Research Spotlight

Böhm, M., S. D. Anker, J. Butler, G. Filippatos, J. P. Ferreira, S. J. Pocock, F. Mahfoud, M. Brueckmann, W. Jamal, A. P. Ofstad, E. Schüler, P. Ponikowski, C. Wanner, F. Zannad and M. Packer (2021). “Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure.” J Am Coll Cardiol 78(13): 1337-1348.

Full text of this article.

BACKGROUND: Empagliflozin reduces the risk of cardiovascular death or heart failure (HF) hospitalization in patients with reduced ejection fraction. Its interplay with systolic blood pressure (SBP) is not known. OBJECTIVES: The goal of this study was to evaluate the interplay of SBP and the effects of empagliflozin in EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction). METHODS: Study patients (N = 3,730) were randomly assigned to groups according to SBP at baseline (<110 mm Hg, n = 928; 110-130 mm Hg, n = 1,755; >130 mm Hg, n = 1,047). This study explored the influence of SBP on the effects of empagliflozin on cardiovascular death or HF hospitalization (primary outcome), as well as on total HF hospitalizations, rate of decline in estimated glomerular filtration rate, renal outcomes, and empagliflozin’s effects and significance on SBP. RESULTS: Over a median of 16 months considering only patients receiving placebo, baseline SBP and the risk of cardiovascular death or hospitalization for HF (P trend = 0.0015) were inversely related. Corrected for placebo, a slight early increase was observed in SBP at <110 mm Hg, no change at 110-130 mm Hg, and a slight reduction at >130 mm Hg. These between-group differences were of borderline significance (P for interaction trend = 0.05-0.10) after 4 and 12 weeks but were not significant later. SBP at baseline did not influence the effect of empagliflozin to reduce the risk of HF events or renal endpoints. When treated with empagliflozin, patients with SBP <110 mm Hg did not have an increased rate of symptomatic hypotension. CONCLUSIONS: Empagliflozin was effective and safe, with no meaningful interaction between SBP and the effects of empagliflozin in the EMPEROR-Reduced trial. (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977).

Mutnal, M. B., S. Johnson, N. Mohamed, R. Abddelgader, L. Morales, M. Volz, K. Walker, A. C. Arroliga and A. Rao (2021). “Surveillance genome sequencing reveals multiple SARS-CoV-2 variants circulating in central Texas, USA, with a predominance of delta variant and review of vaccine breakthrough cases.” J Med Virol.

Full text of this article.

As surges in the COVID-19 pandemic have continued worldwide, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has mutated, spawning several new variants, and impacting, to various degrees, transmission, disease severity, diagnostics, therapeutics, and natural and vaccine-induced immunity. Baylor Scott & White Health has implemented, along with laboratory diagnosis, SARS-CoV-2 sequencing to identify variants in its geographical service area. We analyzed virus sequencing results of specimens collected across Central Texas and found dramatic changes in variant distribution in the first half of 2021. The alpha variant (B 1.1.7) became predominant at week 13 and continued dominance until week 25. A growth rate of 1.20 (R(2)  = 0.92) for the first 15 weeks was noted and this growth gradually declined to -0.55 (R(2)  = 0.99) for the final 13 weeks. Currently, B.1.1.7 is being displaced with B.1.617.2 at a 0.58 growth rate (R(2)  = 0.97). We also investigated vaccine breakthrough cases (VBCs) within our healthcare system and present clinical data on 28 symptomatic patients.

DuBose, J. J., C. C. Burlew, B. Joseph, M. Keville, M. Harfouche, J. Morrison, C. J. Fox, J. Mooney, R. O’Toole, G. Slobogean, L. S. Marchand, D. Demetriades, N. L. Werner, E. Benjamin and T. Costantini (2021). “Pelvic fracture-related hypotension: A review of contemporary adjuncts for hemorrhage control.” J Trauma Acute Care Surg 91(4): e93-e103.

Full text of this article.

