Acute Airway Obstruction: An Unusual Presentation of Posttransplant Lymphoproliferative Disorder in a Renal Transplant Recipient.

Posttransplant lymphoproliferative disorder is a life-threatening complication after solid-organ transplants. In adults, recipients of heart transplants have the highest risk, whereas renal transplant recipients have the lowest risk among all solid-organ transplants. The most common site for posttransplant lymphoproliferative disorders are gastrointestinal tract followed by the graft itself. Airway involvement in posttransplant lymphoproliferative disorder is rarely encountered. We report a case of a 26-year-old renal allograft recipient who presented to the emergency room with airway obstruction necessitating an emergency tracheostomy. Imaging revealed a left tonsillar mass extending into the nasopharynx and retropharyngeal space causing complete oropharyngeal occlusion. Endoscopic biopsy from nasopharyngeal mass showed a diffuse large B-cell lymphoma and was Ebstein-Barr virus positive. Reduction in immunosuppression and treatment with posttransplant lymphoproliferative disorder-1 risk-stratified approach resulted in complete remission.

Patient journey of civilian adults diagnosed with posttraumatic stress disorder-A chart review study.

OBJECTIVE: To assess the journey of individuals from experiencing a traumatic event through onset of symptoms, diagnosis, and treatment of posttraumatic stress disorder (PTSD). METHODS: Patient- and psychiatrist-level data was collected (02/2022-05/2022) from psychiatrists who treated ≥1 civilian adult diagnosed with PTSD. Eligible charts covered civilian adults diagnosed with PTSD (2016-2020), receiving ≥1 PTSD-related treatment (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], atypical antipsychotics [AAs]), and having ≥1 medical visit in the last 12 months. Collected information included clinical and treatment characteristics surrounding the PTSD diagnosis. RESULTS: A total of 273 psychiatrists contributed data on 687 patients with PTSD (average age 36.1; 60.4% female). On average, the traumatic event and symptom onset occurred 8.7 years and 6.5 years prior to PTSD diagnosis, respectively. In the 6 months before diagnosis, 88.9% of patients had received a PTSD-related treatment. At time of diagnosis, 87.8% of patients had intrusion symptoms and 78.9% had alterations in cognition/mood; 41.2% had depressive disorder and 38.7% had anxiety. Diagnosis prompted treatment changes for 79.3% of patients, receiving treatment within 1.9 months on average, often with a first-line SSRI as either monotherapy (52.8%) or combination (24.9%). At the end of the 24-month study period, 34.4% of patients achieved psychiatrist-recorded remission. A total of 23.0% of psychiatrists expressed dissatisfaction with approved PTSD treatments, with 88.3% at least somewhat likely to prescribe AAs despite lack of FDA approval. CONCLUSION: PTSD presents heterogeneously, with an extensive journey from trauma to diagnosis with low remission rates and limited treatment options.

A real-world assessment of healthcare costs associated with agitation in Alzheimer's dementia.

AIMS: To describe and compare clinical characteristics, healthcare costs, and institutionalization/mortality outcomes among patients with and without agitation associated with Alzheimer's dementia (AAD). METHODS: Data from the Reliant Medical Group database (01/01/2016-03/31/2020) were used, including claims, electronic medical records, and clinical information/physician notes abstracted from medical charts. Patients aged ≥55 years with Alzheimer's dementia (AD) were observed during a randomly selected 12-month study period after AD diagnosis. Using information recorded in medical charts, patients were classified into cohorts based on experiencing (agitation cohort) and not experiencing (no agitation cohort) agitated behaviours during the study period. Entropy balancing was used to create reweighted cohorts with similar characteristics. Study outcomes (patient demographic and clinical characteristics, treatments received, healthcare costs, institutionalization and death events) were compared between cohorts; agitation characteristics were described for the agitation cohort only. RESULTS: Among 711 patients included in the study, 240 were classified in the agitation cohort and 471 in the no agitation cohort. After reweighting, several comorbidities were more frequently observed in the agitation versus no agitation cohort, including infection, depression, and altered mental status. Use of antidepressants, anticonvulsants, antipsychotics, and antianxiety medications was more common in the agitation versus no agitation cohort. Common agitated behaviours included hitting (20.8%), pacing/aimless wandering (17.5%), and cursing/verbal aggression (15.0%). Total all-cause healthcare costs were $4287 per-patient-per-year higher in the agitation cohort versus no agitation cohort (p = 0.04), driven by higher inpatient costs. Death was more common and time to death and institutionalization were shorter in the agitation versus no agitation cohort. LIMITATIONS: Results may not be generalizable to the US population with AD. CONCLUSIONS: Among patients with AD, agitation was associated with shorter time to death/institutionalization and increased comorbidities, medication use, and healthcare costs, highlighting the additional clinical and economic burden that agitation poses to patients and the healthcare system.

