Episode 303: 302. Effects of statin therapy on diagnoses of new-onset diabetes

06/13/24 • 6 min

The incidence of new-onset diabetes was basically the same but statistically significantly higher for those individuals on low-to-moderate–intensity statins compared with placebo 1.2 vs 1.3% annually which is a very small difference.

But with high-intensity statins compared with placebo (4.8% vs. 3.5% annually)

Among patients with known diabetes at baseline, glycemia worsened slightly with statin therapy compared with placebo

Here is the problem- diabetes is a number—a surrogate if you will. Statins fix a surrogate but have been proven to improve patient orientated outcomes

https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S2213858724000408?returnurl=https:%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS2213858724000408%3Fshowall%3Dtrue&referrer=https:%2F%2Fwww.jwatch.org%2F

But with high-intensity statins compared with placebo (4.8% vs. 3.5% annually)

Among patients with known diabetes at baseline, glycemia worsened slightly with statin therapy compared with placebo

Here is the problem- diabetes is a number—a surrogate if you will. Statins fix a surrogate but have been proven to improve patient orientated outcomes

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Episode 302: 301. Development and Validation of the American Heart Association's PREVENT Equations

At change in c stats of 0.007 or 0.0009 is not a meaningful change so I cant say we should use this over the PCE—yes this new calculator has the benefit of removal of race, and the use race-based algorithms.

We don’t know that this leads to better outcomes—is the the race algorithms that lead to worse outcomes or was it access to care or is it some other factor we don’t know yet.

I think this is worth nothing and if you want to switch you certainly can but if your goal is a calculator to be used to detect primary CAD or to use in your primary CAD population EITHER seems to be just fine at this time.
https://pubmed.ncbi.nlm.nih.gov/37947085/

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Episode 304: 303. Associations Between Surrogate Markers and Clinical Outcomes

Question What is the strength of association between surrogate markers used as primary end points in clinical trials to support Food and Drug Administration (FDA) approval of drugs treating nononcologic chronic diseases and clinical outcomes?

often surrogate markers are used as primary end points in clinical trials to support FDA approval of drugs

I get it

Surrogate markers offer the advantage of reducing the duration, size, and total cost of trials

n 2018, the Food and Drug Administration (FDA) publicly released an Adult Surrogate Endpoint Table of more than 100 surrogate markers that may be used as primary end points in clinical trials that form the basis of traditional or accelerated approval of new drugs or biologics.

The authors evaluated Thirty-seven surrogate markers listed in FDA’s table of markers that can be used as primary end points in clinical trials across 32 unique nononcologic chronic diseases.

Most surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses.
https://jamanetwork.com/journals/jama/article-abstract/2817850