Multiple burdens of malnutrition and relative remoteness in rural Ecuadorian communities.

OBJECTIVE: Social and economic changes associated with new roads can bring about rapid nutritional transitions. To study this process, we: (1) describe trends in adult overweight and obesity (OW/OB) among rural Afro-Ecuadorians over time and across a gradient of community remoteness from the nearest commercial centre; (2) examine the relationship between male and female adult OW/OB and factors associated with market integration such as changing livelihoods and (3) examine the co-occurrence of adult OW/OB and under-five stunting and anaemia. DESIGN: Adult anthropometry was collected through serial case-control studies repeated over a decade across twenty-eight communities. At the same time, anthropometry and Hb were measured for all children under 5 years of age in every community. SETTING: Northern coastal Ecuador. PARTICIPANTS: Adults (n 1665) and children under 5 years of age (n 2618). RESULTS: From 2003 and 2013, OW/OB increased from 25·1 % to 44·8 % among men and 59·9 % to 70·2 % among women. The inverse relationship between remoteness and OW/OB in men was attenuated when adjusting for urban employment, suggesting that livelihoods mediated the remoteness-OW/OB relationship. No such relationship was observed among women. Communities with a higher prevalence of male OW/OB also had a greater prevalence of stunting, but not anaemia, in children under 5 years of age. CONCLUSIONS: The association between male OW/OB and child stunting at the community level, but not the household level, suggests that changing food environments, rather than household- or individual-level factors, drove these trends. A closer examination of changing socio-economic structures and food environments in communities undergoing rapid development could help mitigate future public health burdens.

Epidemiology and clinical characteristics of interstitial lung disease in patients with rheumatoid arthritis from the JointMan database.

Interstitial lung disease (ILD) is a progressive fibrotic disease associated with rheumatoid arthritis (RA); real-world data for evaluating RA-associated ILD (RA-ILD) are limited. We evaluated prevalence, time to onset, clinical characteristics and prognostic factors in patients diagnosed with RA (n = 8963) in the Discus Analytics JointMan database (2009-2019) with and without ILD. ILD prevalence was 4.1% (95% confidence interval 3.7-4.5); > 90% had an ILD diagnosis after RA diagnosis (mean time to onset 3.3 years). At baseline, a higher proportion of patients with RA-ILD were older (> 65 years), male, with history of chronic obstructive pulmonary disease (COPD) compared with patients in the RA cohort. Patients in the RA-ILD cohort were likely to have more severe RA characteristics and joint evaluation compared with patients without ILD, at baseline and before/after ILD diagnosis. In this large, real-world database patients with (vs without) ILD had a higher burden of RA characteristics. Previously established risk factors for RA-ILD were confirmed (age, baseline COPD, anti-cyclic citrullinated peptide positivity, C-reactive protein, Clinical Disease Activity Index score); thus, recognition of these factors and tracking routine disease activity metrics may help identify patients at higher risk of RA complications and lead to improved diagnosis and earlier treatment.

Effectiveness and Safety of Direct Oral Anticoagulants Among Patients with Non-valvular Atrial Fibrillation and Multimorbidity.

