Background: The global prevalence of type 2 diabetes mellitus (T2DM) in 2019 is estimated to be approximately 500 million
.
T2DM is associated with an increased risk of vascular disease, with approximately one third of patients diagnosed with cardiovascular disease (CVD) and an increased risk of events such as cardiovascular disease (CV) death, myocardial infarction (MI), stroke and amputation2 -4 times
.
Patients with coronary artery disease (CAD) and T2DM represent a particularly high risk group for atherothrombotic events
.
The combination of coronary artery disease and T2DM significantly increases the risk of cardiovascular events even in patients without prior ischemic events, and some estimates place the risk in patients with T2DM and coronary artery disease without prior myocardial infarction to those without T2DM and patients with previous myocardial infarction
.
In addition, typical cardiovascular risk factors such as hypertension and high cholesterol are common in patients with atherosclerotic thrombosis and are often not within the target range, further increasing the risk of cardiovascular events in this population
.
.
T2DM is associated with an increased risk of vascular disease, with approximately one third of patients diagnosed with cardiovascular disease (CVD) and an increased risk of events such as cardiovascular disease (CV) death, myocardial infarction (MI), stroke and amputation2 -4 times
.
Patients with coronary artery disease (CAD) and T2DM represent a particularly high risk group for atherothrombotic events
.
The combination of coronary artery disease and T2DM significantly increases the risk of cardiovascular events even in patients without prior ischemic events, and some estimates place the risk in patients with T2DM and coronary artery disease without prior myocardial infarction to those without T2DM and patients with previous myocardial infarction
.
In addition, typical cardiovascular risk factors such as hypertension and high cholesterol are common in patients with atherosclerotic thrombosis and are often not within the target range, further increasing the risk of cardiovascular events in this population
.
The global prevalence of type 2 diabetes (T2DM) is estimated to be approximately 500 million in 2019
.
T2DM is associated with an increased risk of vascular disease, with approximately one third of patients diagnosed with cardiovascular disease (CVD) and an increased risk of events such as cardiovascular disease (CV) death, myocardial infarction (MI), stroke and amputation2 -4 times
.
Patients with coronary artery disease (CAD) and T2DM represent a particularly high risk group for atherothrombotic events
.
The combination of coronary artery disease and T2DM significantly increases the risk of cardiovascular events even in patients without prior ischemic events, and some estimates place the risk in patients with T2DM and coronary artery disease without prior myocardial infarction to those without T2DM and patients with previous myocardial infarction
.
For patients with established coronary heart disease and T2DM, the current standard of care for antithrombotic prophylaxis is low-dose aspirin
.
Currently, North American and European regulatory agencies state that ticagrelor reduces cardiovascular mortality, myocardial infarction and stroke rates in patients with acute coronary syndrome or a history of myocardial infarction, and Health Canada states that ticagrelor reduces Cardiovascular mortality, myocardial infarction, and stroke rates in patients with coronary heart disease and T2DM with a history of percutaneous coronary intervention (PCI)
.
In the "Intervention Study on the Effects of Ticagrelor on Health Outcomes in Patients with Diabetes [THEMIS;1], the clinical benefit of ticagrelor plus aspirin background preventive therapy was studied in patients with CAD and T2DM without prior myocardial infarction or stroke.
.
NCT01991795].
This
multinational, randomized, double-blind, placebo-controlled trial evaluated 90 mg of ticagrelor (reduced to 60 mg mid-trial according to product labeling) twice daily on cardiovascular death, myocardial Effect of infarction or stroke incidence
.
In THEMIS, the addition of ticagrelor to aspirin reduced the number of composite endpoint events (cardiovascular death, myocardial infarction, and stroke) but increased major bleeding compared with aspirin alone
.
Net clinical benefit was assessed using a prespecified composite of irreversible damage (all-cause death, myocardial infarction, stroke, fatal bleeding, or intracranial hemorrhage)
.
Although there was no net clinical benefit in patients without a history of PCI, there was no Among patients, the net clinical benefit was favorable, with a relative reduction of 15% (p value for interaction = 0.
012)
.
.
Currently, North American and European regulatory agencies state that ticagrelor reduces cardiovascular mortality, myocardial infarction and stroke rates in patients with acute coronary syndrome or a history of myocardial infarction, and Health Canada states that ticagrelor reduces Cardiovascular mortality, myocardial infarction, and stroke rates in patients with coronary heart disease and T2DM with a history of percutaneous coronary intervention (PCI)
.
In the "Intervention Study on the Effects of Ticagrelor on Health Outcomes in Patients with Diabetes [THEMIS;1], the clinical benefit of ticagrelor plus aspirin background preventive therapy was studied in patients with CAD and T2DM without prior myocardial infarction or stroke.
.
NCT01991795].