Patient journey before and after a formal post-traumatic stress disorder diagnosis in adults in the United States - a retrospective claims study.

OBJECTIVE: To describe post-traumatic stress disorder (PTSD)-related symptoms and frequent psychiatric comorbidities, treatments received, healthcare resource utilization (HRU), and healthcare costs pre- and post-PTSD diagnosis among adults in the United States. METHODS: Adults with PTSD who received a PTSD-related pharmacological treatment (selective serotonin reuptake inhibitor [SSRI], serotonin-norepinephrine reuptake inhibitor [SNRI], atypical antipsychotic [AA]) within 24 months of the first observed PTSD diagnosis (index date) were identified using MarketScan Commercial Database (2015-2020). Study outcomes were assessed during the 6-month pre-diagnosis and 24-month post-diagnosis periods. Subgroup analyses included patients treated or not treated with AAs post-PTSD diagnosis. RESULTS: Of the overall patients (N = 26,306; mean age at diagnosis 39.5 years; 73.3% female), 85.9% had PTSD-related symptoms and frequent psychiatric comorbidities during the 6 months pre-diagnosis. Patients treated with AAs post-PTSD diagnosis (N = 9,298) tended to have higher rates of PTSD-related symptoms and comorbidities at diagnosis than those not treated with AAs (N = 7,011). Following diagnosis, the most commonly observed first-line treatments were SSRI (67.4%), AA (23.4%), and SNRI (22.6%). The rate of PTSD-related symptoms and comorbidities, psychotherapy and pharmacological treatments received, HRU, and healthcare costs increased during the 6 months post-diagnosis relative to the 6 months pre-diagnosis and then declined over time during the 24 months post-diagnosis. CONCLUSIONS: The PTSD diagnosis was associated with increased rates of symptoms and frequent psychiatric comorbidities, psychotherapy and pharmacological treatments received, HRU, and healthcare costs, pointing to increased patient monitoring. Within 6 to 12 months after the PTSD diagnosis, these outcomes tended to reduce, perhaps as patients were obtaining targeted and effective care.

Real-world economic and clinical outcomes associated with current hemostatic matrix use in spinal surgery.

Aim: Bleeding during spine surgery is controlled using topical hemostatic agents. Studies have reported outcomes between Surgiflo® and Floseal, the most widely used flowable hemostatic matrices, but have not included the latest Surgiflo formulation which is more adherent to the bleeding surface than prior formulations. Materials & methods: A propensity score-matched analysis was conducted using the Premier Healthcare Database to compare economic and clinical outcomes of adults undergoing inpatient spinal surgery between 2013 and 2018 receiving current Surgiflo or Floseal. Results: This retrospective study included 28,910 patients in each group and found comparable outcomes for bleeding events, overall transfusion rate, inpatient mortality and readmissions between Surgiflo and Floseal. Surgiflo was associated with $430 (USD) lower hospitalization costs, shorter length of stay and shorter operating room time than Floseal.

Topical hemostatic agents such as Surgiflo^® and Floseal are used during invasive surgery to manage bleeding. We compared outcomes of spine surgeries that used either of two most frequently used topical hemostatic agents, Surgiflo or Floseal. This is the largest retrospective study presenting economic and clinical outcomes of patients receiving Surgiflo versus Floseal during spine surgery using the latest product formulations. The study suggests that clinical outcomes are comparable between Surgiflo and Floseal groups and that Surgiflo is associated with lower hospitalization costs, slightly shorter hospital stay and shorter operating room time among patients undergoing spine surgery.

Inactivated vaccine Covaxin/BBV152: A systematic review.

