scholarly journals Effects of linagliptin vs glimepiride stratified by prior insulin secretagogue use in the cardiovascular outcome study of linagliptin versus glimepiride in type 2 diabetes (CAROLINA) trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.K McGuire ◽  
J Rosenstock ◽  
O.E Johansen ◽  
B.J Zinman ◽  
K Khunti ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Study Drug ◽  
Cardiovascular Outcome ◽  
Funding Source ◽  
Outcome Study ◽  
Early Type ◽  
Private Company ◽  
All Cause Mortality

Abstract Background/Introduction The cardiovascular outcome study of linagliptin versus glimepiride in type 2 diabetes (CAROLINA) was designed to compare the effects on cardiovascular (CV) events, and other outcomes, of linagliptin with glimepiride in patients with relatively early type 2 diabetes with elevated CV risk Purpose These post hoc analyses of the CAROLINA randomized controlled trial explore outcomes in subgroups stratified by prior sulfonylurea (SU) or glinide use. 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 with standard of care. 29.5% of patients had prior SU/glinide use. SU/glinides were discontinued at trial entry. Outcomes included time to first CV death/MI/stroke (3P-MACE), time to all-cause mortality, HbA1c change from baseline and time to first hypoglycaemia event. Results 6033 participants received ≥1 study drug dose (mean [SD] age 64.0 [9.5] yrs, HbA1c 7.2 [0.6] %, median diabetes duration 6.3 yrs, 42% with CV disease); 897 linagliptin and 884 glimepiride participants had prior SU/glinide use. Results for 3P-MACE and all-cause mortality were consistent across subgroups with/without prior SU/glinide use (interaction p>0.05; Fig). After some initial differences, there was no meaningful difference in HbA1c between linagliptin vs glimepiride across SU/glinide subgroups and overall. Hypoglycaemia rates were lower with linagliptin vs glimepiride overall and across SU/glinide subgroups, with some heterogeneity for prior SU/glinide use (interaction p<0.01; Fig). Conclusion There was no difference in linagliptin versus glimepiride on 3P-MACE and all-cause mortality, with consistent results across subgroups irrespective of prior SU/glinide use. Hypoglycaemia rates were consistently lower with linagliptin vs glimepiride, regardless of prior SU/glinide use. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boehringer Ingelheim and Eli Lilly and Company

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

Estimating cardiovascular disease-free life-years with the addition of semaglutide in people with type 2 diabetes using pooled data from SUSTAIN 6 and PIONEER 6

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Westerink ◽  
K Sommer Matthiessen ◽  
S Nuhoho ◽  
U Fainberg ◽  
M Lyng Wolden ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Funding Source ◽  
Cvd Risk ◽  
Private Company ◽  
Pooled Data ◽  
Patient Level ◽  
Life Years ◽  
Geographical Regions

Abstract Introduction Cardiovascular disease (CVD) is the leading cause of disability and death in people with type 2 diabetes (T2D). In a post hoc analysis of pooled data (POOLED cohort) from two phase 3, randomized CV outcomes trials, SUSTAIN 6 (NCT01720446) and PIONEER 6 (NCT02692716), the addition of the glucagon-like peptide-1 analogue semaglutide to standard of care (SoC) in people with T2D at high risk of CVD significantly reduced the risk of major adverse CVD events (3-point MACE: CV death, non-fatal stroke and non-fatal myocardial infarction). Purpose To estimate the effect of adding semaglutide to SoC on CVD-free life-years and 10-year CVD risk in patients with T2D by predicting individual patient-level risk of CVD events in the POOLED cohort using the DIAL CVD risk model. Methods The 3-point MACE hazard ratio from the POOLED cohort (N=6480; HR = 0.76 [95% confidence interval [CI]: 0.62–0.92]) was applied to the patient-level lifetime risk of CVD events derived from the DIAL model. CVD-free life-years and 10-year CVD risk were then calculated based on the age-specific risks of CVD events and non-vascular mortality, using standard actuarial methods. Both new and recurrent CVD events were considered. The DIAL model was validated by comparing the predicted and observed number of CVD events after 1 year. The DIAL model was previously developed using data from people with T2D in the Swedish National Diabetes Registry and validated across geographical regions. Results The DIAL model was considered valid for use in the POOLED cohort because the predicted number of CVD events at 1 year was within 5% of the number observed. Adding semaglutide to SoC was associated with a mean reduction in 10-year CVD risk of 20.0% (95% CI: 6.4–32.6%) and a mean increase of 1.72 (95% CI: 0.52–2.96) CVD-free life-years. The number of mean CVD-free life-years gained ranged from 0.62–2.91 years between age groups (Table). For a 60-year-old male with baseline characteristics matched to the average male from the POOLED cohort, adding semaglutide to SoC reduced 10-year CVD risk by 20.8% and provided 2.53 additional CVD-free life-years. The number of CVD-free life-years decreased when baseline age was increased (Figure). Conclusions The addition of semaglutide to SoC was associated with a gain in CVD-free life-years. This analysis helps contextualize the results of CV outcomes trials and may help to inform clinical decision-making. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novo Nordisk A/S

