Pharmaceuticals

Semaglutide Adds to Cardiovascular Resume

Semaglutide continued to add to its cardiovascular resume, with two new studies highlighting its ability to improve heart failure symptoms and cardiorenal outcomes. 

Already a smash hit for its weight loss and obesity benefits, semaglutide’s cardiovascular potential has been gaining attention over the last few months following previous studies finding that the GLP-1 reduces major cardiac event risks by 20% and improves key heart failure quality of life metrics. 

The first of the two latest studies further supported semaglutide’s heart failure impact, showing that it led to a range of improvements among patients with HFpEF and obesity, regardless of LVEF level. In the secondary analysis of the STEP-HFpEF trial (263 semaglutide, 266 placebo; 52 weeks)…

  • Semaglutide takers showed improvements to HFpEF symptoms, physical limitations, exercise function, and inflammation, and weight, with no safety concerns 
  • Improvements and safety were similar across patient LVEF levels, which is notable given that this isn’t the case with other common HF drugs

The second study doesn’t even include data yet, but is more significant. Novo Nordisk announced that it will stop semaglutide’s FLOW kidney outcomes trial early after finding sufficient evidence supporting its efficacy for CKD

  • Starting in 2019, the FLOW trial (n = 3,534 patients w/ T2D & CKD) compared 1mg of semaglutide and a placebo’s ability to slow renal impairment progression and reduce the risk of renal and cardiovascular mortality.

Novo Nordisk will now power down the FLOW trial, and will remain blinded to study data until its conclusion, before releasing results in H1 2024. 

  • However, observers are already viewing this as a major step towards semaglutide’s potential expansion to treating four interrelated conditions (obesity, diabetes, CVD, and CKD).
  • This would also further expand CKD patients’ available treatment options, potentially alongside SGLT2i drugs, which are already used for diabetes and heart failure, and are making progress towards also becoming CKD treatments. 

Takeaway

It’s hard to overstate semaglutide’s impact, given that the GLP-1 has made Novo Nordisk Europe’s most valuable company with a market cap larger than Denmark’s GDP. The fact that semaglutide could soon expand to CVD and CKD might make it one of the most clinically and financially significant drugs we’ve ever seen.

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