ABSTRACT: Major pelvic hemorrhage remains a considerable challenge of modern trauma care associated with mortality in over a third of patients. Efforts to improve outcomes demand continued research into the optimal employment of both traditional and newer hemostatic adjuncts across the full spectrum of emergent care environments. The purpose of this review is to provide a concise description of the rationale for and effective use of currently available adjuncts for the control of pelvic hemorrhage. In addition, the challenges of defining the optimal order and algorithm for employment of these adjuncts will be outlined. LEVEL OF EVIDENCE: Review, level IV.

Crabtree, M. A., W. J. Hale, E. C. Meyer, N. A. Kimbrel, B. B. DeBeer, S. B. Gulliver and S. B. Morissette (2021). “Dynamics of risk: Recent changes in psychological inflexibility precede subsequent changes in returning US veterans’ posttraumatic stress.” J Clin Psychol.

Full text of this article.

OBJECTIVES: As a malleable risk-factor, psychological inflexibility is implicated in the development and maintenance of posttraumatic stress symptoms (PTS). Unfortunately, limited research has addressed whether changes in psychological inflexibility are antecedent to changes in PTS severity over time, or whether such changes are mutually dependent. METHODS: Utilizing bivariate latent difference score modeling, this longitudinal study sequenced intraindividual changes in psychological inflexibility and PTS severity within a sample of 305 returning US veterans. Veterans’ self-reported psychological inflexibility and PTS severity were assessed quarterly over 1 year. RESULTS: Results indicated that early reductions in psychological inflexibility potentiated later declines in veterans’ PTS severity, accounting for veterans’ prior levels of psychological inflexibility and PTS severity. CONCLUSIONS: These findings underscore the unique role of changes in psychological inflexibility as an important mechanism of change in PTS severity and provide empirical support for an antecedent model of the role of psychological inflexibility in PTS recovery.

Strober, B., D. Pariser, A. Deren-Lewis, T. J. Dickerson, M. Lebwohl and A. Menter (2021). “A Survey of Community Dermatologists Reveals the Unnecessary Impact of Trial-and-Error Behavior on the Psoriasis Biologic Treatment Paradigm.” Dermatol Ther (Heidelb) 11(5): 1851-1860.

Full text of this article.

INTRODUCTION: In the USA, psoriasis affects approximately 3% of the population and costs more than $110 billion annually. The development of targeted biologics has revolutionized psoriasis management, but at an increasing cost. According to Joint AAD/NPF guidelines, an important need exists to identify biomarkers that can predict the appropriate biologic agent for patients. METHODS: A survey of community dermatologists was developed to address (1) significant factors influencing biologic therapy utilization in psoriasis; (2) the clinical utility of a test stratifying biologic response. RESULTS: Respondents confirmed that trial and error leads to frequent biologic switching. The survey indicated that 82% of dermatologists switch 10-30% of their patients in the first year and 98% switch intra-class for at least 50% of non-responding patients. The trial and error is due, in part, to formularies influencing the physician 77% of the time, with only 14% reporting that their first choice and the formulary alignment is greater than 75%. Compounding trial and error, 93% of the physicians report that they wait at least 12 weeks before determining non-response, in alignment with AAD/NPF guidelines. The lack of precision medicine and this trial-and-error approach result in unnecessary wasted spending and suboptimal patient outcomes. After being given an overview of Mind.Px, a dermal biomarker patch used to predict therapeutic response to a biologic class, survey participants expressed that: 93% would utilize Mind.Px results to determine first-line therapy even if this differed from initial clinical choice 100% would utilize Mind.Px if part of the prior authorization process 98% say Mind.Px would improve patient outcomes 81% reported Mind.Px would help with prior authorization process CONCLUSIONS: Surveyed dermatologists believe a test that predicts psoriasis treatment response to a class of biologic drugs would lessen trial and error, provide a tool for physicians to make more informed decisions about drug selection, improve patient outcomes, and significantly reduce wasted spending.