INTRODUCTION: In the USA, there is a steady rise of atrial fibrillation due to the aging population with increased morbidity. This study evaluated the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) among elderly patients with non-valvular atrial fibrillation (NVAF) and multimorbidity prescribed direct oral anticoagulants (DOACs). METHODS: Using the CMS Medicare database, a retrospective observational study of adult patients with NVAF and multimorbidity who initiated apixaban, dabigatran, or rivaroxaban from January 1, 2012 to December 31, 2017 was conducted. High multimorbidity was classified as having ≥ 6 comorbidities. Cox proportional hazard models were used to evaluate the hazard ratios of S/SE and MB among three 1:1 propensity score matched DOAC cohorts. All-cause healthcare costs were estimated using generalized linear models. RESULTS: Overall 36% of the NVAF study population had high multimorbidity, forming three propensity score matched (PSM) cohorts: 12,511 apixaban-dabigatran, 60,287 apixaban-rivaroxaban, and 12,567 dabigatran-rivaroxaban patients. Apixaban was associated with a lower risk of stroke/SE and MB when compared with dabigatran and rivaroxaban. Dabigatran had a lower risk of stroke/SE and a similar risk of MB when compared with rivaroxaban. Compared to rivaroxaban, apixaban patients incurred lower all-cause healthcare costs, and dabigatran patients incurred similar all-cause healthcare costs. Compared to dabigatran, apixaban patients incurred similar all-cause healthcare costs. CONCLUSION: Patients with NVAF and ≥ 6 comorbid conditions had significantly different risks for stroke/SE and MB when comparing DOACs to DOACs, and different healthcare expenses. This study's results may be useful for evaluating the risk-benefit ratio of DOAC use in patients with NVAF and multimorbidity.

Treatment persistence and maintenance dose titration among ulcerative colitis patients on biologics: a pooled study of three United States claim databases.

OBJECTIVE: This real-world study evaluated biologic treatment patterns in patients with moderate-to-severe ulcerative colitis (UC). METHODS: IQVIA PharMetrics, IBM MarketScan, and Optum Clinformatics were pooled to identify UC patients with ≥1 claim for UC and ≥1 claim for adalimumab (ADA), golimumab (GOL), infliximab (IFX), or vedolizumab (VDZ). The index date for each biologic was the first claim for that biologic. Patients could be included in >1 cohort if they switched biologics during the identification period. Continuous eligibility for medical/pharmacy benefits was required for 12 months before (baseline) and after (follow-up) the index date. Patients lacking claims for any biologic during baseline were categorized as bio-naïve; those with any biologic claim were categorized as bio-experienced. Persistence was defined as the proportion of patients that remained on the index biologic without a gap between claims of >28 days for ADA, >56 days for GOL, and >112 days for IFX and VDZ. Dose titration was assessed among patients with ≥2 maintenance doses during follow-up among ADA, GOL, and VDZ patients. RESULTS: In total, 6,106 bio-naïve UC patients and 1,027 bio-experienced UC patients were identified. Patients treated with VDZ and IFX had the highest persistence followed by ADA and GOL patients for bio-naïve and bio-experienced, respectively. ADA patients had a numerically higher proportion of patients with 50% dose escalation, followed by VDZ and GOL; 50% dose reduction was observed in ≤1% patients. CONCLUSIONS: In this descriptive study of UC patients without confounder adjustment, VDZ persistence was numerically highest followed by IFX, GOL, and ADA across both populations.

Positioning psychiatric pharmacists to improve mental health care.

Psychiatric pharmacy continues to grow and look to the future with a focus on helping individuals recover from mental health and substance use disorders. The American Association of Psychiatric Pharmacists (AAPP) considers Board Certified Psychiatric Pharmacist (BCPP) the gold standard credential that all psychiatric pharmacists should attain to demonstrate specialized knowledge and expertise in psychiatry. BCPPs are part of collaborative interprofessional teams and practice in hospitals, clinics, and diverse health systems. Two out of 3 BCPPs practicing in clinics have prescriptive authority. BCPPs improve access, safety, medication adherence, and therapeutic outcomes. Every person with a mental health and substance use disorder should have access to a BCPP providing comprehensive medication management (CMM) and psychotropic stewardship aimed at improving population health. BCPPs are in demand owing to their expertise. AAPP envisions growth and expansion of the BCPP role in many areas including coordinating psychiatric transitions of care and telehealth services, managing long-acting injectable medication clinics, providing pharmacogenomic consultation, conducting clozapine and lithium monitoring, managing medications for substance use disorders, leading medication groups, CNS drug development, research, and provider education. To prepare the workforce, colleges and schools of pharmacy should hire BCPPs for optimal curriculum development, and each student pharmacist should have an opportunity to develop a therapeutic alliance with a person recovering from psychiatric illness. Postgraduate year (PGY) 1 residencies should offer learning experiences in psychiatric pharmacy to prepare residents to enter an expanded number of PGY2 psychiatric pharmacy residencies, ultimately earning their BCPP and being well positioned to improve mental health care.

