That's right, FLOW is over. However, I'm not talking about theFlow podcast. I want to talk about the FLOW study known asEffect of semaglutide versus placebo on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease,which was in course and full steam ahead, financed by the manufacturer of Liraglutide, Tirzepatide and also Semaglutide, Novo Nordisk. When suddenly, the study was interrupted on October 10, 2023.
To understand where I'm going, first you must understand what was the purpose of creating medications with GLP-1 analogues in mid-2005. Initially, the medication had a very short half-life, but this was resolved with a medication half-life of one week: semaglutide.Â
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GLP-1 agonists
T2DM treatment is an evolving area, and among drugs, GLP-1 receptor agonists have emerged as a highly effective choice. These medications are based on a deep understanding of the mechanisms underlying blood glucose regulation and demonstrate benefits that make them a respectable treatment option.Â
GLP-1 is a natural hormone released by our intestines in response to food intake. By stimulating insulin secretion from pancreatic cells when glucose levels are high, these medications help control post-meal glucose spikes, a common challenge in patients with diabetes.
In addition, GLP-1 suppresses the secretion of the hormone glucagon. This is particularly important because it reduces excessive glucose production by the liver, a central problem in type 2 diabetes. On the other hand, this medication also slows gastric emptying, which results in slower digestion and absorption of food. Consequently, there is a reduction in post-meal glycemic peaks.
What's new about Flow?
We enthusiastically celebrate the power of these medications to promote weight loss given the strong association between obesity and type 2 diabetes. Now, we also have reason to celebrate,as encouraging evidence emerges that these medications play a role in reducing the progression of chronic kidney disease in patients with diabetes.This is particularly significant since the diagnosis of type 2 diabetes often occurs late. Thus, before glycemic levels begin to deregulate, minimal damage to the nephrons has already been present for at least five years.
FLOW, a phase III clinical trial, was meticulously designed as a large randomized, double-blind, placebo-controlled study. Its objective was toevaluate the effects of Semaglutide on the progression of chronic kidney disease and the risks of renal and cardiovascular mortality in patients with type 2 diabetes and chronic kidney disease. What made this study particularly notable was the decision to stop it early, due to extremely positive results.
Characteristics of the Flow Study
The study sampled more than 3,500 patients from different parts of the world and administered Semaglutide 1.0mg/week as a complement to standard treatment. Its structure allowed for interim analysis once a specific number of primary outcome events occurred. The interim analysis, performed by an Independent Data Monitoring Committee, made a surprising recommendation: stop the study early due to the remarkable efficacy of Semaglutide.
The news of the early interruption of the study brought with it a series of emotions and expectations. It represents a victory for science and, above all, for patients. Stopping early accelerates access to promising treatments that have the potential to change lives. Novo Nordisk is now committed to analyzing the data in detail before sharing findings in the first half of 2024.
However, it is important to note that, as with any medical advancement, Semaglutide's effectiveness comes with evolving safety concerns. In July 2023, the United Kingdom began an investigation into potential risks of self-harm and suicidal ideation in patients takingWegovy, Ozempicand other GLP-1 agonists. Additionally, an article published inJAMAlast year pointed to a possible elevated risk of gastrointestinal side effects associated with this class of medications. These concerns are fundamental and highlight the importance of balancing clinical benefits with patient safety.
FLOW: A New Frontier in Medical Research
On the other hand, the most exciting aspect of this story is the potential to transform the treatment of patients with type 2 diabetes and chronic kidney disease. The early interruption of FLOW demonstrates that medical research is constantly advancing and bringing new hope. Patients can now look forward to future developments and treatment opportunities that may arise.
As Novo Nordisk works tirelessly to analyze data, it is critical for the medical community, patients and healthcare professionals to closely monitor these developments. Medical research is constantly evolving, and stopping FLOW early is just a sample of what can be achieved when science and medicine come together to find solutions to complex problems.
In summary, the FLOW study and its early termination represent a significant milestone in medical research and treatment of conditions such as type 2 diabetes and chronic kidney disease. The positive results obtained so far show great potential for Semaglutide as an effective treatment option not only for cardiovascular diseases, diabetes, obesity but also in protecting against the progression of chronic kidney disease in diabetic patients. Progress in medicine is an ongoing journey, and FLOW is just one step toward a healthier future for everyone.
References
ROSSING, Peter; BAERES, Florian M M; BAKRIS, George; BOSCH-TRABERG, Heidrun; GISLUM, Mette; GOUGH, Stephen C L; IDORN, Thomas; LAWSON, Jack; MAHAFFEY, Kenneth W; MANN, Johannes F e. The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrology Dialysis Transplantation, [S.L.], v. 38, no. 9, p. 2041-2051, 18 Jan. 2023. Oxford University Press (OUP).
NAUCK, Michael A.; QUAST, Daniel R.; WEFERS, Jakob; MEIER, Juris J.. GLP-1 receptor agonists in the treatment of type 2 diabetes – state- of-the-art. Molecular Metabolism, [S.L.], v. 46, p. 101102, apr. 2021. Elsevier BV.
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