Abstract P223: Cost-Effectiveness of Adding Aliskiren to Losartan and Optimal Antihypertensive Therapy in Patients with Hypertension, Type 2 Diabetes and Nephropathy with Residual Proteinuria

2011 ◽  
Vol 4 (suppl_2) ◽  
Author(s):  
Thomas E Delea ◽  
Charu Taneja ◽  
Aaron Moynahan ◽  
Helen Lau ◽  
Jean Lian ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Cost Effectiveness ◽  
Antihypertensive Therapy ◽  
Regression Equations ◽  
Double Blind ◽  
System Perspective ◽  
Life Years ◽  
Lifetime Costs

Background: AVOID was a randomized, double-blind, 6-mo. trial of adding aliskiren to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and nephropathy with residual proteinuria (urinary albumin creatinine ratio [UACR]>100mg/g) after ≥3 mo. of 100mg/d losartan. Aliskiren reduced mean UACR by 20% vs. placebo (P=.009). A previous study examined cost-effectiveness of aliskiren, but did not examine the potential effects of aliskiren on risks, costs, and quality of life effects of cardiovascular disease (CVD). Methods: A Markov model was used to project lifetime incidence of cardiovascular disease (CVD) and end-stage renal disease (ESRD), life years (LYs), quality-adjusted life years (QALYs), and expected lifetime costs (US healthcare system perspective) with losartan plus optimal antihypertensive therapy +/− aliskiren. Albuminuria progression by treatment was projected by generalized linear model regression equations fit to UACR from AVOID. Probabilities of CVD/ESRD by UACR and death without CVD/ESRD by age were obtained by calibrating the model to results for losartan and placebo in the RENAAL study. Other parameters were from published sources. Results: With losartan, mean UACR is projected to increase from approximately 790 mg/g at baseline to approximately 1700 mg/g at 3.5 years and to remain at this level for the duration of the model. Assuming the beneficial effects of aliskiren on the rate of progression of UACR persist for as long as patients remain on therapy, mean UACR with aliskiren plus losartan is projected to decline from 790 mg/g at baseline to 730 mg/g after 1 year, then increase to 740 mg/g after 4 years and remain at that level for the remainder of the model. Under these assumptions, adding aliskiren to losartan and optimal antihypertensive therapy is projected to reduce lifetime incidence of ESRD by 5% and CVD by 4%, increase LY by 0.19 and QALYs by 0.13. Expected lifetime costs are reduced by $7700, as savings from averted CVD ($1500) and ESRD ($12 800) more than offset additional costs associated with aliskiren treatment ($5400). Conclusion: Adding aliskiren to losartan in this setting leads to reduced cost and increased QALYs.

scholarly journals Choice across 10 pharmacologic combination strategies for type 2 diabetes: a cost-effectiveness analysis

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Shuyan Gu ◽  
Lizheng Shi ◽  
Hui Shao ◽  
Xiaoyong Wang ◽  
Xiaoqian Hu ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Chinese Patients ◽  
Oral Drug ◽  
System Perspective ◽  
Treatment Comparison ◽  
Combination Strategies ◽  
Life Years ◽  
The Cost