scholarly journals Lifetime risk of cardiovascular-renal disease in type 2 diabetes: a population-based study in 473399 individuals

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Zhang ◽  
J Mamza ◽  
T Morris ◽  
G Godfrey ◽  
F Asselbergs ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Renal Disease ◽  
Population Based ◽  
Lifetime Risk ◽  
Disease Stage ◽  
Renal Diseases ◽  
Funding Source ◽  
Private Company ◽  
Risk Of Death

Abstract Background Lifetime risks of cardiovascular (CV) and renal diseases are high, particularly in type 2 diabetes (T2D), but rarely studied together, and relative disease contributions are unknown. Knowledge of lifetime risk of cardiovascular-renal disease (CVRD) will better reflect disease burden in T2D. Purpose To investigate the lifetime risks (LTRs) of composite and individual components of major adverse reno-cardiovascular events, MARCE in T2D patients. Method In a population-based cohort study using national electronic health records, we studied 473399 individuals aged 45–99 years with T2D in England 2007–2018. The LTR of composite and individual components of MARCE (including CV death and CVRD: heart failure, HF; chronic kidney disease stage 3 and above, CKD; myocardial infarction, MI; stroke or peripheral artery disease, PAD) were estimated. LTRs by baseline CVRD comorbidity status were compared with individuals free from CVRD at baseline, accounting for the competing risk of death. Results Among T2D patients aged ≥45 years, the LTR of MARCE was 80% for individuals free from CVRD at baseline. LTR of MARCE was 97%, 93%, 98%, 89% and 91% for individuals with specific CVRD comorbidities for HF, CKD, MI, stroke and PAD, respectively at baseline. Within the CVRD-free cohort, LTR of CKD was highest at 54%, followed by CV death (41%), HF (29%), stroke (20%), MI (19%) and PAD (9%). Compared to CVRD-free, HF, MI and CKD at baseline were associated with the highest LTR of MARCE and its component diseases (Table). Conclusion The lifetime risk of CV disease and CKD in T2D patients is estimated to be over 60% and 50% respectively (1–3). When considered together, the LTR of MARCE is 80% in CVRD-free T2D patients, while nearly all those with T2D and HF will develop MARCE over their lifetime. Of the individual components of MARCE, LTR of CKD and HF were the highest among CVRD-free T2D patients. Preventive measures in T2D patients should be a priority in clinical practice to mitigate the burden of these complications. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): AstraZeneca

The mechanism of supply-demand imbalance and clinical outcomes in patients with type 2 myocardial infarction

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Bularga ◽  
A Anand ◽  
F.E Strachan ◽  
K.K Lee ◽  
S Stewart ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Funding Source ◽  
Coronary Syndrome ◽  
All Cause Mortality ◽  
Randomised Controlled

