Trulicity Beats Others in Patient Adherence, Real World Data Shows

New real-world data recently showed that Trulicity had significantly higher patient adherence and longer persistence compared to weekly injections of semaglutide or exenatide in individuals with type 2 diabetes, according to a press release.

Researchers leveraged US claims from the HealthCore Integrated Research Database (HIRD) between August 2017 and June 2019 of people with type 2 diabetes initiating weekly injectable treatment with Trulicity who were new to GLP-1 receptor agonist (RA) treatment.

The primary objective of the study was to compare patient adherence and persistence over six months among people with type 2 diabetes initiating once-weekly glucagon-like peptide-1 receptor agonists, Trulicity (1.5 mg and 0.75 mg) to semaglutide (1 mg and 0.25/0.5 mg) and exenatide, the press release said.

Researchers acquired individual characteristics such as age, gender, adapted Diabetes Complications Severity Index (aDCSI) score and select comorbidities.

At six months, individuals taking Trulicity showed higher patient adherence and persistence than those taking semaglutide or exenatide. And substantially fewer people discontinued treatment with Trulicity compared to semaglutide or exenatide.

Specifically, 59.7 percent of those taking Trulicity adhered to the medication versus 42.7 percent of those taking semaglutide. And individuals saw 143.6 days of persistent use of Trulicity versus 129.9 days for semaglutide

Over 40 percent of patients (40.8 percent) taking semaglutide discontinued use, while only 30.8 percent of those taking Trulicity did the same.

When studying Trulicity versus exenatide, researchers found that 58.1 percent of individuals taking Trulicity adhered to the medication, versus 40.3 percent of those taking exenatide.

Individuals took Trulicity for 142 days consistently, while those taking exenatide took the medication for 121.4 days. Nearly 50 percent of individuals taking exenatide (49.4 percent) discontinued treatment, while just 32.1 percent discontinued Trulicity use.

"Type 2 diabetes is a progressive and personal condition and real-world studies are critical to help us further understand people's experiences with the condition and treatment," Leonard Glass, MD, FACE, vice president of medical affairs, Lilly, said in the press release. 

"This real-world study reinforces the value of the simple approach of once-weekly Trulicity and the long-term impact it can have on not only the treatment experience of people with diabetes, but also on outcomes."

More than 30 million Americans have diabetes and 90 to 95 percent of them have type 2 diabetes, FDA said in a recent announcement. These individuals may suffer from serious medical complications such as nerve damage, kidney and eye damage, sleep apnea, and heart and blood vessel disease.

Back in mid-March, FDA issued new draft guidance evaluating the safety of two new drugs for type 2 diabetes and removing the previous requirement for standardized clinical trials for diabetes drugs. 

The draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” proposed a broader safety evaluation approach before drug approval beyond ischemic cardiovascular disease and inclusion of a broader scope of human subjects.

The new guidance, which replaces the FDA’s 2008 guidance, stems from the FDA’s ongoing evaluation of these cardiovascular trials which noted safety data beyond ischemic cardiovascular was desired to evaluate the safety profile of antidiabetic drugs before they were approved.

“The FDA continues to review new clinical trial evidence and update its recommendation for drug development to reflect emerging scientific information,” Lisa Yanoff, MD, acting director of the division for metabolism and endocrinology products in the FDA’s center for drug evaluation and research, said in the announcement.

“By following FDA recommendations, sponsors have shown that type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients. Now, with this proposed approach, we will have broader, valuable safety information for these medications.”