Safety outcomes of semaglutide by chronic kidney disease severity in the FLOW trial

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Abstract

[INTRODUCTION] People with type 2 diabetes (T2D) and chronic kidney disease (CKD) often experience medication intolerance and side effects that worsen with lower estimated glomerular filtration rate (eGFR). This prespecified secondary analysis assessed the safety of semaglutide by baseline eGFR. [METHODS] FLOW (NCT03819153) was a double-blind, randomized, placebo-controlled trial testing the efficacy of subcutaneous semaglutide 1.0 mg once-weekly on a primary kidney outcome (50% or more eGFR reduction, kidney failure, or death due to kidney or cardiovascular causes) in participants with T2D and CKD. Safety data were collected selectively and included serious adverse events (SAEs), AEs leading to treatment discontinuation, and prespecified AEs of special interest (AESIs). In this descriptive assessment, systematically collected safety data were reported numerically by baseline eGFR. [RESULTS] Of 3533 participants, 1767 received semaglutide and 1766 received placebo. Fewer SAEs were reported with semaglutide than placebo across baseline eGFR subgroups (45.1% versus 50.4% in the 60 or more ml/min per 1.73 m2 subgroup, and 56.4% versus 60.4% in the under 30 ml/min per 1.73 m2 subgroup). SAEs related to infections and infestations; cardiac disorders; respiratory, thoracic and mediastinal disorders; and metabolism and nutrition disorders were generally less frequent with semaglutide than placebo, regardless of baseline eGFR. Treatment discontinuations due to AEs were higher with lower baseline eGFR across treatment groups (60 or more ml/min per 1.73 m2: semaglutide 11.2%, placebo 11.3%; under30 ml/min per 66 1.73 m2: semaglutide 18.8%, placebo 18.7%). Discontinuations specifically due to gastrointestinal AEs were reported more frequently with semaglutide (4.5%) than placebo (1.1%), regardless of baseline eGFR. Frequencies of AESI were similar between treatment groups across baseline eGFR subgroups. [CONCLUSIONS] In this safety assessment, SAEs were reported less frequently with semaglutide than placebo, with corresponding patterns observed for treatment discontinuations and AESIs. No unexpected safety concerns were identified across the spectrum of eGFR represented in the FLOW trial.

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