Model-based predictions on health benefits and budget impact of implementing empagliflozin in people with type 2 diabetes and established cardiovascular disease

Aim

To perform a model-based analysis of the short- and long-term health benefits and costs of further increased implementation of empagliflozin for people with type 2 diabetes and established cardiovascular disease (eCVD) in Sweden.

Materials and Methods

The validated Institute for Health Economics Diabetes Cohort Model (IHE-DCM) was used to estimate health benefits and a 3-year budget impact, and lifetime costs per quality-adjusted life years (QALY) gained of increased implementation of adding empagliflozin to standard of care (SoC) for people with type 2 diabetes and eCVD in a Swedish setting. Scenarios with 100%/75%/50% implementation were explored. Analyses were based on 30 model cohorts with type 2 diabetes and eCVD (n = 131 412 at baseline) from national health data registers. Sensitivity analyses explored the robustness of results.

Results

Over 3 years, SoC with empagliflozin (100% implementation) versus SoC before empagliflozin resulted in 7700 total life years gained and reductions in cumulative incidence of cardiovascular deaths by 30% and heart failures by 28%. Annual costs increased by 15% from higher treatment costs and increased survival. Half of these benefits and costs are not yet reached with current implementation below 50%. SoC with empagliflozin yielded 0.37 QALYs per person, with an incremental cost-effectiveness ratio of 16 000 EUR per QALY versus SoC before empagliflozin.

Conclusions

Model simulations using real-world data and trial treatment effects indicated that a broader implementation of empagliflozin, in line with current guidelines for treatment of people with type 2 diabetes and eCVD, would lead to further benefits even from a short-term perspective.     

Culprit lesion plaque characterization and thrombus grading by high-definition intravascular ultrasound in patients with ST-segment elevation myocardial infarction

Background

Dedicated prospective studies investigating high-definition intravascular ultrasound (HD-IVUS)-guided primary percutaneous coronary intervention (PCI) are lacking. The aim of this study was to qualify and quantify culprit lesion plaque characteristics and thrombus using HD-IVUS in patients presenting with ST-segment elevation myocardial infarction (STEMI).

Methods

The SPECTRUM study is a prospective, single-center, observational cohort study investigating the impact of HD-IVUS-guided primary PCI in 200 STEMI patients (NCT05007535). The first 100 study patients with a de novo culprit lesion and a per-protocol mandated preintervention pullback directly after vessel wiring were subject to a predefined imaging analysis. Culprit lesion plaque characteristics and different thrombus types were assessed. An IVUS-derived thrombus score, including a 1-point adjudication for a long total thrombus length, long occlusive thrombus length, and large maximum thrombus angle, was developed to differentiate between low (0–1 points) and high (2–3 points) thrombus burden. Optimal cut-off values were obtained using receiver operating characteristic curves.

Results

The mean age was 63.5 (±12.1) years and 69 (69.0%) patients were male. The median culprit lesion length was 33.5 (22.8–38.9) mm. Plaque rupture and convex calcium were appreciated in 48 (48.0%) and 10 (10.0%) patients, respectively. Thrombus was observed in 91 (91.0%) patients (acute thrombus 3.3%; subacute thrombus 100.0%; organized thrombus 22.0%). High IVUS-derived thrombus burden was present in 37/91 (40.7%) patients and was associated with higher rates of impaired final thrombolysis in myocardial infarction flow (grade 0–2) (27.0% vs. 1.9%, p < 0.001).

Conclusions

HD-IVUS in patients presenting with STEMI allows detailed culprit lesion plaque characterization and thrombus grading that may guide tailored PCI.     

Medication-related osteonecrosis of the jaw: A disease of significant importance for older patients

Background

Medication-related osteonecrosis of the jaw (MRONJ) is clinically defined as a non-healing jawbone ulcerative-necrotic lesion appearing after dental therapy or minor trauma in patients treated previously with anti-resorptive, anti-angiogenic or immunomodulators. Older patients with osteoporosis and cancer receive these pharmacological agents regularly. As these patients are long-term survivors, efficient treatment is of paramount importance for their quality of life.

