Two promising heart drugs did not perform better than placebo in large clinical trials — a blow to many cardiologists and companies who were betting on the drugs’ promise, The New York Times reported Nov. 7.
Novartis’ pelacarsen and Novo Nordisk’s ziltivekimab were widely expected to bring a new era of heart disease prevention. Pelacarsen sharply lowers levels of lipoprotein(a), a blood protein widely believed to cause heart attacks and strokes, while ziltivekimab blocks IL-6, an inflammatory protein.
But the final results, presented at the annual meeting of the American Heart Association, found neither drug performed better than placebo. In addition, neither trial found a benefit in any subgroup of patients.
The results “are about as neutral as they can be,” Karol Watson, MD, a director of UCLA’s preventive cardiology program, told the Times.
The reasons for the failures are unclear, but researchers have presented several theories to the Times.
In the Zeus trial of ziltivekimab, which enrolled 6,376 patients with severe heart disease and advanced kidney disease, the drug lowered inflammation but did not improve outcomes. Principal investigator Paul Ridker, MD, of Mass General Brigham, questioned whether the trial targeted the wrong protein or patient population, or whether patients’ disease was too advanced to be helped.
For pelacarsen, Horizon trial principal investigator Steven Nissen, MD, of Cleveland Clinic, said patients may have had disease too advanced to benefit. Roger Blumenthal, MD, of Johns Hopkins, suggested patients’ blood pressure and LDL cholesterol were already so well controlled that lowering Lp(a) couldn’t reduce their risk further. Dr. Ridker noted all Horizon patients were taking anti-clotting medications, which may have blunted the drug’s effect.
Novo Nordisk is continuing to test ziltivekimab in patients who have had a heart attack, with results expected next year.
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