P6270Empagliflozin reduces the total burden of first and recurrent hospitalisations in patients with type 2 diabetes and established cardiovascular disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D McGuire ◽  
B Zinman ◽  
S E Inzucchi ◽  
S D Anker ◽  
C Wanner ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Recurrent Events ◽  
Negative Binomial ◽  
Cox Regression ◽  
Standard Of Care ◽  
History Of ◽  
Outcome Trial ◽  
Cv Disease ◽  
Total Burden

Abstract Background and aims The EMPA-REG OUTCOME trial included patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular (CV) disease. Empagliflozin reduced the risk of 3-point major adverse CV events (MACE; composite of CV death, myocardial infarction [MI], or stroke) by 14%, CV death by 38% and hospitalisation for heart failure (HF) by 35% vs placebo in analyses of time to first event. We assessed the effect of empagliflozin on all-cause hospitalisation in post-hoc analyses of all (first and recurrent) events. Materials and methods Patients were randomised to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo in addition to standard of care. We assessed the effects of empagliflozin pooled vs placebo on first event of all-cause hospitalisation using Cox regression and all (first and recurrent) events of all-cause hospitalisation using a negative binomial model. Results A total of 7020 patients were treated (4687 empagliflozin; 2333 placebo, mean [SD] age 63 [9] years, 71% male, 47% with history of MI, 23% with history of stroke, 10% with HF). In this analysis, 1725/4687 (36.8%) empagliflozin patients and 925/2333 (39.6%) placebo patients experienced an event leading to hospitalisation. The adjusted hazard ratio (HR; 95% CI) vs placebo for first all-cause hospitalisation using the Cox regression model was 0.89 (0.82, 0.96; p=0.0033; Figure); In analyses of all (first and recurrent) hospitalisation events, there were 3168 events in the empagliflozin group and 1863 in the placebo group. The adjusted event rate ratio (95% CI) vs placebo was 0.83 (0.76, 0.91; p<0.0001; Figure). Conclusion In the EMPA-REG OUTCOME trial, risk reductions with empagliflozin were seen in both first and all hospitalisation events and were numerically more favourable in analyses of all events vs analyses of first events. These analyses expand on the favourable CV effects of empagliflozin by also showing a reduction in the total burden of hospitalisation events in patients with T2D and established CV disease. Acknowledgement/Funding Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance

Abstract 14960: Empagliflozin Reduces the Total Burden of Cardiovascular Events Including Recurrent Events in the EMPA-REG OUTCOME Trial

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
David H Fitchett ◽  
Silvio E Inzucchi ◽  
Bernard Zinman ◽  
Christoph Wanner ◽  
Stefan D Anker ◽  
...  
Keyword(s):  
Recurrent Events ◽  
Negative Binomial ◽  
Event Rate ◽  
Coronary Revascularization ◽  
Number Of Patients ◽  
Outcome Trial ◽  
Cv Disease ◽  
Total Burden ◽  
Ischemic Attack

Introduction: In EMPA-REG OUTCOME, empagliflozin (EMPA) reduced the risk of major adverse cardiovascular (CV) events (MACE), CV mortality and hospitalization for heart failure (HHF) in analyses of first events in patients with type 2 diabetes (T2D) and atherosclerotic CV disease (ASCVD). We assessed the effect of EMPA on the total burden of CV events. Methods: Patients were randomized to EMPA 10 mg, EMPA 25 mg, or placebo. We assessed the effects of EMPA pooled vs placebo on any (first plus recurrent) adjudicated CV event (composite of myocardial infarction (MI), stroke, coronary revascularization (CR), hospitalization for unstable angina, transient ischemic attack, HHF, and CV death) using a negative binomial model. Results: Among 7,020 treated patients (mean [SD] age 63 [9] years), there were 2,142 total adjudicated CV events, most frequently CR (585), MI (421), and HHF (321). EMPA reduced the risk of total adjudicated CV events by 24% vs placebo (event rate ratio (95% CI): 0.76 (0.67, 0.87), p<0.0001) (Figure). Risk reductions were driven predominantly by reductions in HHF (0.58 (0.42, 0.81), p=0.0012), MI (0.79 (0.620, 0.998), p=0.0486), and CV death (0.62 (0.49, 0.77), p<0.0001). The estimated number of total CV events prevented with EMPA was 414.4, and the number of patients needed to treat over 3 years to prevent one event was 10.2 (6.6, 22.7). Conclusions: EMPA produced a sizeable risk reduction in the total burden of any adjudicated CV outcome, including HHF, MI and CV death, in patients with T2D and ASCVD.

