Novo Nordisk presented the full results of STRIDE, a phase 3b peripheral artery disease (PAD) outcomes trial that looked at the effects of once-weekly injectable Ozempic® (semaglutide 1.0 mg) in adults with type 2 diabetes and PAD, at the American College of Cardiology’s (ACC) Annual Scientific Session and Expo in Chicago, US.
These new data from phase 3b trials were published in the journal The Lancet.
Novo Nordisk presented the full results of STRIDE, a phase 3b peripheral artery disease (PAD) outcomes trial that looked at the effects of once-weekly injectable Ozempic® (semaglutide 1.0 mg) in adults with type 2 diabetes and PAD, at the American College of Cardiology’s (ACC) Annual Scientific Session and Expo in Chicago, US.
Peripheral artery disease (PAD) may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks, such as retrieving the mail challenging. In individuals with PAD and diabetes, the disease can be even more severe, affecting small blood vessels and limiting the effectiveness of revascularization procedures and other treatments. Semaglutide 1.0 mg is the first medication in over two decades to show improvements in cardiometabolic and cardiovascular outcomes as well as meaningful improvements in functional capacity and quality of life, which could address a critical unmet need for those with both PAD and type 2 diabetes,
The significant improvements in walking distance and patient-reported quality of life observed with semaglutide 1.0 mg in the STRIDE trial are promising and represent an important step forward on the path to advancing treatment options for this patient population.
Marc P. Bonaca
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PAD is a severe form of atherosclerotic cardiovascular disease that is under-screened and underdiagnosed, affecting roughly 230 million individuals worldwide. Type 2 diabetes is a major risk factor for PAD, and roughly one-third of those with the disease have it. There are few medicines available to explicitly improve functional limits in PAD, leaving a substantial unmet demand in this population.
The STRIDE trial’s safety results are consistent with the well-established safety and tolerability profile of once-weekly semaglutide, as supported by long-term safety data spanning more than 33 million patient-years of exposure. There were fewer serious adverse events (SAEs) recorded in the semaglutide group compared to the placebo group (74 [19%] vs 78 [20%]). Two people (1%) in the semaglutide group and two participants (1%) in the placebo group experienced SAE, which was most likely related to the medication.
Based on the results of the STRIDE clinical trial, Novo Nordisk applied to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for a label extension for Ozempic®. A decision is expected around 2025.
STRIDE
STRIDE is a double-blind, randomized, placebo-controlled phase 3b clinical trial that examines the effect of once-weekly injectable semaglutide 1.0 mg, known as Ozempic®, on functional ability. It enlisted 792 people with type 2 diabetes, symptomatic PAD, and walking-induced leg pain. The primary endpoint was maximal walking distance on a constant load treadmill for persons treated with semaglutide versus placebo at week 52. STRIDE is the only specialized PAD functional outcomes trial that uses a GLP-1 RA.
Source: Novo Nordisk
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