In the Journals

Medication adherence explains HbA1c gap between real-world, trial patients

Medication adherence must be addressed to ensure that real-world patients with type 2 diabetes are reaping the same benefits of diabetes medications as patients with type 2 diabetes participating in randomized controlled trials, study data show.

Ginger S. Carls, PhD, of the Analysis Group in Menlo Park, California, and colleagues evaluated data from 11 randomized controlled trials and 873 real-world adults with type 2 diabetes to estimate and explain the gap between clinical efficacy and real-world effectiveness of type 2 diabetes medications 12 months after starting a GLP-1 receptor agonist or DPP-IV inhibitors.

Seven of the randomized controlled trials evaluated the effectiveness of GLP-1 receptor agonists and four evaluated DPP-IV inhibitors. Among the real-world participants, 652 participants received DPP-IV therapy and 221 received GLP-1 receptor agonists, and most received the recommended or maximum dose.

HbA1c levels at baseline were similar among all participants using GLP-1 receptor agonists but were higher in real-world participants compared with randomized controlled trial participants using DPP-IV inhibitors. Use of advanced therapy at baseline was higher among real-world participants compared with randomized controlled trial participants.

Through follow-up, medication adherence was relatively low among real-world participants for GLP-1 receptor agonists (29%) and DPP-IV inhibitors (37%), which was lower than would usually be reported in randomized controlled trials.

Overall change in HbA1c was similar among real-world participants for GLP-1 receptor agonists (–0.52%) and DPP-IV inhibitors (–0.51%), whereas changes in HbA1c were greater among randomized controlled trial participants for GLP-1 receptor agonists (–1.03%) and DPP-IV inhibitors (–0.68%). There was a gap of 0.51% between real-world and randomized controlled trial participants for change in HbA1c for GLP-1 receptor agonists (P < .01) and 0.18% for DPP-IV inhibitors (P = .07). Seventy-five percent of the gap for GLP-1 receptor agonists and 72% of the gap for DPP-IV inhibitors could be explained by medication adherence.

According to the researchers, the study results suggest a need for strategies for real-world patients to improve medication adherence to ensure the full benefit of therapy is realized. – by Amber Cox

Disclosure: Intarcia Therapeutics provided research funding. Carls is an employee of the Analysis Group, which has received consultancy fees from Intarcia Therapeutics to conduct the study and for medical writing assistance. Please see the study for all other authors’ relevant financial disclosures.

Medication adherence must be addressed to ensure that real-world patients with type 2 diabetes are reaping the same benefits of diabetes medications as patients with type 2 diabetes participating in randomized controlled trials, study data show.

Ginger S. Carls, PhD, of the Analysis Group in Menlo Park, California, and colleagues evaluated data from 11 randomized controlled trials and 873 real-world adults with type 2 diabetes to estimate and explain the gap between clinical efficacy and real-world effectiveness of type 2 diabetes medications 12 months after starting a GLP-1 receptor agonist or DPP-IV inhibitors.

Seven of the randomized controlled trials evaluated the effectiveness of GLP-1 receptor agonists and four evaluated DPP-IV inhibitors. Among the real-world participants, 652 participants received DPP-IV therapy and 221 received GLP-1 receptor agonists, and most received the recommended or maximum dose.

HbA1c levels at baseline were similar among all participants using GLP-1 receptor agonists but were higher in real-world participants compared with randomized controlled trial participants using DPP-IV inhibitors. Use of advanced therapy at baseline was higher among real-world participants compared with randomized controlled trial participants.

Through follow-up, medication adherence was relatively low among real-world participants for GLP-1 receptor agonists (29%) and DPP-IV inhibitors (37%), which was lower than would usually be reported in randomized controlled trials.

Overall change in HbA1c was similar among real-world participants for GLP-1 receptor agonists (–0.52%) and DPP-IV inhibitors (–0.51%), whereas changes in HbA1c were greater among randomized controlled trial participants for GLP-1 receptor agonists (–1.03%) and DPP-IV inhibitors (–0.68%). There was a gap of 0.51% between real-world and randomized controlled trial participants for change in HbA1c for GLP-1 receptor agonists (P < .01) and 0.18% for DPP-IV inhibitors (P = .07). Seventy-five percent of the gap for GLP-1 receptor agonists and 72% of the gap for DPP-IV inhibitors could be explained by medication adherence.

According to the researchers, the study results suggest a need for strategies for real-world patients to improve medication adherence to ensure the full benefit of therapy is realized. – by Amber Cox

Disclosure: Intarcia Therapeutics provided research funding. Carls is an employee of the Analysis Group, which has received consultancy fees from Intarcia Therapeutics to conduct the study and for medical writing assistance. Please see the study for all other authors’ relevant financial disclosures.