Methods

Literature searches via PubMed were conducted to identify relevant MRONJ studies. Basic information on MRONJ classification, clinical features, and pathosphysiology is presented herein as well as various clinical studies dealing with MRONJ in patients with osteoporosis and cancer. Lastly, we discuss current managment of patients and new trends in treatment of MRONJ.

Results

Although close follow-up and local hygiene have been advocated by some authors, severe forms of MRONJ are not responsive to conservative therapy. At present, there is no “gold standard” therapy for this condition. However, as the physiopathological basis of MRONJ is represented by the anti-angiogenic action of various pharmacological agents, new methods to increase and promote local angiogenesis and vascularization have recently been successfully tested in vitro, limited preclinical studies, and in a pilot clinical study.

Conclusions

It appears that the best method implies application on the lesion of endothelial progenitor cells as well as pro-angiogenic factors such as Vascular Endothelial Growth Factor (VEGF) and other related molecules. More recently, scaffolds in which these factors have been incorporated have shown positive results in limited trials. However, these studies must be replicated to include a large number of cases before any official therapeutic protocol is adopted.     

Severity of Contracture and Self-reported Disability in Patients with Dupuytren’s Contracture Referred for Surgery

The purpose of the study was to explore the relationship between preoperative flexion contracture (FC) and self-reported disability in patients undergoing surgical release by fasciectomy or dermofasciectomy. The study design used was a prospective observational study: Dupuytren’s disease (DD) is a fibroproliferative disorder of the palmar fascia and may lead to functional deficits requiring surgical intervention. Outcomes are usually reported using digital range of motion although recent studies have also included patient-rated outcome measures with the extensively validated Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire commonly used. One hundred fifty-four patients consecutively enrolled in a prospective randomized trial were assessed before surgery for active range of movement using goniometry and self-reported functioning using DASH questionnaire. The small finger was affected in 69% of patients with a mean FC of 77.8 degrees (standard deviation = 43.5°). The mean DASH score was 16 points (range, 0-62). The correlation between severity of FC in all four fingers and DASH was weak (r = 0.264, p = 0.001). At individual digital level, the correlation between FC and DASH was weak in the index (r = 0.26), middle (r = 0.28), and ring (r = 0.21) fingers but almost absent in the small finger (r = 0.07). These results show that the relationship between severity of FC and functional disability measured by the DASH questionnaire appear to be very weak or even absent. Level of evidence: Level III prospective cohort study.     

Planned Place of Birth in New Zealand: Does it Affect Mode of Birth and Intervention Rates Among Low‐Risk Women?

Abstract: Background: Midwives providing care as lead maternity caregivers in New Zealand provide continuity of care to women who may give birth in a variety of settings, including home, primary units, and secondary and tertiary level hospitals. The purpose of this study was to compare mode of birth and intrapartum intervention rates for low‐risk women planning to give birth in these settings under the care of midwives. Methods: Data for a cohort of low‐risk women giving birth in 2006 and 2007 were extracted from the Midwifery Maternity Provider Organisation database. Mode of birth, intrapartum interventions, and neonatal outcomes were compared with results adjusted for age, parity, ethnicity, and smoking. Results: Women planning to give birth in secondary and tertiary hospitals had a higher risk of cesarean section, assisted modes of birth, and intrapartum interventions than similar women planning to give birth at home and in primary units. The risk of emergency cesarean section for women planning to give birth in a tertiary unit was 4.62 (95% CI: 3.66–5.84) times that of a woman planning to give birth in a primary unit. Newborns of women planning to give birth in secondary and tertiary hospitals also had a higher risk of admission to a neonatal intensive care unit (RR: 1.40, 95% CI: 1.05–1.87; RR: 1.78, 95% CI: 1.31–2.42) than women planning to give birth in a primary unit. Conclusions: Planned place of birth has a significant influence on mode of birth and rates of intrapartum intervention in childbirth. (BIRTH 38:2 June 2011)