Real-world effectiveness of liraglutide versus dulaglutide in Japanese patients with type 2 diabetes: a retrospective study.
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SUBMITTER: Tanaka K
PROVIDER: S-EPMC8742102 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionInjectable semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that was previously shown to be superior to liraglutide and dulaglutide in head-to-head comparisons in GLP-1 RA-naïve individuals. It is hypothesized that semaglutide will cause further reductions in glycated hemoglobin A1c (HbA1c) and weight in type 2 diabetes mellitus (T2DM) patients previously treated with liraglutide or dulaglutide. The REALISE-DM study provides the first real-world evidence of the effectiveness and tolerability of semaglutide in patients switching from another GLP-1 RA.MethodsThis retrospective real-world effectiveness analysis included T2DM adults who were on a stable dose of liraglutide or dulaglutide prior to switching to semaglutide. The primary outcome was change in HbA1c. Secondary outcomes were the changes in weight and body mass index (BMI), the occurrence of gastrointestinal side effects (GSEs), and discontinuations. Linear mixed models were used to estimate changes in HbA1c, weight, and BMI, and logistic regression was employed to analyze GSEs and discontinuations.ResultsSix months after the 164 patients in this study had switched to semaglutide, their mean HbA1c had decreased by 0.65% (7.1 mmol/mol) (95% prediction interval [PI]: 0.48, 0.81% [5.2, 8.9 mmol/mol]) from a baseline of 7.9% (interquartile range [IQR]: 7.3, 8.8) (62.8 mmol/mol [IQR: 56.3, 72.7]), while their weight and BMI had reduced by 1.69 kg (95% PI: 1.01, 2.37) and 0.59 kg/m2 (95% PI: 0.34, 0.84), respectively. Nineteen patients (11.6%) developed GSEs after switching.ConclusionsThis study supports switching T2DM patients on liraglutide or dulaglutide to injectable semaglutide to achieve further reductions in HbA1c and weight. Although a small number of GSEs occurred, semaglutide was well tolerated by the majority of the patients.
| S-EPMC7846659 | biostudies-literature
Project description:IntroductionRandomized controlled trials (RCTs) have demonstrated the efficacy of dulaglutide in adults with type 2 diabetes mellitus (T2DM), but results may not be generalizable in routine practice. This pragmatic literature review aimed to summarize real-world evidence (RWE) for dulaglutide.MethodsThe MEDLINE, EMBASE, NHS Economic Evaluation Database, and Health Technology Assessment databases were searched from January 2014 to July 2019 for studies providing RWE for dulaglutide in adults with T2DM regarding at least one outcome of interest (change in glycated hemoglobin [HbA1c]; weight; adherence; persistence; discontinuation; costs; healthcare resource utilization; health-related quality of life; patient satisfaction; and preference). Relevant congress abstracts were identified from EMBASE.ResultsA total of 29 studies (11 articles; 18 abstracts) were included. RWE for dulaglutide was not identified for all outcomes of interest. Dulaglutide reduced HbA1c from baseline to 3-24 months by 0.5-2.2% across studies (n = 20), and 23.4-55.7% of patients achieved HbA1c < 7.0%. Weight was reduced by 2.1-6.4 kg across studies of 3-12 months (n = 15). Based on outcomes from ten studies, 27.2-61.0% of dulaglutide patients were adherent. Mean persistence was 146-152 days and > 250 days in 6- and 12-month studies, respectively. Most studies reported discontinuation rates of 26.2-37.0%. Adherence and persistence were consistently reported to be greater in dulaglutide-treated patients in RW settings compared with other glucagon-like peptide-1 receptor agonists. Dulaglutide was associated with lower costs per 1% reduction in HbA1c compared with exenatide, liraglutide, or basal insulin (n = 3 studies).ConclusionEvidence from RWE studies suggests that dulaglutide may be associated with clinically relevant reductions in HbA1c, with a favorable adherence, persistence, and discontinuation profile in patients with T2DM in routine clinical practice. These findings provide additional insights regarding the potential value of dulaglutide in real-world settings that may assist healthcare decision makers in the delivery of patient-centered care.
