A real-world analysis of outcomes and healthcare costs of patients on perindopril/indapamide/amlodipine single-pill vs. multiple-pill combination in Italy.

OBJECTIVES: This analysis compared adherence, cardiovascular (CV) events and all-cause mortality incidence, and healthcare costs among hypertensive patients treated with perindopril (PER)/indapamide (IND)/amlodipine (AML) in single-pill combination (SPC) vs. multiple-pill combination, in a real-world setting in Italy. METHODS: In this observational retrospective analysis of Italian administrative databases, adult patients treated with PER/IND/AML between 2010 and 2020 were divided into two cohorts: single-pill vs. multiple-pill. Patient data were available for at least one year before and after index date. Propensity score matching (PSM) was applied to reduce selection bias. Adherence was defined as proportion of days covered: non-adherence, <40%; partial adherence, 40-79%, and adherence ≥80%. Mortality incidence and CV events as single, or composite, endpoints were evaluated after first year of follow-up. Healthcare cost analyses were performed from the perspective of the Italian National Health Service. RESULTS: Following PSM, the single-pill cohort included 12 150 patients, and the multiple-pill cohort, 6105. The SPC cohort had a significantly higher percentage of adherent patients vs. the multiple-pill cohort (59.9% vs. 26.9%, P  < 0.001). Following the first year of follow-up, incidence of all-cause mortality, and combined endpoint of all-cause mortality and CV events were lower in the SPC cohort compared with multiple-pill cohort. Average annual direct healthcare costs were lower in the single-pill cohort (€2970) vs. multiple-pill cohort (€3642); cost of all drugs and all-cause hospitalizations were major contributors. CONCLUSION: The SPC of PER/IND/AML, compared with multiple-pill combination, is associated with higher adherence to medication, lower incidence of CV events and mortality, and reduced healthcare costs.

Comparing Cardiovascular Outcomes and Costs of Perindopril-, Enalapril- or Losartan-Based Antihypertensive Regimens in South Africa: Real-World Medical Claims Database Analysis.

INTRODUCTION: Differences in class or molecule-specific effects between renin-angiotensin-aldosterone system (RAAS) inhibitors have not been conclusively demonstrated. This study used South African data to assess clinical and cost outcomes of antihypertensive therapy with the three most common RAAS inhibitors: perindopril, losartan and enalapril. METHODS: Using a large, South African private health insurance claims database, we identified patients with a hypertension diagnosis in January 2015 receiving standard doses of perindopril, enalapril or losartan, alone or in combination with other agents. From claims over the subsequent 5 years, we calculated the risk-adjusted rate of the composite primary outcome of myocardial infarction, ischaemic heart disease, heart failure or stroke; rate of all-cause mortality; and costs per life per month (PLPM), with adjustments based on demographic characteristics, healthcare plan and comorbidity. RESULTS: Overall, 32,857 individuals received perindopril, 16,693 losartan and 13,939 enalapril. Perindopril-based regimens were associated with a significantly lower primary outcome rate (205 per 1000 patients over 5 years) versus losartan (221; P < 0.0001) or enalapril (223; P < 0.0001). The risk-adjusted all-cause mortality rate was lower with perindopril than enalapril (100 vs. 139 deaths per 1000 patients over 5 years; P = 0.007), but not losartan (100 vs. 94; P = 0.650). Mean (95% confidence interval) overall risk-adjusted cost PLPM was Rands (ZAR) 1342 (87-8973) for perindopril, ZAR 1466 (104-9365) for losartan (P = 0.0044) and ZAR 1540 (77-10,546) for enalapril (P = 0.0003). CONCLUSION: In South African individuals with private health insurance, a perindopril-based antihypertensive regimen provided better clinical and cost outcomes compared with other regimens.

Intravenous fluid therapy: a randomized controlled trial to investigate the effectiveness of the IV(2) flow medical device.

OBJECTIVES: To investigate the hypothetical benefits of the IV(2) flow medical device. BACKGROUND: Intravenous fluid administration is a standard hospital procedure with assumed inadequacies. The IV-Event Study [Fraser N, Nel G, Snyman J & Wessels F (2004) IV-EVENT Study: Intravenous Infusion Therapy--Management and Adverse Events. Data on File: Varori International (Pty) Ltd., Centurion, South Africa] quantified these inadequacies; The 'Stargait' intervention trial investigated the effectiveness and possible cost-benefit of the IV(2) flow. The IV(2) flow is intended for routine use with gravitational intravenous infusion sets. The IV(2) flow should reduce the incidence rate of adverse events and maintain a set flow rate. METHOD: Nursing staff assisted by study assessors captured relevant data. Consented patients were enrolled for the period of their prescribed infusions. Intervention. The Stargait Trial compared the treatment group (standard gravitational sets with the IV(2) flow) with the control group (standard gravitational infusion sets without IV(2) flow). The difference in observed events and the cost benefit derived from this were measured. RESULTS: A total of 2387 drip hours were observed in 52 patients. The adverse event rates were: Control group (without IV(2) flow) 33.8%. The treatment group (IV(2) flow) 15.4%. This 55% reduction is statistically significant (p = 0.0069). Adverse event related monetary wastage (labour and consumables) is reduced by 76% for infusion bags in the intervention group (with IV(2) flow). There was a significant difference between the treatment group and control group as far as deviation in flow rate was concerned (p = 0.00818). The mean deviation of the IV(2) flow group was just more than 5 ml per hour. The standard line group had a mean deviation of more than 30 ml per hour. CONCLUSION: Gravitational intravenous therapy compromises quality of patient care. The Stargait Trial has proven the care-effectiveness and cost-effectiveness of the IV(2) flow. RELEVANCE TO CLINICAL PRACTICE: The IV(2) flow improves quality of patient care and reduces associated wastage.