Independent testing results for quality and purity
Although an association with urinary congenital malformations was identified, it was based on limited unadjusted data and may reflect confounding by maternal diabetes or obesity rather than a true treatment effect
Primary results for SOLSTICE and VISTA to be shared for the first time Vanita R
Figure 4: Time to First Occurrence of Hospitalization for Heart Failure or CV Death in the DECLARE Trial Figure 5: Time to First Occurrence of Hospitalization for Heart Failure in the DECLARE Trial 14.4 Chronic Kidney Disease The Trial to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease (DAPA-CKD, NCT03036150) was an international, multicenter, randomized, double-blind, placebo-controlled trial in adult patients with chronic kidney disease (CKD) (eGFR between 25 and 75 mL/min/1.73 m2) and albuminuria [urine albumin creatinine ratio (UACR) between 200 and 5000 mg/g] who were receiving standard of care background therapy, including a maximally tolerated, labeled daily dosage of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
Regulatory environment (external): Active uncertainty - FDA's April 2026 proposal to restrict 503B compounding remains open for public comment through June 29, 2026
Phase 3 clinical trials recorded an average of 28.7% body weight reduction at 68 weeks roughly 71 pounds alongside a 75.8% reduction in knee osteoarthritis pain scores
