treated with antidepressants for depression that achieves remission represents a missed clinical and public health opportunity to optimize depression treatment. Closer monitoring of symptoms through measurement-based care and setting symptom remission as a goal can help improve outcomes for adults with depression.


Antidepressive Agents/therapeutic use , Depressive Disorder, Major , Depressive Disorder, Treatment-Resistant , Drug Monitoring , Health Services Misuse/prevention & control , Adult , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/epidemiology , Depressive Disorder, Treatment-Resistant/diagnosis , Depressive Disorder, Treatment-Resistant/drug therapy , Depressive Disorder, Treatment-Resistant/epidemiology , Diagnostic and Statistical Manual of Mental Disorders , Drug Monitoring/methods , Drug Monitoring/standards , Drug Resistance/drug effects , Drug Substitution/methods , Drug Substitution/statistics & numerical data , Drug Synergism , Female , Humans , Male , Medication Therapy Management/standards , Medication Therapy Management/statistics & numerical data , Nutrition Surveys/statistics & numerical data , Remission Induction/methods , United States/epidemiology
4.
PLoS One ; 16(8): e0255478, 2021.
Article En | MEDLINE | ID: mdl-34358258

Why do so many people struggle with their medicines despite decades of research on medicines taking? Research into how people experience medicines in their everyday life remains scarce with the majority of research in this area of focusing on whether or not people take their medicines as prescribed. Hence, this study used a phenomenological hermeneutical qualitative design to gain a deeper understanding of individuals' perspectives on the lived experience of medicine-taking. Findings from this study highlight five main themes where participants experience medicines as: 1) life-saving and indispensable, 2) normal and a daily routine, 3) confusing and concerning, 4) unsuitable without adjustment, and 5) intrusive and unwelcome. These results can be the basis for mutually agreed prescribing through a co-creative approach that aims at enhancing open and honest dialogues between patients and healthcare professionals in partnership about medicines.


Attitude to Health , Medication Adherence/psychology , Medication Adherence/statistics & numerical data , Medication Therapy Management/statistics & numerical data , Pharmaceutical Preparations/administration & dosage , Self Administration/psychology , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Qualitative Research
5.
Pediatr Rheumatol Online J ; 19(1): 130, 2021 Aug 21.
Article En | MEDLINE | ID: mdl-34419078

BACKGROUND: Juvenile idiopathic arthritis constitutes a significant cause of disability and quality of life impairment in pediatric and adult patients. The aim of this study was to ascertain clinical remission (CR) and subsequent relapse in juvenile idiopathic arthritis (JIA) patients, according to therapeutic approach and JIA subtype. Evidence in literature regarding its predictors is scarce. METHODS: We conducted an observational, ambispective study. Patients diagnosed of JIA, treated with synthetic and/or biologic disease modifying antirheumatic drugs (DMARD) were included and followed-up to December 31st, 2015. Primary outcome was clinical remission defined by Wallace criteria, both on and off medication. In order to ascertain CR according to therapeutic approach, DMARD treatments were divided in four groups: 1) synthetic DMARD (sDMARD) alone, 2) sDMARD combined with another sDMARD, 3) sDMARD combined with biologic DMARD (bDMARD), and 4) bDMARD alone. RESULTS: A total of 206 patients who received DMARD treatment were included. At the time the follow-up was completed, 70% of the patients in the cohort had attained CR at least once (144 out of 206), and 29% were in clinical remission off medication (59 out of 206). According to treatment group, CR was more frequently observed in patients treated with synthetic DMARD alone (53%). Within this group, CR was associated with female sex, oligoarticular persistent subtypes, ANA positivity, Methotrexate treatment and absence of HLA B27, comorbidities and DMARD toxicity. 124 DMARD treatments (62%) were withdrawn, 64% of which relapsed. Lower relapse rates were observed in those patients with persistent oligoarticular JIA (93%) when DMARD dose was tapered before withdrawal (77%). CONCLUSIONS: More than two thirds of JIA patients attained CR along the 9 years of follow-up, and nearly one third achieved CR off medication. Females with early JIA onset, lower active joint count and ANA positivity were the ones achieving and sustaining remission more frequently, especially when receiving synthetic DMARD alone and in the absence of HLA B27, comorbidities or previous DMARD toxicity.


