Background: Sodium-glucose cotransporter 2 (SGLT2) 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 to investigate the cardiac effects of empagliflozin in patients in NYHA functional class II to IV with a left ventricular (LV) ejection fraction ≤40% and type 2 diabetes or prediabetes. Patients were randomized 1:1 to empagliflozin 10 milligrams once daily or placebo, stratified by age (<65 and ≥65 years) and glycemic status (diabetes or prediabetes). The co-primary outcomes were change from baseline to 36 weeks in LV end-systolic volume indexed to body surface area (LVESVi) and LV global longitudinal strain (LV GLS) measured using cardiovascular magnetic resonance (CMR). Secondary efficacy outcomes included other CMR measures (LVEDVi, LVEF), diuretic intensification, symptoms (Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)), 6-minute walk distance (6MWD), B-lines on lung ultrasound and biomarkers (including NT-proBNP). Results: From April 2018 to August 2019, 105 patients were randomized: 77 (73.3%) male, mean age 68.7 [SD 11.1] years, 82 (78.1%) diabetes and 23 (21.9%) prediabetes, mean LVEF 32.5% [9.8%], and 81 (77.1%) NYHA II and 24 (22.9%) NYHA III. Patients received standard treatment for HFrEF. Compared with placebo, empagliflozin reduced LVESVi by 6.0 (-10.8 to -1.2) ml/m 2 (p=0.015). There was no difference in LV GLS. Empagliflozin reduced LVEDVi by 8.2 (-13.7 to -2.6) ml/m 2 (p=0.0042) and reduced NT-proBNP by 28 (2 to 47) %, p=0.038. There were no between-group differences in other CMR measures, KCCQ-TSS, 6MWD or B-lines. Conclusions: The SGLT2 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 SGLT2 inhibitors reduce HF hospitalization and mortality in HFrEF. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT03485092.
Glasgow city has the highest cardiovascular disease (CVD) mortality rate in the UK. Patients with left ventricular systolic dysfunction after acute myocardial infarction represent a ‘high-risk’ cohort for adverse CVD outcomes. The optimisation of secondary prevention medication in this group is often suboptimal. Our aim was to improve the use and target dosing of ACE inhibitors (ACEI), angiotensin II receptor blockers (ARBs) and beta-blockers in such patients, through pharmacist-led clinics and cardiology multidisciplinary team collaboration. Retrospective audits characterised baseline care. Prospective pharmacist-led clinics were piloted and rolled out across seven hospitals and primary care localities over four Plan–Do–Study–Act cycles. ‘Hub’ and ‘spoke’ clinics utilised independent prescribing pharmacists with different levels of cardiology experience. Pharmacists were trained through a bespoke training programme—‘Teach and Treat’. Consultant cardiologists provided senior support and governance. Patients attending prospective pharmacist-led clinics were more likely to be prescribed an ACEI (or ARB) and beta-blocker (n=856/885 (97%) vs n=233/255 (91%), p<0.001 and n=813/885 (92%) vs n=224/255 (88%), p=0.048, respectively) and be on target dose of ACEI (or ARB) and beta-blocker (n=585/885 (66%) vs n=64/255 (25%), p<0.001 and n=218/885 (25%) vs n=17/255 (7%), p<0.001, respectively) compared with baseline. The mean dose of ACEI (or ARB) and beta-blocker was also higher (79% vs 48% of target dose, p<0.001% and 48% vs 33% of target dose, p<0.001, respectively) compared with baseline. Use of secondary prevention medication was significantly improved by pharmacist and cardiology collaboration. These improvements were sustained across a 4-year period, supported by a novel approach called ‘Teach and Treat’ which linked training to defined clinical service delivery. Further work is needed to assess the impact of the programme on long-term CVD outcomes.
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.
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