Abstract Background Type 2 myocardial infarction is common and associated with substantial risk of adverse clinical outcomes, worse than type 1 myocardial infarction, with as few as 30% of patients still alive at five years. However, this broad diagnostic term encompasses multiple mechanisms of supply-demand imbalance, which may be associated with different risks of adverse outcomes. Purpose We aimed to assess the prevalence and clinical outcomes of different mechanisms of supply-demand imbalance related to survival in the High-STEACS (High-Sensitivity Troponin in the Evaluation of patients with Acute Coronary Syndrome) randomised controlled trial. Methods The High-STEACS trial was a stepped wedge cluster randomised controlled trial in ten hospitals across Scotland, including 48,282 consecutive patients with suspected acute coronary syndrome. The diagnosis was adjudicated according to the Fourth Universal Definition of Myocardial Infarction. In patients with type 2 myocardial infarction, we prospectively adjudicated the cause for supply demand imbalance. Linkage of electronic healthcare records was used to track investigation, treatments and clinical outcomes. We used the Kaplan-Meier method, the log rank test and cox regression models adjusted for age, sex, renal function and co-morbidities to evaluate the risk of future all-cause mortality between categories. Results We identified 1,121 patients with type 2 myocardial infarction (age 74- ± 14, 55% female). At one year, death from any cause occurred in 23% (258/1,121) of patients. The most common reason for supply-demand imbalance was tachyarrhythmia in 55% (616/1,121), followed by hypoxaemia in 20% (219/1,121) of patients. Tachyarrhythmia was associated with reduced future risk of all-cause mortality (adjusted HR 0.69, 95% CI 0.43–1.09), similar to those with type 1 myocardial infarction. Comparatively, patients with hypoxaemia appeared at highest risk (adjusted HR 1.75, 95% CI 1.09–2.80). Conclusion The mechanism of myocardial oxygen supply-demand imbalance is associated with future prognosis, and should be considered when risk stratifying patients with type 2 myocardial infarction. Supply-demand imbalance survival Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): British Heart Foundation

Achievement of ESC/EAS lipid treatment goals with evolocumab in patients with type 2 diabetes: analyses of the BANTING and BERSON trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A.J Lorenzatti ◽  
J Chen ◽  
M.L Monsalvo ◽  
H Wang ◽  
J.A.G Lopez ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Funding Source ◽  
Treatment Goals ◽  
Cvd Risk ◽  
Private Company ◽  
Double Blind ◽  
Very High

Abstract Background BANTING and BERSON showed evolocumab in type 2 diabetes (T2D) effectively lowered low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and non-high-density lipoprotein-cholesterol (Non-HDL-C), all targets in cardiovascular disease (CVD) prevention. Purpose To evaluate the achievement of lipid treatment goals with evolocumab vs placebo in T2D. Methods We pooled two double-blind, randomised, phase 3 studies. In BANTING, participants received maximally-tolerated statins. In BERSON, participants began atorvastatin 20 mg post-baseline; almost half enrolled in China. LDL-C and non-HDL-C goal achievement were assessed at the mean of weeks 10 and 12; and ApoB at week 12. Results Of 1,402 participants analysed, 89.4% were at very high CVD risk. Treatment goals achievement was significantly greater in evolocumab vs placebo. Results were consistent in the Chinese subpopulation. Conclusion Evolocumab plus statins enabled most T2D patients at very-high/high CVD risk to achieve their lipid treatment goals Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen Inc.

scholarly journals Cardiovascular outcomes in patients with type 2 diabetes and reduced eGFR and albuminuria: a REWIND post hoc subgroup analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Colhoun ◽  
R Malik ◽  
F Botros ◽  
C Atisso ◽  
H Gerstein
Keyword(s):  
Risk Factors ◽  
Type 2 Diabetes ◽  
Risk Reduction ◽  
Subgroup Analysis ◽  
Funding Source ◽  
Private Company ◽  
First Occurrence ◽  
Cv Disease ◽  
Post Hoc