Antirheumatic Agents , Arthritis, Juvenile , Biological Products , Methotrexate , Quality of Life , Remission Induction/methods , Adolescent , Antirheumatic Agents/administration & dosage , Antirheumatic Agents/adverse effects , Antirheumatic Agents/classification , Arthritis, Juvenile/diagnosis , Arthritis, Juvenile/drug therapy , Arthritis, Juvenile/physiopathology , Arthritis, Juvenile/psychology , Biological Products/administration & dosage , Biological Products/adverse effects , Child, Preschool , Clinical Protocols , Drug Monitoring/methods , Female , HLA-B27 Antigen/analysis , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Male , Medication Therapy Management/statistics & numerical data , Methotrexate/administration & dosage , Methotrexate/adverse effects , Monitoring, Immunologic/methods , Recurrence , Sex Factors
6.
Pediatr Rheumatol Online J ; 19(1): 131, 2021 Aug 21.
Article En | MEDLINE | ID: mdl-34419107

BACKGROUND: We aimed to characterize etanercept (ETN) use in juvenile idiopathic arthritis (JIA) patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. METHODS: The CARRA Registry is a convenience cohort of patients with paediatric onset rheumatic diseases, including JIA. JIA patients treated with ETN for whom the month and year of ETN initiation were available were included. Patterns of ETN and methotrexate (MTX) use were categorized as follows: combination therapy (ETN and MTX started concurrently), step-up therapy (MTX started first and ETN added later), switchers (MTX started and then stopped when or before ETN started), MTX add-on (ETN started first and MTX added later), and ETN only (no MTX use). Data were described using parametric and non-parametric statistics as appropriate. RESULTS: Two thousand thirty-two of the five thousand six hundred forty-one patients with JIA met inclusion criteria (74% female, median age at diagnosis 6.0 years [interquartile range 2.0, 11.0]. Most patients (66.9%) were treated with a non-biologic disease modifying anti-rheumatic drug (DMARD), primarily MTX, prior to ETN. There was significant variability in patterns of MTX use prior to starting ETN. Step-up therapy was the most common approach. Only 34.0% of persistent oligoarticular JIA patients continued treatment with a non-biologic DMARD 3 months or more after ETN initiation. ETN persistence overall was 66.3, 49.4, and 37.3% at 24, 36 and 48 months respectively. ETN persistence among spondyloarthritis patients (enthesitis related arthritis and psoriatic JIA) varied by MTX initiation pattern, with higher ETN persistence rates in those who initiated combination therapy (68.9%) and switchers/ETN only (73.3%) patients compared to step-up (65.4%) and MTX add-on (51.1%) therapy. CONCLUSION: This study characterizes contemporary patterns of ETN use in the CARRA Registry. Treatment was largely in keeping with American College of Rheumatology guidelines.


Arthritis, Juvenile/drug therapy , Drug Therapy, Combination/methods , Etanercept , Methotrexate , Arthritis, Juvenile/diagnosis , Arthritis, Juvenile/epidemiology , Arthritis, Juvenile/immunology , Child , Clinical Protocols , Drug Monitoring/methods , Duration of Therapy , Etanercept/administration & dosage , Etanercept/adverse effects , Female , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Male , Medication Therapy Management/statistics & numerical data , Methotrexate/administration & dosage , Methotrexate/adverse effects , Registries/statistics & numerical data , Tumor Necrosis Factor Inhibitors/administration & dosage , Tumor Necrosis Factor Inhibitors/adverse effects , United States/epidemiology
8.
Med Sci Monit ; 27: e929474, 2021 Jul 31.
Article En | MEDLINE | ID: mdl-34330885

BACKGROUND The impact of therapeutic drug management (TDM) on reducing toxicity and improving efficacy in colorectal cancer (CRC) patients receiving fluorouracil-based chemotherapy is still unclear. MATERIAL AND METHODS A total of 207 patients (Study Group n=54, Historical Group n=153) with metastatic colorectal cancer were enrolled. All of them received 6 administrations of the 5-FU based regimens. Initial 5-FU dosing of all patients was calculated using body surface area (BSA). In the Study Group, individual exposure during each cycle was measured using a nanoparticle immunoassay, and the 5-FU blood concentration was calculated using the area under the curve (AUC). We adjusted the 5-FU infusion dose of the next cycle based on the AUC data of the previous cycle to achieve the target of 20-30 mg×h/L. RESULTS In the fourth cycle, patients in the target concentration range (AUC mean, 26.3 mg×h/L; Median, 28 mg×h/L; Range, 14-38 mg×h/L; CV, 22.4%) accounted for 46.8% of all patients, which were more than the ones in the first cycle (P<0.001). 5-FU TDM significantly reduced the toxicity of chemotherapy and improved its efficacy. The Study Group (30/289) showed a lower percentage of severe adverse events than that in the Historical Group (185/447) (P<0.001). The incidences of complete response and partial response in the Study Group were higher than those in the Historical Group (P=0.032). CONCLUSIONS TDM in colorectal cancer can reduce toxicity, improve efficacy and clinical outcome, and can be routinely used in 5-FU-based chemotherapy.


