Research Spotlight

Defayette, A., A. Perrello, T. Brewer, J. Picano and S. Ahmed (2020). “Enteral baclofen withdrawal managed with intravenous dexmedetomidine: A case report.” Am J Health Syst Pharm 77(5): 352-355.

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PURPOSE: Acute enteral baclofen withdrawal can be clinically severe if not identified and managed appropriately. Treatment of baclofen withdrawal includes supportive care and reinitiation of baclofen. There are limited pharmacotherapeutic interventions available to manage symptoms of acute enteral baclofen withdrawal, especially in nonintubated patients. SUMMARY: We describe a 61-year-old Caucasian male with a past medical history of chronic back pain and spinal stenosis who was admitted to the medical intensive care unit with confusion, insomnia, agitation, delirium, and auditory and visual hallucinations. For control of agitation, the patient was administered 10 mg of i.v. haloperidol, 1 mg of i.v. lorazepam, and 14 mg of i.v. midazolam, with minimal improvement noted; therefore, dexmedetomidine was initiated, which led to clinical resolution of his symptoms. Upon further investigation it was determined that the patient was taking approximately 10 baclofen 20-mg tablets a day. According to his pharmacy records, he had filled prescriptions for a total of 738 baclofen tablets in the previous 12 weeks. The patient’s presentation and sudden discontinuation of high-dose baclofen led to a diagnosis of baclofen withdrawal. Baclofen was subsequently restarted, and dexmedetomidine was weaned over 36 hours. CONCLUSION: Dexmedetomidine controlled this patient’s agitation and delirium without suppressing his respiratory drive and should be considered for management of acute enteral baclofen withdrawal.

Cork, D. P., P. A. McCullough, H. S. Mehta, C. M. Barker, J. Van Houten, C. Gunnarsson, M. P. Ryan, E. R. Baker, S. Mollenkopf and P. Verta (2020). “The economic impact of clinically significant tricuspid regurgitation in a large, administrative claims database.” J Med Econ Mar 2. [Epub ahead of print].

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Aim: This study aimed to quantify the healthcare burden of clinically significant tricuspid regurgitation (TR) in patients with and without heart failure (HF).Materials and Methods: Data were from the IBM MarketScan Research Databases from October 2011 to September 2016. Eligible patients met the following inclusion criteria: age >/=18 with a TR diagnosis, 12 months pre (baseline), and 6 months post (landmark) medical enrollment. The landmark period was used to categorize TR severity, defined as a record of pulmonary hypertension with ascites, lower extremity edema or hepatic insufficiency, or tricuspid valve surgery. Cohorts were defined based on TR etiology and severity: (1) no HF and no clinically significant TR; (2) HF with no clinically significant TR; (3) no HF with clinically significant TR; and (4) HF with clinically significant TR. Outcomes of interest were all-cause hospitalizations, hospital days, and expenditures. Multivariable models were fit for each of the annualized outcomes and adjusted for patient demographics, comorbidities, and other concomitant valve diseases.Results: There were 92,994 patients eligible for analysis. Patients with no HF and no clinically significant TR had the annualized healthcare burden of 0.20 all-cause hospitalizations (approximately one inpatient hospitalization every 5 years), 1.07 hospital days, and $17,478 in expenditures. The presence of clinically significant TR, alone or with HF, significantly increased healthcare utilization and expenditures. For patients with no HF with clinically significant TR, the annualized economic burden increased to 0.41 all-cause hospitalizations, 3.13 hospital days, and $29,985 in expenditures. For patients with HF and clinically significant TR, the annualized economic burden was even greater with 0.59 all-cause hospitalizations, 4.31 hospital days, and $42,255 in expenditures.Conclusion: The presence of clinically significant TR is associated with an increase in healthcare utilization and expenditures, irrespective of the presence of HF.

Cook, J. M., J. E. Zeber, V. Simiola, R. Rossom, J. F. Scherrer, A. A. Owen-Smith, B. K. Ahmedani, K. Zolfaghari and L. A. Copeland (2020). “Comparisons Between Patients Diagnosed with PTSD in Primary Care Versus Mental Health Care in Five Large Civilian Health Care Systems.” J Clin Psychol Med Settings Feb 11. [Epub ahead of print].

