Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
To compare the safety and efficacy of empagliflozin versus other treatments in Pakistani
 Muslim population with type II diabetes mellitus.
Diabetes is the one of the most common non-communicable diseases affecting 425 million adults
 worldwide. This figure is expected to rise to 629 million by the year 2045.1 90% of the
 diabetic population has type 2 diabetes. 2 As of 2018, more than 500 million individuals are
 residing with type 2 diabetes mellitus globally. 3 In Pakistan, the situation is similarly
 alarming. According to a recent survey, 16.98% of the Pakistani population has diabetes.4 The
 primary target of therapy in diabetes mellitus is optimum blood glucose control. In case of
 type 2 diabetes, this is achieved by a combination of oral hypoglycemic agents and injectable
 drugs with insulin as a last resort.

 A number of oral agents targeting various sites of action are available. Sodium-glucose
 cotransporter-2 (SGLT2) inhibitors are newer class of drugs that have been introduced. They
 have a unique mechanism of action. By acting at the sodium glucose co-transporter, they block
 the reabsorption of glucose leading to an increase in urinary glucose excretion and lowering
 of plasma glucose.5 This action is completely independent of the beta cell function. There
 are several theoretical advantages to this approach. In addition to lowering blood glucose,
 the urinary glucose excretion results in loss of calories and weight reduction and the
 associated osmotic diuretic effect can aid in lowering blood pressures.6,7 Numerous studies
 have demonstrated a favorable risk benefit ratio of empagliflozin as monotherapy8 as well as
 add-on therapy to other hypoglycemic agents.9,10,11,12 They also have additional
 cardiovascular benefits with several studies documenting a reduction in mortality.13,14
 Moreover, the sodium glucose co-transporters also demonstrated a reduction in the onset and
 worsening of nephropathy and preservation of renal function.15 This effect is not restricted
 to empagliflozin alone, as other drugs in the class have also demonstrated this benefit.16
 Empagliflozin with its novel mechanism of action has its own set of side effects. Increased
 urinary glucose losses lead to a higher proportion of urinary tract infections and genital
 tract infections. This has been evidenced in various studies.17 The osmotic diuresis that
 benefits in lowering blood pressures at one end, also predisposes the patients to volume
 depletion.Empagliflozin, one of the three drugs from this class, approved by the FDA for
 treatment of type 2 diabetes. According to the recent ADA and the EASD guidelines, they have
 become an essential component of the algorithm recommended for managing type 2 diabetes.18
 The recently published consensus statement by the South Asian Federation of Endocrine
 Societies has incorporated sodium glucose co-transporter 2 inhibitors in the treatment of
 patients with type 2 diabetes as monotherapy in patients who are intolerant to or have any
 contraindication to metformin therapy. Additionally, drugs belonging to this class are also
 recommended as combination therapy with other oral hypoglycemic agents as well as insulin.19
 Empagliflozin, however, has not been studied in the Pakistani population as yet. The main aim
 of this study is to establish the efficacy and safety of empagliflozin in optimum control of
 blood sugar in type 2 diabetes. This is the first study of its kind being performed in the
 Pakistani population.
Inclusion Criteria:

 -  Pakistani muslim male / female, type 2 diabetic patient having age from 18 years to 75
 years

 -  Patient who give informed consent voluntarily

 -  BMI ≤45 kg/m2

 -  Glycosylated hemoglobin of 7 - ≤10%

 Exclusion Criteria:

 -  Patients who are on empagliflozin treatment

 -  Indication of liver disease, defined by serum levels of either alanine
 aminotransferase, aspartate aminotransferase, and alkaline phosphatase above 3 times
 upper limit to normal

 -  Estimated glomerular filtration rate (eGFR) <45 mL /min /1.73m2

 -  History of recurrent urinary tract infection (UTI) and/or past 3 months' history of
 UTI and its treatment

 -  Patients with positive urine culture for UTI at the time of screening

 -  Patients who have been admitted to the hospital in the past 3 months for diabetic
 ketoacidosis (DKA) and hyperosmolar hyperglycemic state

 -  Patients with past 3 months' history of fungal infection and its treatment

 -  History of blood dyscrasias or any disorders causing haemolysis or unstable red blood
 cell

 -  History of benign prostate hyperplasia

 -  Any acute coronary syndrome, stroke and/or transient ischemic attack (TIA) in the
 previous 3 months

 -  Any contraindication for patients to Biguanides, Sulfonylureas, DPP-IV inhibitors,
 SGLT-2 Inhibitors

 -  Treatment with anti-obesity drugs or any other treatment leading to unstable body
 weight

 -  Patients with past 6 weeks treatment history with systemic steroids or thyroid
 hormones or any other uncontrolled endocrine disorder except T2DM

 -  Pre-menopausal women who are nursing or pregnant or are of childbearing potential and
 not practicing an acceptable method of birth control

 -  Any other clinical condition that would jeopardize patients safety while participating
 in this study