Non-persistence to Oral Anticoagulation Treatment in Patients with Non-valvular Atrial Fibrillation in the USA.

BACKGROUND: Studies have shown that patients with non-valvular atrial fibrillation (NVAF) who discontinue oral anticoagulants (OACs) are at higher risk of complications such as stroke. OBJECTIVE: This analysis compared the risk of non-persistence with OACs among patients with NVAF. METHODS: Adult patients with NVAF who initiated apixaban, dabigatran, rivaroxaban, or warfarin were identified using 01JAN2013-30JUN2019 data from Centers for Medicare and Medicaid Services and four US commercial claims databases. Non-persistence was defined as discontinuation (no evidence of index OAC use for ≥ 60 days from the last days' supply) or switch to another OAC. Kaplan-Meier curves were generated to illustrate time to non-persistence along with cumulative incidences of non-persistence. Baseline and time-varying covariates were evaluated, and adjusted Cox proportional hazards models were used to evaluate non-persistence risk. RESULTS: In total, 363,823 patients receiving apixaban, 57,121 receiving dabigatran, 282,831 receiving rivaroxaban, and 317,337 receiving warfarin were included. Of these, 47-72% discontinued/switched OAC therapy within an average 9-month follow-up. Apixaban was associated with a lower risk of non-persistence than were dabigatran (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.61-0.62), rivaroxaban (HR 0.76; 95% CI 0.75-0.76), and warfarin (HR 0.74; 95% CI 0.74-0.75). Dabigatran was associated with a higher risk of non-persistence than were warfarin (HR 1.21; 95% CI 1.19-1.22) and rivaroxaban (HR 1.23; 95% CI 1.22-1.25), and rivaroxaban was associated with a lower risk of non-persistence than was warfarin (HR 0.98; 95% CI 0.97-0.98). Clinical events (stroke/systemic embolism and major bleeding [MB]) during follow-up were predictors of non-persistence (stroke HR 1.57; 95% CI 1.53-1.61; MB HR 2.96; 95% CI 2.92-3.00). CONCLUSION: In over one million patients with NVAF, our results suggest differences in anticoagulation treatment persistence across OAC agents, even after accounting for clinical events after OAC initiation. It is important for clinicians and patients to take these differences into consideration, especially as non-persistence to OAC therapy is associated with thromboembolic complications.

Impact of apixaban treatment discontinuation on the risk of hospitalization among patients with nonvalvular atrial fibrillation and COVID-19.

INTRODUCTION: This study evaluated the risk of hospitalization among nonvalvular atrial fibrillation (NVAF) patients with an outpatient COVID-19 diagnosis who discontinued vs continued apixaban treatment. METHODS: Adult patients with NVAF with an apixaban prescription prior to an outpatient COVID-19 diagnosis were identified from Optum Clinformatics claims database (1 April 2020-31 March 2021). Continuers were those who continued apixaban as of the index date (date of initial outpatient COVID-19 diagnosis) and discontinuers were those who had the last day of apixaban supply on or before index. Patients were followed from COVID-19 diagnosis to change of continuation/discontinuation status, switch, death, end of continuous coverage or study end, whichever occurred first. Inverse probability treatment weighting (IPTW) was performed to balance cohorts. Cox proportional hazard models were used to compare the risk of all-cause hospitalization and hospitalization for ischemic stroke (IS), venous thromboembolism (VTE), myocardial infarction (MI), bleeding and mortality. RESULTS: A total of 7869 apixaban patients with COVID-19 were included: 6676 continuers (84.8%) and 1193 discontinuers (15.2%). Compared with continuers, discontinuers had a higher risk of all-cause hospitalization (hazard ratio [HR]: 1.23; 95% confidence interval [CI]: 1.08-1.40), IS (HR: 2.00; 95% CI: 1.03-3.87), VTE (HR: 2.37; 95% CI: 1.06-5.27) and mortality (HR: 2.28; 95% CI: 1.85-2.80). There were no significant differences in the risk of MI (HR: 1.01; 95% CI: 0.54-1.90) or bleeding-related hospitalization (HR: 1.13; 95% CI: 0.73-1.76). CONCLUSION: NVAF patients with COVID-19 who discontinued apixaban had a higher risk of hospitalization and thrombotic events vs those who continued apixaban, with no significant difference in bleeding-related hospitalization.

