Acute kidney injury, renal impairment and renal failure associated with sodium glucose co-transporter-2 inhibitors in at-risk groups: A systematic review.

Randomized controlled trials (RCTs) show a reduction in acute kidney injury, renal impairment and acute renal failure after initiation of a sodium glucose cotransporter-2 inhibitor. Observational literature on the association is conflicting, but important to understand for populations with a higher risk of medication-related adverse renal events. We aimed to systematically review the literature to summarize the association between sodium glucose cotransporter-2 inhibitor use and acute kidney injury, renal impairment and acute renal failure in three at-risk groups: older people aged >65 years, people with heart failure and people with reduced renal function. A systematic search of Embase (1974 until 23 February 2024) and PubMed (1946 until 23 February 2024) was performed. RCTs were included if they reported numbers of acute kidney injury or acute renal failure in people using sodium glucose cotransporter-2 inhibitors compared to other diabetic therapies. Studies needed to report results by level of renal function, heart failure status or age. Of 922 results, eight studies were included. The absolute risk of acute kidney injury or acute renal failure was higher in people >65 years compared to those <65 years, higher in people with heart failure (vs without) and higher in people with reduced kidney function (vs preserved kidney function), but insufficient evidence to determine if the relative effect of sodium glucose cotransporter-2 inhibitors on this risk was similar for each group. At-risk cohorts are associated with a higher incidence of acute kidney problems in users of sodium glucose cotransporter-2 inhibitors.

Clinical outcome measures in the assessment of impact of pharmacists in cardiology ambulatory care: A systematic review.

AIMS: Pharmacists are involved in the care of patients with cardiac disease within the ambulatory setting across multiple modes of delivery and practice settings. There is a lack of consensus surrounding the assessments used to measure the impact of pharmacist care. This heterogeneity may undermine confidence and limit utilisation of pharmacists in cardiology ambulatory care. A systematic review was conducted to understand how pharmacist interventions in cardiology ambulatory care were assessed and the impacts of these interventions on patient-centred outcomes. METHODS AND RESULTS: A comprehensive search was conducted of MEDLINE, CINAHL Plus, Cochrane Register of Randomised Controlled Trials and EMBASE from 2000 to 2020 with search terms involving pharmacist interventions among cardiology patients in the ambulatory care setting; with studies restricted to randomised controlled trials. Search results were independently screened by two reviewers. The Cochrane Risk of Bias in Randomised Trials tool was used for quality assessment of the included studies. Assessments of pharmacist impact were analysed and compared to established quality indicators of cardiology care. The search produced 3380 individual studies, following screening, 26 studies involving 9013 participants met inclusion criteria. Across the 26 included studies, eleven different intervention types were identified. Four main outcome measures assessing the impact of these interventions were identified: direct measure of cardiovascular disease risk factor, major adverse cardiovascular events, medication adherence, validated risk score for cardiovascular events. There was a high degree of variance in both the way these interventions influenced the outcome as well the outcome measures selected to assess the impact of the intervention. Of the 26 studies, sixteen listed positive impacts on primary outcomes and the remaining 10 listed neutral effects. CONCLUSION: Several outcome measures have been used to assess the impact of pharmacist intervention in cardiology ambulatory care. Aligning outcome measures with known indicators of cardiology care quality, as well as more detailed descriptions of intervention, will provide clinicians vital information in designing effective and measurable interventions in cardiology ambulatory care.

NPS MedicineWise application in supporting medication adherence in chronic heart failure: an acceptability and feasibility pilot study.

