Efficacy and Safety of Linagliptin (Tradjenta) in Adults With Type-2 Diabetes Mellitus

INTRODUCTION Current estimates indicate that diabetes affects approximately 26 million people in the U.S. (8.3% of the population). Almost 19 million people have diabetes, and the disease remains undiagnosed in an estimated 7 million people. Diabetes is associated with significant morbidity, including kidney failure, nontraumatic lower-limb amputations, neuropathies, hypertension, periodontal disease, and blindness. In addition, diabetes is a major risk factor for heart disease and stroke and is the seventh leading cause of death in the U.S.1 Diabetes also incurs a substantial financial burden. In 2007, the estimated total cost (direct costs plus indirect costs) associated with diabetes was $174 billion in the U.S. Direct medical costs totaled $116 billion, and indirect costs accounted for $58 billion.1 The burden of uncontrolled diabetes, in terms of hospitalizations, is also substantial, according to the National Hospital Discharge Survey (NHDS). Based on NHDS data, the total number of hospitalizations in the U.S. was estimated to be 38.8 million in 2004. Approximately 5.2 million admissions had at least one diagnostic code indicating diabetes, and approximately 609,000 admissions were primarily the result of diabetes. Of the latter, approximately 191,181 (31.4%) admissions were due to uncontrolled diabetes. Most of the hospitalizations were categorized as emergencies or urgent. INDICATION Linagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes. This drug should not be used in patients with type-1 diabetes or in those with diabetic keto acidosis. Linagliptin has not been studied in combination with insulin.6