Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF).

BACKGROUND: Sodium-glucose cotransporter 2 inhibitors reduce the risk of heart failure hospitalization and cardiovascular death in patients with heart failure and reduced ejection fraction (HFrEF). However, their effects on cardiac structure and function in HFrEF are uncertain. METHODS: We designed a multicenter, randomized, double-blind, placebo-controlled trial (the SUGAR-DM-HF trial [Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus, or Prediabetes, and Heart Failure]) to investigate the cardiac effects of empagliflozin in patients in New York Heart Association functional class II to IV with a left ventricular (LV) ejection fraction ≤40% and type 2 diabetes or prediabetes. Patients were randomly assigned 1:1 to empagliflozin 10 mg once daily or placebo, stratified by age (<65 and ≥65 years) and glycemic status (diabetes or prediabetes). The coprimary outcomes were change from baseline to 36 weeks in LV end-systolic volume indexed to body surface area and LV global longitudinal strain both measured using cardiovascular magnetic resonance. Secondary efficacy outcomes included other cardiovascular magnetic resonance measures (LV end-diastolic volume index, LV ejection fraction), diuretic intensification, symptoms (Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, B-lines on lung ultrasound, and biomarkers (including N-terminal pro-B-type natriuretic peptide). RESULTS: From April 2018 to August 2019, 105 patients were randomly assigned: mean age 68.7 (SD, 11.1) years, 77 (73.3%) male, 82 (78.1%) diabetes and 23 (21.9%) prediabetes, mean LV ejection fraction 32.5% (9.8%), and 81 (77.1%) New York Heart Association II and 24 (22.9%) New York Heart Association III. Patients received standard treatment for HFrEF. In comparison with placebo, empagliflozin reduced LV end-systolic volume index by 6.0 (95% CI, -10.8 to -1.2) mL/m2 (P=0.015). There was no difference in LV global longitudinal strain. Empagliflozin reduced LV end-diastolic volume index by 8.2 (95% CI, -13.7 to -2.6) mL/m2 (P=0.0042) and reduced N-terminal pro-B-type natriuretic peptide by 28% (2%-47%), P=0.038. There were no between-group differences in other cardiovascular magnetic resonance measures, diuretic intensification, Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, or B-lines. CONCLUSIONS: The sodium-glucose cotransporter 2 inhibitor empagliflozin reduced LV volumes in patients with HFrEF and type 2 diabetes or prediabetes. Favorable reverse LV remodeling may be a mechanism by which sodium-glucose cotransporter 2 inhibitors reduce heart failure hospitalization and mortality in HFrEF. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03485092.

Patient experiences of pharmacist independent prescriber-led post-myocardial infarction left ventricular systolic dysfunction clinics.

OBJECTIVES: Left ventricular systolic dysfunction (LVSD) is common following myocardial infarction (MI). Pharmacological management of secondary prevention is known to be sub-optimal. Integration of pharmacists into clinical teams improves prescribing and quantitative outcomes. Few data have been published on patient views of pharmacist input. We aimed to explore patient experiences of attending a dedicated pharmacist independent prescriber (PIP)-led clinic. METHODS: Semi-structured face-to-face interviews. Participants were aged ≥18 years with new incident MI and echocardiographically confirmed LVSD. Patients were recruited from three pharmacist-led clinics at point of clinic discharge. Interviews were transcribed verbatim. Thematic analysis was undertaken. KEY FINDINGS: Twelve patients were recruited, median age 67.5 years and ten male. Six core themes were identified: multidisciplinary working; satisfaction; confidence in the pharmacist; comparative care; prescribing behaviours; and monitoring. Pharmacist clinics complemented other established post-MI services, and participants perceived benefits obtained through effective inter-professional working. Participants welcomed dedicated appointment time, the opportunity to ask questions and address problems. Pharmacist explanations of condition and medicines, prescribing at the point of care and monitoring were beneficial and reduced patient stress. CONCLUSIONS: This study demonstrates that a PIP-led post-MI LVSD clinic delivers a positive initial patient experience. More research is needed to understand the longer-term patient experiences, the impact of such models on medication taking behaviours and the experiences of carers and other members of the multidisciplinary team.