Abstract Background/Introduction Diabetic kidney disease affects up to 40% of people with diabetes and is associated with higher cardiovascular (CV) risk. REWIND was a multicentre, randomised, double-blind, placebo-controlled trial with a primary outcome of first occurrence of the composite endpoint of CV death, nonfatal myocardial infarction, or nonfatal stroke (Major Adverse Cardiovascular Event [MACE]-3). Dulaglutide treatment reduced the incidence of MACE-3 in patients with type 2 diabetes (T2D) with or without established CV disease. Purpose This REWIND post hoc subgroup analysis evaluated the effect of dulaglutide on MACE-3 in patients with an eGFR<60 and ≥60 mL/min/1.73m2 and patients with micro-/macro-albuminuria (UACR ≥30 mg/g) or normoalbuminuria (UACR <30 mg/g). Methods Eligible patients were those ≥50 years old with T2D who had either a previous CV event or CV risk factors. Patients were randomised (1:1) to dulaglutide 1.5 mg or placebo, both in addition to standard of care. A Cox proportional hazards model with treatment, eGFR subgroup (<60 and ≥60 mL/min/1.73 m2), and treatment by eGFR subgroup interaction was used to analyse time to the first occurrence of MACE-3. These analyses were also conducted for albuminuria subgroups (micro-/macro-albuminuria or normoalbuminuria). Estimates of hazard ratios (HR) with 95% confidence intervals (CI) were calculated for each subgroup. Results At baseline, 2,199 of 9,901 patients (22.2%) had an eGFR <60 mL/min/1.73 m2, 2,676 (27.0%) had microalbuminuria, and 791 (8.0%) had macroalbuminuria. This post hoc subgroup analysis showed that dulaglutide treatment was consistently associated with MACE-3 risk reduction in patients with eGFR <60 and ≥60 mL/min/1.73 m2 (HR [95% CI]: 0.93 [0.76–1.13] and 0.86 [0.75–0.99], respectively; interaction p=0.545). Similarly, MACE-3 risk reduction was consistent in patients with micro-/macro-albuminuria or normoalbuminuria (HR [95% CI]: 0.84 [0.72–0.99] and 0.93 [0.79–1.10], respectively; interaction p=0.374). Conclusions Regardless of baseline eGFR or albuminuria status, dulaglutide reduces MACE-3 outcomes in patients with T2D and established CV disease or multiple CV risk factors. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Eli Lilly and Company

Apabetalone, a selective BET protein inhibitor, reduces ischemic cardiovascular events and hospitalization for heart failure in patients with acute coronary syndrome and type 2 diabetes

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
S.J Nicholls ◽  
K.A Buhr ◽  
H.N Ginsberg ◽  
K Kalantar-Zadeh ◽  
...  
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Acute Coronary Syndrome ◽  
Number Needed To Treat ◽  
Funding Source ◽  
Protein Inhibitor ◽  
Private Company ◽  
Coronary Syndrome ◽  
Bet Protein

Abstract Background Despite established treatments, patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome (ACS) are at higher risk of ischemic cardiovascular (CV) events and hospitalization for heart failure (HHF) compared to those without T2DM. LDL-C lowering or use of GLP-1 agonists predominantly affects ischemic CV events, with little effect on HHF. Conversely, treatment with SGLT-2 inhibitors reduces HHF, with less effect on ischemic CV events. Preclinical studies indicate that bromodomain and extra-terminal (BET) proteins coordinate gene transcription for pathways that promote atherothrombotic events as well as heart failure. We assessed the clinical effect of apabetalone (APB), a novel BET protein inhibitor, on a composite of non-fatal ischemic CV events, HHF, and CV death in a post hoc analysis of the BETonMACE trial Methods BETonMACE was a double-blind, placebo-controlled phase 3 study in patients with T2DM and recent acute coronary syndrome receiving standard of care risk factor management. In 13 countries, 2425 patients were enrolled. We conducted a time-to-event analysis for first adjudicated CV death or non-fatal MI, stroke, or HHF using a log-rank test and Cox proportional hazards model. Results At baseline median age was 62 years, 25.6% were female, 87.6% white, and use of high intensity statin, ACE inhibitors/ angiotensin II blockers, dual antiplatelet therapy and beta blocker were 90, 88, 92 and 91% respectively. A total of 312 subjects had an endpoint event, with 139 (11.5%) patients in the ABP group and 173 (14.3%) among PBO (HR 0.78, 95% CI 0.63–0.98, p=0.03, Figure). At 26 months, the absolute risk reduction was 3.2% and number needed to treat was 31. Numerically favorable HRs were observed for each component endpoint except for stroke (Table). Conclusion This present analysis suggests that BET inhibition with APB may be a novel pathway through which to reduce both HHF and ischemic CV events in high risk patients with T2DM thus impacting broader clinical outcomes with potentially large benefits for patients and healthcare systems. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Resverlogix Corp

scholarly journals External applicability of SGLT2 inhibitor cardiovascular outcome trials to patients with type 2 diabetes and cardiovascular disease

