The effect of SGLT2 inhibitors,GLP1 agonists,and their sequential combination on cardiometabolic parameters: A randomized,prospective, intervention study

BackgroundPulse wave velocity (PWV) and augmentation index (AIx) are indices used to assess arterial stiffness. We aim to compare the effect of empagliflozin, liraglutide and their sequential combination on arterial stiffness indices in patients with type 2 diabetes (T2D).MethodsThis was a randomized single blind study evaluating the effect of empagliflozin vs liraglutide in adult patients with T2D. Patients were randomized to liraglutide titrated gradually to 1.8 mg or empagliflozin 25 mg in 1:1 ratio. Three months later empagliflozin was added to the liraglutide group, and liraglutide was added to the empagliflozin group. Patients were assessed with non-invasive tests for arterial stiffness (i.e., carotid-femoral PWV and AIx of aortic pressure) at baseline, 3-month and 9-month visits (final visit was extended for 3 months from the initial design due to Covid 19 pandemic). The primary outcome was the between-group difference of PWV change (ΔPWV) and ΔAIx at 3 months. Secondary outcomes included the between-group difference of ΔPWV and ΔAIx at 9 months, as well as the ΔPWV and ΔAIx between baseline and 9-month visit when total study population was assessed.ResultsA total of 62 patients with T2D (30 started liraglutide; 32 empagliflozin, mean age 63 years, 25 % with established cardiovascular disease) participated in the study. We failed to show any significant between-group differences of ΔPWV and ΔΑΙx at 3 and 9 months, as well as between-group difference of ΔPWV and ΔAIx for the total study population between baseline and 9-month visit. In contrast, systemic vascular resistance and lipoprotein(a) levels improved, showing better results with liraglutide than empagliflozin. Favorable effects were also observed on body weight, body mass index, body and visceral fat, blood pressure, HbA1c, and uric acid levels.ConclusionNo evidence of a favorable change in arterial stiffness indices was seen with empagliflozin or liraglutide or their combination in this study. Well-designed powerful studies are needed to address any potential effects on arterial stiffness in selected populations.     

Patient-Reported Outcomes During and After Hepatitis C Virus Direct-Acting Antiviral Treatment Among People Who Inject Drugs

ObjectivesPeople who inject drugs (PWID) are at a high risk of hepatitis C virus (HCV) infection. HCV cure is associated with improved patient-reported outcomes (PROs), but there are little data among PWID. This study aimed to assess the change in PROs during and after HCV direct-acting antiviral (DAA) treatment.MethodsThis analysis used data from 2 clinical trials of DAA treatment in PWID. PROs assessed included health-related quality of life, social functioning, psychological distress, housing, and employment. Generalized estimating equations and group-based trajectory modeling were used to assess changes in PROs over time.ResultsNo significant changes in the 3-level version of EQ-5D scores, EQ visual analogue scale scores, social functioning, psychological distress, and housing were observed over the 108-week study period. There was a significant increase in the proportion of participants employed (18% [95% confidence interval (CI) 12%-23%] at baseline to 28% [95% CI 19%-36%] at the end of the study). Participants were more likely to be employed at 24 weeks and 108 weeks after commencing treatment. Having stable housing increased the odds of being employed (odds ratio 1.70; 95% CI 1.00-2.90). The group-based trajectory modeling demonstrated that most outcomes remained stable during and after DAA treatment.ConclusionsAlthough no significant improvement was identified in health-related quality of life after HCV DAA treatment, there was a modest but significant increase in employment during study follow-up. The study findings support the need for multifaceted models of HCV care for PWID addressing a range of issues beyond HCV treatment to improve quality of life.     

Grading Evidence to Support Legislative and Budget Proposals—Veterans Health Administration’s Key to Implementing the Evidence Act

ObjectivesThe Foundations for Evidence-Based Policymaking Act of 2018 requires cabinet-level agencies to use evidence to justify and support budget and policy making. As investigators from the Quality Enhancement Research Initiative (QUERI) program, we were tasked with assisting Veterans Health Administration (VHA) leadership with the implementation of the Evidence-Based Policymaking Act of 2018. Through meetings with stakeholders, we identified a gap in the review process for legislative and budget proposals; no systematic process existed to evaluate the supporting evidence base for proposals.MethodsHere, we describe the development, refinement, and use of a checklist to assess the strength of evidence included in VHA legislative and budget proposals for changes to care delivery; clinical, research, and administrative operations; and staffing and workforce issues.ResultsThe evidence assessment checklist is now part of the regular review process for VHA legislative and budget proposals. It is also being adapted for use elsewhere within the Department of Veterans Affairs. The checklist has provided a framework for briefings and training on best practices for using evidence to guide policy and budget decisions.ConclusionIncluding evidence reviews in the legislative and budget proposal prioritization process may be an effective institutional arrangement to promote the use of evidence to inform high-level health policy decisions and to build a “culture of evidence” within the government.