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Utilization, Outcomes, and Safety of Novel Antidiabetic Drugs Among Medicare Beneficiaries With Type 2 Diabetes and Heart Failure
Utilization, Outcomes, and Safety of Novel Antidiabetic Drugs Among Medicare Beneficiaries With Type 2 Diabetes and Heart Failure
상세정보
- 자료유형
- 학위논문 서양
- 최종처리일시
- 20260202105120
- ISBN
- 9798293868674
- DDC
- 614.4
- 저자명
- Shen, Tsung-Hua.
- 서명/저자
- Utilization, Outcomes, and Safety of Novel Antidiabetic Drugs Among Medicare Beneficiaries With Type 2 Diabetes and Heart Failure
- 발행사항
- [Sl] : University of Minnesota, 2025
- 발행사항
- Ann Arbor : ProQuest Dissertations & Theses, 2025
- 형태사항
- 209 p
- 주기사항
- Source: Dissertations Abstracts International, Volume: 87-03, Section: B.
- 주기사항
- Advisor: Farley, Joel F.
- 학위논문주기
- Thesis (Ph.D.)--University of Minnesota, 2025.
- 초록/해제
- 요약Aim 1IntroductionNearly one-third of persons with type 2 diabetes (T2D) have established cardiovascular disease, for whom guidelines recommend glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose co-transporter-2 (SGLT2) inhibitors as preferred treatment options. This study aimed to assess the utilization and geographic distribution of these medications as well as the social determinants of health (SDOH) influencing their use among Medicare beneficiaries with T2D.MethodsThis retrospective cohort study analyzed Medicare claims from 2014-2019 for T2D beneficiaries using at least one oral antidiabetic drug. Annual trends and geographic patterns in SGLT2 inhibitor use were assessed by U.S. county. Patient demographics and ZIP code-level SDOH were evaluated using geographic mapping and linked data from the Agency for Healthcare Research and Quality. Logistic regression models with ZIP code-level SDOH were established to identify potential disparities.ResultsAmong 1,238,981 Medicare beneficiaries with T2D, 115,413 (9.3%) used SGLT2 inhibitors and 35,402 (2.9%) used GLP-1RAs. The overall utilization rate increased to 6.0% by 2019 but varied geographically, with lower use observed in nonmetropolitan areas. In terms of demographics, older adults (≥85 years: OR, 0.14; 95% CI, 0.13-0.15) and Black patients (OR, 0.75; 95% CI, 0.73-0.76) were significantly less likely to use these medications. Regarding SDOH, patients residing in areas with a higher percentage of limited English-speaking households (OR, 0.98; 95% CI, 0.96-0.99) and lower median household income (OR, 0.95; 95% CI, 0.92-0.97) were also less likely to use GLP-1RAs or SGLT2 inhibitors. Conversely, residents of areas with a higher percentage of individuals holding a bachelor's degree or higher were more likely to receive these therapies (OR, 1.03; 95% CI, 1.01-1.05).ConclusionsSGLT2 inhibitor use among Medicare beneficiaries with T2D remains suboptimal, with disparities linked to SDOH. Addressing access barriers and improving utilization, particularly in underserved populations, are critical steps in reducing the burden of diabetes-related complications.Aim 2IntroductionOver one-third of heart failure (HF) patients may develop end-stage renal disease (ESRD), significantly worsening their prognosis. While sodium-glucose co-transporter 2 (SGLT2) inhibitors show promise in improving kidney outcomes, real world evidence is limited in terms of the effects of SGLT-2i in preventing ESRD in persons with diabetes and HF. This study uses real-world data to evaluate long-term kidney outcomes and offers valuable insights into the kidney benefits of SGLT2 inhibitors.MethodsThis retrospective cohort study compared SGLT2 inhibitors to dipeptidyl peptidase-4 (DPP-4) inhibitors using a 20% random sample of Medicare claims data from 2014-2019. Study participants included Medicare beneficiaries with type 2 