We systematically reviewed and summarized studies focusing on Bharat Biotech's Whole Virion Inactivated Corona Virus Antigen BBV152 (Covaxin), which is India's indigenous response to fighting the SARS-CoV-2 pandemic. Studies were searched for data on the efficacy, immunogenicity, and safety profile of BBV152. All relevant studies published up to March 22, 2022, were screened from major databases, and 25 studies were eventually inducted into the systematic review. The studies focused on the virus antigen (6 µg) adjuvanted with aluminium hydroxide gel and/or Imidazo quinolin gallamide (IMDG), aTLR7/8 agonist. Pre-clinical, phase I, and II clinical trials showed appreciable immunogenicity. Both neutralizing and binding antibody titers were significant and T cell responses were Th1-biased. Phase III trials on the 6 µg +Algel-IMDG formulation showed a 93.4% efficacy against severe COVID-19. Data from the trials revealed an acceptable safety profile with mostly mild-moderate local and systemic adverse events. No serious adverse events or fatalities were seen, and most studies reported milder and lesser adverse events with Covaxin when compared with other vaccines, especially Oxford-Astra Zeneca's AZD1222 (Covishield). The immunogenicity performance of Covaxin, which provided significant protection only after the second dose, was mediocre and it was consistently surpassed by Covishield. One study reported adjusted effectiveness against symptomatic infection to be just 50% at 2 weeks after the second dose. Nonetheless, appreciable results were seen in previously infected individuals administered both doses. There was some evidence of coverage against the Alpha, Beta, and Delta variants. However, neither Covaxin nor Covishield showed sufficient protection against the Omicron variant. Two studies reported super-additive results on mixing Covaxin with Covishield. Further exploration of heterologous prime-boost vaccination with a combination of an inactivated vaccine and an adenoviral vector-based vaccine for tackling future variants may be beneficial.

Physician preferences for attributes of pediatric combination vaccines in the United States.

OBJECTIVE: To understand physician preferences for various attributes of pediatric combination vaccines. METHODS: An online survey was completed by 400 US physicians (pediatricians and family physicians) who routinely administer vaccines to infants aged 1-12 months in outpatient settings. Respondents completed a discrete choice experiment (DCE) by selecting their preferred options from different hypothetical vaccine profiles with systematic variation in the levels of five attributes: vaccine presentation, number of injections administered at a single visit, completion rates, timeliness rates (within 30 days of recommended age), and years of availability for routine use, assuming similar cost, safety, and efficacy. Odds ratios and relative attribute importance scores were estimated using a random parameters logit model. RESULTS: Physicians (mean age 50.4 years, 52.5% women) preferred combination vaccines that reduced the number of injections administered at a single visit, facilitated higher completion and timeliness rates for the primary DTaP series, were available as a pre-filled syringe rather than a vial needing reconstitution and had been available for routine use for more than 1 year. All odds ratios were statistically significant. Physicians were twice as likely to prefer administering three injections in a single visit instead of four. The most important attribute was the number of injections administered at a single visit (relative importance 38%), followed by timeliness, completion rates, and vaccine presentation; years a vaccine has been available was the least important attribute. CONCLUSION: US physicians prefer pediatric combination vaccines that enable fewer injections to be administered at a single visit, facilitate higher completion and timeliness rates, are offered as a pre-filled syringe, and have been available for routine use for more than 1 year. The most important attribute of pediatric combination vaccines was a reduction in the number of injections administered at a single visit.

Retrospective Database Analysis to Explore Patterns and Economic Burden of Switchback to Brand After Generic or Authorized Generic Utilization.

Background: Despite demonstration of bioequivalence of generics to brands and the potential for reduced costs, some patients switch back from a generic to the brand. A prior retrospective analysis suggested that this switchback rate may be lower among patients that had initially switched to authorized generics (AG), often both produced and marketed by the brand company, compared to those initially switched to another generic. Objective: Explore switching patterns of brands, AGs, and generics, switchback rates, and the potential impact of switchbacks on healthcare costs. Methods: An analysis of the Pharmetrics Plus™ database (2007-2019), a United States (US) payer administrative database, was conducted to examine the use of Upjohn medications available as AGs across multiple therapeutic areas. Patients initiating treatment with brand medication in the 6 months prior to generic market entry were identified and switch rates to generics and AGs, as well as switchback rates, were evaluated. Costs were descriptively compared between patients who switched back to brand and those who remained on any generic. Results: Across 14 brand medications, more than half of the patients initiating treatment with the brand medication were switched to a generic. Generally, switching to AG, which ranged from 0.5 to 39.6%, was lower than switching to non-AG generics (16.7-79.9%). The comparison of switchback rates from AGs to brand and non-AGs to brand showed similar results (AG:1.3-7.5%; non-AG:1.4-12.9%); however, the most substantial differences were observed where non-AG switchbacks were higher. Patients that switched back to brand remained on AG or generic for an average of 1-3 months (32-88 days). The analysis showed a tendency towards increased medical costs in the period immediately preceding switchback for all medications except sildenafil in both indications (erectile dysfunction and pulmonary arterial hypertension). For the remaining medications, medical costs ranged from $63 to $1544 higher for the switchback population. Pharmacy costs similarly tended to be higher for patients who had a switchback, with the exception of sildenafil for pulmonary arterial hypertension and sirolimus. Conclusion: Patients receiving a brand medication are likely to be switched to a generic upon market availability. Some patients switch back to the brand medication, usually within 1-3 months; this may be associated with increased medical costs. Additional research is needed to understand switching, its potential disruption to patients, and the role of brands, generics, and AGs.