P6272First plus recurrent CV and hospitalization events in the CArdiovascular and Renal Microvascular outcomE study with LINAgliptin (CARMELINA) in patients with type 2 diabetes and cardiorenal disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
N Marx ◽  
D K McGuire ◽  
O Johansen ◽  
J Rosenstock ◽  
S E Kahn ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Type 2 Diabetes ◽  
Recurrent Events ◽  
Negative Binomial ◽  
High Volume ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
History Of ◽  
Cv Disease

Abstract Background/Introduction CARMELINA was a randomized placebo-controlled clinical trial designed to demonstrate the cardiovascular (CV) safety of linagliptin in patients with type 2 diabetes (T2D) and concomitant cardiorenal disease. Despite a particularly elevated CV risk, only limited long-term evidence from randomized controlled trials for safety and efficacy of glucose lowering medications is available for this population. Purpose To characterize the effects of linagliptin on net CV disease and hospitalization burden in this population. Methods People with T2D and either i) urine albumin creatinine ratio (UACR) >30 mg/g with concomitant CV disease, or ii) estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 regardless of UACR, or eGFR ≥45–75 mL/min/1.73m2 and UACR >200 mg/g, were randomized to linagliptin 5 mg or placebo q.d. in a double-blind fashion in addition to standard of care. We assessed the effects of linagliptin versus placebo on all first plus recurrent CV events and all-cause hospitalizations using a using a negative binomial model to account for within-subject correlation. Results A total of 6979 participants were enrolled (mean age 66 years, 63% male, eGFR 54.6 ml/min/1.73m2, median UACR 162 mg/g, 59% with history of ischemic heart disease, 27% with history of heart failure (HF)) and followed for a median of 2.2 years. Adding recurrent events increased the number of events for analysis from 5.3–57.5% across CV/HF outcomes and 112.4% for hospitalizations. In analyses of first plus recurrent events, the event rate ratio (95% CI) with linagliptin versus placebo was 0.98 (0.82, 1.16; p=0.78) for 3-point MACE, 1.03 (0.79, 1.35; p=0.83) for myocardial infarction 1.03 (0.83, 1.29; p=0.77) for myocardial infarction plus revascularization, 0.89 (0.65, 1.22; p=0.48) for stroke, 0.94 (0.70, 1.27; p=0.69) for stroke plus TIA, 0.94 (0.75, 1.20; p=0.63) for hospitalized HF, 0.92 (0.77, 1.11; p=0.40) for the composite of CV death or hospitalized HF, and 0.96 (0.87, 1.06; p=0.40) for all-cause hospitalization (Figure). Conclusion Linagliptin showed similar risk of either first or recurrent CV or hospitalization events compared with placebo in patients with T2D and cardiorenal disease. These data support the CV safety of linagliptin and, considering the high volume of recurrent events, underscores the significant CV disease burden experienced by patients with T2D and cardiorenal disease Acknowledgement/Funding Boehringer Ingelheim and Eli Lilly

Analysis of first plus recurrent cardiovascular (CV) and hospitalisation events in the CAROLINA trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
N Marx ◽  
D.K McGuire ◽  
O.E Johansen ◽  
J Rosenstock ◽  
E Pfarr ◽  
...  
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Recurrent Events ◽  
Negative Binomial ◽  
Cox Regression ◽  
Funding Source ◽  
Early Type ◽  
Private Company ◽  
Cv Disease

