SAN DIEGO — A groundbreaking study highlights the significant kidney and cardiovascular benefits associated with ongoing treatment for individuals suffering from chronic kidney disease (CKD). Over a two-year treatment period with the drug empagliflozin, the observed benefits wane substantially within approximately one year after patients cease their treatment. This underscores an imperative need for continued therapy to sustain these advantages.
William G. Herrington, MD, the leading author of the study and a member of the Renal Studies Group at the Nuffield Department of Population Health, University of Oxford, UK, emphasized during a press briefing at the American Society of Nephrology (ASN) Kidney Week 2024, “We know that empagliflozin is safe and effective; now it is clear that maintaining patients on this treatment is essential to maximizing its benefits.”
The research findings were published concurrently in the esteemed journal New England Journal of Medicine.
Part of the comprehensive EMPA-KIDNEY trial, this study investigated the efficacy of empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The trial revealed that this medication significantly reduces the risk of worsening kidney disease across diverse patient profiles. Due to promising preliminary outcomes, the trial was halted early.
To further explore the long-lasting effects of empagliflozin post-discontinuation, Herrington and his colleagues analyzed data from 4,891 out of 6,609 active trial participants, all of whom had CKD and participated in an additional two-year observational follow-up.
The selection criteria targeted adult patients with CKD, specifically those with an estimated glomerular filtration rate (eGFR) of 20 to 45 mL/min/1.73 m2, or those with an eGFR of 45 to 90 mL/min/1.73 m2 alongside elevated urine albumin-to-creatinine ratios of 200 mg/g or higher.
At the start of the post-trial phase, participants had a mean age of 63 years, with 34% identifying as female. Approximately 57% of the cohort had no history of diabetes, with a mean eGFR of 37 mL/min/1.73 m2. About 35% of respondents from both treatment groups had a mean eGFR of less than 30 mL/min/1.73 m2.
Patients were randomly assigned to receive empagliflozin at a dose of 10 mg once daily or a placebo that matched the treatment in appearance.
Herrington pointed out, “The lack of a significant difference in SGLT2 inhibitor use post-trial permits the evaluation of any persisting effects of the previous treatment.”
In analyzing results from both active and post-trial periods, the primary composite outcome—comprising kidney disease progression or cardiovascular mortality—was observed in 865 out of 3,304 patients (26.2%) within the empagliflozin group, contrasted with 1,001 out of 3,305 patients (30.3%) in the placebo group, yielding a hazard ratio (HR) of 0.79; P
During the solely post-trial period, the significance of the hazard ratio for the primary outcome remained, though it diminished to 0.87 (P = .04).
Specifically regarding other outcomes, the incidence of kidney disease progression was reported at 23.5% for the empagliflozin group versus 27.1% for the placebo group. The combined risk for death or progression to end-stage kidney disease was found to be 16.9% for those receiving empagliflozin and 19.6% for the placebo. Cardiovascular mortality rates were 3.8% in the empagliflozin cohort compared to 4.9% among placebo participants.
Moreover, mortality due to non-cardiovascular causes displayed no disparity between the groups, each standing at 5.3%.
Overall, the research indicated that the carry-over effect resulted in a 13% reduction in risk for the primary outcome, which is significantly lower than the 28% reduction experienced during the active trial phase. This carry-over effect appeared to persist for approximately 12 months.
Furthermore, the analyses regarding the long-term eGFR trajectory during the active trial have demonstrated that empagliflozin effectively decelerated progression among all subgroups based on albuminuria.
The overarching conclusion drawn by the researchers is that while post-trial benefits were evident, they were notably lesser than those observed during the treatment period and seemed temporary in nature. Herrington stated, “To maximize the cardiorenal clinical benefits of SGLT2 inhibitors requires long-term treatment approaches for CKD patients.”
In a professional commentary on the study, Emily Chang, MD, an associate professor in the Division of Nephrology and Hypertension at the University of North Carolina at Chapel Hill, supported the findings, emphasizing the implications that discontinuation of empagliflozin may bring about for patients at any disease stage. “These drugs are likely intended for lifelong use,” affirmed Chang, adding that she has already structured her practice with that understanding.
While noting the potential effects of other SGLT2 inhibitors, Chang remarked that validation through further studies is required to corroborate the anticipated outcomes across the entire class of SGLT2 inhibitors. “If tolerated, my recommendation would be to retain these patients on this medication indefinitely,” she concluded.
