Invokana (canagliflozin) is a sodium-glucose co-transporter 2(SGLT2) inhibitor that got approval from FDA on March 31st2013 for the treatment of Type II diabetes mellitus. Invokana is the first diabetes treatment approved which falls in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokana contains the active ingredient canagliflozin, an inhibitor of sodium-glucose co transporter 2 (SGLT2). SGLT2 is a member of the sodium glucose co-transporter family which are sodium-dependent glucose transport proteins. SGLT2 is the major co-transporter involved in glucose reabsorption in the kidney. Invokana works by blocking the reabsorption of glucose by the kidney thus increasing glucose excretion and lowering blood glucose levels. Its safety and effectiveness were evaluated in nine clinical trials involving total 10,285 patients with type 2 diabetes who manifested improvement in hemoglobin A1c levels and fasting plasma glucose levels. |
The hemoglobin A1c test also known as glycated hemoglobin test or glycohemoglobin test is an important blood test used to determine how well a patient’s diabetes is being controlled. Hemoglobin A1c provides an average of blood sugar control over a six to 12 week period and is used in conjunction with home blood sugar monitoring. When the sugar level is high it combines with hemoglobin, becoming "glycated." Therefore, the average amount of sugar in blood can be determined by measuring a hemoglobin A1c level. Inhibiting SGLT2 is believed to reduce blood glucose levels by increasing the amount of glucose excreted in the urine. Invokana is specifically indicated as an adjunct to diet and used to improve glycemic control in adults with type 2 diabetes mellitus.
Diabetes mellitus type 2 (formerly known as noninsulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes) is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. Type 2diabetes is initially managed by increasing exercise and dietary modifications. If blood glucose levels are not adequately lowered by applying these measures, medications should be used. The classic symptoms are excess thirst, frequent urination, and constant hunger. Obesity is thought to be the primary cause of type2 diabetes in people who are genetically predisposed to the disease. Long-term complications from high blood sugar could include heart disease, stroke, diabetic retinopathy(eyesight is affected), kidney function failure leading to dialysis, poor circulation of limbs leading to even amputations. Controlling blood sugar is the key to prevent the side effects caused by diabetes, such as vision loss, nerve damage, kidney damage and increased risk of heart attack and stroke. Type 2diabetes comprises of about 90% of cases of diabetes with the other 10% due primarily to diabetes mellitus type 1 and gestational diabetes.
Commonly, the newly diagnosed diabetes patients are prescribed with metformin (Glucophage, Glumetza, others), a diabetes medication that improves tissues' sensitivity to insulin and lowers glucose production in the liver. At this stage doctors also recommend lifestyle changes, such as losing weight and becoming more active. When metformin is not enough to control glucose level, other oral or injected medications are used to treat type 2 diabetes. Medications lower glucose in different ways. Some diabetes medications stimulate the pancreas to produce and release more insulin. These include glipizide (Glucotrol), glyburide (Diabeta, Glynase) and glimepiride (Amaryl).While others block the action of enzymes that break down carbohydrates in the intestine, such as acarbose (Precose).
Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. It contains canagliflozin, an inhibitor of sodium-glucose co transporter 2 (SGLT2), the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. It is available as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. The recommended starting dose of Invokana is 100 mg once daily which has to be taken before the first meal of the day. In patients tolerating Invokana 100 mg once daily who have an EGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control, the dose can be increased to 300 mg once daily.
Invokana (canagliflozin) is a sodium-glucose co-transporter 2(SGLT2)inhibitor. Sodium-glucose co-transporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Canagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG), and thereby increases urinary glucose excretion.
The FDA approval of Invokana was based in part on a monotherapy study. Invokana was also studied in combination with metformin, sulfonylurea, metformin and sulfonylurea, metformin and thiazolidinedione and in combination with insulin (with or without other antihyperglycemic agents). The efficacy of Invokana was compared to a dipeptidyl peptidase-4 (DPP-4) inhibitor (sitagliptin) and a sulfonylurea (glimepiride).In Phase III studies, Invokana manifested reduction in body weight and systolic blood pressure in the patients.
The important side effects caused by this drug include dehydration which may cause dizziness, fainting, light headedness, or weak feeling especially in standing position. This drug also predisposes to Yeast infections in the genitals for both men and women and urinary tract infections (UTIs).
Invokana should not be used for patients with Type 1 diabetes and Diabetic ketoacidosis in which ketones are present in urine or blood. According to the FDA Janssen Pharmaceuticals, Inc. (part of Johnson & Johnson) will have to carry out post-marketing studies on cardiovascular outcomes to check for liver abnormalities, photosensitivity reactions, adverse pregnancy outcomes, malignancies, severe hypersensitivity reactions and serious cases of pancreatitis.
Thus Invokana has got approval from FDA on the basis efficacy data manifested by this drug till date. The future study reports will conclude if this drug will remain in market for long term treatment and could be a future “blockbuster” for the treatment of type II Diabetes.
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