Abstract Background/Introduction CAROLINA (cardiovascular outcome study of linagliptin versus glimepiride in type 2 diabetes) was a randomised controlled clinical trial designed to compare the effects of linagliptin with glimepiride on CV events and other outcomes in patients with relatively early type 2 diabetes at elevated CV risk. Purpose To characterise the effects on net CV disease and the hospitalisation burden of this population, we assessed the effects of linagliptin vs glimepiride on all first plus recurrent CV events and all cause hospitalisations. Methods Participants with relatively early type 2 diabetes, high CV risk and HbA1c 6.5–8.5% were randomized to linagliptin 5 mg or glimepiride 1–4 mg once daily on top of standard of care. Cox regression was used to produce hazard ratios for time to first event. A negative binomial model was used to produce event rate ratios for all events. Results A total of 6033 participants were enrolled (mean age 64.0 years, HbA1c 7.2%, body mass index 30.1 kg/m2, eGFR 77 ml/min/1.73 m2, median type 2 diabetes duration 6.3 years, urine albumin:creatine ratio 10 mg/g, 42% with CV disease, 4.5% with heart failure). Adding recurrent events increased the number of events for analysis from first event by 10% more to 77% across CV/heart failure outcomes and by 119% for all cause hospitalisations, with corresponding increases in rates per 100-patient years in both treatment groups (e.g. for the composite of CV death/MI/stroke from 2.1 to 2.8 for linagliptin and 2.1 to 2.9 for glimepiride) over a median follow up of 6.3 years. Results of analyses of first-event and first plus recurrent events are presented below (Fig). Conclusion No significant differences were observed between linagliptin and glimepiride for either first or first + recurrent CV or hospitalisation events. These data underscore the significant CV disease burden experienced even in relatively early type 2 diabetes and reinforce the similar CV safety between linagliptin and glimepiride, differing only on hypoglycaemia risk. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boehringer Ingelheim and Eli Lilly and Company

scholarly journals Cost-effectiveness analysis of empagliflozin in the treatment of patients with type 2 diabetes and established cardiovascular disease in Italy, based on the results of the EMPA-REG OUTCOME study

2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Sergio Iannazzo ◽  
Edoardo Mannucci ◽  
Odette Reifsnider ◽  
Aldo Pietro Maggioni
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Previous History ◽  
Cost Effectiveness Analysis ◽  
Effectiveness Analysis ◽  
Life Years ◽  
History Of ◽  
Outcome Trial ◽  
Cv Disease

INTRODUCTION: The EMPA-REG OUTCOME trial demonstrated the efficacy of empagliflozin in the treatment of type 2 diabetes (T2D) with a previous history of cardiovascular (CV) disease. The drug is currently reimbursed for T2D Italian patients, but the reduction of CV mortality and morbidity shown in the trial opens a new treatment perspective in those patients with associated high CV risk.OBJECTIVE: Cost-effectiveness analysis of empagliflozin for the treatment of T2D patients with a previous history of CV disease, from the Italian National Health Service (NHS) perspective.METHODS: The analysis was performed with an individual simulation model, which can predict the time to CV events or death through a set of time-dependent regressions estimated on the patient-level data of the EMPA-REG OUTCOME trial. This design allows the direct simulation of long-term outcomes and costs without the need for surrogate endpoints.The model was adapted to the Italian setting, considering local epidemiological data, baseline quality of life (QoL) utility, background mortality and unit costs from current prices and tariffs. The cost perspective was that of the Italian NHS and the horizon of the simulation was lifetime. Costs and benefits were discounted at a 3.5% rate.RESULTS: Base case results were estimated on a cohort of 5,000 patients, which ensured the convergence of the simulation. Patients treated with empagliflozin in add-on to the standard of care (SoC) lived on the average 13.8 undiscounted years as compared to 11.8 years of patients on SoC alone. The gain in discounted quality-adjusted life years (QALYs) was 1.0, due to improved survival and QoL linked to the reduced incidence of CV events and CV mortality. The incremental cost-effectiveness ratio (ICER) was 4,811 €/QALY, well below the commonly applied threshold of 30,000-50,000 €/QALY.CONCLUSION: Empagliflozin in add-on to the SoC is a highly cost-effective strategy for the treatment of T2D patients with known CV disease in the Italian setting.

