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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...
Utilization, Outcomes, and Safety of Novel Antidiabetic Drugs Among Medicare Beneficiaries With Type 2 Diabetes and Heart Failure

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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  
Medicare beneficiaries
키워드  
Pharmacoepidemiology
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  
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■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.

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