Abstract Background Clinical guidelines recommend a stepped-escalation treatment strategy for type 2 diabetes (T2DM). Across multiple treatment strategies varying in efficacy and costs, no clinical or economic studies directly compared them. This study aims to estimate and compare the cost-effectiveness of 10 commonly used pharmacologic combination strategies for T2DM. Methods Based on Chinese guideline and practice, 10 three-stepwise add-on strategies were identified, which start with metformin, then switch to metformin plus one oral drug (i.e., sulfonylurea, thiazolidinedione, α-glucosidase inhibitor, glinide, or DPP-4 inhibitor) as second line, and finally switch to metformin plus one injection (i.e., insulin or GLP-1 receptor agonist) as third line. A cohort of 10,000 Chinese patients with newly diagnosed T2DM was established. From a healthcare system perspective, the Cardiff model was used to estimate the cost-effectiveness of the strategies, with clinical data sourced from a systematic review and indirect treatment comparison of 324 trials, costs from claims data of 1164 T2DM patients, and utilities from an EQ-5D study. Outcome measures include costs, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and net monetary benefits (NMBs). Results Over 40-year simulation, the costs accumulated for a patient ranged from $7661 with strategy 1 to $14,273 with strategy 10, while the QALY gains ranged from 13.965 with strategy 1 to 14.117 with strategy 8. Strategy 7 was dominant over seven strategies (strategies 2~6, 9~10) with higher QALYs but lower costs. Additionally, at a willingness-to-pay threshold of $30,787/QALY (i.e., 3 times GDP/capita for China), strategy 7 was cost-effective compared with strategy 1 (ICER of strategy 7 vs. 1, $3371/QALY) and strategy 8 (ICER of strategy 8 vs. 7, $132,790/QALY). Ranking the strategies by ICERs and NMBs, strategy 7 provided the best value for money when compared to all other strategies, followed by strategies 5, 9, 8, 1, 3, 6, 10, 2, and 4. Scenario analyses showed that patients insist on pharmacologic treatments increased their QALYs (0.456~0.653) at an acceptable range of cost increase (ICERs, $1450/QALY~$12,360/QALY) or even at cost saving compared with those not receive treatments. Conclusions This study provides evidence-based references for diabetes management. Our findings can be used to design the essential drug formulary, infer clinical practice, and help the decision-maker design reimbursement policy.

scholarly journals Cost–effectiveness analysis of empagliflozin compared with glimepiride in patients with Type 2 diabetes in China

2021 ◽  
Author(s):  
Ahmed Salem ◽  
Peng Men ◽  
Mafalda Ramos ◽  
Yan-Jun Zhang ◽  
Anastasia Ustyugova ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Cost Effective ◽  
Quality Adjusted Life Years ◽  
System Perspective ◽  
Diabetes Model ◽  
Life Years ◽  
Cost Effective Treatment ◽  
The Cost

Aim: The study assesses the cost–effectiveness of empagliflozin versus glimepiride in patients with Type 2 diabetes and uncontrolled by metformin alone in China, based on the EMPA-REG H2H-SU trial. Materials & methods: A calibrated version of the IQVIA Core Diabetes Model was used. Cost of complications and utility were taken from literature. The Chinese healthcare system perspective and 5% discounting rates were applied. Results: Empagliflozin+metformin provides additional quality-adjusted life-years (0.317) driven by a reduction in the number of cardiovascular and renal events, for an additional cost of $1382 (CNY9703) compared with glimepiride+metformin. Conclusion: Empagliflozin is cost-effective treatment versus glimepiride applying a threshold of $30,290 (CNY212,676).

scholarly journals The Cost-Effectiveness of Empagliflozin Versus Liraglutide Treatment in People with Type 2 Diabetes and Established Cardiovascular Disease

2021 ◽  
Author(s):  
Lars Holger Ehlers ◽  
Mark Lamotte ◽  
Sofia Monteiro ◽  
Susanne Sandgaard ◽  
Pia Holmgaard ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Cost Effectiveness ◽  
The Cost

Estimating cardiovascular disease-free life-years with the addition of semaglutide in people with type 2 diabetes using pooled data from SUSTAIN 6 and PIONEER 6

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Westerink ◽  
K Sommer Matthiessen ◽  
S Nuhoho ◽  
U Fainberg ◽  
M Lyng Wolden ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Funding Source ◽  
Cvd Risk ◽  
Private Company ◽  
Pooled Data ◽  
Patient Level ◽  
Life Years ◽  
Geographical Regions