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Posttraumatic stress disorder (PTSD) is a serious mental health disorder that may not be adequately detected or treated in primary care (PC). The purpose of this study was to compare the clinical characteristics and health care utilization of PTSD patients diagnosed in PC versus in specialty mental health care (MHC) across five large, civilian, not-for-profit healthcare systems. Electronic claims and medical record data on patients treated during 2014 were analyzed. Treatment was considered in terms of initiation and dose (i.e., psychotherapy sessions; pharmacotherapy-prescription psychotropics). Of 5256 patients aged 15-88 with a diagnosis of PTSD, 84.4% were diagnosed by a MHC provider. Patients diagnosed by MHC providers had 4 times the rate of and more enduring psychotherapy than those diagnosed by PC providers. Receipt of psychotropics varied by provider type, with generally higher prescription fill levels for patients in MHC. Strategies to better align patient needs with access and treatment modality in PC settings are needed.

Cobleigh, M., D. A. Yardley, A. M. Brufsky, H. S. Rugo, S. M. Swain, P. A. Kaufman, D. Tripathy, S. A. Hurvitz, J. O’Shaughnessy, G. Mason, V. Antao, H. Li, L. Chu and M. Jahanzeb (2020). “Baseline Characteristics, Treatment Patterns, and Outcomes in Patients with HER2-Positive Metastatic Breast Cancer by Hormone Receptor Status from SystHERs.” Clin Cancer Res 26(5): 1105-1113.

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PURPOSE: We report treatments and outcomes in a contemporary patient population with HER2-positive metastatic breast cancer (MBC) by hormone receptor (HR) status from the Systemic Therapies for HER2-positive Metastatic Breast Cancer Study (SystHERs). EXPERIMENTAL DESIGN: SystHERs (NCT01615068) was an observational, prospective registry study of U.S.-based patients with newly diagnosed HER2-positive MBC. Endpoints included treatment patterns and clinical outcomes. RESULTS: Of 977 eligible patients (enrolled from 2012 to 2016), 70.1% (n = 685) had HR-positive and 29.9% (n = 292) had HR-negative disease. Overall, 59.1% (405/685) of patients with HR-positive disease received any first-line endocrine therapy (with or without HER2-targeted therapy or chemotherapy); 34.9% (239/685) received HER2-targeted therapy + chemotherapy + sequential endocrine therapy. Patients with HR-positive versus HR-negative disease had longer median overall survival (OS; 53.0 vs 43.4 months; hazard ratio, 0.70; 95% confidence interval, 0.56-0.87). Compared with patients with high HR-positive staining (10%-100%, n = 550), those with low HR-positive staining (1%-9%, n = 60) received endocrine therapy less commonly (64.2% vs 33.3%) and had shorter median OS (53.8 vs 40.1 months). Similar median OS (43.4 vs 40.1 months) was observed in patients with HR-negative versus low HR-positive tumors (1%-9%). CONCLUSIONS: Despite evidence that first-line HER2-targeted therapy, chemotherapy, and sequential endocrine therapy improves survival in patients with HR-positive, HER2-positive disease, only 34.9% of patients in this real-world setting received such treatment. Patients with low tumor HR positivity (1%-9%) had lower endocrine therapy use and worse survival than those with high tumor HR positivity (10%-100%).

Chiruvolu, A., A. Medders and Y. Daoud (2020). “Effects of Umbilical Cord Milking on Term Infants Delivered by Cesarean Section.” Am J Perinatol Feb 18. [Epub ahead of print].

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OBJECTIVE: Umbilical cord milking (UCM) is an efficient way to achieve optimal placental transfusion in term infants born by cesarean section (CS). However, it is not frequently performed due to concern for short-term adverse effects of increased blood volume, such as polycythemia and hyperbilirubinemia. The aim of this study is to evaluate the short-term effects of UCM on term infants delivered by CS. STUDY DESIGN: We conducted a pre- and postimplementation cohort study comparing term infants delivered by CS who received UCM five times (141 infants, UCM group) during a 6-month period (August 1, 2017 to January 31, 2018) to those who received immediate cord clamping (ICC) during the same time period (105 infants, postimplementation ICC) and during a 3-month period (October1, 2016 to December 31, 2016) prior to the implementation of UCM (141 infants, preimplementation ICC). RESULTS: Mothers were older in UCM group compared with both ICC groups. There were no significant differences in other maternal or neonatal characteristics. Although this study was not powered to detect differences in outcomes, the occurrence of hyperbilirubinemia needing phototherapy, symptomatic polycythemia, NICU admissions, or readmissions for phototherapy was similar between the groups. CONCLUSION: UCM intervention was not associated with increased incidence of phototherapy or symptomatic polycythemia in term infants delivered by CS.