Real-World Clinical and Economic Outcomes Associated with Surgiflo® vs Floseal in Cardiovascular Surgeries in the US.

Background: Topical hemostatic agents are an option for controlling bleeding during cardiovascular surgery. Previous studies comparing topical hemostatic agents in cardiovascular surgery predate the 2012 reformulation of Surgiflo®, which had been re-engineered to increase paste viscosity and thus be more adherent to the bleeding surface. Objective: To compare clinical and economic outcomes in patients receiving the current formulation of Surgiflo vs Floseal during cardiovascular surgeries. Methodology: A retrospective analysis was conducted using the Premier Healthcare Database. Eligible patients had an inpatient cardiovascular surgery between 1/1/2013 and 6/1/2018, were ≥18 years old and received the current formulation of Surgiflo or Floseal during surgery. Propensity score matching was performed, with exact matching on the surgery year and surgery type (aortic, coronary artery bypass grafting, valve, or other). Descriptive analysis and generalized estimating equations models compared outcomes between the Surgiflo and Floseal groups. Results: The matched sample included 5768 patients in each group (mean age: 66.5 years; 66.3% male). In the matched sample, rates of any documented bleeding event were similar in Surgiflo and Floseal groups (6.9% vs 7.2%; P = 0.576). Differences in transfusion rates between patients receiving Surgiflo vs Floseal varied by operational definition and timing of measurement but did not differ by >2 percentage points. Compared to Floseal, patients who received Surgiflo experienced longer surgery duration (306.0 vs 299.4 minutes), lower hospitalization cost ($44,146 vs $46,812), and lower odds of readmission at 30, 60, and 90 days post-discharge (all P < 0.05). Inpatient mortality and LOS were comparable between Surgiflo and Floseal (all P > 0.05). Conclusion: In this large study of real-world clinical and economic outcomes after cardiovascular surgery involving the current formulation of Surgiflo vs Floseal, Surgiflo was associated with mostly similar clinical outcomes as compared with Floseal. Differences in selected economic/resource use outcomes were also observed, for which root-cause analysis in future research would be informative.

Cost impact of hydroxocobalamin in the treatment of patients with known or suspected cyanide poisoning due to smoke inhalation from closed-space fires.

BACKGROUND & OBJECTIVES: Cyanide poisoning can occur due to exposure to smoke in closed-space fires. With no point of care cyanide test at the scene of a fire, first responders and clinicians base decisions to treat with cyanide antidote on patient history, clinical signs, and other indirect data points that have not been proven to correspond with actual systemic levels of cyanide. The aim of this exploratory study was to determine the economic implications of treating patients with known or suspected cyanide poisoning due to smoke inhalation with hydroxocobalamin. METHODS: A decision analysis model was developed from the US hospital perspective. Healthcare resource utilization was estimated from a retrospective evaluation of clinical outcomes in hydroxocobalamin-treated patients and in historical controls without hydroxocobalamin use (Nguyen, et al. 2017). Epidemiologic parameters and costs were estimated from the published literature, and publicly-available hospital charges were identified. Outcomes reported in the analysis included expected healthcare resource utilization in the US population and per-patient costs with and without the use of hydroxocobalamin. A cost-to-charge ratio was applied so that all costs would reflect hospital costs rather than hospital charges. Deterministic sensitivity analysis was performed to identify the most influential model parameters. All costs were reported in 2017 US dollars. RESULTS: Use of hydroxocobalamin reduces healthcare resource utilization and contributes to decreased per-patient hospital costs ($15,381 with hydroxocobalamin treatment versus $22,607 with no cyanide antidote). The most substantive cost-savings resulted from decreased hospital length of stay (i.e., intensive care unit [ICU] and non-ICU). Costs attributed to mechanical ventilation also decreased with use of hydroxocobalamin. A univariate sensitivity analysis demonstrated that the most impactful variables in the cost analysis were related to hospital length of stay (ICU followed by non-ICU stay), followed by the daily cost of ICU stay. CONCLUSIONS: Use of hydroxocobalamin in patients with known or suspected cyanide poisoning from closed-space fire smoke inhalation may decrease hospital costs and contribute to more efficient healthcare resource utilization.