Abstract Introduction Cardiovascular disease (CVD) is the leading cause of disability and death in people with type 2 diabetes (T2D). In a post hoc analysis of pooled data (POOLED cohort) from two phase 3, randomized CV outcomes trials, SUSTAIN 6 (NCT01720446) and PIONEER 6 (NCT02692716), the addition of the glucagon-like peptide-1 analogue semaglutide to standard of care (SoC) in people with T2D at high risk of CVD significantly reduced the risk of major adverse CVD events (3-point MACE: CV death, non-fatal stroke and non-fatal myocardial infarction). Purpose To estimate the effect of adding semaglutide to SoC on CVD-free life-years and 10-year CVD risk in patients with T2D by predicting individual patient-level risk of CVD events in the POOLED cohort using the DIAL CVD risk model. Methods The 3-point MACE hazard ratio from the POOLED cohort (N=6480; HR = 0.76 [95% confidence interval [CI]: 0.62–0.92]) was applied to the patient-level lifetime risk of CVD events derived from the DIAL model. CVD-free life-years and 10-year CVD risk were then calculated based on the age-specific risks of CVD events and non-vascular mortality, using standard actuarial methods. Both new and recurrent CVD events were considered. The DIAL model was validated by comparing the predicted and observed number of CVD events after 1 year. The DIAL model was previously developed using data from people with T2D in the Swedish National Diabetes Registry and validated across geographical regions. Results The DIAL model was considered valid for use in the POOLED cohort because the predicted number of CVD events at 1 year was within 5% of the number observed. Adding semaglutide to SoC was associated with a mean reduction in 10-year CVD risk of 20.0% (95% CI: 6.4–32.6%) and a mean increase of 1.72 (95% CI: 0.52–2.96) CVD-free life-years. The number of mean CVD-free life-years gained ranged from 0.62–2.91 years between age groups (Table). For a 60-year-old male with baseline characteristics matched to the average male from the POOLED cohort, adding semaglutide to SoC reduced 10-year CVD risk by 20.8% and provided 2.53 additional CVD-free life-years. The number of CVD-free life-years decreased when baseline age was increased (Figure). Conclusions The addition of semaglutide to SoC was associated with a gain in CVD-free life-years. This analysis helps contextualize the results of CV outcomes trials and may help to inform clinical decision-making. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novo Nordisk A/S

scholarly journals Cost-effectiveness of empagliflozin in patients with type 2 diabetes and established cardiovascular disease in China

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Mafalda Ramos ◽  
Peng Men ◽  
Xu Wang ◽  
Anastasia Ustyugova ◽  
Mark Lamotte
Keyword(s):  
Risk Factors ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Cost Effectiveness ◽  
Willingness To Pay ◽  
Incremental Cost ◽  
Treatment Effects ◽  
Specific Treatment ◽  
Treatment Comparison

Abstract Background In several cardiovascular outcome trials (CVOTs), empagliflozin (SGLT-2 inhibitor), sitagliptin (DPP-4 inhibitor) and liraglutide (GLP-1 receptor agonist) + standard of care (SoC) were compared to SoC in patients with type 2 diabetes and established cardiovascular disease (CVD). This study assessed the cost-effectiveness (CE) of empagliflozin + SoC in comparison to sitagliptin + SoC and liraglutide + SoC based on the respective CVOT. Methods The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the CVOT outcomes. EMPA-REG OUTCOME baseline characteristics and CVOT specific treatment effects on risk factors for cardiovascular disease (HbA1c, BMI, blood pressure, lipids) were applied. Three-year observed cardiovascular events of empagliflozin + SoC versus sitagliptin + SoC and liraglutide + SoC were derived from EMPA-REG OUTCOME and an indirect treatment comparison. Relative risk adjustments to calibrate the CDM were obtained after a trial and error process to match as closely the observed and CDM-predicted outcomes. The drug-specific treatment effects were considered up until HbA1c reached 8.5% and treatment switch occurred. After this switch, the United Kingdom Prospective Diabetes Study 82 risk equations predicted events based on co-existing risk factors and treatment intensification to basal bolus insulin were applied. The analysis was conducted from the perspective of the Chinese healthcare system applying 3% discounting. The time horizon was lifelong. Results Empagliflozin + SoC provides additional Quality Adjusted Life years (QALY + 0.564) for an incremental cost of 42,497RMB (US$6053) compared to sitagliptin + SoC, resulting in an Incremental Cost Utility Ratio of 75,349RMB (US$10,732), thus below the willingness-to-pay threshold of 212,676RMB, corresponding to three times the Gross Domestic Product in China (2019). Compared to liraglutide + SoC, empagliflozin + SoC use leads to 0.211QALY gained and cost savings of 71,427RMB (US$10,173) and is as such dominant. Scenario and probabilistic sensitivity analyses demonstrated the robustness of the results. Conclusion Results suggest that empagliflozin + SoC is cost-effective compared to sitagliptin + SoC and liraglutide + SoC at a willingness-to-pay threshold of 212,676RMB ($30,292)/QALY.