193Qualifying event proximity, cardiovascular risk, and benefit of empagliflozin in patients with type 2 diabetes and stable atherosclerosis in the EMPA-REG OUTCOME trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Udell ◽  
B Zinman ◽  
C Wanner ◽  
M Von Eynatten ◽  
J T George ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Type 2 Diabetes ◽  
Cox Regression ◽  
Arterial Disease ◽  
Outcome Trial ◽  
Artery Disease ◽  
Peripheral Arterial ◽  
Risk And Benefit ◽  
Similar Risk

Abstract Background In type 2 diabetes, the temporal proximity of an atherosclerotic cardiovascular (CV) event can impact prognosis, but whether timing influences sodium glucose co-transporter 2 inhibitor effects is unknown. We explored the association of time from last qualifying CV event before randomisation (myocardial infarction [MI], stroke, coronary artery disease or peripheral arterial disease) with CV outcomes and benefit of empagliflozin (EMPA) in EMPA-REG OUTCOME. Methods Patients (pts) were randomised to EMPA 10 mg, 25 mg or placebo and followed for 3.1 years (median). Risk of major adverse CV events (3P MACE: CV death, MI, stroke), CV death or hospitalisation for heart failure (HHF) were evaluated using Cox regression in subgroups of ≤1/>1 year since last qualifying CV event. Qualifying event stratification was possible in 6796 (97%) pts. Results In the overall population, N=6796 (4547 EMPA and 2249 placebo pts), median (Q1, Q3) time from last CV event was 3.8 (1.5–7.6) years. Overall, 1214 (EMPA 841; placebo 373) and 5582 (EMPA 3706; placebo 1876) pts had a last qualifying CV event ≤1 and >1 year, respectively. Pts with more recent events had similar risk for CV outcomes compared with pts >1 year from qualifying event (Figure). Moreover, the benefit of EMPA on CV outcomes was consistent between pts enrolled ≤1 or >1 year from the qualifying CV event (all p-interaction >0.05; Figure). Conclusion Although most pts had a qualifying CV event >1 year before randomisation in EMPA-REG OUTCOME, the benefits of EMPA appear to extend to pts with more recent CV events. Acknowledgement/Funding Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance

scholarly journals Pain in Patients With Type 2 Diabetes-Related Polyneuropathy Is Associated With Vascular Events and Mortality

2020 ◽  
Vol 105 (9) ◽  
pp. 3005-3014
Author(s):  
Brittany R Lapin ◽  
Kevin M Pantalone ◽  
Alex Milinovich ◽  
Shannon Morrison ◽  
Andrew Schuster ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Proportional Hazards ◽  
Negative Binomial ◽  
Cox Proportional Hazards ◽  
Vascular Events ◽  
Proportional Hazards Regression ◽  
Increased Risk ◽  
History Of ◽  
Mortality Hazard Ratio

