Background
The effects of the sodium-glucose co-transporter-2 inhibitor empagliflozin on renal and cardiovascular disease have not been tested in a dedicated population of people with chronic kidney disease (CKD).
Methods
The EMPA-KIDNEY trial is an international randomized, double-blind, placebo-controlled trial assessing whether empagliflozin 10 mg daily reduces risk of kidney disease progression or cardiovascular death in people with CKD. People with or without diabetes mellitus (DM) were eligible provided they had: (i) an estimated glomerular filtration rate (eGFR) ≥20, <45 mL/min/1.73m2; or (ii) an eGFR ≥ 45, <90 mL/min/1.73m2 with a urinary albumin: creatinine ratio (uACR) ≥200 mg/g. The trial design is streamlined: extra work for collaborating sites is kept to a minimum, and only essential information is collected.
Results
Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized. Mean age at randomization was 63.8 (SD 13.9) years, 2192 (33%) were female, and 3570 (54%) had no prior history of DM. Mean eGFR was 37.5 (14.8) mL/min/1.73m2, including 5185 (78%) with an eGFR < 45 mL/min/1.73m2. Median (Q1-Q3) uACR was 412 (94–1190) mg/g, with a uACR < 300 mg/g in 3194 (48%). The causes of kidney disease included diabetic kidney disease (n = 2057 [31%]), glomerular disease (n = 1669 [25%]), hypertensive/renovascular disease (n = 1445 [22%]), other (n = 808 [12%]), and unknown causes (n = 630 [10%]).
Conclusions
EMPA-KIDNEY will evaluate the efficacy and safety of empagliflozin in a widely generalizable population of people with CKD at risk of kidney disease progression. Results are anticipated in 2022.
A new 11 Be(d, p) 12 Be transfer reaction experiment was carried out in inverse kinematics at 26.9A MeV, with special efforts devoted to the determination of the deuteron target thickness and of the required optical potentials from the present elastic scattering data. In addition a direct measurement of the cross section for the 0 + 2 state was realized by applying an isomer-tagging technique. The s-wave spectroscopic factors of 0.20 +0.03 −0.04 and 0.41 +0.11 −0.11 were extracted for the 0 + 1 and 0 + 2 states, respectively, in 12 Be. Using the ratio of these spectroscopic factors, together with the previously reported results for the p-wave components, the single-particle component intensities in the bound 0 + states of 12 Be were deduced, allowing a direct comparison with the theoretical predictions. It is evidenced that the ground-state configuration of 12 Be is dominated by the d-wave intruder, exhibiting a dramatic evolution of the intruding mechanism from 11 Be to 12 Be, with a persistence of the N = 8 magic number broken.
A cluster-transfer experiment of 9 Be( 9 Be, 14 C → α+ 10 Be)α at an incident energy of 45 MeV was carried out in order to investigate the molecular structure in high-lying resonant states in 14 C. This reaction is of extremely large Q-value, making it an excellent case to select the reaction mechanism and the final states in outgoing nuclei. The high-lying resonances in 14 C are reconstructed for three sets of well discriminated final states in 10 Be. The results confirm the previous decay measurements with clearly improved decay-channel selections and show also a new state at 23.5(1) MeV. The resonant states at 22.4(3) and 24.0(3) MeV decay primarily into the typical molecular states at about 6 MeV in 10 Be, indicating a well developed cluster structure in these high-lying states in 14 C. Further measurements of more states of this kind are suggested.
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