diabetes (T2D) and HF, excluding those with established ESRD. The primary outcomes were ESRD and acute kidney injury (AKI)-related hospitalizations. A Fine-Gray competing risk model was applied for survival analysis. Inverse probability treatment weighting with time-varying exposure weighting was used to estimate per-protocol treatment effects.ResultsWe compared 1,920 SGLT2 inhibitor users to 10,327 DPP-4 inhibitor users over a median of 2.7-year follow-up. A total of 779 patients (6.8%) developed ESRD. The adjusted incidence rates of ESRD were 1.32 and 2.19 per 100 person-years for the SGLT2 and DPP-4 inhibitor groups, respectively. In per-protocol analyses, SGLT2 inhibitor use was associated with a 38% reduction in risk of ESRD compared to DPP-4 inhibitors (HR, 0.62; 95% CI, 0.45-0.84). Subgroup analyses showed significant risk reduction with SGLT-2i among both male and female patients, across White and non-White populations, and in select populations with comorbidities, including those with obesity, ischemic heart disease, and stroke. Additionally, SGLT2 inhibitors significantly reduced the risk of AKI-related hospitalizations risk by 18% (HR, 0.82; 95%CI, 0.71-0.98).ConclusionsSGLT2 inhibitor use is associated with a reduced risk of major kidney outcomes among Medicare beneficiaries with HF and T2D, both in the overall population and in patients with common comorbidities. Our findings support previous clinical trial results while addressing their limitations by including a more heterogeneous population, enhancing the generalizability of the evidence.Aim 3BackgroundConcerns about fractures and amputations associated with sodium-glucose co-transporter-2 (SGLT2) inhibitors have been debated. However, no study has examined these risks in Medicare beneficiaries with type 2 diabetes (T2D) and heart failure (HF). Given the growing role of SGLT2 inhibitors in HF treatment, a comprehensive evaluation of these risks specifically in HF populations is essential.MethodsIn this retrospective cohort study, we compared patients with T2D and HF who initiated SGLT2 or dipeptidyl peptidase-4 (DPP-4) inhibitors between 2014-2019 from fee-for-service Medicare Claims. The primary outcomes were overall fractures and amputations, while secondary outcomes included lower-limb fractures, hip fractures, and below-knee amputations. We utilized a Fine-Gray competing risk model and inverse probability treatment weighting with time-varying exposure to estimate per-protocol effects.OutcomesAmong 11,121 eligible patients, 1,792 and 9,329 initiated SGLT2 and DPP-4 inhibitors. Over a median of 2.5-year follow-up, the adjusted incidence rate of overall fractures was 3.47 and 3.67 per 100 person-years in the SGLT2 and DPP-4 inhibitor groups, respectively, with an adjusted hazard ratio (aHR) of 0.97 (95% CI, 0.76-1.14) in the per-protocol cohort (SGLT2 vs DPP-4 inhibitor) when treatment adherence was accounted for. For overall amputation, the adjusted incidence rate was 1.85 and 2.12 per 100 person-years in the SGLT2 and DPP-4 inhibitor groups, respectively, with an aHR of 0.87 (95% CI, 0.65-1.18) in the per-protocol cohort (SGLT2 vs DPP-4 inhibitor).ConclusionsSGLT2 inhibitor was not associated with an increased risk of fractures or amputations compared to DPP-4 inhibitors among Medicare beneficiaries with T2D and HF. These findings support the safety profile of SGLT2 inhibitors with respect to fracture and amputation risks.
- 일반주제명
- Epidemiology
- 일반주제명
- Public health
- 일반주제명
- Pharmaceutical sciences
- 키워드
- Heart failure
- 키워드
- SGLT2 inhibitors
- 키워드
- Type 2 diabetes
- 기타저자
- University of Minnesota Social and Administrative Pharmacy
- 기본자료저록
- Dissertations Abstracts International. 87-03B.
- 전자적 위치 및 접속
- 로그인 후 원문을 볼 수 있습니다.
