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Question clinique
Does dapagliflozin improve renal and cardiovascular outcomes in patients with chronic kidney disease?
L’Essentiel
In patients with chronic kidney disease and a glomerular filtration rate (GFR) between 25 and 75, with or without type 2 diabetes mellitus (T2DM), dapagliflozin 10 mg once daily reduces the likelihood of death (number needed to treat [NNT] = 48) and the need for dialysis or renal transplant (NNT = 71) when taken for a median of 2.4 years. The cost of the medication in the United States is $500 per month (www.goodrx.com [November 3, 2020]). 1b
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Industry
Cadre: Outpatient (any)
Sommaire
Dapagliflozin is an SGLT-2 inhibitor used to treat T2DM. Another drug in this class, canagliflozin, has been shown to improve renal and cardiovascular outcomes in patients with T2DM. The current industry-funded study identified adults with chronic kidney disease (estimated GFR 25 to 75 mL per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio of 200 to 5000), all of whom were taking an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. At baseline, the patients' mean age was 62 years, 33% were women, the mean GFR was 43, 67.5% had T2DM, 38% had cardiovascular disease, and 11% had heart failure. The groups were balanced at baseline and analysis was by intention to treat. Patients were randomized to receive dapagliflozin 10 mg once daily or matching placebo and they were followed up for a median 2.4 years, with excellent retention (99.7%) in the trial. Fewer patients in the dapagliflozin group required chronic dialysis or underwent renal transplant (3.2% vs 4.6%; hazard ratio [HR] 0.66; 95% CI 0.49 - 0.90; NNT = 71 for 2.4 years). There was no significant difference between the groups in deaths from renal or cardiovascular causes, though all-cause mortality was lower in the dapagliflozin group (4.7% vs 6.8%; P = .004; NNT = 48 over 2.4 years). Adverse events were similar between groups. Results were similar for older and younger patients, by race, and whether or not the patient had T2DM.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Commentaires
Cost
I think when sending out this content the title should mention the significant economic cost of this treatment. Stating the monthly per patient cost doesn’t go far enough in my opinion. In order to show a difference of one death in this 2.4 year study the cost is over $690,000 and the cost to prevent one patient going on to dialysis was over $1,000,000. Seems more than relevant to the discussion of possible benefit to me.
renal failure
hemodialysis is expensive, a huge burden for the patient and our health care system and every month it can be avoided is good for all.