Trial Files Throwback: Apixaban for VTE Associated with Cancer, Dapagliflozin in CKD, Angiotensin–Neprilysin Inhibition vs. Enalapril in HF
How does an anticoagulant compare to a LMWH for VTE in cancer patients?
Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer (Caravaggio)
Agnelli G et al. NEJM (March 2020)
Bottom Line: This was a randomized, open-label, noninferiority trial with 1155 patients who had active cancer and newly diagnosed proximal deep-vein thrombosis or pulmonary embolism. Patients were randomized in a 1:1 ratio to receive either oral apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily) or subcutaneous dalteparin for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the treatment period. Results showed recurrent venous thromboembolism in 5.6% of the apixaban group and 7.9% of the dalteparin group, meeting criteria for noninferiority. Major bleeding occurred in 3.8% of the apixaban group and 4.0% of the dalteparin group, demonstrating that apixaban was an effective and safe alternative to low-molecular-weight heparin for the treatment of cancer-associated venous thromboembolism.
What is the effect of an SGLT2i on CKD, with or without DM2?
Dapagliflozin in Patients with Chronic Kidney Disease (DAPA-CKD)
Heerspink HJL et al. NEJM (September 2020)
Bottom line: This was a randomized, double-blind, placebo-controlled trial with 4304 patients with chronic kidney disease, with or without type 2 diabetes. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg once daily or placebo, in addition to standard therapy. The primary outcome was a composite of a sustained decline of at least 50% in estimated glomerular filtration rate, end-stage kidney disease, or death from renal or cardiovascular causes. Results showed that the primary outcome occurred in 9.2% of the dapagliflozin group and 14.5% of the placebo group. Dapagliflozin significantly reduced the risk of kidney failure and death and demonstrated a favorable safety profile in patients with chronic kidney disease.
What is the effect of sacubitril-valsartan on cardiovascular outcomes?
Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure (PARADIGM-HF)
McMurray JJV et al. NEJM (September 2014)
Bottom Line: This was a randomized, double-blind trial with 8442 patients who had chronic heart failure with a reduced ejection fraction. Patients were randomized in a 1:1 ratio to receive sacubitril–valsartan or enalapril, in addition to standard heart failure therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. Results showed that the primary outcome occurred in 21.8% of the sacubitril–valsartan group and 26.5% of the enalapril group. Sacubitril–valsartan significantly reduced the risk of cardiovascular death and heart failure hospitalization and was associated with an acceptable safety profile.
Trial Files Issue #2026-06
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