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Economic evaluation of dapagliflozin versus metformin in Chinese patients whose diabetes is inadequately controlled with diet and exercise.

ABSTRACT: Background:To investigate the long-term economic outcome of dapagliflozin versus metformin in Chinese patients with type 2 diabetes mellitus (T2DM) whose diet and exercise have not provided sufficient glycemic control. Methods:An economic analysis of dapagliflozin versus metformin was conducted by using the Chinese Outcomes Model for T2DM with a time horizon of lifetime, which was developed and validated based on the Chinese population. The efficacy data of lowering HbA1c of dapagliflozin and metformin was derived from a network meta-analysis. Other clinical, cost and utility inputs were obtained from published sources. Lifetime discounted quality-adjusted life-years, cost, and incremental cost-effectiveness ratio were measured. The uncertainty was facilitated by one-way and probabilistic sensitivity analyses. Results:The comparison of metformin and dapagliflozin in Chinese patients with insufficient glycemic control by diet and exercise showed that dapagliflozin was more costly and produced fewer health benefits in our simulated cohort. The sensitivity analyses indicated that the results were robust. Conclusions:Dapagliflozin is not likely to be cost-effective compared with metformin for Chinese patients with T2DM inadequately controlled with diet and exercise.

SUBMITTER: Nian H

PROVIDER: S-EPMC7048053 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Economic evaluation of dapagliflozin versus metformin in Chinese patients whose diabetes is inadequately controlled with diet and exercise.

Nian Hua H Wan Xu X Ma Jing J Jie Fu F Wu Bin B

Cost effectiveness and resource allocation : C/E 20200228

<h4>Background</h4>To investigate the long-term economic outcome of dapagliflozin versus metformin in Chinese patients with type 2 diabetes mellitus (T2DM) whose diet and exercise have not provided sufficient glycemic control.<h4>Methods</h4>An economic analysis of dapagliflozin versus metformin was conducted by using the Chinese Outcomes Model for T2DM with a time horizon of lifetime, which was developed and validated based on the Chinese population. The efficacy data of lowering HbA1c of dapag ...[more]

PMID: 32140079

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Project description:BackgroundManagement of type 2 diabetes with metformin often does not provide adequate glycemic control, thereby necessitating add-on treatment. In a 24-week clinical trial, dapagliflozin, an investigational sodium glucose cotransporter 2 inhibitor, improved glycemic control in patients inadequately controlled with metformin. The present study is an extension that was undertaken to evaluate dapagliflozin as long-term therapy in this population.MethodsThis was a long-term extension (total 102 weeks) of a 24-week phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group trial. Patients were randomly assigned (1:1:1:1) to blinded daily treatment (placebo, or dapagliflozin 2.5 to 5, or 10 mg) plus open-label metformin (≥1,500 mg). The previously published primary endpoint was change from baseline in glycated hemoglobin (HbA1c) at 24 weeks. This paper reports the follow-up to week 102, with analysis of covariance model performed at 24 weeks with last observation carried forward; a repeated measures analysis was utilized to evaluate changes from baseline in HbA1c, fasting plasma glucose (FPG), and weight.ResultsA total of 546 patients were randomized to 1 of the 4 treatments. The completion rate for the 78-week double-blind extension period was lower for the placebo group (63.5%) than for the dapagliflozin groups (68.3% to 79.8%). At week 102, mean changes from baseline HbA1c (8.06%) were +0.02% for placebo compared with -0.48% (P = 0.0008), -0.58% (P <0.0001), and -0.78% (P <0.0001) for dapagliflozin 2.5 to 5, and 10 mg, respectively. In addition, all dapagliflozin groups had sustained reductions from baseline in FPG (-1.07 to -1.47 mmol/l) and body weight (-1.10 to -1.74 kg) at 102 weeks, whereas increases were noted in placebo-treated patients for both of these outcomes. Events of hypoglycemia were rare and were not severe. Evidence suggestive of genital infection was reported in 11.7% to 14.6% of dapagliflozin patients and 5.1% of placebo patients, with one related discontinuation (dapagliflozin 5 mg). Evidence suggestive of urinary tract infection was reported in 8.0% to 13.3% of dapagliflozin patients and 8.0% of placebo patients, with one related discontinuation (dapagliflozin 2.5 mg).ConclusionsDapagliflozin added to metformin for 102 weeks enabled sustained reductions in HbA1c, FPG, and weight without increased risk of hypoglycemia in patients with type 2 diabetes who were inadequately controlled on metformin alone.Trial registrationClinicalTrials.gov: NCT00528879.

Project description:OBJECTIVE:Among patients with type 2 diabetes uncontrolled with metformin, exenatide once weekly (QW) plus dapagliflozin combination produced greater reductions in glycemia, weight, and systolic blood pressure (SBP) at 28 weeks than exenatide QW or dapagliflozin alone (DURATION-8). Here, we investigated the safety and maintenance of efficacy at 52 weeks, after a 24-week extension. RESEARCH DESIGN AND METHODS:This phase 3, multicenter, double-blind study randomized adults with type 2 diabetes (with glycated hemoglobin [HbA1c] 8.0-12.0% [64-108 mmol/mol] and on metformin ≥1,500 mg/day) to exenatide QW (2-mg subcutaneous injection) plus once-daily dapagliflozin (10-mg oral tablet), exenatide QW plus oral placebo, or dapagliflozin plus injected placebo. Extension-period P values were nominal. RESULTS:Of 1,375 patients screened, 695 were randomized (mean baseline HbA1c 9.3% [78 mmol/mol]); 81.2% completed the study, and 75.3% completed treatment. At 52 weeks, HbA1c reductions were greater with exenatide QW plus dapagliflozin (least squares mean change -1.75% [-19.1 mmol/mol]) versus exenatide QW (-1.38% [-15.1 mmol/mol]; P = 0.006) or dapagliflozin (-1.23% [-13.4 mmol/mol]; P < 0.001); mean HbA1c values were 6.9% (52 mmol/mol), 7.2% (55 mmol/mol), and 7.4% (57 mmol/mol), respectively. Weight and SBP reductions were greater with exenatide QW plus dapagliflozin (-3.31 kg and -4.5 mmHg) versus exenatide QW (-1.51 kg and -0.7 mmHg; both P < 0.001) but similar to those with dapagliflozin (-2.28 kg and -2.7 mmHg; P = 0.057 and P = 0.100, respectively). The exenatide QW plus dapagliflozin regimen was well tolerated with no unexpected safety findings; more patients treated with exenatide QW experienced gastrointestinal and injection site-related adverse events. No major hypoglycemia occurred. CONCLUSIONS:Among patients with type 2 diabetes uncontrolled with metformin, exenatide QW plus dapagliflozin provided sustained improvements in glycemia, weight, and SBP over 52 weeks, with no unexpected safety findings.

Dataset Information

Economic evaluation of dapagliflozin versus metformin in Chinese patients whose diabetes is inadequately controlled with diet and exercise.

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Economic evaluation of dapagliflozin versus metformin in Chinese patients whose diabetes is inadequately controlled with diet and exercise.

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