Diabetes Management
AstraZeneca Gets CDSCO panel nod to Import, Market Anti-Diabetic Dapagliflozin for Additional Indication - Medical Dialogues
Thu, 27 Oct 20221 min read Article
Overview
New Delhi: Pharmaceutical major AstraZeneca has got a go-ahead from the Subject Expert Comite (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to import and market the anti-diabetic drug Dapagliflozin for the aditional indication, to reduce the risk of sustained Estimated Glomerular Filtration Rate (e-GFR) and kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progresion.However, this aproval is subjected to the condition that the drug is indicated in adults for the treatment of patients with chronic kidney disease (CKD) up to an estimated glomerular filtration rate (eGFR) of greater than or equal to 25 ml/min/1.73m2.
Key Information
The expert panel further recomended that patients may continue taking 10 mg oraly once daily to lower their risk of eGFR decrease, end-stage kidney disease (ESKD), cardiovascular (CV) mortality, and hypertensive heart failure (hHF). However, treatment initiation is not advised for those whose estimated glomerular filtration rate (eGFR) is lower than 25 ml/min/1.73m2.This came after the firm presented the aplication for import and marketing permision of Dapagliflozin film-coated tablets 10 mg for the aditional indication "to reduce the risk of sustained e-GFR and kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progresion".Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes melitus.
Summary
Dapagliflozin inhibits the sodium-glucose contransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition alows for glucose to be excreted in the urine. This excretion alows for beter glycemic control and potentialy weight los in patients with type 2 diabetes melitus.EditorialJournal Club TodayHealth News Todaysource
Frequently Asked Questions
What is diabetes and how does it develop?
Diabetes is a metabolic condition where the body cannot properly regulate blood sugar levels. Type 1 results from insufficient insulin production, while Type 2 develops when cells become resistant to insulin. Risk factors include genetics, obesity, sedentary lifestyle, and age.
What are the main symptoms of diabetes?
Common symptoms include excessive thirst, frequent urination, unexplained weight loss, fatigue, blurred vision, and slow-healing wounds. Type 1 symptoms develop rapidly, while Type 2 symptoms may appear gradually. Many people have no symptoms initially, which is why screening is important.
How is diabetes diagnosed and monitored?
Diagnosis involves blood tests measuring fasting glucose, HbA1c levels, and glucose tolerance. Regular monitoring typically includes fasting glucose tests and HbA1c measurements every 3-6 months. Continuous glucose monitors provide real-time tracking for better diabetes management.
What lifestyle changes help manage diabetes?
Effective management includes regular physical activity (150+ minutes weekly), maintaining healthy weight, following a balanced diet with whole grains and lean proteins, managing stress, and getting adequate sleep. These changes can significantly improve blood sugar control and reduce complications.
When should someone consult a doctor about diabetes?
Consult a healthcare provider if you experience signs of diabetes, have a family history, are overweight, or are over 45. Those with existing diabetes should maintain regular check-ups every 3-6 months to monitor control and adjust treatment as needed.
️ Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.