Antineoplastic Combined Chemotherapy Protocols , Colorectal Neoplasms , Drug Monitoring/methods , Drug-Related Side Effects and Adverse Reactions , Fluorouracil , Neoplasm Metastasis , Aged , Antimetabolites, Antineoplastic/administration & dosage , Antimetabolites, Antineoplastic/adverse effects , Antimetabolites, Antineoplastic/blood , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Area Under Curve , China/epidemiology , Colorectal Neoplasms/blood , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/epidemiology , Colorectal Neoplasms/pathology , Drug Dosage Calculations , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/prevention & control , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Fluorouracil/blood , Humans , Male , Medication Therapy Management/statistics & numerical data , Neoplasm Metastasis/pathology , Neoplasm Metastasis/therapy , Neoplasm Staging , Risk Adjustment/methods , Treatment Outcome
10.
CNS Drugs ; 35(7): 769-779, 2021 07.
Article En | MEDLINE | ID: mdl-34283391

BACKGROUND: Children and adolescents with attention deficit hyperactivity disorder (ADHD) are at higher risk of all-cause poisoning by drugs and chemicals (intentional or accidental). Currently, there is limited data on whether medication treatment for ADHD can reduce the risk of all-cause poisoning. METHODS: Patients aged 5-18 years with a methylphenidate (MPH) prescription and an incident poisoning diagnosis between January 2001 and June 2020 were identified from the Hong Kong Clinical Data Analysis and Reporting System. A self-controlled case series study design was used to compare the incidence rate ratios (IRRs) of all-cause poisoning during different risk windows (30 days before the first MPH prescription, exposure periods within 30 days of the first prescription, and periods of subsequent exposure) compared with the reference window (other non-exposure periods). RESULTS: 42,203 patients were prescribed ADHD medication in Hong Kong during the study period. Of these, 417 patients who had both an MPH prescription and poisoning incident recorded were included in the main analysis. Compared with other non-exposed periods, a higher risk of poisoning was found in the 30 days before the first prescription (IRR 2.64, 95% confidence interval [CI] 1.33-5.22) and exposure periods within 30 days of the first prescription (IRR 2.18, 95% CI 1.06-4.48), but not during prolonged exposure. However, compared with 30 days before the first prescription as well as exposure periods within 30 days of the first prescription, there was a lower risk during the subsequent exposure (IRRs 0.49 and 0.60, respectively). Similar results to the main analysis were also found in the subgroup analysis of intentional poisoning and females, but not in that of accidental poisoning and males. CONCLUSIONS: The risk of all-cause poisoning was higher shortly before and after the first MPH prescription and became lower during the subsequent prescription period. Our results do not support an association between the use of MPH and an increased risk of all-cause poisoning in children and adolescents and, in fact, suggest that longer-term use of MPH may be associated with a lower risk of all-cause poisoning, although this latter finding requires further study.


Attention Deficit Disorder with Hyperactivity , Methylphenidate , Poisoning , Adolescent , Attention Deficit Disorder with Hyperactivity/drug therapy , Attention Deficit Disorder with Hyperactivity/epidemiology , Attention Deficit Disorder with Hyperactivity/psychology , Central Nervous System Stimulants/administration & dosage , Central Nervous System Stimulants/adverse effects , Child , Female , Hong Kong/epidemiology , Humans , Incidence , Male , Medication Therapy Management/statistics & numerical data , Methylphenidate/administration & dosage , Methylphenidate/adverse effects , Poisoning/diagnosis , Poisoning/epidemiology , Poisoning/etiology , Risk Adjustment/methods , Risk Assessment/methods , Risk Factors
12.
Heart ; 107(17): 1407-1416, 2021 09.
Article En | MEDLINE | ID: mdl-34088766