| S-EPMC7324465 | biostudies-literature
Project description:INTRODUCTION:This study compared the clinical and economic outcomes of long-term use of liraglutide versus sitagliptin for the treatment of type 2 diabetes (T2DM) in real-world practice in the USA. METHODS:We identified adult patients (≥ 18 years old) with T2DM who initiated liraglutide or sitagliptin in 2010-2014 using a large claims database. Quarterly glycemic control measures and annual healthcare costs were assessed during the 1st and 2nd years of persistent medication use. Their associations with medication use (liraglutide or sitagliptin) were estimated using multivariable regression models adjusted for patient demographic and clinical characteristics. RESULTS:A total of 3113 patients persistently used liraglutide (N = 493) or sitagliptin (N = 2620) for ≥ 1 year [mean age (standard deviation, SD): 53 (8.5) vs. 56 (9.7) years; 48.3% vs. 62.3% males; both p < 0.05]; 911 (including 113 liraglutide users) were persistent users for ≥ 2 years. During the 1st-year follow-up, liraglutide users (versus sitagliptin users, after adjustment) experienced larger glycated hemoglobin (HbA1c) reductions from baseline (ranging from 0.34%-point in quarter 1 to 0.21%-point in quarter 4); higher likelihoods of obtaining HbA1c reductions of ≥ 1%-points or ≥ 2%-points [odds ratios (ORs) range 1.47-2.04]; and higher likelihoods of reaching HbA1c goals of < 6.5% or < 7% (ORs range 1.51-2.12) (all p < 0.05). Liraglutide users also experienced HbA1c reductions from baseline in the 2nd-year follow-up (0.53-0.33%-point, all p < 0.05). Although liraglutide users incurred higher healthcare costs than sitagliptin users during the 1st-year follow-up, they had $2674 (per patient) lower all-cause medical costs (adjusted cost ratio: 0.67, p < 0.05) and similar total costs (all-cause and diabetes-related) in the 2nd year. CONCLUSION:Long-term use of liraglutide for 1 or 2 years was associated with better glycemic control than using sitagliptin. Savings in medical costs were realized for liraglutide users during the 2nd year of persistent treatment, which offset differences in pharmacy costs. FUNDING:Novo Nordisk Inc.
| S-EPMC5984935 | biostudies-literature
Project description:BACKGROUND:Head-to-head comparison of clinical effectiveness between dulaglutide and liraglutide in Asia is limited. This study was aimed to assess the real-world comparative effectiveness of dulaglutide versus liraglutide. METHODS:We conducted a retrospective cohort study by utilizing multi-institutional electronic medical records to identify real-world type 2 diabetes patients treated with dulaglutide or liraglutide during 2016-2018 in Taiwan and followed up until 2019. Effectiveness outcomes were assessed at every 3 months in the 1-year follow-up. Propensity score techniques were applied to enhance between-group comparability. Significant differences in changes of effectiveness outcomes between treatment groups during the follow-up were examined and further analyzed using mixed-model repeated-measures approaches. RESULTS:A total of 1512 subjects receiving dulaglutide and 1513 subjects receiving liraglutide were identified. At 12 months, significant HbA1c changes from baseline were found in both treatments (dulaglutide: -?1.06%, p?<?0.001; liraglutide: -?0.83%, p?<?0.001), with a significant between-group difference (-?0.23%, 95% confidence interval -?0.38 to -?0.08%, p?<?0.01). Both treatments yielded significant declines in weight, alanine aminotransferase level, and estimated glomerular filtration rate from baseline (dulaglutide: -?1.14 kg, -?3.08 U/L and -?2.08 mL/min/1.73 m2, p?<?0.01; liraglutide: -?1.64 kg, -?3.65 U/L and -?2.33 mL/min/1.73 m2, p?<?0.001), whereas only dulaglutide yielded a significant systolic blood pressure reduction (-?2.47 mmHg, p?<?0.001). Between-group differences in changes of weight, blood pressure, and liver and renal functions at 12 months were not statistically significant. CONCLUSIONS:In real-world T2D patients, dulaglutide versus liraglutide was associated with better glycemic control and comparable effects on changes of weight, blood pressure, and liver and renal functions.
| S-EPMC7547475 | biostudies-literature
Project description:Aims/introductionThis study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan.Materials and methodsThis prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan. Investigators reported data via an electronic data capture system. Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years).ResultsThe analysis population (N = 3,136) included 1,538 (49.04%), 869 (27.71%), and 729 (23.25%) patients aged <65 years, ≥65 to <75 years, and ≥75 years, respectively. Overall, 231 patients (7.37%) experienced ≥1 adverse drug reactions, with the highest frequency in the ≥75 years group. The most common adverse drug reactions were gastrointestinal disorders (n = 106; 3.38%). Severe hypoglycemia (n = 4; 0.13%), major adverse cardiovascular events (n = 4; 0.13%), and acute pancreatitis (n = 1; 0.03%) were uncommon. The mean glycated hemoglobin and bodyweight were reduced from baseline by -0.76% and -1.6 kg, respectively (last observation carried forward). The rate of dulaglutide continuation at 36 months was 58.03% overall and 59.43%, 63.13%, and 48.88% in the <65, ≥65 to <75, and ≥75 years groups, respectively. A factor analysis showed age ≥65 years was associated with a greater incidence of gastrointestinal adverse drug reactions as well as larger reductions in glycated hemoglobin and bodyweight.ConclusionsThe current real-world data are in accordance with clinical trial findings and further confirm the safety and effectiveness of dulaglutide for elderly patients, whose numbers were limited in the clinical trials.
