title: Patient-reported outcomes in trials of incretin-based therapies in patients with type 2 diabetes mellitus.
abstract: Incretin-based therapies have a glucose-dependent mode of action that results in excellent glucose-lowering efficacy with very low risk of hypoglycaemia, and weight neutrality [dipeptidyl peptidase-4 (DPP-4) inhibitors] or weight loss [glucagon-like peptide-1 (GLP-1) receptor agonists], in people with type 2 diabetes mellitus (T2DM). Patient-reported outcomes (PROs) complement physician evaluations of efficacy and tolerability and offer insights into the subjective experience of using modern diabetes treatments. We conducted a systematic search of clinical trials of the GLP-1 receptor agonists liraglutide, exenatide and long-acting exenatide, one of which included the oral DPP-4 inhibitor sitagliptin as a comparator. No other PRO data for DPP-4 inhibitors were identified. This review summarizes PRO data from eight clinical trials, the majority of which used the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and/or Impact of Weight on Quality of Life-Lite (IWQOL-Lite) to evaluate patient experience. People with T2DM were highly satisfied with modern incretin-based therapies compared with traditional therapies. Treatment satisfaction (including perceptions of convenience and flexibility) was high and generally higher with GLP-1 agonists in association with their greater glucose-lowering efficacy and tendency to facilitate weight loss. Weight-related quality of life (QoL) also improved in people using incretin therapies. The glycaemic improvements achieved with GLP-1 receptor agonists, coupled with the low incidence of hypoglycaemia and ability to cause weight loss, seemed to offset potential concern about injections. It is plausible that superior patient-reported benefits found in clinical trials may translate into improved, clinically meaningful, long-term outcomes through increased treatment acceptability. Long-term, prospective data are needed to ascertain whether this is the case in practice.
authors.affiliation: Department of Cardiovascular Sciences, University of Leicester, UK. melanie.davies@uhl-tr.nhs.uk
authors.forename: M
authors.initials: M
authors.lastname: Davies
authors.forename: J
authors.initials: J
authors.lastname: Speight
mesh_terms: D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000077270:Exenatide; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000494:pharmacology; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D006943:Hyperglycemia / Q000097:blood / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000494:pharmacology*; D054795:Incretins / Q000378:metabolism*; D007279:Injections, Subcutaneous; D000069450:Liraglutide; D008297:Male; D017060:Patient Satisfaction; D010455:Peptides / Q000008:administration & dosage / Q000494:pharmacology; D011719:Pyrazines / Q000008:administration & dosage / Q000494:pharmacology; D012648:Self Care; D000068900:Sitagliptin Phosphate; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage / Q000494:pharmacology; D014688:Venoms / Q000008:administration & dosage / Q000494:pharmacology; D015431:Weight Loss / Q000187:drug effects*; D016903:Drug Monitoring
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D000077270:Exenatide; D052216:Glucagon-Like Peptide 1; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D054795:Incretins; D000069450:Liraglutide; D010455:Peptides; D011719:Pyrazines; D000068900:Sitagliptin Phosphate; D014230:Triazoles; D014688:Venoms; C517652:hemoglobin A1c protein, human