AstraZeneca India (AstraZeneca Pharma India Limited), a leading science-led biopharmaceutical company, has announced the full results from the clinical trials of its latest diabetes drug, Dapagliflozin, showing significant benefits in reducing chronic kidney disease (CKD) progression in patients with and without type-2 diabetes.

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This CKD benefit is over and above the superior anti-diabetic and heart failure benefits. Chronic kidney disease (CKD) is emerging to be an important chronic disease globally. One reason is the rapidly increasing worldwide incidence of diabetes and hypertension (increased blood pressure). The prevalence of CKD in India is estimated to be 17.2 percent, given its population >1 billion, the rising incidence of CKD is likely to pose major problems for both healthcare and the economy in future years.

Chronic kidney disease means kidneys are damaged and can not filter blood the way they should. The disease is called “chronic” because the damage to kidneys happens slowly over a long period of time. Chronic kidney disease can also cause other significant health problems, such as heart disease. If one has kidney disease, it increases chances of having a stroke or heart failure. High blood pressure can be both a cause and a result of kidney disease.

In the early stages of chronic kidney disease, individual may have few signs or symptoms, like swelling of the feet and ankles, itching, muscle cramps, nausea, vomiting and the lack of hunger. However, chronic kidney disease may not become apparent until kidney function is significantly impaired. Getting evaluated with tests like Serum Creatinine, Blood Urea and Urine albumin are essential as a screening tool for individuals at risk. Once diagnosed, treatment for chronic kidney disease focuses on slowing the progression of the kidney damage, usually by controlling the underlying cause.

Chronic kidney disease can progress to end-stage kidney failure, which is fatal without dialysis or a kidney transplant. Kidney disease can lead to other health problems like heart failure, cardiovascular death, etc. Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that dapagliflozin along with standard of care reduced the worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with chronic kidney disease (CKD). The results were consistent in patients both with and without type-2 diabetes (T2D).

Dr. Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said, “Due to life style changes, increased life expectancy, and high prevalence of non-communicable diseases, chronic kidney disease is uniformly affecting low and middle income countries including India. Despite currently available therapies, a significant unmet need for effective management of CKD continues to exist globally. The DAPA-CKD trial which included 201 Indian patients with CKD into a global clinical study enrolling 4,304 patients, was able to show a benefit in patients with CKD. Now this goes on show that Dapagliflozin which is effective in Type 2 Diabetes, select Heart Failure patients has demonstrated significant efficacy now even in Chronic Kidney Disease.”

Dr. Sujoy Ghosh, Professor - Department of Endocrinology – Institute of Post Graduate Medical Education and Research (IPGMER) - Kolkata, said, “Diabetes and hypertension account for most cases of CKD world-wide. Uncontrolled diabetes and hypertension in certain ethnic groups, including Asian Indians, are at high risk of developing CKD. Once these diseases are diagnosed they should be screened for kidney disease at diagnosis and at least annually, thereafter. Routine screening tests should include detection of albuminuria and serum creatinine with determination of eGFR. Any abnormalities in the same warrants further investigations.” This is the only SGLT2 inhibitor that has shown significant benefits in the treatment of Chronic Kidney Diseases in adult patients with and without type-2 diabetes.