OBJECTIVE: To evaluate the effectiveness of angiotensin receptor-neprilysin inhibitor (ARNI) versus renin-angiotensin system (RAS) blockade alone in older adults with heart failure with reduced ejection fraction (HFrEF). METHODS: We conducted a cohort study using US Medicare fee-for-service claims data (2014-2017). Patients with HFrEF ≥65 years were identified in two cohorts: (1) initiators of ARNI or RAS blockade alone (ACE inhibitor, ACEI; or angiotensin receptor blocker, ARB) and (2) switchers from an ACEI to either ARNI or ARB. HR with 95% CI from Cox proportional hazard regression and 1-year restricted mean survival time (RMST) difference with 95% CI were calculated for a composite outcome of time to first worsening heart failure event or all-cause mortality after adjustment for 71 pre-exposure characteristics through propensity score fine-stratification weighting. All analyses of initiator and switcher cohorts were conducted separately and then combined using fixed effects. RESULTS: 51 208 patients with a mean age of 76 years were included, with 16 193 in the ARNI group. Adjusted HRs comparing ARNI with RAS blockade alone were 0.92 (95% CI 0.84 to 1.00) among initiators and 0.79 (95% CI 0.74 to 0.85) among switchers, with a combined estimate of 0.84 (95% CI 0.80 to 0.89). Adjusted 1-year RMST difference (95% CI) was 4 days in the initiator cohort (-1 to 9) and 12 days (8 to 17) in the switcher cohort, resulting in a pooled estimate of 9 days (6 to 12) favouring ARNI. CONCLUSION: ARNI treatment was associated with lower risk of a composite effectiveness endpoint compared with RAS blockade alone in older adults with HFrEF.


Angiotensin Receptor Antagonists , Heart Failure, Systolic , Neprilysin/antagonists & inhibitors , Aged , Angiotensin Receptor Antagonists/adverse effects , Angiotensin Receptor Antagonists/therapeutic use , Disease Progression , Drug Substitution/methods , Drug Substitution/statistics & numerical data , Drug Therapy, Combination/methods , Enzyme Inhibitors/adverse effects , Enzyme Inhibitors/therapeutic use , Female , Heart Failure, Systolic/diagnosis , Heart Failure, Systolic/drug therapy , Heart Failure, Systolic/epidemiology , Heart Failure, Systolic/metabolism , Hospitalization/statistics & numerical data , Humans , Male , Medicare/statistics & numerical data , Medication Therapy Management/standards , Medication Therapy Management/statistics & numerical data , Mortality , Treatment Outcome , United States/epidemiology
13.
CNS Drugs ; 35(4): 451-460, 2021 04.
Article En | MEDLINE | ID: mdl-33837915

BACKGROUND: Many patients with schizophrenia discontinue antipsychotic medication, frequently with adverse outcomes. Although different antipsychotic formulations are associated with different times to discontinuation, not much is known about discontinuation rates with oral-weekly formulations. Such a formulation of penfluridol is available in both the Netherlands and several other countries. OBJECTIVES: We aimed to investigate the impact of antipsychotic formulations on time to discontinuation, especially the oral-weekly formulation. METHODS: In a large, registry-based, retrospective cohort study from 1 January 2013 to 31 December 2016, we determined the time to medication discontinuation during the follow-up period with antipsychotic formulations, including oral-daily, oral-weekly, depot, or a combination of these. Patients with schizophrenia aged between 18 and 69 years were included and stratified according to the duration of recent antipsychotic use (taking the same formulation for ≤ 60 days or > 60 days before follow-up: short-term or long-term recent antipsychotic use). Medication discontinuation was defined as discontinuation of current antipsychotic formulation. RESULTS: Overall, 8257 patients were included for analyses, with 80% of patients discontinuing antipsychotic medication. Time to discontinuation was longer in those with long-term recent antipsychotic use before the follow-up period and longest for oral-daily formulations. Patterns for discontinuation of oral-weekly and depot formulations were similar, regardless of the duration of recent antipsychotic use before follow-up. More prior discontinuations were associated with shorter time to discontinuation. CONCLUSIONS: Time to discontinuation differed considerably between formulations. The duration of recent antipsychotic use was a strong predictor of time to discontinuation. While oral-daily formulations had the longest time to discontinuation in the long-term recent antipsychotic use group, discontinuation trends were similar for oral-weekly and depot formulations. An oral-weekly formulation, whose administration route is noninvasive, might therefore be considered an alternative to depot formulations.


