T4 PPTs Flashcards

1
Q

What are CVOTs?

A

Cardiovascular Outcomes Trials, designed to assess the cardiovascular safety of diabetes medications.

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2
Q

What led to the FDA’s requirement for CVOTs in diabetes medications?

A

A study showing possible increased cardiovascular risk with rosiglitazone.

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3
Q

What are the key components measured in CVOTs?

A

MACE (Major Adverse Cardiac Events) including cardiovascular death, non-fatal MI, non-fatal stroke.

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4
Q

What was the result of the EMPA-REG Outcomes Trial?

A

Empagliflozin reduced cardiovascular death by 38% and MACE by 14%.

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5
Q

What did the CANVAS trial show regarding canagliflozin?

A

It reduced MACE by 14% and cardiovascular death by 13%.

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6
Q

How do SGLT2 inhibitors impact heart failure?

A

They significantly reduce the risk of hospitalization for heart failure.

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7
Q

What is the significance of the LEADER trial?

A

Liraglutide reduced cardiovascular events by 13% and MACE by 22%.

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8
Q

Which medications showed renal benefits in CVOTs?

A

SGLT2 inhibitors like empagliflozin and GLP-1 receptor agonists like liraglutide.

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9
Q

What is the FDA indication for canagliflozin in patients with CKD?

A

To reduce the risk of ESRD in adults with T2DM and diabetic nephropathy.

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10
Q

Which CVOT showed benefits in heart failure with or without diabetes?

A

Dapagliflozin in the DAPA-HF trial.

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11
Q

What is the definition of chronic kidney disease (CKD)?

A

Kidney damage determined by elevated urinary albumin or low eGFR.

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12
Q

What is the leading cause of end-stage renal disease (ESRD)?

A

Diabetes and hypertension.

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13
Q

What percentage of patients with diabetes develop CKD?

A

20-40% of patients with diabetes.

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14
Q

What is albuminuria?

A

Urinary albumin-to-creatinine ratio >30 mg/g.

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15
Q

What is considered abnormal eGFR in CKD?

A

eGFR <60 mL/min/1.73 m².

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16
Q

How does CKD impact pharmacologic management in diabetes?

A

CKD progression influences the choice and dose of diabetes medications.

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17
Q

What is the first-line treatment for CKD in patients with diabetes?

A

SGLT2 inhibitors to reduce the risk of CKD progression.

18
Q

How is CKD progression measured?

A

By tracking eGFR and urinary albumin levels.

19
Q

What is the importance of SGLT2 inhibitors in CKD management?

A

They slow the progression of CKD and reduce cardiovascular risk.

20
Q

What medications should be avoided in patients with advanced CKD?

A

Metformin and NSAIDs due to the risk of lactic acidosis and kidney damage.

21
Q

What is ASCVD?

A

Atherosclerotic cardiovascular disease, a major complication of diabetes.

22
Q

What are common conditions coexisting with diabetes that increase ASCVD risk?

A

Hypertension, dyslipidemia, and obesity.

23
Q

How does diabetes itself impact cardiovascular risk?

A

It independently increases the risk of ASCVD.

24
Q

What are the key CV risk factors for patients with diabetes?

A

Hypertension, smoking, dyslipidemia, obesity, and CKD.

25
Q

What are the ADA indicators of high CV risk?

A

Age >55 with two or more risk factors like hypertension, dyslipidemia, or albuminuria.

26
Q

What is the recommended treatment for patients with ASCVD and diabetes?

A

SGLT2 inhibitors or GLP-1 receptor agonists with cardiovascular benefits.

27
Q

What is the impact of GLP-1 receptor agonists on cardiovascular risk?

A

They reduce major adverse cardiovascular events (MACE) and lower blood pressure.

28
Q

Why is early detection of ASCVD important in diabetes management?

A

It helps guide pharmacologic therapy and improves long-term outcomes.

29
Q

What is the primary goal of pharmacologic therapy in patients with ASCVD?

A

To reduce cardiovascular risk while managing glycemic control.

30
Q

Which medications have demonstrated the greatest cardiovascular benefits in CVOTs?

A

SGLT2 inhibitors and GLP-1 receptor agonists.

31
Q

What is the role of MACE in CVOTs?

A

It measures the composite of cardiovascular death, non-fatal MI, and non-fatal stroke.

32
Q

Which drug class was first to show a reduction in both cardiovascular and renal outcomes in CVOTs?

A

SGLT2 inhibitors.

33
Q

What is the role of GLP-1 receptor agonists in reducing stroke risk?

A

They lower the risk of ischemic stroke in patients with diabetes and ASCVD.

34
Q

How does dapagliflozin benefit patients with heart failure?

A

It reduces hospitalization for heart failure in patients with or without diabetes.

35
Q

Which CVOT focused on renal disease as the primary endpoint?

A

The CREDENCE trial with canagliflozin.

36
Q

What are the two primary types of cardiovascular events measured in CVOTs?

A

Cardiovascular death and non-fatal myocardial infarction.

37
Q

Why was the EMPA-REG Outcomes Trial significant?

A

It was the first trial to show cardiovascular and renal benefits for empagliflozin.

38
Q

What are the FDA-approved indications for empagliflozin?

A

To reduce the risk of cardiovascular death and hospitalization for heart failure.

39
Q

What is the impact of liraglutide on cardiovascular risk?

A

It reduces the risk of major cardiovascular events by 22% in the LEADER trial.

40
Q

How does GLP-1 receptor agonist therapy impact renal outcomes?

A

It reduces the risk of new or worsening nephropathy in patients with diabetes.