Facial Nerve Palsy with Total Ophthalmoplegia; a Novel Presentation of Fungal Invasion.

Mucormycosis is an expeditious invasion of a fungus of angioinvasive nature, predominant in immunocompromised individuals, often leading to organ malfunction and loss. Facial nerve involvement and total ophthalmoplegia are its rare presentations. Early detection and treatment can alter natural disease course and prevent potential catastrophic outcomes in diabetic patients. Facial nerve palsy is mostly attributed to peripheral neuropathy in patients with advanced diabetes mellitus. It rarely raises alarm about an invasive fungal infection. Here, we report the case of a 38-year-old male with type 2 diabetes mellitus, who presented to us with left lower motor neuron type facial palsy and left-sided total ophthalmoplegia due to invasive rhino-orbito-cerebral mucormycosis (ROCM). Despite aggressive measures, including antifungal therapy and repeated endoscopic debridement, he subsequently developed central retinal artery occlusion (CRAO) and underwent left eye exenteration.

Results from a cross-sectional, observational study to assess inadequate pain relief in patients with knee and/or hip osteoarthritis in Mexico / Resultados de un estudio transversal y observacional para valorar el alivio inadecuado del dolor en pacientes de osteoartritis de rodilla y/o cadera en México

Introduction and objectives: There is limited data that characterizes osteoarthritis (OA) patients who experience moderate to severe pain despite analgesic treatment in Mexico. In this study, we estimate the real-world prevalence of inadequate pain relief (IPR) among individuals with knee and/or hip OA who have been prescribed analgesic therapy and characterize this patient population for each country separately. Materials and methods:This is a multinational, multi-site, cross-sectional, observational study. Participating physicians enrolled patients over 50 years of age with diagnosed knee and/or hip OA who had been prescribed topical and/or oral pain medication for at least 30 days prior to study visit, extracted data from their medical charts, and collected patient data using established questionnaires. Results: 301 patients treated by 35 physicians in Mexico were enrolled in the study. More than half of the patients (53%) met the definition of IPR. Patients with IPR were significantly older (66.8 vs. 63.5 years, p=0.002) and were more likely to be obese (24.2% vs. 11.9%, p=0.006). Patients in the IPR group were more likely to report moderate/severe problems across all 5 dimensions of the EQ-5D and reported higher scores, indicating worse outcomes, on all three WOMAC subscales. Patients in the IPR group also reported reduced work productivity and greater treatment dissatisfaction compared to patients without IPR. Discussion and conclusions: IPR is highly prevalent among individuals with knee and/or hip OA in Mexico. Patients with IPR experience decreased health-related quality of life HRQoL and work productivity, impaired function, and poor treatment satisfaction. Health care professionals need to be aware of the high prevalence of IPR, work toward improving OA patient management, and facilitate early intervention or changes in drug and other treatment modalities.(AU)

Introducción y objetivos: Existen datos limitados que caractericen a los pacientes de osteoartritis (OA) que experimentan dolor de moderado a severo a pesar del tratamiento analgésico en México. En este estudio calculamos la prevalencia en el mundo real del alivio inadecuado del dolor (AID) entre individuos con OA de rodilla y/o cadera a quienes se ha prescrito terapia analgésica, y caracterizamos a esta población de pacientes por país, de manera separada. Materiales y métodos: Este estudio es multinacional, multicéntrico, transversal y observacional. Los médicos participantes reclutaron a pacientes mayores de 50años, con diagnóstico de OA de rodilla y/o cadera, a quienes se había prescrito medicación analgésica tópica y/u oral durante al menos 30días previos a la visita del estudio. Dichos facultativos extrajeron datos de sus cuadros médicos y recopilaron los datos de los pacientes utilizando cuestionarios establecidos. Resultados: Se incluyó en el estudio a 301 pacientes tratados por 35 facultativos en México. Más de la mitad de los pacientes (53%) cumplió la definición de AID. Los pacientes con AID eran significativamente mayores (66,8 vs. 63,5años, p=0,002) y con mayor probabilidad de ser obesos (24,2% vs. 11,9%, p=0,006). Los pacientes del grupo AID tenían mayor probabilidad de reportar problemas moderados/severos en las 5 dimensiones de EQ-5D, y reportaron puntuaciones más altas, lo cual es indicativo de peores resultados, en las tres subescalas de WOMAC. Los pacientes del grupo AID reportaron también una reducción de la productividad laboral y mayor insatisfacción con el tratamiento, en comparación con los pacientes sin AID. Discusión y conclusiones: El AID es altamente prevalente entre los individuos con OA de rodilla y/o cadera en México. Los pacientes con AID experimentan una disminución de la calidad de vida relacionada con la salud (HRQoL) y la productividad laboral, deterioro funcional y mala satisfacción con el tratamiento.(AU)

Results from a cross-sectional, observational study to assess inadequate pain relief in patients with knee and/or hip osteoarthritis in Mexico.