Delayed-Action Preparations , Duration of Therapy , Patient Selection , Penfluridol , Schizophrenia , Administration, Oral , Adult , Antipsychotic Agents/administration & dosage , Antipsychotic Agents/pharmacology , Delayed-Action Preparations/administration & dosage , Delayed-Action Preparations/pharmacology , Female , Humans , Male , Medication Adherence/psychology , Medication Adherence/statistics & numerical data , Medication Therapy Management/standards , Medication Therapy Management/statistics & numerical data , Middle Aged , Netherlands/epidemiology , Penfluridol/administration & dosage , Penfluridol/pharmacology , Prognosis , Registries/statistics & numerical data , Schizophrenia/diagnosis , Schizophrenia/drug therapy , Schizophrenia/epidemiology , Schizophrenic Psychology
14.
Eur J Vasc Endovasc Surg ; 61(6): 881-887, 2021 06.
Article En | MEDLINE | ID: mdl-33827781

OBJECTIVE: Current guidelines recommending rapid revascularisation of symptomatic carotid stenosis are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today. The risk of stroke and its predictors among patients with symptomatic carotid stenosis awaiting revascularisation in recent randomised controlled trials (RCTs) and in medical arms of earlier RCTs was assessed. METHODS: The pooled data of individual patients with symptomatic carotid stenosis randomised to stenting (CAS) or endarterectomy (CEA) in four recent RCTs, and of patients randomised to medical therapy in three earlier RCTs comparing CEA vs. medical therapy, were compared. The primary outcome event was any stroke occurring between randomisation and treatment by CAS or CEA, or within 120 days after randomisation. RESULTS: A total of 4 754 patients from recent trials and 1 227 from earlier trials were included. In recent trials, patients were randomised a median of 18 (IQR 7, 50) days after the qualifying event (QE). Twenty-three suffered a stroke while waiting for revascularisation (cumulative 120 day risk 1.97%, 95% confidence interval [CI] 0.75 - 3.17). Shorter time from QE until randomisation increased stroke risk after randomisation (χ2 = 6.58, p = .011). Sixty-one patients had a stroke within 120 days of randomisation in the medical arms of earlier trials (cumulative risk 5%, 95% CI 3.8 - 6.2). Stroke risk was lower in recent than earlier trials when adjusted for time between QE and randomisation, age, severity of QE, and degree of carotid stenosis (HR 0.47, 95% CI 0.25 - 0.88, p = .019). CONCLUSION: Patients with symptomatic carotid stenosis enrolled in recent large RCTs had a lower risk of stroke after randomisation than historical controls. The added benefit of carotid revascularisation to modern medical care needs to be revisited in future studies. Until then, adhering to current recommendations for early revascularisation of patients with symptomatic carotid stenosis considered to require invasive treatment is advisable.


Carotid Stenosis , Endarterectomy, Carotid , Ischemic Stroke , Medication Therapy Management/statistics & numerical data , Percutaneous Coronary Intervention , Carotid Stenosis/complications , Carotid Stenosis/diagnosis , Carotid Stenosis/physiopathology , Carotid Stenosis/therapy , Cerebral Revascularization/trends , Endarterectomy, Carotid/methods , Endarterectomy, Carotid/statistics & numerical data , Humans , Ischemic Stroke/diagnosis , Ischemic Stroke/etiology , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/statistics & numerical data , Risk Assessment , Stents , Waiting Lists
15.
Cancer Rep (Hoboken) ; 4(4): e1371, 2021 08.
Article En | MEDLINE | ID: mdl-33739629

