Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies
Kelly F Bell, Arie Katz, John J Sheehan AstraZeneca, Wilmington, DE, USA Background: The use of quality measures attempts to improve safety and health outcomes and to reduce costs. In two Phase III trials in treatment-naive patients with type 2 diabetes, dapagliflozin 5 or 10 mg/d...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2016-10-01
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| Series: | Risk Management and Healthcare Policy |
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| Online Access: | https://www.dovepress.com/quality-measure-attainment-with-dapagliflozin-plus-metformin-extended--peer-reviewed-article-RMHP |
| _version_ | 1818981644039618560 |
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| author | Bell KF Katz A Sheehan JJ |
| author_facet | Bell KF Katz A Sheehan JJ |
| author_sort | Bell KF |
| collection | DOAJ |
| description | Kelly F Bell, Arie Katz, John J Sheehan AstraZeneca, Wilmington, DE, USA Background: The use of quality measures attempts to improve safety and health outcomes and to reduce costs. In two Phase III trials in treatment-naive patients with type 2 diabetes, dapagliflozin 5 or 10 mg/d as initial combination therapy with metformin extended-release (XR) significantly reduced glycated hemoglobin (A1C) from baseline to 24 weeks and allowed higher proportions of patients to achieve A1C <7% vs dapagliflozin or metformin monotherapy. Objective: A pooled analysis of data from these two studies assessed the effect of dapagliflozin 5 or 10 mg/d plus metformin XR (combination therapy) compared with placebo plus metformin XR (metformin monotherapy) on diabetes quality measures. Quality measures include laboratory measures of A1C and low-density lipoprotein cholesterol (LDL-C) as well as vital status measures of blood pressure (BP) and body mass index (BMI). The proportion of patients achieving A1C, BP, and LDL-C individual and composite measures was assessed, as was the proportion with baseline BMI ≥25 kg/m2 who lost ≥4.5 kg. Subgroup analyses by baseline BMI were also performed. Results: A total of 194 and 211 patients were treated with dapagliflozin 5- or 10-mg/d combination therapy, respectively, and 409 with metformin monotherapy. Significantly higher proportions of patients achieved A1C ≤6.5%, <7%, or <8% with combination therapy vs metformin monotherapy (P<0.02). Significantly higher proportions of patients achieved BP <140/90 mmHg (P<0.02 for each dapagliflozin dose) and BP <130/80 mmHg (P<0.02 with dapagliflozin 5 mg/d only) with combination therapy vs metformin monotherapy. Similar proportions (29%–33%) of patients had LDL-C <100 mg/dL across treatment groups. A higher proportion of patients with baseline BMI ≥25 kg/m2 lost ≥4.5 kg with combination therapy. Combination therapy had a more robust effect on patients with higher baseline BMI. Conclusion: Initial combination therapy with dapagliflozin 5 or 10 mg/d and metformin improved quality measures relevant to clinical outcomes and diabetes care. Keywords: dapagliflozin, metformin, quality measures, type 2 diabetes |
| first_indexed | 2024-12-20T17:34:35Z |
| format | Article |
| id | doaj.art-2d61dc148f9c4255917f6f3a6a714917 |
| institution | Directory Open Access Journal |
| issn | 1179-1594 |
| language | English |
| last_indexed | 2024-12-20T17:34:35Z |
| publishDate | 2016-10-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Risk Management and Healthcare Policy |
| spelling | doaj.art-2d61dc148f9c4255917f6f3a6a7149172022-12-21T19:31:14ZengDove Medical PressRisk Management and Healthcare Policy1179-15942016-10-01Volume 923124129446Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studiesBell KFKatz ASheehan JJKelly F Bell, Arie Katz, John J Sheehan AstraZeneca, Wilmington, DE, USA Background: The use of quality measures attempts to improve safety and health outcomes and to reduce costs. In two Phase III trials in treatment-naive patients with type 2 diabetes, dapagliflozin 5 or 10 mg/d as initial combination therapy with metformin extended-release (XR) significantly reduced glycated hemoglobin (A1C) from baseline to 24 weeks and allowed higher proportions of patients to achieve A1C <7% vs dapagliflozin or metformin monotherapy. Objective: A pooled analysis of data from these two studies assessed the effect of dapagliflozin 5 or 10 mg/d plus metformin XR (combination therapy) compared with placebo plus metformin XR (metformin monotherapy) on diabetes quality measures. Quality measures include laboratory measures of A1C and low-density lipoprotein cholesterol (LDL-C) as well as vital status measures of blood pressure (BP) and body mass index (BMI). The proportion of patients achieving A1C, BP, and LDL-C individual and composite measures was assessed, as was the proportion with baseline BMI ≥25 kg/m2 who lost ≥4.5 kg. Subgroup analyses by baseline BMI were also performed. Results: A total of 194 and 211 patients were treated with dapagliflozin 5- or 10-mg/d combination therapy, respectively, and 409 with metformin monotherapy. Significantly higher proportions of patients achieved A1C ≤6.5%, <7%, or <8% with combination therapy vs metformin monotherapy (P<0.02). Significantly higher proportions of patients achieved BP <140/90 mmHg (P<0.02 for each dapagliflozin dose) and BP <130/80 mmHg (P<0.02 with dapagliflozin 5 mg/d only) with combination therapy vs metformin monotherapy. Similar proportions (29%–33%) of patients had LDL-C <100 mg/dL across treatment groups. A higher proportion of patients with baseline BMI ≥25 kg/m2 lost ≥4.5 kg with combination therapy. Combination therapy had a more robust effect on patients with higher baseline BMI. Conclusion: Initial combination therapy with dapagliflozin 5 or 10 mg/d and metformin improved quality measures relevant to clinical outcomes and diabetes care. Keywords: dapagliflozin, metformin, quality measures, type 2 diabeteshttps://www.dovepress.com/quality-measure-attainment-with-dapagliflozin-plus-metformin-extended--peer-reviewed-article-RMHPdapagliflozinmetforminquality measurestype 2 diabetes |
| spellingShingle | Bell KF Katz A Sheehan JJ Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies Risk Management and Healthcare Policy dapagliflozin metformin quality measures type 2 diabetes |
| title | Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies |
| title_full | Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies |
| title_fullStr | Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies |
| title_full_unstemmed | Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies |
| title_short | Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies |
| title_sort | quality measure attainment with dapagliflozin plus metformin extended release as initial combination therapy in patients with type 2 diabetes a post hoc pooled analysis of two clinical studies |
| topic | dapagliflozin metformin quality measures type 2 diabetes |
| url | https://www.dovepress.com/quality-measure-attainment-with-dapagliflozin-plus-metformin-extended--peer-reviewed-article-RMHP |
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