INTRODUCTION AND OBJECTIVES: There is limited data that characterizes osteoarthritis (OA) patients who experience moderate to severe pain despite analgesic treatment in Mexico. In this study, we estimate the real-world prevalence of inadequate pain relief (IPR) among individuals with knee and/or hip OA who have been prescribed analgesic therapy and characterize this patient population for each country separately. MATERIALS AND METHODS: This is a multinational, multi-site, cross-sectional, observational study. Participating physicians enrolled patients over 50 years of age with diagnosed knee and/or hip OA who had been prescribed topical and/or oral pain medication for at least 30 days prior to study visit, extracted data from their medical charts, and collected patient data using established questionnaires. RESULTS: 301 patients treated by 35 physicians in Mexico were enrolled in the study. More than half of the patients (53%) met the definition of IPR. Patients with IPR were significantly older (66.8 vs. 63.5 years, p=0.002) and were more likely to be obese (24.2% vs. 11.9%, p=0.006). Patients in the IPR group were more likely to report moderate/severe problems across all 5 dimensions of the EQ-5D and reported higher scores, indicating worse outcomes, on all three WOMAC subscales. Patients in the IPR group also reported reduced work productivity and greater treatment dissatisfaction compared to patients without IPR. DISCUSSION AND CONCLUSIONS: IPR is highly prevalent among individuals with knee and/or hip OA in Mexico. Patients with IPR experience decreased health-related quality of life HRQoL and work productivity, impaired function, and poor treatment satisfaction. Health care professionals need to be aware of the high prevalence of IPR, work toward improving OA patient management, and facilitate early intervention or changes in drug and other treatment modalities.

Copper and Zinc Status in Psoriasis: Correlation with Severity.

Psoriasis is a common and an inflammatory skin disease. Trace elements play an important role in the skin metabolism such as keratinisation and melanin formation as well as immunological and inflammatory reactions. Henceforth, the present study was aimed to evaluate the essential metals with special reference to Cu and Zn. In this study, 72 psoriatic patients and 50 controls were enrolled. On the basis of PASI score psoriatic group comprising of 48 mild and 24 severe psoriatic patients were grouped. The serum trace elements analysis in the subjects revealed that serum Cu levels and Cu/Zn ratio was significantly higher in the psoriatic patients as compared to controls. Interestingly, severity of the psoriasis was well correlated with the serum Cu levels. Taking together, all these findings suggest that Cu may be a major culprit in the pathogenesis as well as in the severity of the disease.

Cost-Minimization Analysis of Dexmedetomidine Compared to Other Sedatives for Short-Term Sedation During Mechanical Ventilation in the United States.

PURPOSE: Mechanical ventilation (MV) remains a substantial cost driver in intensive care units (ICU) in the United States (US). Evaluations of standard sedation treatments used to relieve pain and discomfort in this setting have found varying impacts on ICU length of stay. This cost analysis examines both length-of=stay costs and the total cost implications among MV patients receiving common sedative treatments (dexmedetomidine, propofol, or midazolam) in short-term sedation settings (<24 hours). METHODS: A cost-minimization model was conducted from the hospital provider perspective. Clinical outcomes were obtained from published literature and included ICU length of stay, MV duration, prescription of sedatives and pain medication, and the occurrence of adverse events. Outcomes costs were obtained from previously conducted ICU cost studies and Medicare payment fee schedules. All costs were estimated in 2018 US Dollars. RESULTS: The per patient costs associated with dexmedetomidine, propofol, and midazolam were estimated to be $21,115, $27,073, and $27,603, respectively. Dexmedetomidine was associated with a savings of $5958 per patient compared to propofol and a saving of $6487 compared to midazolam. These savings were primarily driven by a reduction in ICU length of stay and the degree of monitoring and management. CONCLUSION: Dexmedetomidine was associated with reduced costs when compared to propofol or midazolam used for short-term sedation during MV in the ICU, suggesting sedative choice can have a potential impact on overall cost per episode.

Is evaluation of non-HDL-C better than calculated LDL-C in CAD patients? MMIMSR experiences.