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Lisanne C. A. Smidt ◽  
Frank L. J. Visseren ◽  
Wendela L. de Ranitz-Greven ◽  
Hendrik M. Nathoe ◽  
L. Jaap Kappelle ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Clinical Practice ◽  
Daily Clinical Practice ◽  
Cardiovascular Outcome ◽  
Exclusion Criteria ◽  
Cardiovascular Outcome Trials ◽  
All Cause Mortality ◽  
Diabetes Patients

Abstract Background Recent treatment guidelines support the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes and cardiovascular disease based on the results of cardiovascular outcome trials (CVOTs). Applicability of these trials to everyday patients with type 2 diabetes and cardiovascular disease is however unknown. The aim of this study is to assess the external applicability of SGLT2i CVOTs in daily clinical practice type 2 diabetes patients with established cardiovascular disease. Methods Trial in- and exclusion criteria from EMPA-REG OUTCOME, CANVAS, DECLARE-TIMI 58 and VERTIS-CV were applied to 1389 type 2 diabetes patients with cardiovascular disease in the Utrecht Cardiovascular Cohort-Secondary Manifestations of ARTerial disease (UCC-SMART). To evaluate the difference in cardiovascular risk (MACE) and all-cause mortality between trial eligible and ineligible patients, age and sex-adjusted Cox-regression analyses were performed. Results After applying trial in- and exclusion criteria, 48% of UCC-SMART patients with type 2 diabetes and cardiovascular disease would have been eligible for DECLARE-TIMI 58, 35% for CANVAS, 29% for EMPA-REG OUTCOME and 21% for VERTIS-CV. Without the eligibility criteria of HbA1c, eligibility was 58–88%. For all trials the observed risk for cardiovascular events and all-cause mortality was similar in eligible and ineligible patients after adjustment for age and gender. Conclusion A large proportion of patients with type 2 diabetes and cardiovascular disease in daily clinical practice would have been eligible for participation in the SGLT2i CVOTs. Trial eligible and ineligible patients have the same risk for MACE and all-cause mortality.

scholarly journals Independent predictors of heart failure in patients with type 2 diabetes and chronic kidney disease: modeling from the CREDENCE trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.W Mahaffey ◽  
J Li ◽  
T.I Chang ◽  
A Sarraju ◽  
R Agarwal ◽  
...  
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Estimated Glomerular Filtration Rate ◽  
Disease Modeling ◽  
Funding Source ◽  
Private Company ◽  
Potent Predictor

Abstract Background SGLT2 inhibitors have been shown to reduce hospitalization for heart failure (HHF). We sought to determine independent baseline predictors for HHF specifically in a population with type 2 diabetes and chronic kidney disease (CKD). Methods CREDENCE randomized 4401 participants with type 2 diabetes and CKD to canagliflozin 100 mg versus placebo. We evaluated the baseline clinical and demographic factors using multivariate regression modeling to identify the independent predictors of HHF. Results Overall, 230 participants (89 canagliflozin; 141 placebo) had at least 1 HHF event. Canagliflozin reduced the incidence of HHF compared with placebo (4.0% vs 6.4%; HR 0.61; 95% CI 0.47–0.80). Participants with HHF events postrandomization were older (65.8 vs 62.9 y), and had a longer duration of diabetes (17.4 vs 15.7 y), higher prevalence of prior HF (30.4% vs 14.0%), higher urinary albumin:creatinine ratio (1347 vs 904 mg/g), lower estimated glomerular filtration rate (51.5 vs 56.4 mL/min/1.73m2), and higher prevalence of prior cardiovascular disease (65.7% vs 49.6%) compared to those without HHF. Independent predictors of HHF are shown in the Table. Conclusions HHF is common in patients with type 2 diabetes and CKD. Canagliflozin reduces HHF by 39% compared with placebo. Higher urinary albumin:creatinine ratio was the most potent predictor of HHF and should be part of patient risk assessment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Janssen Research & Development, LLC

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