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In FDA-designed cohort study, mortality risk not related to paclitaxel-coated devices

In the SAFE-PAD cohort study of patients with peripheral artery disease designed in part by the FDA, there was no difference in mortality between those treated with paclitaxel-coated devices and those treated with uncoated devices.The results of SAFE-PAD, a retrospective cohort study designed after feedback from the FDA, were presented by Eric A. Secemsky, MD, MSc, RPVI, FACC, FSCAI, FSVM, ....

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PARAGON-HF: Sacubitril/valsartan reduces triglyceride levels in HFpEF

PARAGON-HF: Sacubitril/valsartan reduces triglyceride levels in HFpEF
Source:
Selvaraj S, et al. Public Health and Heart Failure: Emerging Evidence. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).
Disclosures:
Selvaraj reports no relevant financial disclosures. Please see the study for the other authors’ relevant financial disclosures.
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Big Drops in LDL Cholesterol With Inclisiran, but US Clinicians Still Await Drug's Approval

March 03, 2021
A pooled analysis of clinical trials testing inclisiran (Novartis) that confirms the agent’s potent effects on LDL cholesterol has now been published. Yet the small interfering RNA (siRNA) molecule, which has since been approved in Europe, remains in limbo in the United States.
The analysis, combining patients from three ORION trials, was first presented at the virtual 2020 American College of Cardiology Scientific Session and was published this week in the
Journal of the American College of Cardiology. However, the ultimate green light from the US Food and Drug Administration, which had been hoped for last year, has not yet been given. Last December, the FDA declined to approve inclisiran after identifying problems with a European manufacturing site, a decision that came within weeks of European regulators clearing the siRNA molecule for lowering LDL-cholesterol levels in patients with hypercholesterolemia or mixed dyslipidemia. ....

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