New drug approved by US FDA for treatment of type 2 diabetes, empagliflozin alone and combination drug containing empagliflozin + Metformin hydrochloride
US FDA on 20-06-2023 approved drugs containing empagliflozin
alone and combination drug containing empagliflozin + Metformin hydrochloride.
For treatment of type two diabetes in children of age more than 10 years.
Empagliflozin was already approved by US FDA-approved in 2014 for treatment of
type 2 diabetes, now it is approved for children above 10 years of age.
The drug Jardiance (empagliflozin) and Synjardy
(empagliflozin and metformin hydrochloride) are approved for type 2 diabetes
for patients of age group more than 10 and above. Under priority review
designation.
Type two diabetes develops over the period as pancreases do
not produce sufficient insulin or the insulin produced is not effective in
reducing blood sugar level. The US FDA had approved Metformin hydrochloride in
year 2000 which was the only approved drug for treatment of diabetes in
children, and for pediatric use.
Diabetes if not treated causes serious consequences like,
congestive cardiac arrest, damage to myelin sheath of nerves leading to nerve
damage. Ketoacidosis which is life threatening, patients lose consciousness
shortness of breathing.
Information about empagliflozin:
The drug Empagliflozin is a drug of class which enhances the
excretion of glucose from renal tubules. Drug Empagliflozin facilitates
excretion of glucose through urine, in normal scenario the kidney renal tubules
keep on reabsorbing glucose and sodium and potassium ions to keep the balance
of the body, which maintains the electrolyte balance.
In the early age of the patient, the cardiac events and
ketoacidosis the drug used in shorter duration to bring the blood sugar under
control and later on maintained over metformin helps patients to have better
quality of life, In following cases Empagliflozin is preferred.
1.patients with atherosclerotic cardiovascular disease or
heart failure.
2.Type 2 diabetes Patient with Nephropathy.
3.Patients with weight gain and metformin alone are not
sufficient to control hyperglycemia, and who are not able to take insulin.
Use of Empagliflozin should be made very carefully
evaluating the total risk due to diabetes. Long-term use of the Empagliflozin
should be avoided.
Mode of action Empagliflozin:
Drug act by inhibiting sodium dependent sodium-glucose
co-transporter (SGLT-2) enzyme. Which keeps on reabsorbing the glucose back in
the blood, which is excreted from the body through the process of urine
formation.
Our body reabsorbs back part of sodium and glucose which is
initially secreted into proximal renal tubules. Which helps in maintaining the
electrolyte balance of the body. Which also is responsible for high blood
pressure and higher glucose in the body.
The reabsorption of glucose from proximal renal tubule is
facilitated by Sodium/glucose cotransporter 2 enzyme system. SLC5A2 gene is
responsible for the coding and production of Sodium/glucose cotransporter 2
enzyme.
Safety and efficacy
trial is conducted in 157 patients of age group 10 to 17 it was a double blind
trial in patients having inadequate controlled type 2 diabetes. Safety and
efficacy was evaluated and found satisfactory compared to other approved drugs.
Significant decrease in HbA1c, the hemoglobin conjugated glucose, marker for
diabetes.
Side effects of Empagliflozin:
Weight loss.
Urinary tract infection.
Thrush
Itchy skin.
Increased risk of fournier gangrene.
Hypoglycemia.
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