MARC
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■020 ▼a9798293868674
■035 ▼a(MiAaPQ)AAI32238300
■040 ▼aMiAaPQ▼cMiAaPQ
■0820 ▼a614.4
■1001 ▼aShen, Tsung-Hua.
■24510▼aUtilization, Outcomes, and Safety of Novel Antidiabetic Drugs Among Medicare Beneficiaries With Type 2 Diabetes and Heart Failure
■260 ▼a[Sl]▼bUniversity of Minnesota▼c2025
■260 1▼aAnn Arbor▼bProQuest Dissertations & Theses▼c2025
■300 ▼a209 p
■500 ▼aSource: Dissertations Abstracts International, Volume: 87-03, Section: B.
■500 ▼aAdvisor: Farley, Joel F.
■5021 ▼aThesis (Ph.D.)--University of Minnesota, 2025.
■520 ▼aAim 1IntroductionNearly one-third of persons with type 2 diabetes (T2D) have established cardiovascular disease, for whom guidelines recommend glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose co-transporter-2 (SGLT2) inhibitors as preferred treatment options. This study aimed to assess the utilization and geographic distribution of these medications as well as the social determinants of health (SDOH) influencing their use among Medicare beneficiaries with T2D.MethodsThis retrospective cohort study analyzed Medicare claims from 2014-2019 for T2D beneficiaries using at least one oral antidiabetic drug. Annual trends and geographic patterns in SGLT2 inhibitor use were assessed by U.S. county. Patient demographics and ZIP code-level SDOH were evaluated using geographic mapping and linked data from the Agency for Healthcare Research and Quality. Logistic regression models with ZIP code-level SDOH were established to identify potential disparities.ResultsAmong 1,238,981 Medicare beneficiaries with T2D, 115,413 (9.3%) used SGLT2 inhibitors and 35,402 (2.9%) used GLP-1RAs. The overall utilization rate increased to 6.0% by 2019 but varied geographically, with lower use observed in nonmetropolitan areas. In terms of demographics, older adults (≥85 years: OR, 0.14; 95% CI, 0.13-0.15) and Black patients (OR, 0.75; 95% CI, 0.73-0.76) were significantly less likely to use these medications. Regarding SDOH, patients residing in areas with a higher percentage of limited English-speaking households (OR, 0.98; 95% CI, 0.96-0.99) and lower median household income (OR, 0.95; 95% CI, 0.92-0.97) were also less likely to use GLP-1RAs or SGLT2 inhibitors. Conversely, residents of areas with a higher percentage of individuals holding a bachelor's degree or higher were more likely to receive these therapies (OR, 1.03; 95% CI, 1.01-1.05).ConclusionsSGLT2 inhibitor use among Medicare beneficiaries with T2D remains suboptimal, with disparities linked to SDOH. Addressing access barriers and improving utilization, particularly in underserved populations, are critical steps in reducing the burden of diabetes-related complications.Aim 2IntroductionOver one-third of heart failure (HF) patients may develop end-stage renal disease (ESRD), significantly worsening their prognosis. While sodium-glucose co-transporter 2 (SGLT2) inhibitors show promise in improving kidney outcomes, real world evidence is limited in terms of the effects of SGLT-2i in preventing ESRD in persons with diabetes and HF. This study uses real-world data to evaluate long-term kidney outcomes and offers valuable insights into the kidney benefits of SGLT2 inhibitors.MethodsThis retrospective cohort study compared SGLT2 inhibitors to dipeptidyl peptidase-4 (DPP-4) inhibitors using a 20% random sample of Medicare claims data from 2014-2019. Study participants included Medicare beneficiaries with type 2 diabetes (T2D) and HF, excluding those with established ESRD. The primary outcomes were ESRD and acute kidney injury (AKI)-related hospitalizations. A Fine-Gray competing risk model was applied for survival analysis. Inverse probability treatment