The study was funded and sponsored by Boehringer Ingelheim. Herrington disclosed receiving additional financial support from Eli Lilly and the UK Medical Research Council, while Chang reported no relevant financial relationships.
Dialysis Drama: Continuing the Quest for Kidney Health with Empagliflozin
Welcome, fellow kidney aficionados and cardiovascular crusaders! Today, we’re diving deep into the murky waters of chronic kidney disease (CKD) treatment, where every drop of knowledge can make a serious splash. We’re talking about a recent study that’s making some waves at the American Society of Nephrology Kidney Week 2024, revealing that discontinuing empagliflozin might just turn your renal benefits into a fleeting memory—like that time you drunkenly texted your ex and woke up wondering what went wrong. Spoiler alert: it’s not a one-night stand kind of drug!
The Rundown: What’s Happening with Empagliflozin?
For those unacquainted with this miracle maker, empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor—try saying that five times fast while balancing on one leg! This little pill has shown great promise in not only halting the progression of CKD but also providing cardiovascular benefits that could make the heart flutter faster than a first date. However, the new findings reveal that this magic sauce wears off quicker than a cheap cologne after a night out.
The lead wizard of this study, William G. Herrington, MD, from the University of Oxford, dropped a truth bomb during a press briefing: “We know that empagliflozin is safe, we know it works, and now we know we need to keep people on the treatment to maximize the benefits.” And just like a bad breakup, the sign is clear—once you stop, the remarkable results tend to vanish faster than your willpower in a bakery. After a year of treatment, the significant benefits begin to slide to the left, leaving us pondering if we should simply label these medications as lifelong commitments—kind of like your Netflix subscription you forgot to cancel.
Trial by Fire: The Numbers
In the extensive EMPA-KIDNEY trial, researchers pulled data from a whopping 4,891 active participants, which is about 74% of the original trial group. Let’s get into the nitty-gritty: those lucky patients were assigned to either the empagliflozin group (aka the ‘cool kids’ club) or the placebo group (the ‘we’ll just watch and hope for the best’ group). When they compared outcomes, they found that a solid 26.2% of the empagliflozin users faced the grim reaper of kidney disease or cardiovascular death, versus 30.3% from the placebo side—because who doesn’t love a sweet victory over a 3.5% difference?
But here’s where the plot thickens: the effects dwindled to a 13% risk reduction after stopping the treatment, compared to that original fabulous 28% while still enjoying their daily empagliflozin. Think of it like a favorite TV show that gets canceled just as it starts getting really good.
The “Temporary” Benefit—Or How Life Can Be Like a Snapchat?
To wrap our heads around this, the post-trial benefits were rather short-lived and proved to be almost as trivial as your cousin’s stories from his gap year. After about 12 months, the miracles of empagliflozin began to show signs of wearing off faster than last year’s fashion trends. As Herrington aptly stated, “The post-trial benefit was smaller than the benefit when taking study treatment.” Therefore, if you thought you could breathe easy after the trial, it’s time to think again. Maintaining these magical treatment levels is not just optional; it might just be the key to keeping your kidneys and heart purring like a well-tuned engine!
Expert Opinions: A Lifelong Affair with Meds?
Chiming in with some sage advice, Dr. Emily Chang, an associate professor of medicine, highlighted the all-too-real implications of discontinuing empagliflozin. She suggests we treat these drugs as lifelong companions for patients with CKD—because why not sign up for a lifetime of health if it means living longer? She even mused, “If tolerated, my plan is to leave these patients on this medicine lifelong.” Talk about commitment—perhaps Dr. Chang should also run a dating service, given her enthusiasm!
Conclusion: The Long and Winding Road to Kidney Health
So, there you have it—empagliflozin isn’t just a fleeting fling; it’s the partner you need for the long haul if you want to protect your kidneys and heart. As we navigate these kidney waters, remember that while a good relationship with empagliflozin promises protection, it’s clearly a drug that needs continuous nurturing. No one likes the idea of lifelong meds, but hey, if it keeps our insides running smoother than a well-oiled machine, then we’d better commit!
Until next time, stay positively kidney-minded, keep your humor intact, and always remember that when it comes to CKD management, it’s not just about playing the field; it’s about staying in the game for the long run!
Disclaimer: The study was funded and sponsored by Boehringer Ingelheim. Dr. Herrington reported other financial support from Eli Lilly and the UK Medical Research Council. Dr. Chang reported no relevant financial relationships.
This article uses humor and a sharp observational style to present complex medical information in an engaging, accessible manner. Enjoy your kidneys, and remember to keep that sense of humor intact!