| S-EPMC9889676 | biostudies-literature
Project description:IntroductionAlthough patient-reported outcome (PRO) measures provide important information beyond clinical data, studies that assess the PROs of type 2 diabetes mellitus (T2DM) patients initiating injectable glucose-lowering medications in routine clinical practice are limited. We describe the perspectives of patients based on a diversified panel of generic and disease-specific PRO measures at the time of enrollment (baseline) in the TROPHIES study.MethodsTROPHIES is a 24-month prospective observational study performed in France, Germany, and Italy in patients with T2DM who initiated their first injectable glucose-lowering medication with once-weekly dulaglutide or once-daily liraglutide. To better understand the perspectives of these patients regarding their overall health, treatment satisfaction, and quality of life and work, the patients' responses to the following questionnaires were collected at baseline before they initiated treatment with dulaglutide or liraglutide: EQ-5D-5L (scale: 0-1), EQ-VAS (visual analog scale: 0-100), Impact of Weight on Self-Perceptions Questionnaire (IW-SP; scale: 0-100), Diabetes Treatment Satisfaction Questionnaire Status (DTSQs; scale: 0-36), and Diabetes Productivity Measure (DPM; scale: 0-100). Analyses were descriptive in nature, with higher scores reflecting better outcomes.ResultsData from patients at the time of enrollment were analyzed. At baseline, patients initiating dulaglutide (N = 1130) or liraglutide (N = 1051) rated their quality of life in terms of mean EQ-5D-5L index as 0.84 and 0.83, and in terms of mean EQ-VAS as 67.5 and 67.5, respectively. The mean baseline scores in patients initiating dulaglutide or liraglutide were 59.8 and 61.3 for IW-SP, 24.6 and 25.8 for DTSQs, 78.6 and 79.5 for DPM Life Productivity, and 87.5 and 86.8 for DPM Work Productivity, respectively.ConclusionThe information from this varied panel of PRO instruments collected at baseline complements clinical outcomes data.
| S-EPMC7509014 | biostudies-literature
Project description:IntroductionThe TROPHIES observational study enrolled patients with type 2 diabetes mellitus (T2DM) initiating their first injectable treatment with the glucagon-like peptide 1 receptor agonists (GLP-1 RAs) dulaglutide or liraglutide. This manuscript focuses on the study design, baseline characteristics of the enrolled population, and factors associated with GLP-1 RA choice.MethodsTROPHIES is a prospective, observational, 24-month study conducted in France, Germany, and Italy. Inclusion criteria include adult patients with T2DM, naïve to injectable antihyperglycemic treatments, initiating dulaglutide or liraglutide per routine clinical practice. The primary outcome is the duration of treatment on dulaglutide or liraglutide without a significant treatment change.ResultsThe analysis included 2181 patients (dulaglutide, 1130; liraglutide, 1051) (cutoff date May 15, 2019). The population was 56% male with mean [standard deviation (SD)] patient characteristics at baseline as follows: age, 59.2 (11.0) years; body mass index (BMI), 33.9 (6.6) kg/m2; T2DM duration, 8.5 (6.9) years; and glycated hemoglobin (HbA1c), 8.2 (1.3)%. Between-cohort demographic and clinical characteristics were balanced. The mean (SD) HbA1c and BMI values for French, German, and Italian patients were, respectively, 8.6 (1.4)%, 8.2 (1.4)%, 8.0 (0.8)%; 33.3 (6.1) kg/m2, 36.0 (7.2) kg/m2, and 32.6 (5.9) kg/m2.ConclusionThis study analysis at baseline provides an opportunity to evaluate between-country differences in baseline HbA1c, weight, macrovascular complications, and factors driving GLP-1 RA selection for patients with T2DM in daily practice.
