T4 PPTs Flashcards
What are CVOTs?
Cardiovascular Outcomes Trials, designed to assess the cardiovascular safety of diabetes medications.
What led to the FDA’s requirement for CVOTs in diabetes medications?
A study showing possible increased cardiovascular risk with rosiglitazone.
What are the key components measured in CVOTs?
MACE (Major Adverse Cardiac Events) including cardiovascular death, non-fatal MI, non-fatal stroke.
What was the result of the EMPA-REG Outcomes Trial?
Empagliflozin reduced cardiovascular death by 38% and MACE by 14%.
What did the CANVAS trial show regarding canagliflozin?
It reduced MACE by 14% and cardiovascular death by 13%.
How do SGLT2 inhibitors impact heart failure?
They significantly reduce the risk of hospitalization for heart failure.
What is the significance of the LEADER trial?
Liraglutide reduced cardiovascular events by 13% and MACE by 22%.
Which medications showed renal benefits in CVOTs?
SGLT2 inhibitors like empagliflozin and GLP-1 receptor agonists like liraglutide.
What is the FDA indication for canagliflozin in patients with CKD?
To reduce the risk of ESRD in adults with T2DM and diabetic nephropathy.
Which CVOT showed benefits in heart failure with or without diabetes?
Dapagliflozin in the DAPA-HF trial.
What is the definition of chronic kidney disease (CKD)?
Kidney damage determined by elevated urinary albumin or low eGFR.
What is the leading cause of end-stage renal disease (ESRD)?
Diabetes and hypertension.
What percentage of patients with diabetes develop CKD?
20-40% of patients with diabetes.
What is albuminuria?
Urinary albumin-to-creatinine ratio >30 mg/g.
What is considered abnormal eGFR in CKD?
eGFR <60 mL/min/1.73 m².
How does CKD impact pharmacologic management in diabetes?
CKD progression influences the choice and dose of diabetes medications.
What is the first-line treatment for CKD in patients with diabetes?
SGLT2 inhibitors to reduce the risk of CKD progression.
How is CKD progression measured?
By tracking eGFR and urinary albumin levels.
What is the importance of SGLT2 inhibitors in CKD management?
They slow the progression of CKD and reduce cardiovascular risk.
What medications should be avoided in patients with advanced CKD?
Metformin and NSAIDs due to the risk of lactic acidosis and kidney damage.
What is ASCVD?
Atherosclerotic cardiovascular disease, a major complication of diabetes.
What are common conditions coexisting with diabetes that increase ASCVD risk?
Hypertension, dyslipidemia, and obesity.
How does diabetes itself impact cardiovascular risk?
It independently increases the risk of ASCVD.
What are the key CV risk factors for patients with diabetes?
Hypertension, smoking, dyslipidemia, obesity, and CKD.
What are the ADA indicators of high CV risk?
Age >55 with two or more risk factors like hypertension, dyslipidemia, or albuminuria.
What is the recommended treatment for patients with ASCVD and diabetes?
SGLT2 inhibitors or GLP-1 receptor agonists with cardiovascular benefits.
What is the impact of GLP-1 receptor agonists on cardiovascular risk?
They reduce major adverse cardiovascular events (MACE) and lower blood pressure.
Why is early detection of ASCVD important in diabetes management?
It helps guide pharmacologic therapy and improves long-term outcomes.
What is the primary goal of pharmacologic therapy in patients with ASCVD?
To reduce cardiovascular risk while managing glycemic control.
Which medications have demonstrated the greatest cardiovascular benefits in CVOTs?
SGLT2 inhibitors and GLP-1 receptor agonists.
What is the role of MACE in CVOTs?
It measures the composite of cardiovascular death, non-fatal MI, and non-fatal stroke.
Which drug class was first to show a reduction in both cardiovascular and renal outcomes in CVOTs?
SGLT2 inhibitors.
What is the role of GLP-1 receptor agonists in reducing stroke risk?
They lower the risk of ischemic stroke in patients with diabetes and ASCVD.
How does dapagliflozin benefit patients with heart failure?
It reduces hospitalization for heart failure in patients with or without diabetes.
Which CVOT focused on renal disease as the primary endpoint?
The CREDENCE trial with canagliflozin.
What are the two primary types of cardiovascular events measured in CVOTs?
Cardiovascular death and non-fatal myocardial infarction.
Why was the EMPA-REG Outcomes Trial significant?
It was the first trial to show cardiovascular and renal benefits for empagliflozin.
What are the FDA-approved indications for empagliflozin?
To reduce the risk of cardiovascular death and hospitalization for heart failure.
What is the impact of liraglutide on cardiovascular risk?
It reduces the risk of major cardiovascular events by 22% in the LEADER trial.
How does GLP-1 receptor agonist therapy impact renal outcomes?
It reduces the risk of new or worsening nephropathy in patients with diabetes.
