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Real-world HbA1c reduction with liraglutide matches large clinical trial
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Despite differences typically seen between large randomized controlled trial populations and real-world cohorts, researchers observed similar reductions in HbA1c associated with use of liraglutide, according to findings published in Diabetes Care.
“Seventy-three percent of real-world patients initiating liraglutide in Northern Denmark would have been ineligible for the trials leading to the approval of liraglutide,” Jakob Schöllhammer Knudsen, MD, a doctoral student in the department of clinical epidemiology, Aarhus University Hospital, Denmark, told Endocrine Today. “These patients, however, experienced similar reductions in mean HbA1c as both real-world patients eligible for trials and patients participating in the trials.”
Liraglutide (Victoza, Novo Nordisk), a GLP-1 receptor agonist, was approved by the European Medicines Agency in 2009 and by the FDA in 2010, based on findings from the Liraglutide Effect and Action in Diabetes (LEAD) 1-5 trials.
In the current study, Knudsen and colleagues reviewed data from population-based medical databases in Denmark to evaluate whether patients who initiated liraglutide in a real-world clinical care setting would have been eligible to participate in the LEAD trials. Included in this analysis were 9,251 individuals residing in northern Denmark who filled a first-time liraglutide prescription between 2009 and 2015. The researchers adapted each criterion for the LEAD 1-5 trials (such as age, comorbid conditions, current drug use and HbA1c level) to the Danish National Patient Registry, the Danish Prescription Registry and the clinical laboratory information system as was suitable.
The researchers found that 73.2% of routine clinical care users of liraglutide often had comorbidities that would have rendered them ineligible for the LEAD 1-5 trials, including ongoing noninsulin therapy for less than 3 months (11.4%), clinically significant active cardiovascular disease (28.6%), other significant disease (11.2%), an HbA1c level outside the eligible range (27.3%), current insulin treatment (36.9%), impaired renal function (4.3%), cancer (3.5%) or recurring hypoglycemia (0.5%).
After the study interval, liraglutide was approved for expanded indications, which permitted the use of liraglutide combined with other glucose-lowering drug therapies, such as insulin. Moreover, liraglutide was subsequently found to have a beneficial effect in patients with CVD.
In an analysis that left out previous glucose-lowering drug use and pre-existing CVD as exclusion criteria, the researchers found that 45% of real-world users would not have been eligible for LEAD 1-5.
In general, patients who were not eligible for clinical trial participation had higher HbA1c before starting liraglutide (8.7%) than those who were eligible (8.4%). At 6 months, however, these patients demonstrated similar HbA1c reductions as those who were eligible (–1% vs. –0.9%).
“Real-world patients ineligible for trial participation can expect to see the same drug effect as eligible patients,” Schöllhammer Knudsen said. “However, due to a high prevalence of comorbidities, more safety studies are needed for these patients.” – by Jennifer Byrne
For more information:
Jakob Schöllhammer Knudsen, MD, can be reached at jsk@clin.au.dk.
Disclosures: One of the study authors reports he has received funding for his institution from Novo Nordisk for unrelated projects; another author reports he has served on advisory or speakers boards, as a consultant or received research support from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gubra, MedImmune, Merck, Norgine, Novo Nordisk, Sanofi and Zealand Pharma.
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