Burden of Pneumonia Among Hospitalized Patients with Influenza: Real-World Evidence from a US Managed Care Population.

INTRODUCTION: Pneumonia is among the most prevalent complications of influenza. The purpose of this study is to quantify the burden of pneumonia among hospitalized patients with influenza. METHODS: Real-world retrospective data from 01JAN2014-30JUN2019 (study period) were obtained from Optum's de-identified Clinformatics® Data Mart Database (2007-2020) for patients who had ≥ 1 diagnosis for influenza during the identification period and ≥ 1 all-cause inpatient visit within 1 day of diagnosis. Cases had ≥ 1 diagnosis claim for an influenza-related pneumonia within the 30 days after the initial influenza diagnosis date. Controls had no evidence of influenza-related pneumonia in the 30 days following the initial influenza diagnosis. Final 1:1 matching was determined using propensity score matching (PSM). Statistical significance between the cohorts was tested. RESULTS: After PSM, there were 4878 hospitalized patients with influenza in each of the case and control groups. During the index hospitalization, cases vs. controls had longer length of stay [Mean (standard deviation): 6.5 (8.3) vs. 1.9 (3.7)], greater intensive care unit (ICU) use (38.4 vs. 16.8%), and greater mechanical ventilation use (invasive: 11.4 vs. 2.3%; non-invasive: 6.8 vs. 2.6%) (all p < 0.001). Cases also had higher readmission rates than controls (12.3 vs. 3.5% within 30 days; 20.0 vs. 6.1% within 90 days; p < 0.001 for both). Post-index date direct all-cause healthcare costs were higher for cases than for controls (median total cost: $18,428 vs. $621 for 30 days; $21,774 vs. $3312 for 90 days; $25,960 vs. $8699 for 6 months; $35,875 vs. $21,619 for 1 year; all p < 0.001). CONCLUSIONS: Pneumonia as a complication of influenza increases risk of mortality and leads to greater healthcare resource use and direct medical costs among patients hospitalized with influenza. These effects are seen early during the index hospitalization and within the first 30 days after diagnosis, but their impact continues throughout a year of follow-up.

Real-world persistence to direct oral anticoagulants in patients with atrial fibrillation: a systematic review and network meta-analysis.

OBJECTIVE: To conduct a systematic review and network meta-analysis of real-world evidence comparing adherence, persistence, cost, and utilization between oral anticoagulant (OAC) in non-valvular atrial fibrillation (NVAF) patients. METHODS: A systematic search of MEDLINE and Embase (inception-July 2019) was conducted for published observational cohort studies comparing outcomes between ≥2 OACs. A network meta-analysis was performed to estimate odds ratios for non-persistence using a random-effects model. RESULTS: There were 80 studies evaluating the outcomes of interest. However, due to a paucity in adherence studies and heterogeneity in adherence, cost, and utilization definitions, persistence was the focus of this network meta-analysis. There were 36 studies evaluating non-persistence in 395,593 participants, 24 of which used 3 gap definitions (30-, 60-, and 90-days); 18 unique studies evaluating non-persistence at 12 months were included in the network meta-analysis. Using 30- and 90-day gaps, all NOACs, when compared with VKAs, had lower odds of non-persistence (30-day OR (95%CI): apixaban: 0.63 (0.58, 0.69); rivaroxaban: 0.69 (0.62, 0.76); dabigatran: 0.89 (0.82, 0.97); 90-day OR (95%CI): apixaban: 0.33 (0.22, 0.47); rivaroxaban: 0.47 (0.36, 0.61); dabigatran 0.61 (0.44, 0.85)). When using a 60-day gap, dabigatran had higher odds of non-persistence vs VKAs (OR: 1.35; 95%CI: 1.12, 1.61), but there were no significant differences for apixaban and rivaroxaban. Apixaban had the lowest probability of non-persistence across the 3-gap definitions (95.7% with 30-day gap, 76.9% with 60-day gap, 98.4% with 90-day gap). CONCLUSIONS: The current findings, despite multiple limitations, can raise awareness and understanding of real-world persistence associated with OAC therapy in NVAF patients.