This
multinational, randomized, double-blind, placebo-controlled trial evaluated 90 mg of ticagrelor (reduced to 60 mg mid-trial according to product labeling) twice daily on cardiovascular death, myocardial Effect of infarction or stroke incidence
.
In THEMIS, the addition of ticagrelor to aspirin reduced the number of composite endpoint events (cardiovascular death, myocardial infarction, and stroke) but increased major bleeding compared with aspirin alone
.
Net clinical benefit was assessed using a prespecified composite of irreversible damage (all-cause death, myocardial infarction, stroke, fatal bleeding, or intracranial hemorrhage)
.
Although there was no net clinical benefit in patients without a history of PCI, there was no In patients, the net clinical benefit was favorable, with a relative reduction of 15% (p-value for interaction = 0.
012)
.
Currently, ticagrelor is indicated by North American and European regulatory agencies to reduce acute coronary syndrome or a history of myocardial infarction.
Cardiovascular mortality, myocardial infarction and stroke rates in patients, Health Canada noted that ticagrelor reduces cardiovascular mortality, myocardial infarction rates in patients with coronary heart disease and T2DM with a history of percutaneous coronary intervention (PCI).
and stroke rates
.
Objective: To evaluate the health economics of ticagrelor in patients with type 2 diabetes and coronary heart disease from the perspective of multinational payers
.
The cost-effectiveness and cost-effectiveness of ticagrelor were assessed in the entire THEMIS (Ticagrelor Effect Intervention Study on Health Outcomes in Patients with Diabetes) trial population and in a predetermined group of patients with prior percutaneous coronary intervention
.
.
The cost-effectiveness and cost-effectiveness of ticagrelor were assessed in the entire THEMIS (Ticagrelor Effect Intervention Study on Health Outcomes in Patients with Diabetes) trial population and in a predetermined group of patients with prior percutaneous coronary intervention
.
Methods and results: A Markov model was developed to infer patient lifetime outcomes
.
The primary outcome was incremental cost-effectiveness ratios (ICERs), compared with traditional willingness-to-pay (WTP) thresholds (47,000 €/quality-adjusted life-year [QALY] in Sweden and 30,000 €/QALY in other countries)
.
Ticagrelor treatment resulted in QALY gains as high as 0.
045 in the overall population and as high as 0.
099 in PCI patients
.
The incremental costs and benefits of converting to ICERs ranged between €27,894 and €42,252/QALY for the total population of Sweden, Germany, Italy and Spain
.
Among patients with a history of PCI, estimated ICERs improved to €18, 449, €20, 632, €20, 233 and € in Sweden, Germany, Italy and Spain, respectively, due to higher event rates and treatment benefit 13, 228/QALY
.
.
The primary outcome was incremental cost-effectiveness ratios (ICERs), compared with traditional willingness-to-pay (WTP) thresholds (47,000 €/quality-adjusted life-year [QALY] in Sweden and 30,000 €/QALY in other countries)
.
Ticagrelor treatment resulted in QALY gains as high as 0.
045 in the overall population and as high as 0.
099 in PCI patients
.
The incremental costs and benefits of converting to ICERs ranged between €27,894 and €42,252/QALY for the total population of Sweden, Germany, Italy and Spain
.
Among patients with a history of PCI, estimated ICERs improved to €18, 449, €20, 632, €20, 233 and € in Sweden, Germany, Italy and Spain, respectively, due to higher event rates and treatment benefit 13, 228/QALY
.
Figure 1 Cost-benefit acceptance curve
Figure 1 Cost-benefit acceptance curveTable 1
.
Baseline characteristics of the overall population and PCI history and PCI history and stent subgroup data are presented as mean standard deviation or n (%)
.
Baseline characteristics of the overall population and PCI history and PCI history and stent subgroup data are presented as mean standard deviation or n (%)
Table 2 Hazard ratios associated with ticagrelor treatment
.
.
Conclusions: Ticagrelor plus aspirin may be more cost-effective than aspirin alone in some European countries in patients with T2DM and coronary heart disease without prior myocardial infarction or stroke, according to THEMIS findings
.
In addition, ticagrelor may be more cost-effective in European countries for patients with a history of PCI
.
.
In addition, ticagrelor may be more cost-effective in European countries for patients with a history of PCI
.
In some European countries, ticagrelor plus aspirin may be more cost-effective than aspirin alone in patients with T2DM and coronary heart disease without prior myocardial infarction or stroke, according to the THEMIS study
.
In addition, ticagrelor may be more cost-effective in European countries for patients with a history of PCI
.
Original source: Steg PG, Bhatt DL, James SK, et al.
Cost-effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease: a European economic evaluation of the THEMIS trial.
Eur Heart J Cardiovasc Pharmacother 2022 Apr 30
Cost-effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease: a European economic evaluation of the THEMIS trial.
Eur Heart J Cardiovasc Pharmacother 2022 Apr 30 Cost- effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease: a European economic evaluation of the THEMIS trial.
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