scholarly journals Effect of Arterial Hypertension on the ICAM-1, VCAM-1 and Е-selectin Level in Type 2 Diabetes Patients

2021 ◽  
pp. 43-47
Author(s):  
Liliia Mogylnytska
Keyword(s):  
Insulin Resistance ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Endothelial Dysfunction ◽  
Serum Level ◽  
Control Group ◽  
Regression Equations ◽  
Multifactor Regression ◽  
Diabetes Patients

Cardiovascular disease is the leading cause of death in diabetes mellitus. Endothelial dysfunction is the first step in the development of atherosclerotic vascular lesions, which underlies cardiovascular pathology, and adhesion molecules secreted by the endothelium during inflammatory changes are involved in the progression of this lesion. The objective: the serum level of adhesive molecules (ІCAM-1, VCAM-1, Е-selectin) in hypertensive and non-hypertensive type 2 diabetes patients as a marker of endothelial dysfunction and its relationship with other risk factors for cardiovascular disease was studied. Materials and methods. We examined 64 patients with type 2 diabetes, which were divided into two subgroups: the first subgroup – 41 hypertensive type 2 diabetes patients (age – 53,56±7,14 years, BMI – 32,2±87,4; HbA1c – 9,97±2,02%), the second subgroup – 23 nonhypertensive type 2 diabetes patients (age – 50,5±4,92 years, BMI – 25,4±5,22; HbA1c – 9,09±1,95%). The control group included 18 people without diabetes with normal blood pressure (age – 50,72±6,98 years, BMI – 24,71±4,88; HbA1c – 5,26±0,42%). The serum level was determined by immunoenzyme assay. The significance of the difference between the mean values was determined by the t-Student test. Multifactor regression analysis was used to assess the relationships between the studied factors. Results. We revealed an increase of serum levels of ІCAM-1, VCAM-1, Е-selectin in hypertensive (+71,62%, +68,42%, +66,95%, respectively) and non-hypertensive type 2 diabetes patients (+46,17%, +62,79%, +42,85%, respectively) compared with the control group (p<0,01). The serum concentration of ІCAM-1, Е-selectin was higher in hypertensive type 2 diabetes patients compared to non-hypertensive type 2 diabetes patients (+17,27%, +16,86%, respectively, p<0,01). There was a significant effect of Hb1Ac, lipids, insulin resistance on the serum level of ІCAM-1, VCAM-1, Е-selectin (p<0,01). The corresponding regression equations are derived. Conclusion. There is an increase of serum level of ІCAM-1, VCAM-1, Е-selectin in hypertensive and non-hypertensive type 2 diabetes patients, which indicates the development of endothelial dysfunction. Hypertension, hyperglycemia, dyslipidemia and insulin resistance contribute to the development of these changes.

scholarly journals Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Kausik K. Ray ◽  
Stefano Del Prato ◽  
Dirk Müller-Wieland ◽  
Bertrand Cariou ◽  
Helen M. Colhoun ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Atherosclerotic Cardiovascular Disease ◽  
Open Label ◽  
Double Blind ◽  
Mixed Dyslipidemia