Clozapine-induced myocarditis: Two case reports and review of clinical presentation and recognition.

Myocarditis is a potentially fatal cardiac disease marked by inflammation of the heart muscle. With a noted black-box warning, rates of clozapine-induced myocarditis are reportedly as high as 3%. Since the first case of clozapine-induced myocarditis was documented in 1994, more than 250 cases have been described in literature with an approximate 33% case-fatality rate. We report 2 cases of patients with primary psychotic disorders treated with clozapine, who developed signs and symptoms of myocarditis. The first was a 35-year-old white male patient with a primary diagnosis of schizoaffective disorder (bipolar type) who was initiated on clozapine after nonresponse to several therapies. On day 26, the patient was admitted to the emergency department for chest pain presenting with eosinophilia and notable elevations in several biomarkers, including troponin and C-reactive protein. The second patient was a 45-year-old black male who was initiated on clozapine for treatment-resistant schizophrenia. On day 13, the patient reported cardiac-related concerns (tachycardia) and flu-like symptoms resulting in hospitalization. Similarly, this patient demonstrated elevated biomarkers (troponin and creatine kinase). Both patients experienced resolution of symptoms after discontinuation of clozapine. Clozapine was not rechallenged for either patient. Review of literature further elucidates the relationship between clozapine and myocarditis, including potential risk factors, pathophysiology, and symptom presentation. Due to the potentially fatal nature of this condition, clinical vigilance and awareness is warranted upon initiation of clozapine through monitoring of symptoms along with cardiac and inflammatory biomarkers as indicated.

Bloodstream infections in cancer patients. Risk factors associated with mortality.

OBJECTIVE: The aim of this study was to evaluate the clinical characteristics and risk factors associated with mortality in cancer patients with bloodstream infections (BSI), analyzing multidrug resistant bacteria (MDR). METHODS: We conducted a prospective observational study at a cancer referral center from August 2016 to July 2017, which included all BSI. RESULTS: 4220 patients were tested with blood cultures; 496 were included. Mean age was 48 years. In 299 patients with solid tumors, secondary BSI and Central Line-Associated BSI (CLABSI) were the most common (55.9% and 31.8%, respectively). In 197 hematologic patients, primary and mucosal barrier injury (MBI) BSI were the main type (38.6%). Gram-negative were the most frequent bacteria (72.8%), with Escherichia coli occupying the first place (n=210, 42.3%), 48% were Extended-Spectrum Beta-Lactamase (ESBL) producers, and 1.8% were resistant to carbapenems. Mortality at day 30, was 22%, but reached 70% when patients did not receive an appropriate antimicrobial treatment. Multivariate analysis showed that progression or relapse of the oncologic disease, inappropriate antimicrobial treatment, and having resistant bacteria were independently associated with 30-day mortality. CONCLUSIONS: Emergence of MDR bacteria is an important healthcare problem worldwide. Patients with BSI, particularly those patients with MDR bacteria have a higher mortality risk.

Consumer satisfaction with National Alliance on Mental Illness written medicine information.

