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New Approved Complete Diabetes Regimen in One Tablet

Nov 9, 2019
 
Editor: David L. Joffe, BSPharm, CDE, FACA

Author: Adam Chalela, B.S. Doctor of Pharmacy Candidate USF College of Pharmacy

Qternmet XR: diabetes has never been simpler to control with this once daily pill.

Currently, first line options for the control of diabetes depend on the patient-specific HbA1C percentage at the time of diagnosis: less than 7.5% warrants monotherapy while an HbA1C of greater than or equal to 7.5% warrants initial combination therapy with two first-line agents. Patients who do not demonstrate adequate control of their blood sugars after three months are then candidates for triple therapy with a metformin backbone. As we already know, one of the largest barriers to entry for better patient health is medication adherence, and one of the best ways to improve medication adherence is through a reduced pill burden.

Following the initial approval of dual combination therapy in 2017, Qtern (dapagliflozin/saxagliptin) manufacturer AstraZeneca sought to reduce pill burden even further in patients with type 2 diabetes who had inadequate blood glucose control with either dapagliflozin alone or both dapagliflozin and saxagliptin dual therapy. As metformin is already the key backbone of many diabetes therapy regimens, plans for the creation of Qternmet XR were easily created. Qternmet XR is an oral triple-combination therapy of dapagliflozin, a sodium-glucose co-transporter inhibitor, saxagliptin, a dipeptidyl peptidase inhibitor, and metformin, a biguanide, in a single once daily oral tablet.

Qternmet XR was approved on the basis of the results from two separate phase III studies. These studies aimed to determine the effects of adding dapagliflozin and saxagliptin as add on therapy on overall glycemic control in patients with diabetes already taking metformin. Safety and efficacy profiles of the triple combination therapy were evaluated. A total of 492 patients within these placebo controlled, double blinded, phase III studies underwent treatment with a combination of dapagliflozin and saxagliptin added to metformin. The average patient in these studies was a 54 year old white female who had diabetes for between 7 and 8 years with a mean HbA1c of over 8% with normal kidney function.

The primary efficacy end points of these studies were change in HbA1c at 24 weeks. A combination of dapagliflozin and saxagliptin added to metformin was compared to the results of each individual medication added to metformin alone. Overall, 42.8% of patients randomized to triple combination therapy achieved a goal HbA1c of <7% at 24 weeks while only 21.8% of patients taking dapagliflozin and metformin and 28.5% of patients taking saxagliptin and metformin reached their A1c goal. The most common adverse reactions that were observed within the patient population that was treated with triple combination therapy of dapagliflozin, saxagliptin, and metformin include dyslipidemia, headache, infection (upper respiratory, urinary tract, and genital), and gastrointestinal related events. Incidence of declining renal function was observed in few patients within the study cohort. Overall, adverse event profiles of the individual drugs matched their profile when taken in combination.

Dr. Ralph DeFronzo is a Professor of Medicine out of the University of Texas Health Diabetes Center in San Antonio, Texas and carries an immense passion for diabetes care. He is the chief of the diabetes division within his college and also holds a deputy director title at the Texas Diabetes Institute. In a 2017 interview with Steve Freed, editor in chief of Diabetes In Control, Dr. DeFronzo emphasizes the importance of taking control of diabetes in the earliest and most aggressive way possible to allow patients with diabetes to stay in control of the progression of their health. Dr. DeFronzo mentions that the best way to achieve this goal is through triple combination therapy, though he does mention that cost and availability of medications plays a large role in medication non-compliance. Drug manufacturers often provide co-pay assistance programs for patients with and without active prescription insurance coverage, especially in the instance of new and novel drugs like Qternmet XR. 

Practice Pearls:

  • Qternmet XR is a single, once daily oral tablet made of dapagliflozin, saxagliptin, and metformin and carries an adverse reaction profile similar to the profiles of each individual medication.
  • Results show that the combination of dapagliflozin and saxagliptin have improved glycemic outcomes when added to metformin in patients with diabetes as compared to either individual agent added to metformin.
  • It is important to be aware of potential coupons and manufacturer co-pay assistance programs that may be available for patients to use.

 

Qternmet XR [package insert]. Wilmington DE: AstraZeneca Pharmaceuticals; 2019.

Freed S. Current Interview: Dr. Ralph DeFranzo on the Effectiveness of Triple Therapy. Diabetes in Control; 2017. Available at: http://www.diabetesincontrol.com/current-interview-dr-ralph-defronzo/

Adam Chalela, Doctor of Pharmacy Candidate, USF College of Pharmacy