OBJECTIVE: The present study aimed to establish a better marker for the assessment of coronary artery disease (CAD). METHODS: One hundred patients of CAD (aged 20-60 years) of both sex and patients of hypertension with symptoms of CAD were selected for the study.50 age and sex matched healthy controls were chosen for the present study. Serum total cholesterol, triglycerides and HDL-C were estimated in Simens Dimensions RxL. LDL-C, VLDL-C were calculated by Friedwald Formula while non-HDL-C was calculated by subtracting HDL-C level from total cholesterol level. The comparison of non-HDL-C and friedwald calculated LDL-C was made in terms of independent't' test, serum TG levels (TG ≤ 200 mg/dl and TG > 200 mg/dl) and area under receiver operating characteristic (AUROC) curve. RESULTS & CONCLUSION: The non-HDL-C levels (mean ± S.D) were higher in both test and control groups to that of the levels of friedwald calculated LDL-C. The area under receiver operating characteristic (AUROC) curve was significantly higher for non-HDL-C than for friedwald calculated LDL-C. The predictive value of non-HDL-C and friedwald calculated LDL-C were also compared in group A (serum TG ≤ 200 mg/dl) and group B (serum TG > 200 mg/dl). Non-HDL-C levels showed a significant difference in both the groups while the results were non-significant to that of friedwald calculated LDL. Thus, non-HDL-C is much specific and sensitive parameter for assessment of CAD risk. Moreover, non-HDL-C levels can also be done in non-fasting state with accuracy, thereby, it is patient friendly parameter. Therefore, the authors strongly suggest the incorporation of non-HDL-C in routine lipid profile panel.

Cost-Effectiveness of Early Treatment with Originator Biologics or Their Biosimilars After Methotrexate Failure in Patients with Established Rheumatoid Arthritis.

INTRODUCTION: Evidence supports the clinical benefits of early aggressive biologic treatment in patients with rheumatoid arthritis (RA) who have an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but the cost-effectiveness of early intervention with originator biologics such as tumor necrosis factor inhibitors (TNFis) or their biosimilars has not been well studied. METHODS: We developed a Markov model to estimate lifetime costs and utilities for patients with established RA who do not respond to methotrexate (MTX) therapy. A cost-effectiveness analysis was conducted comparing a standard intervention pathway (addition of originator biologic TNFis to MTX monotherapy at 12 months) and two early intervention pathways (either addition of originator biologic TNFis or addition of biosimilar TNFis to MTX monotherapy at 6 months). RESULTS: Early intervention with an originator biologic TNFi at 6 months was associated with increases in total lifetime costs of £1692 and utilities of 0.10 quality-adjusted life-years (QALYs) per patient compared with standard intervention at 12 months, resulting in an incremental cost-effectiveness ratio (ICER) of £17,335/QALY. Early intervention with a biosimilar TNFi increased costs by £70 and utilities by 0.10 QALYs per patient and was associated with an ICER of £713/QALY. CONCLUSION: Switching from MTX monotherapy to combination therapy with either an originator biologic or biosimilar TNFis at 6 months after csDMARD failure in patients with RA was cost-effective at a threshold of £30,000/QALY. FUNDING: Pfizer Inc.

Sex hormone Profile in Human Immunodeficiency Virus-Infected Men and It's Correlation with CD4 Cell Counts.

BACKGROUND: In human immunodeficiency virus (HIV)-infected men, hypogonadism is the most common endocrinological disorder, and most cases of hypogonadism are secondary. The aim of this study was to find out the hormonal abnormalities in HIV-infected males and it's correlation with CD4 cell counts. MATERIALS AND METHODS: One hundred HIV-infected male patients were evaluated in the Department of Medicine, Postgraduate Institute of Medical Education and Research and Dr. Ram Manohar Lohia Hospital, New Delhi, India, over a period of 12 months from September 2014 to August 2015 using history, physical examination, routine baseline investigations, and CD4 counts. Free testosterone, dehydroepiandrosterone sulfate (DHEAS), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prolactin were measured using an overnight fasting sample. Patients were divided into three groups on the basis of CD4 counts (Group A: CD4 counts ≥350/mm3, Group B: CD4 counts between 200 and 349/mm3, and Group C: CD4 counts <200/mm3). Data were analyzed using Student's t-test, ANOVA test, Chi-square test, and Pearson's test and P ≤ 0.05 was considered statistically significant. RESULTS: In 100 HIV-infected males, overall prevalence of hypogonadism was found to be 66%, and 30%-35% patients had symptoms of hypoandrogenemia. Hypogonadotropic hypogonadism was found in 42% of patients. A significant association (P = 0.027) was found between prevalence of hypogonadism and the level of immunodeficiency with an increase in the prevalence of hypogonadism as CD4 counts decreased. Lower levels of free testosterone and DHEAS were found in cases of severe immunosuppression with a statistically significant correlation with CD4 counts. Correlation of other sex hormones (LH, FSH, and prolactin) with CD4 counts not statistically significant. Mean free testosterone and FSH were found to be significantly higher in patients on antiretroviral therapy (ART) than in those not on ART (P = 0.028 and P = 0.045, respectively), but no specific ART drug or their drug combination was found to have a significant correlation with levels of any sex hormone. CONCLUSION: Hypogonadism (hypogonadotropic hypogonadism) was found to be a common endocrinological disorder in HIV-infected male population, seen more commonly in association with low CD4 counts.