INTRODUCTION: Written medicine information (WMI) is a collection of facts for a specific medication, and it helps facilitate patient understanding of medication therapy. The primary objective of this study was to assess consumer satisfaction with National Alliance on Mental Illness (NAMI) WMI. A secondary objective was to assess health care professional satisfaction. METHODS: National Alliance on Mental Illness WMI and surveys were offered to consumers, health care professionals, and trainees at 3 treatment centers with psychiatric services. All adults who received medication counseling were eligible for inclusion. Survey responses were evaluated using descriptive statistics. RESULTS: Most consumers (82.4%) and providers (74.5%) reported overall satisfaction with NAMI WMI. Consumers were least satisfied with information on how to manage unwanted effects, drug-drug interactions, and readability (9.5%, 14.9%, 41.9% dissatisfaction). DISCUSSION: Evaluation and feedback from consumers and health care professionals may influence decisions to refine NAMI WMI to meet consumer needs.

Hospitalizations and emergency room visits after initiation of long-acting injectable antipsychotics.

INTRODUCTION: Long-acting injectable antipsychotics (LAIs) serve as a means to ensure medication adherence with the intention of improving outcomes for psychiatric patients. Evidence remains inconclusive regarding the impact of LAIs on relapses and psychiatric hospitalizations rates. METHODS: The primary objective of this retrospective pre/post study was to determine whether initiating an LAI in a veteran population with schizophrenia, schizoaffective disorder, or bipolar disorder is associated with a decrease in the 1-year rate of psychiatric hospitalizations and emergency room (ER) visits. RESULTS: For the combined primary endpoint, the 1-year rate of psychiatric hospitalizations and ER visits for patients with schizophrenia, schizoaffective disorder, or bipolar disorder was not significantly reduced after initiation of LAIs (n = 50, median [interquartile range]: 1.5 [1, 3] to 1 [0, 3], P = .055). However, the secondary endpoint of the 1-year rate of psychiatric hospitalizations was reduced (1 [0, 3] to 0 [0, 2], P = .026). Additionally, for those who received injections on a regular basis, the 1-year rate of hospitalizations and ER visits was significantly reduced (2 [1, 3] to 0 [0, 1.5], P = .009). DISCUSSION: This retrospective study suggests that the initiation of LAIs is associated with a reduced rate of psychiatric hospitalizations as well as a reduced rate of psychiatric hospitalizations and ER visits for those patients who receive injections on a regular basis.

Serum thyroxine concentrations and pregnancy rates 15 to 16 days after ovulation in broodmares.

OBJECTIVE: To determine whether serum thyroxine (T4) concentration was associated with pregnancy rates 15 to 16 days after ovulation in mares and to determine whether thyroid hormone supplementation would enhance fertility in mares. DESIGN: Cohort study. ANIMALS: 329 clinically normal broodmares. PROCEDURE: Mares were examined 15 to 16 days after ovulation to determine whether they were pregnant; blood samples for determination of serum T4 concentration were collected at the same time. Sixty mares were receiving thyroid hormone supplementation prior to the study because of low serum T4 concentration (< 16 microg/dl) prior to breeding. RESULTS: Serum T4 concentration ranged from 4.5 to 53.9 mg/dl. Forty (12%) mares had low (< 16 microg/dl) concentrations, 283 (86%) had normal concentrations, and 6 (2%) had high (> 45 microg/dl) concentrations. Two hundred thirty-one mares were pregnant 15 to 16 days after ovulation. A significant association between serum T4 concentration (low, normal, or high) and pregnancy (yes or no) was not detected, and logistic regression analysis indicated that serum T4 concentration was not significantly related to pregnancy. Of the 269 mares not receiving thyroid hormone supplementation, 187 were pregnant, and of the 60 mares receiving thyroid supplementation, 44 were pregnant. There was no significant relationship between thyroid hormone supplementation and pregnancy status. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that serum T4 concentration in mares is not significantly associated with pregnancy 15 to 16 days after ovulation. Results also suggest that supplementation of mares that only have low T4 concentrations is not indicated or likely to be beneficial.