Introduction: Heart failure (HF) is an increasing global concern. Despite evidence-based pharmacotherapy, associated morbidity and mortality remain high. This study aimed to assess the acceptability, feasibility, and value of the NPS MedicineWise dose reminder app in a tiered, pharmacist-led intervention to address medication non-adherence in patients with HF. Methods: This prospective, single-blinded, randomised controlled trial recruited 55 patients with HF between September 2019 and October 2020. Participants were randomly assigned to either the intervention or control arms. Intervention participants used the app which prompted medication administration at each dosing interval. Control participants received standard care and remained blinded to the app throughout the study. Treatment non-adherence prompted a tiered, pharmacist-led intervention. Comparison of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS) at baseline and 6-months measured the app's value in supporting medication adherence. Secondary outcome measures included self-reported medication knowledge, health-related quality of life, psychological wellbeing, and signs and symptoms of HF. Data were analysed using standard statistical tests with significance set at α 0.05. Results: Approximately half of respondents reported managing HF and medications better by using the MedicineWise app (Tier 1). Most respondents expressed satisfaction with the in-app messages (Tier 2) and pharmacists' phone calls (Tier 3). The intervention participants demonstrated a significant improvement in the SEAMS between baseline and 6-months follow-up. Discussion: It is feasible and potentially of value to use the MedicineWise app with a tiered, pharmacist-led intervention to support medication adherence in patients with HF. Our findings provide clinicians with "real-world" information on the practicality and potential value of using mobile health to support treatment adherence in patients with HF. Trial registration number: Australian New Zealand Clinical Trials Registry Clinical trial registration number: ACTRN12619000289112p (http://www.ANZCTR.org.au/ACTRN12619000289112p.aspx).

Acceptability and feasibility of the NPS MedicineWise mobile phone application in supporting medication adherence in patients with chronic heart failure: Protocol for a pilot study.

INTRODUCTION: Heart failure (HF) is an increasing global concern. Despite evidence-based pharmacotherapy, morbidity and mortality remain high in HF. Medication non-adherence is a crucial factor in optimising clinical outcomes. A growing number of smartphone applications (apps) assist management. While evidence support their use to promote treatment adherence, apps alone may not be the solution. The objective of this pilot study is to assess the acceptability and feasibility of a tiered intervention added to the NPS MedicineWise dose reminder app (MedicineWise app) in supporting medication adherence in HF. METHODS AND ANALYSIS: This prospective, single-blinded, randomised controlled trial will recruit 55 Australian patients with HF to be randomly assigned to either intervention (MedicineWise app + usual care) or control (usual care alone) arm. Control participants will remain unaware of the intervention throughout the study. At baseline, intervention participants will be instructed in the MedicineWise app. A reminder will then prompt medication administration at each dosing interval. If non-adherence is suggested from 24 hourly reports (critical medications) or 72 hours (non-critical medications), the individual/s will be escalated through a tiered, pharmacist-led intervention. The primary outcome will be the acceptability and feasibility of this approach in supporting adherence. Between-group comparison of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS) at baseline, 3 and 6 months will be used to measure the app's value in supporting adherence. Secondary outcome measures include self-reported medication adherence and knowledge, health-related quality of life, psychological wellbeing, signs and symptoms of HF, and medication and HF knowledge. ETHICS AND DISSEMINATION: The protocol received ethics approval from Central Adelaide Clinical Human Research Ethics Committee (Protocol number R20190302) and University of South Australia Human Research Ethics Committee (Protocol number 202450). Findings will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry Clinical trial number: ACTRN12619000289112p (http://www.ANZCTR.org.au/ACTRN12619000289112p.aspx).

Real-world incidence of patient-reported dyspnoea with ticagrelor.

Dyspnoea, a common and multifactorial symptom in patients with acute coronary syndrome, has been associated with lower quality of life and hospital readmission. Prescriber preference for antiplatelet therapy, the standard of care in this patient group, is shifting to ticagrelor due to mortality benefits demonstrated in trials compared with clopidogrel. In these trials, dyspnoea was more commonly reported in patients prescribed ticagrelor but the aetiology is still debated. An observational cohort study was conducted to quantify the rates and severity of dyspnoea reported in patients with acute coronary syndrome and newly prescribed ticagrelor compared with those prescribed clopidogrel. Dyspnoea was more commonly reported in patients prescribed ticagrelor at each follow up post-discharge (p = 0.016). Rates were higher than previously reported in clinical trials. In some patients, dyspnoea necessitated drug therapy change and was associated with readmission to hospital (p = 0.046). As ticagrelor is widely prescribed as a first-line antiplatelet agent for a range of patients with acute coronary syndrome, the incidence of dyspnoea in a generalized patient cohort may result in higher rates of drug discontinuation. This in turn could lead to higher rates of rehospitalisation and potential treatment failure than that reported from the controlled setting of a clinical trial.