欧唐静®（恩格列净）在慢性肾病患者中疗效积极——了解慢性肾病

Introduction: Boehringer Ingelheim and Eli Lilly and Company recently announced that the EMPA-KIDNEY Phase III clinical trial of Otangjing® () will be terminated early. The reason for the termination was that in a clinical study "evaluating the efficacy of empagliflozin in the treatment of adult patients with chronic kidney disease (CKD)", empagliflozin demonstrated positive clinical efficacy and met the preset positive efficacy criteria. Let’s learn about chronic kidney disease.

Definition of chronic kidney disease

Renal damage, that is, pathology, blood, urine, and imaging abnormalities, for more than or equal to 3 months; glomerular filtration rate is less than 60mL/min/m².

Those who meet any of the above conditions can be diagnosed as chronic kidney disease. Including: glomerulonephritis, latent nephritis, pyelonephritis, Henoch-Schönlein purpura nephritis, lupus nephritis, ventilated kidney, IgA nephropathy, nephrotic syndrome, membranous nephropathy, nephrotic syndrome, diabetic nephropathy, hypertensive nephropathy, polycystic kidney disease, etc.

Stages of chronic kidney disease

Stage 1, glomerular filtration rate greater than 90mL/min/m²

Stage 2, glomerular filtration rate 60-89mL/min/m²

Stage 3, glomerular filtration rate 30-59mL/min/m²

Stage 4, glomerular filtration rate 15-29mL/min/m²

Stage 5, glomerular filtration rate less than 15mL/min/m²

Symptoms of chronic kidney disease

Understanding the early symptoms of chronic kidney disease can help patients and their families detect the disease in time and receive timely treatment, which can have a positive impact on the prognosis.

When there is a large amount of foam in the urine, blood in the urine, or increased nocturia, routine urine examination may show urine protein and red blood cells, which are very likely to indicate the occurrence of early kidney disease. These early symptoms are often not obvious and do not attract attention. Generally, patients do not feel obvious discomfort. However, once these symptoms of abnormal urine appear, it is recommended to seek medical treatment immediately.

If you wait until symptoms such as obvious fatigue, anemia, and edema appear before you think of seeking medical treatment, you may miss the early stages of the disease and lose the best opportunity for treatment, which will bring greater difficulties to the treatment of kidney disease in the future.

Digestive symptoms of chronic kidney disease: nausea, vomiting, glossitis, ammonia smell in the mouth, oral ulcers, diarrhea, etc.; neurological symptoms of chronic kidney disease: fatigue, numbness of limbs, listlessness, insomnia, delirium, etc.; cardiovascular symptoms of chronic kidney disease: hypertension, heart failure, myocardial infarction, arrhythmia, cardiomyopathy, etc. Respiratory symptoms of chronic kidney disease: End-stage renal disease may include uremic pneumonia, bronchitis, etc. Skin manifestations of chronic kidney disease: dryness, itching, rash, pigmentation, etc. In addition, patients with chronic kidney disease may also experience symptoms such as dehydration, edema, water intoxication, and metabolic disorders.

Aboutempagliflozin

Empagliflozin is an SGLT2 inhibitor. SGLT2 inhibitors were previously used to treat diabetes. They were approved for marketing in China in September 2017. They can be used alone, in combination with metformin, or in combination with metformin and sulfonylureas to improve blood sugar control in patients with type 2 diabetes.

Later, researchers found that empagliflozin not only had a clear hypoglycemic effect, but also had additional benefits of weight loss, blood pressure lowering, and uric acid lowering. It can reduce the risk of cardiovascular and kidney diseases in patients with diabetes.

Through the results of the EMPA-KIDNEY phase III clinical trial announced this time, we can see that empagliflozin is not only suitable for patients with diabetic nephropathy, but also has significant effects on non-diabetic nephropathy (chronic kidney disease).

EMPA-KIDNEYTest

EMPA-KIDNEY (NCT03594110) is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the effect of empagliflozin on clinically relevant outcomes of kidney disease progression and risk of cardiovascular death. The primary outcome was time to first cardiovascular death or renal disease progression event. Renal disease progression refers to end-stage renal disease (requiring renal replacement therapy, such as dialysis or kidney transplantation), sustained decrease in estimated glomerular filtration rate (eGFR) to <10 mL/min/1.73 m2, renal death, or sustained decrease in eGFR of ≥40% after randomization. EMPA-KIDNEY expects to enroll approximately 6,000 patients with chronic kidney disease, including those with or without diabetes or proteinuria. These patients received empagliflozin 10 mg or placebo in addition to existing standard of care.