Abstract Purpose Type 2 diabetes–related polyneuropathy (DPN) is associated with increased vascular events and mortality, but determinants and outcomes of pain in DPN are poorly understood. We sought to examine the effect of neuropathic pain on vascular events and mortality in patients without DPN, DPN with pain (DPN + P), and DPN without pain (DPN-P). Methods A retrospective cohort study was conducted within a large health system of adult patients with type 2 diabetes from January 1, 2009 through December 31, 2016. Using an electronic algorithm, patients were classified as no DPN, DPN + P, or DPN-P. Primary outcomes included number of vascular events and time to mortality. Independent associations with DPN + P were evaluated using multivariable negative binomial and Cox proportional hazards regression models, adjusting for demographics, socioeconomic characteristics, and comorbidities. Results Of 43 945 patients with type 2 diabetes (age 64.6 ± 14.0 years; 52.1% female), 13 910 (31.7%) had DPN: 9104 DPN + P (65.4%) vs 4806 DPN-P (34.6%). Vascular events occurred in 4538 (15.1%) of no DPN patients, 2401 (26.4%) DPN + P, and 1006 (20.9%) DPN-P. After adjustment, DPN + P remained a significant predictor of number of vascular events (incidence rate ratio [IRR] = 1.55, 95% CI, 1.29-1.85), whereas no DPN was protective (IRR = 0.70, 95% CI, 0.60-0.82), as compared to DPN-P. Compared to DPN-P, DPN + P was also a significant predictor of mortality (hazard ratio = 1.42, 95% CI, 1.25-1.61). Conclusions Our study found a significant association between pain in DPN and an increased risk of vascular events and mortality. This observation warrants longitudinal study of the risk factors and natural history of pain in DPN.

scholarly journals Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial

2020 ◽  
Author(s):  
Antonio Ceriello ◽  
Anne Pernille Ofstad ◽  
Isabella Zwiener ◽  
Stefan Kaspers ◽  
Jyothis George ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Standard Deviation ◽  
Cox Regression ◽  
Glucose Variability ◽  
Cardiovascular Death ◽  
Baseline Risk ◽  
Increased Risk ◽  
Outcome Trial ◽  
Hba1c Variability

Abstract Background: Glucose variability has been associated with cardiovascular outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and cardiovascular death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular death by 38%. We explore post-hoc the association between HbA1c variability and cardiovascular death, and the potential mediating effects of HbA1c variability on empagliflozin’s cardiovascular death reductions.Methods: In total, 7,020 patients with type 2 diabetes and established cardiovascular disease received placebo, empagliflozin 10 mg or 25 mg. We defined within-patient HbA1c variability as standard deviation, coefficient of variation and range of HbA1c measurements (%) post-baseline. First, we compared HbA1c variability until week 28 and 52 by Wilcoxon tests. We explored the association between cardiovascular death and HbA1c variability in placebo and pooled empagliflozin arms separately with landmark analyses at week 28 and 52, and additionally with HbA1c variability as a time-dependent co-variate. We used Cox regression models adjusted for baseline risk factors including changes in HbA1c from baseline to week 12, and the interaction term HbA1c variability* treatment.Results: HbA1c variability was lower with empagliflozin compared to placebo. In all Cox analyses, high HbA1c variability increased the risk for cardiovascular death in both treatment arms with no interaction with treatment: e.g.an increase in HbA1c variability of one unit for the standard deviation at week 28 was associated with a subsequent increased risk of CV death with HRs of 1.97 (95% CI 1.36, 2.84) and 1.53 (1.01, 2.31) in the placebo and empagliflozin groups, separately, interaction p-value 0.3615.Conclusions: HbA1c variability was reduced by empagliflozin and high values of HbA1c variability were associated with an increased risk of cardiovascular death. Empagliflozin’s reduction in cardiovascular death did not appear to be mediated by reductions in HbA1c variability.ClinicalTrials.gov number, NCT01131676

scholarly journals Gestational Diabetes Mellitus and the Risks of Overall and Type-Specific Cardiovascular Diseases: A Population- and Sibling-Matched Cohort Study

2021 ◽  
Author(s):  
Yongfu Yu ◽  
Melissa Soohoo ◽  
Henrik Toft Sørensen ◽  
Jiong Li ◽  
Onyebuchi A. Arah
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Cohort Study ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Cox Regression ◽  
Maternal History ◽  
History Of ◽  
The Impact