BACKGROUND: The differences in the clinical pharmacy services (CPS) provided by oncology and non-oncology pharmacists have not been sufficiently explained. AIM: This study aimed to demonstrate the differences in direct CPS provided by oncology and non-oncology pharmacists for patients and physicians, and to assess the potential impact of these services on medical costs. METHODS: We retrospectively examined CPS provided by oncology and non-oncology pharmacists for outpatients who underwent chemotherapy between January and December 2016. RESULTS: In total, 1177 and 1050 CPS provided by oncology and non-oncology pharmacists, respectively, were investigated. The rates of interventions performed by oncology and non-oncology pharmacists for physicians-determined treatment were 18.5% and 11.3%, respectively (p < .001). The rates of oncology and non-oncology pharmacist interventions accepted by physicians were 84.6 and 78.8%, respectively (p = .12). Level 4 and Level 5 interventions accounted for 64.6% of all oncology pharmacist interventions and 53.0% of all non-oncology pharmacist interventions (p = .03). The rates of improvement in symptoms from adverse drug reactions among patients resulting from interventions by oncology and non-oncology pharmacists were 89.4 and 72.1%, respectively (p = .02). Conservative assessments of medical cost impact showed that a single intervention by an oncology and by a non-oncology pharmacist saved ¥6355 and ¥3604, respectively. CONCLUSION: The results of the present study suggested that CPS by oncology pharmacists enable safer and more effective therapy for patients with cancer and indirectly contribute to reducing health care fees.


Antineoplastic Agents/administration & dosage , Medical Oncology/statistics & numerical data , Medication Therapy Management/statistics & numerical data , Neoplasms/drug therapy , Pharmacists/statistics & numerical data , Adult , Aged , Aged, 80 and over , Ambulatory Care/organization & administration , Ambulatory Care/statistics & numerical data , Antineoplastic Agents/adverse effects , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/prevention & control , Female , Humans , Male , Medical Oncology/organization & administration , Medication Therapy Management/organization & administration , Middle Aged , Outpatient Clinics, Hospital/organization & administration , Outpatient Clinics, Hospital/statistics & numerical data , Pharmacists/organization & administration , Pharmacy Service, Hospital/organization & administration , Pharmacy Service, Hospital/statistics & numerical data , Professional Role , Retrospective Studies , Young Adult
16.
J Am Heart Assoc ; 10(7): e015816, 2021 04 06.
Article En | MEDLINE | ID: mdl-33759539

Background To evaluate the cost-effectiveness of combination pulmonary arterial hypertension specific therapy in systemic sclerosis-related PAH. Methods and Results Health outcomes and costs were captured through data linkage. Health utility was derived from Medical Outcomes Study Short Form-36 scores. A probabilistic discrete-time model was developed to simulate lifetime changes in costs and health utility. Mortality was predicted using a Gompertz parametric survival model. For both treatment arms, the simulations were started using the same cohort of 10 000 patients. Probabilistic sensitivity analysis was performed using the Monte Carlo simulation with 1000 sets of sampled parameter values. Of 143 patients with systemic sclerosis-related pulmonary arterial hypertension, 89 were on monotherapy and 54 on combination therapy. Mean simulated costs per patient per year in monotherapy and combination therapy groups were AU$23 411 (US$16 080) and AU$29 129 (US$19 982), respectively. Mean life years and quality-adjusted life years from pulmonary arterial hypertension diagnosis to death of patients receiving monotherapy were 7.1 and 3.0, respectively, and of those receiving combination therapy were 9.2 and 3.9, respectively. Incremental costs per life year and quality-adjusted life year gained of combination therapy compared with monotherapy were AU$47 989 (US$32 920) and AU$113 823 (US$78 082), respectively. At a willingness-to-pay threshold of AU$102 000 (US$69 972) per life year gained, and of AU$177 222 (US$121 574) per quality-adjusted life year gained, the probability of combination therapy being cost-effective was 0.95. Conclusions The incremental cost per quality-adjusted life year gained of combination therapy compared with monotherapy was substantial in the base case analysis. Given the fatal prognosis of systemic sclerosis-related pulmonary arterial hypertension and the incremental cost per life year of AU$47 989 (US$32 920), combination therapy could be considered cost-effective in systemic sclerosis-related pulmonary arterial hypertension.


Antihypertensive Agents , Drug Therapy, Combination , Pulmonary Arterial Hypertension , Scleroderma, Systemic , Vasodilator Agents , Antihypertensive Agents/classification , Antihypertensive Agents/economics , Antihypertensive Agents/therapeutic use , Australia/epidemiology , Cost-Benefit Analysis , Drug Therapy, Combination/economics , Drug Therapy, Combination/methods , Female , Humans , Male , Medication Therapy Management/statistics & numerical data , Medication Therapy Management/trends , Middle Aged , Prognosis , Pulmonary Arterial Hypertension/drug therapy , Pulmonary Arterial Hypertension/economics , Pulmonary Arterial Hypertension/epidemiology , Pulmonary Arterial Hypertension/etiology , Scleroderma, Systemic/complications , Scleroderma, Systemic/mortality , Survival Analysis , Treatment Outcome , Vasodilator Agents/classification , Vasodilator Agents/economics , Vasodilator Agents/therapeutic use
18.
Int Forum Allergy Rhinol ; 11(7): 1041-1046, 2021 07.
Article En | MEDLINE | ID: mdl-33728824