Ezetimibe Use and LDL-C Goal Achievement: A Retrospective Database Analysis of Patients with Clinical Atherosclerotic Cardiovascular Disease or Probable Heterozygous Familial Hypercholesterolemia.

BACKGROUND: Ezetimibe is recommended by clinical practice guidelines as a second-line therapy for lowering low-density lipoprotein cholesterol (LDL-C) levels, but little is known about its use and effectiveness in real-world populations. OBJECTIVE: To understand the real-world impact of adding or switching to ezetimibe on LDL-C goal achievement in patients with clinical atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH). METHODS: Patients aged ≥ 18 years with an LDL-C measurement available between January 1, 2013, and June 30, 2014, were identified using the Inovalon MORE 2 database; this included commercial, health insurance exchange, Medicare Advantage, and managed Medicaid patients. The index date was the date of the first LDL-C measurement. Patients were required to have evidence of clinical ASCVD or probable HeFH based on ICD-9-CM codes and ≥ 1 outpatient pharmacy claim for a statin in the 1-year pre-index period, as well as continuous medical and pharmacy coverage for 1 year pre- and post-index. Patients who added ezetimibe to existing statin therapy or switched to ezetimibe within 90 days post-index LDL-C measurement were identified in order to replicate the typical time a clinician takes to assess the use of ezetimibe. The primary outcome was the proportion of patients who met the LDL-C goal of < 70 mg/dL within the follow-up period. LDL-C goal achievement was evaluated by baseline LDL-C level groupings: < 70 mg/dL, 70-99 mg/dL, 100-129 mg/dL, or ≥ 130 mg/dL; and across 4 patient diagnosis categories: all patients, ASCVD only, probable HeFH only, and ASCVD and probable HeFH. Descriptive analyses were reported. Categorical variables were summarized as the number of and corresponding percentage of patients. Continuous variables were presented as the mean and SD of the number of observations and median and range where appropriate. RESULTS: Of 125,330 patients who met selection criteria, mean age was 70.1 (SD = 9.9) years and mean LDL-C baseline was 90.7 (SD = 34.0) mg/dL. Over one half of patients (70%) were receiving statin therapy. Within the post-index time frame, 1.05% (n = 1,309) of patients added or switched to ezetimibe. Of these, 26% achieved LDL-C goal during the 90-day follow-up (59.5% did not achieve goal and 14.4% did not have a follow-up lab value). Therapeutic targets were reached by 30% of patients with baseline LDL-C levels of 70-99 mg/dL; 14% of those with baseline LDL-C of 100-129 mg/dL; and 7% of those with baseline LDL-C of ≥ 130 mg/dL. Achievement of LDL-C goals also varied by baseline diagnosis category. CONCLUSIONS: The addition of or switch to ezetimibe therapy was associated with a relatively small percentage of LDL-C goal achievement (< 70 mg/dL) in patients with clinical ASCVD and/or HeFH, even among patients with baseline LDL-C between 70 and 99 mg/dL. To provide superior individualized care for patients with hyperlipidemia, there is a potential role for newer therapies in lipid lowering, such as PCSK9 inhibitors, in appropriate high-risk populations. DISCLOSURES: This study was sponsored by Amgen. Menzin, Yu, and Stern are employees of Boston Health Economics, which was contracted by Amgen to perform this study. Aggarwal is a former employee of Boston Health Economics. Boatman, Patel, and Harrison are employees and stockholders of Amgen. Study concept and design were contributed by Menzin, Aggarwal, Harrison, and Patel. Aggarwal, Stern, and Yu collected the data. Data interpretation was performed by Aggarwal, Harrison, Patel, and Boatman. The manuscript was written and revised primarily by Aggarwal, with assistance from the other authors.