<b>OBJECTIVE</b> <p>To evaluate associations between gestational diabetes mellitus (GDM) and various incident cardiovascular disease (CVD) endpoints, considering the effects of mediating role of type 2 diabetes and shared environmental/familial factors.</p> <p><b>RESEARCH DESIGN AND METHODS</b></p> <p>This population-based cohort study included 1002486 parous women in Denmark during 1978-2016. We used Cox regression to (i) examine the associations of GDM with overall and type-specific CVDs using full-cohort and sibling-matched analysis; (ii) quantify the impact of type 2 diabetes after GDM using mediation analysis; and (iii) assess whether these associations were modified by pre-pregnancy obesity or maternal history of CVD.</p> <p><b>RESULTS</b></p> <p>Women with a history of GDM had a 40% increased overall CVD risk (hazard ratio [HR]: 1.40, 95% confidence interval [CI]: 1.35-1.45). Sibling-matched analyses yielded similar results(HR, 1.44; 95%CI, 1.28-1.62). Proportion of association between GDM and overall CVD explained by subsequent type 2 diabetes was 23.3%(15.4%-32.8%). We observed increased risks of specific CVDs, including 65% increased stroke risk and more than two-fold risks for myocardial infarction, heart failure, and peripheral artery disease. The elevated overall risks were more pronounced among women with GDM and pre-pregnancy obesity or maternal history of CVD. </p> <p><b>CONCLUSIONS</b></p> <p>A history of GDM was associated with increased risks of overall and specific CVDs. Increased risks were partly explained by subsequent type 2 diabetes and the need to identify other pathways remains important. Continuous monitoring of women with a history of GDM, especially those with pre-pregnancy obesity or maternal history of CVD, may provide better opportunities to reduce their cardiovascular risk.</p>

Abstract 12630: Cardiovascular Safety of Liraglutide: Pooled Analysis of Major Adverse Cardiovascular Events across Weight Management and Type 2 Diabetes Development Programs

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Ian D Caterson ◽  
Stephen C Bain ◽  
Jorge Gross ◽  
John House ◽  
Adam C Salisbury ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Management ◽  
Cardiovascular Events ◽  
Pooled Analysis ◽  
Drug Dose ◽  
Major Adverse Cardiovascular Events ◽  
Cardiovascular Safety ◽  
History Of ◽  
Cv Disease

The cardiovascular safety of liraglutide in individuals with overweight/obesity and those with type 2 diabetes (T2D) is unknown. A meta-analysis of five phase II/III liraglutide (dose up to 3.0 mg) weight management (WM) trials was performed. Additional sensitivity meta-analyses of 21 liraglutide T2D trials (dose up to 1.8 mg) and a pre-specified pooled analysis of all WM and T2D trials (27 trials; WM+T2D) were also conducted. The primary endpoint was first occurrence of adjudicated major adverse cardiovascular events (MACE) (non-fatal myocardial infarction, non-fatal stroke or cardiovascular death) with liraglutide (any dose) or pooled total comparator (placebo, active) and analysis was using a Cox proportional hazards model stratified by trial. Prospective adjudication (blinded, independent) was implemented in three of the WM trials; post-hoc adjudication was conducted for all other trials. For WM trials, the observation period was from the first drug dose to the last drug dose plus a 30-day follow-up; for the SCALE Obesity and Prediabetes trial, data to October 1, 2014 were included. For WM trials (liraglutide: n=3,872; comparator: n=2,036), baseline characteristics were: 71% women; history of CV disease, 9%; mean age, 47 yrs; mean BMI, 38 kg/m 2 . For T2D trials (liraglutide: n=5,511; comparator: n=2,748): 43% women; history of CV disease, 13%; mean age, 56 yrs; mean BMI, 30 kg/m 2 . In WM trials (n=20 events), the hazard ratio (HR) [95% confidence interval (CI)] for MACE (liraglutide/comparator) was 0.45 [0.18; 1.10] (Figure 1A). In T2D trials (n=49 events), the HR was 0.64 [0.35, 1.15] (Figure 1A). For the WM+T2D analysis (n=69 events), the HR was 0.57 [0.35, 0.94] (Figure 1B). In a pooled analysis of WM+T2D trials, MACE was significantly lower in patients treated with liraglutide. The dedicated cardiovascular outcomes trial, LEADER, will provide further insights into the cardiovascular safety of liraglutide.

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