(Glasgow, Scotland) New findings from the landmark FLOW trial, presented at the 63rd ERA Congress, show that once-weekly semaglutide significantly improved health-related quality of life in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD), equivalent to around eight additional days in full health per year.1
The trial previously demonstrated that semaglutide reduced the risk of major kidney disease events by 24% and all-cause mortality by 20% compared with placebo over a median treatment duration of 3.4 years.² This new analysis provides complementary patient-centred evidence, showing that the benefits of semaglutide may extend beyond traditional clinical outcomes to how patients feel and function in everyday life.
For people living with both T2D and CKD, symptoms, treatment burden and reduced physical functioning can substantially affect day-to-day well-being, making quality of life an increasingly important treatment goal.
Among 3,533 randomised participants in the FLOW trial, 1,767 received semaglutide and 1,766 received placebo. Health-related quality of life (QoL) was assessed using the EQ-5D-5L questionnaire, a patient-reported measure of health status and well-being covering mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and overall health perception. Participants completed the questionnaire at baseline and yearly thereafter.
After two years of treatment, health utility scores – which range from 0 (equivalent to death) to 1 (perfect health) – remained stable in the semaglutide group but declined in those receiving placebo. The estimated treatment difference of +0.021 (p=0.0001) corresponded to approximately eight additional days per year spent in full health.
Self-rated general health scores, measured using a visual analogue scale, also improved with semaglutide but worsened with placebo, with a significant treatment difference of +2.15 (p<0.0001), again becoming worse over time with placebo while stable on semaglutide.
Four of the five areas assessed by the EQ-5D-5L questionnaire (mobility, self-care, usual activities, and pain/discomfort) improved significantly with semaglutide compared with placebo (all p<0.03). No significant difference was observed in anxiety/depression (p=0.55). Benefits were broadly consistent across patient subgroups, including age, BMI, kidney function, urine albumin-to-creatinine ratio and previous cardiovascular events.
"We were surprised by the extent of the quality-of-life benefits seen with semaglutide, because they were not only clinically meaningful but consistently experienced across multiple aspects of daily life, including physical functioning and overall well-being," said Professor Johannes Mann, lead author of the study.
"We were uncertain about quality-of-life outcomes because gastrointestinal side effects are common with GLP-1 receptor agonists," Prof. Mann explained. "Our findings, however, confirm that the benefits of semaglutide in chronic kidney disease extend beyond traditional clinical endpoints to subjective outcomes that matter directly to patients."
Globally, over 850 million people are living with CKD, and cases have more than doubled since 1990.3 It is a long-term condition in which there are abnormalities in kidney structure or function for at least three months with an impact on health, and is closely associated with diabetes, hypertension and cardio-kidney-metabolic conditions.4,5 CKD increases the risk of kidney failure and premature death, making early detection vital to enable timely interventions that may help slow disease progression.6
The findings may also influence how clinicians discuss treatment goals with patients living with T2D and CKD.
"When speaking with representatives of CKD patient groups and in discussions around clinical trial outcomes, patients often place considerable importance on quality of life alongside longevity," said Prof. Mann. "Our findings reinforce the importance of a broader, patient-centred approach to treatment goals. They suggest that, overall, well-being may improve with semaglutide despite gastrointestinal side effects, complementing previously reported reductions in kidney and mortality risks."
A key next step for researchers will be to better understand what specifically drives the quality-of-life improvements observed with semaglutide and the mechanisms underlying these effects.