Abstract Background Individuals with diabetes often have high levels of atherogenic lipoproteins and cholesterol reflected by elevated low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and LDL particle number (LDL-PN). The presence of atherosclerotic cardiovascular disease (ASCVD) increases the risk of future cardiovascular events. We evaluated the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, alirocumab, among individuals with type 2 diabetes (T2DM), high LDL-C or non-HDL-C, and established ASCVD receiving maximally tolerated statin in ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) and DM-INSULIN (NCT02585778). Methods In DM-DYSLIPIDEMIA, individuals with T2DM and mixed dyslipidemia (non-HDL-C ≥ 100 mg/dL; n = 413) were randomized to open-label alirocumab 75 mg every 2 weeks (Q2W) or usual care (UC) for 24 weeks, with UC options selected before stratified randomization. In DM-INSULIN, insulin-treated individuals with T2DM (LDL-C ≥ 70 mg/dL; n = 441) were randomized in a double-blind fashion to alirocumab 75 mg Q2W or placebo for 24 weeks. Study participants also had a glycated hemoglobin < 9% (DM-DYSLIPIDEMIA) or < 10% (DM-INSULIN). Alirocumab dose was increased to 150 mg Q2W at week 12 if week 8 LDL-C was ≥ 70 mg/dL (DM-INSULIN) or non-HDL-C was ≥ 100 mg/dL (DM-DYSLIPIDEMIA). Lipid reductions and safety were assessed in patients with ASCVD from these studies. Results This analysis included 142 DM-DYSLIPIDEMIA and 177 DM-INSULIN participants with ASCVD, including 95.1% and 86.4% with coronary heart disease, and 32.4% and 49.7% with microvascular diabetes complications, respectively. At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control. This translated into a greater proportion of individuals achieving non-HDL-C < 100 mg/dL (64.6% alirocumab/23.8% UC [DM-DYSLIPIDEMIA]; 65.4% alirocumab/14.9% placebo [DM-INSULIN]) and ApoB < 80 mg/dL (75.1% alirocumab/35.4% UC and 76.8% alirocumab/24.8% placebo, respectively) versus control at week 24 (all P < 0.0001). In pooling these studies, 66.4% (alirocumab) and 67.0% (control) of individuals reported treatment-emergent adverse events. The adverse event pattern was similar with alirocumab versus controls. Conclusions Among individuals with T2DM and ASCVD who had high non-HDL-C/LDL-C levels despite maximally tolerated statin, alirocumab significantly reduced atherogenic cholesterol and LDL-PN versus control. Alirocumab was generally well tolerated. Trial registration Clinicaltrials.gov. NCT02642159. Registered 30 December 2015 and Clinicaltrials.gov. NCT02585778. Registered 23 October 2015

scholarly journals Effect of Empagliflozin on Endothelial Function in Patients With Type 2 Diabetes and Cardiovascular Disease: Results from the Multicenter, Randomized, Placebo-Controlled, Double-Blind EMBLEM Trial

Diabetes Care ◽  
2019 ◽  
Vol 42 (10) ◽  
pp. e159-e161 ◽  
Author(s):  
Atsushi Tanaka ◽  
Michio Shimabukuro ◽  
Noritaka Machii ◽  
Hiroki Teragawa ◽  
Yosuke Okada ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Endothelial Function ◽  
Double Blind

COST-EFFECTIVENESS OF EXERCISE PROGRAMS IN TYPE 2 DIABETES

2012 ◽  
Vol 28 (3) ◽  
pp. 228-234 ◽  
Author(s):  
Doug Coyle ◽  
Kathryn Coyle ◽  
Glen P. Kenny ◽  
Normand G. Boulé ◽  
George A. Wells ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Exercise Training ◽  
Exercise Program ◽  
Cost Effective ◽  
Exercise Programs ◽  
Combined Exercise ◽  
Use Of Resources ◽  
Life Years

Background: A randomized controlled trial has shown that supervised, facility-based exercise training is effective in improving glycemic control in type 2 diabetes. However, these programs are associated with additional costs. This analysis assessed the cost-effectiveness of such programs.Methods: Analysis used data from the Diabetes Aerobic and Resistance Exercise (DARE) clinical trial which compared three different exercise programs (resistance, aerobic or a combination of both) of 6 months duration with a control group (no exercise program). Clinical outcomes at 6 months were entered for individual patients into the UKPDS economic model for type 2 diabetes adapted for the Canadian context. From this, expected life-years, quality-adjusted life-years (QALYs) and costs were estimated for all patients within the trial.Results: The combined exercise program was the most expensive ($40,050) followed by the aerobic program ($39,250), the resistance program ($38,300) and no program ($31,075). QALYs were highest for combined (8.94), followed by aerobic (8.77), resistance (8.73) and no program (8.70). The incremental cost per QALY gained for the combined exercise program was $4,792 compared with aerobic alone, $8,570 compared with resistance alone, and $37,872 compared with no program. The combined exercise program remained cost-effective for all scenarios considered within sensitivity analysis.Conclusions: A program providing training in both resistance and aerobic exercise was the most cost-effective of the alternatives compared. Based on previous funding decisions, exercise training for individuals with diabetes can be considered an efficient use of resources.

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