| S-EPMC8266969 | biostudies-literature
Project description:IntroductionIn clinical trials, liraglutide has proven to be an effective drug for the treatment of type 2 diabetes mellitus (T2DM). The real-world effectiveness of liraglutide has been investigated in numerous studies. The aim of this systematic literature review is to collate evidence on the real-world clinical effectiveness of liraglutide.MethodsA review of publications from Medline, EMBASE, the Cochrane Library, and conference proceedings was conducted to identify observational studies that assessed the clinical effectiveness of liraglutide in real-world clinical practice. This review was conducted according to the National Institute of Health and Care Excellence (NICE) guidance. No language or time limits were applied, except to the conference proceedings (2013-2015). Endpoints for data extraction were decided a priori. Study quality appraisal was done for full-text journal articles.ResultsOf 124 publications included in the review, 43 were full-text articles. Liraglutide significantly reduces glycated hemoglobin (HbA1c) within 6 months of initiating treatment (mean change in HbA1c from baseline: -0.9% to -2.2%; HbA1c <7.0%: 29.5-65.0%). The NICE composite endpoint (HbA1c reduction ≥1% and weight reduction ≥3%) was met in 16.9-47.0% of patients with liraglutide treatment. Liraglutide therapy led to a mean change in absolute weight from baseline of -1.3 to -8.65 kg. Liraglutide treatment was well tolerated in patients with T2DM. The rate of occurrence of hypoglycemia with liraglutide monotherapy was ≤0.8%. Hypoglycemia was more common in patients taking antidiabetic medications (0.0-15.2%) together with liraglutide. The beneficial glycemic and weight effect of liraglutide therapy in patients with T2DM was maintained for at least 12 months.ConclusionEvidence from observational studies reflecting real-world clinical practice demonstrates that liraglutide therapy improves glycemic control with a low risk of hypoglycemia, and is associated with significant weight loss in patients with T2DM. These observations are consistent with clinical trial findings.FundingNovo Nordisk A/S, Søborg, Denmark.
| S-EPMC5014786 | biostudies-literature
Project description:IntroductionThis study aimed to investigate the efficacy and clinical factors affecting the glycemic response to dulaglutide in type 2 diabetes (T2D) in a real-world clinical setting.MethodsWe conducted a retrospective study of 234 patients at the Asan Medical Center, Republic of Korea, who had T2D and initiated dulaglutide from June 2016 to December 2017. The primary outcome was the change in glycated hemoglobin (HbA1c) concentration between baseline and 6 months after the initiation of therapy. Multivariate regression analysis was used to determine the clinical parameters contributing to a superior glycemic response to dulaglutide.ResultsThe mean age of the patients was 53, and 50% were male. Their mean baseline HbA1c, body mass index and duration of diabetes were 8.8%, 27.6 kg/m2 and 10.2 years, respectively. The change in HbA1c between baseline and 6 months was - 0.92% (95% CI: - 1.1% to - 0.74%, p < 0.001). The reduction in body weight over the same period was -2.1 kg (95% CI: - 2.9 to - 1.3 kg, p < 0.001). Using multivariate regression analysis, baseline HbA1c was found to be a significant predictor of superior glycemic response to dulaglutide.ConclusionThe use of dulaglutide was associated with a significant reduction in HbA1c and body weight over a 6-month period in a real-world clinical setting. T2D patients with higher baseline HbA1c concentrations were more likely to demonstrate good clinical responses to dulaglutide.
| S-EPMC6612352 | biostudies-literature
Project description:IntroductionWhile the liraglutide effect and action in diabetes (LEAD-6) clinical trial compared the efficacy and safety of liraglutide once daily (LIRA) to exenatide twice daily (EXEN) in adult patients with type 2 diabetes, few studies have explored the associated per-patient costs of glycemic goal achievement of their use in a real-world clinical setting.MethodsThis retrospective cohort study used integrated medical and pharmacy claims linked with glycated hemoglobin A1C (A1C) results from the IMS Patient-Centric Integrated Data Warehouse. Patients' ≥18 years and naïve to incretin therapies during a 6-month pre-index period, with ≥1 prescription for LIRA or EXEN between January 2010 and December 2010, were included. Patients with evidence of insulin use (pre- or post-index) were excluded. Only patients who were persistent on their index treatment during a 180-day post-index period were included. Follow-up A1C assessments were based on available laboratory data within 45 days before or after the 6-month post-index point in time. Diabetes-related pharmacy costs over the 6-month post-index period were captured and included costs for both the index drugs and concomitant diabetes medications.Results234 LIRA and 182 EXEN patients were identified for the analysis. The adjusted predicted diabetes-related pharmacy costs per patient over the 6-month post-index period were higher for LIRA compared to EXEN ($2,002 [95% confidence interval (CI): $1,981, $2,023] vs. $1,799 [95% CI: $1,778, $1,820]; P < 0.001). However, a higher adjusted predicted percentage of patients on LIRA reached A1C < 7% goal (64.4% [95% CI: 63.5, 65.3] vs. 53.6% [95% CI: 52.6, 54.6]; P < 0.05), translating into lower average diabetes-related pharmacy costs per successfully treated patient for LIRA as compared to EXEN ($3,108 vs. $3,354; P < 0.0001).ConclusionsAlthough predicted diabetes-related pharmacy costs were greater with LIRA vs. EXEN, a higher proportion of patients on LIRA achieved A1C < 7%, resulting in a lower per-patient cost of A1C goal achievement with LIRA compared to EXEN.
| S-EPMC3930836 | biostudies-literature