weighting with time-varying exposure weighting was used to estimate per-protocol treatment effects.ResultsWe compared 1,920 SGLT2 inhibitor users to 10,327 DPP-4 inhibitor users over a median of 2.7-year follow-up. A total of 779 patients (6.8%) developed ESRD. The adjusted incidence rates of ESRD were 1.32 and 2.19 per 100 person-years for the SGLT2 and DPP-4 inhibitor groups, respectively. In per-protocol analyses, SGLT2 inhibitor use was associated with a 38% reduction in risk of ESRD compared to DPP-4 inhibitors (HR, 0.62; 95% CI, 0.45-0.84). Subgroup analyses showed significant risk reduction with SGLT-2i among both male and female patients, across White and non-White populations, and in select populations with comorbidities, including those with obesity, ischemic heart disease, and stroke. Additionally, SGLT2 inhibitors significantly reduced the risk of AKI-related hospitalizations risk by 18% (HR, 0.82; 95%CI, 0.71-0.98).ConclusionsSGLT2 inhibitor use is associated with a reduced risk of major kidney outcomes among Medicare beneficiaries with HF and T2D, both in the overall population and in patients with common comorbidities. Our findings support previous clinical trial results while addressing their limitations by including a more heterogeneous population, enhancing the generalizability of the evidence.Aim 3BackgroundConcerns about fractures and amputations associated with sodium-glucose co-transporter-2 (SGLT2) inhibitors have been debated. However, no study has examined these risks in Medicare beneficiaries with type 2 diabetes (T2D) and heart failure (HF). Given the growing role of SGLT2 inhibitors in HF treatment, a comprehensive evaluation of these risks specifically in HF populations is essential.MethodsIn this retrospective cohort study, we compared patients with T2D and HF who initiated SGLT2 or dipeptidyl peptidase-4 (DPP-4) inhibitors between 2014-2019 from fee-for-service Medicare Claims. The primary outcomes were overall fractures and amputations, while secondary outcomes included lower-limb fractures, hip fractures, and below-knee amputations. We utilized a Fine-Gray competing risk model and inverse probability treatment weighting with time-varying exposure to estimate per-protocol effects.OutcomesAmong 11,121 eligible patients, 1,792 and 9,329 initiated SGLT2 and DPP-4 inhibitors. Over a median of 2.5-year follow-up, the adjusted incidence rate of overall fractures was 3.47 and 3.67 per 100 person-years in the SGLT2 and DPP-4 inhibitor groups, respectively, with an adjusted hazard ratio (aHR) of 0.97 (95% CI, 0.76-1.14) in the per-protocol cohort (SGLT2 vs DPP-4 inhibitor) when treatment adherence was accounted for. For overall amputation, the adjusted incidence rate was 1.85 and 2.12 per 100 person-years in the SGLT2 and DPP-4 inhibitor groups, respectively, with an aHR of 0.87 (95% CI, 0.65-1.18) in the per-protocol cohort (SGLT2 vs DPP-4 inhibitor).ConclusionsSGLT2 inhibitor was not associated with an increased risk of fractures or amputations compared to DPP-4 inhibitors among Medicare beneficiaries with T2D and HF. These findings support the safety profile of SGLT2 inhibitors with respect to fracture and amputation risks.
■590 ▼aSchool code: 0130.
■650 4▼aEpidemiology
■650 4▼aPublic health
■650 4▼aPharmaceutical sciences
■653 ▼aHeart failure
■653 ▼aMedicare beneficiaries
■653 ▼aPharmacoepidemiology
■653 ▼aSGLT2 inhibitors
■653 ▼aType 2 diabetes
■690 ▼a0766
■690 ▼a0573
■690 ▼a0572
■71020▼aUniversity of Minnesota▼bSocial and Administrative Pharmacy.
■7730 ▼tDissertations Abstracts International▼g87-03B.
■790 ▼a0130
■791 ▼aPh.D.
■792 ▼a2025
■793 ▼aEnglish
■85640▼uhttp://www.riss.kr/pdu/ddodLink.do?id=T17359451▼nKERIS▼z이 자료의 원문은 한국교육학술정보원에서 제공합니다.