The frequent association between coronavirus disease 2019 (COVID-19) and olfactory dysfunction is creating an unprecedented demand for a treatment of the olfactory loss. Systemic corticosteroids have been considered as a therapeutic option. However, based on current literature, we call for caution using these treatments in early COVID-19-related olfactory dysfunction because: (1) evidence supporting their usefulness is weak; (2) the rate of spontaneous recovery of COVID-19-related olfactory dysfunction is high; and (3) corticosteroids have well-known potential adverse effects. We encourage randomized placebo-controlled trials investigating the efficacy of systemic steroids in this indication and strongly emphasize to initially consider smell training, which is supported by a robust evidence base and has no known side effects.


Adrenal Cortex Hormones/pharmacology , COVID-19 , Medication Therapy Management/statistics & numerical data , Olfaction Disorders , COVID-19/complications , COVID-19/physiopathology , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/prevention & control , Global Health , Humans , Medication Therapy Management/standards , Needs Assessment , Olfaction Disorders/drug therapy , Olfaction Disorders/epidemiology , Olfaction Disorders/etiology , Olfactory Mucosa/drug effects , Olfactory Mucosa/virology , Remission, Spontaneous , Research Design , SARS-CoV-2/pathogenicity
20.
Isr Med Assoc J ; 23(1): 12-16, 2021 Jan.
Article En | MEDLINE | ID: mdl-33443336

BACKGROUND: Dietary modifications and patient-tailored medical management are significant in controlling renal stone disease. Nevertheless, the literature regarding effectiveness is sparse. OBJECTIVES: To explore the impact of dietary modifications and medical management on 24-hour urinary metabolic profiles (UMP) and renal stone status in recurrent kidney stone formers. METHODS: We reviewed our prospective registry database of patients treated for nephrolithiasis. Data included age, sex, 24-hour UMP, and stone burden before treatment. Under individual treatment, patients were followed at 6-8 month intervals with repeat 24-hour UMP and radiographic images. Nephrolithiasis-related events (e.g., surgery, renal colic) were also recorded. We included patients with established long-term follow-up prior to the initiation of designated treatment, comparing individual nephrolithiasis status before and after treatment initiation. RESULTS: Inclusion criteria were met by 44 patients. Median age at treatment start was 60.5 (50.2-70.2) years. Male:Female ratio was 3.9:1. Median follow-up was 10 (6-25) years and 5 (3-6) years before and after initiation of medical and dietary treatment, respectively. Metabolic abnormalities detected included: hypocitraturia (95.5%), low urine volume (56.8%), hypercalciuria (45.5%), hyperoxaluria (40.9%), and hyperuricosuria (13.6%). Repeat 24-hour UMP under appropriate diet and medical treatment revealed a progressive increase in citrate levels compared to baseline and significantly decreased calcium levels (P = 0.001 and 0.03, respectively). A significant decrease was observed in stone burden (P = 0.001) and overall nephrolithiasis-related events. CONCLUSIONS: Dietary modifications and medical management significantly aid in correcting urinary metabolic abnormalities. Consequently, reduced nehprolithiasis-related events and better stone burden control is expected.


Diet Therapy/methods , Kidney Calculi , Nephrolithiasis , Aftercare/methods , Aftercare/statistics & numerical data , Calcium/urine , Citric Acid/urine , Female , Humans , Israel/epidemiology , Kidney Calculi/complications , Kidney Calculi/epidemiology , Kidney Calculi/physiopathology , Male , Medication Therapy Management/statistics & numerical data , Metabolome/drug effects , Metabolome/physiology , Middle Aged , Monitoring, Physiologic/methods , Nephrolithiasis/diagnosis , Nephrolithiasis/diet therapy , Nephrolithiasis/drug therapy , Nephrolithiasis/metabolism , Outcome and Process Assessment, Health Care , Renal Colic/epidemiology , Renal Colic/etiology , Secondary Prevention/methods , Secondary Prevention/statistics & numerical data , Surgical Procedures, Operative/statistics & numerical data , Uric Acid/urine
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