Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients ...with type 2 diabetes.
To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity.
For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up.
A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 calculated as weight in kilograms divided by height in meters squared), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio uACR >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51).
The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety.
A total of 100 patients (mean SD age, 51.4 7.6 years; 55 55% male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed.
After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
ClinicalTrials.gov Identifier: NCT01821508.
The latest recommendations from the American Diabetes Association and the European Association for the Study of Diabetes prioritize the use of drugs with proven cardiovascular (CV) benefit in ...patients with established CV disease. Especially among the glucagon-like peptide (GLP)-1 receptor agonists (GLP-1RA) class, results of cardiovascular outcomes trials (CVOT) have been heterogeneous. Baseline characteristics of the population, study design, drugs in the control arm, modifications of CV risk factors, including glycemic control, reduction of hypoglycemia, and the GLP-1RA direct effects on CV cells and tissues, were considered. Ultimately, the time of exposure to the GLP-1RA appears to be the factor most prominently explaining trial heterogeneity. Thus, the CV benefit should be regarded as a class effect of GLP-1RA, as largely similar results are seen for drugs sharing a common mechanism of action.
ELIXA was the only GLP-1RA CVOT that failed to show any CV benefit over usual care. In LEADER, SUSTAIN-6, HARMONY Outcomes, and REWIND, GLP-1RA showed statistical superiority on MACEs compared to usual care, while EXSCEL (P=0.06) just grazed it and PIONEER 6 showed a nonsignificant 21% reduction (P=0.17). However, SUSTAIN-6 lacked a prespecified analysis for superiority.Dulaglutide significantly decreased the incidence of MACEs by 12% in a population at a lower CV risk compared to previous CVOT.Although GLP-1RA CVOT were not powered to detect such differences, GLP-1RA seemed to affect the individual MACE components according to specific patterns: liraglutide and oral semaglutide produced significant reductions of CV death; subcutaneous semaglutide and dulaglutide promoted a significant decrease in non-fatal stroke; albiglutide largely reduced non-fatal MI; and exenatide LAR did not show a significant effect in any component.
Glucagon-like peptide-1 receptor agonists reduce albuminuria and may stabilize the estimated glomerular filtration rate (eGFR) in people with type 2 diabetes (T2D). In this post hoc analysis of the ...SUSTAIN 6/PIONEER 6 trials encompassing 6480 participants at high cardiovascular risk (semaglutide, 3239 participants; placebo, 3241 participants), we investigated the effects of semaglutide versus placebo on eGFR decline. Pooled data by treatment were evaluated for annual eGFR change (total annual eGFR slope in ml/min per 1.73 m2) from baseline to end of treatment and time to persistent eGFR reductions of 30%, 40%, 50% and 57% or more, including subgroup analyses by baseline eGFR (30 to under 60 or 60 and over ml/min per 1.73 m2). In the overall population, the estimated treatment difference (ETD; semaglutide versus placebo) in annual eGFR slope was significant at 0.59 ml/min per 1.73 m2 (95% confidence interval 0.29; 0.89). The ETD was numerically largest in the 30 to under 60 ml/min per 1.73 m2 eGFR subgroup, 1.06 ml/min per 1.73 m2 (0.45; 1.67), but no significant interaction was observed for treatment effect by subgroup. Hazard ratios (semaglutide versus placebo) for time to persistent eGFR decline were under 1.0 for all eGFR thresholds in the overall population; and were numerically lower in the baseline eGFR 30 to under 60 ml/min per 1.73 m2 subgroup versus the overall population, although no significant interaction was observed for treatment effect by subgroup. Thus, pooled analyses of clinical trial data in patients with T2D suggest that semaglutide may reduce the rate of eGFR decline.
Display omitted
The systemic inflammatory response index (SIRI) is a novel inflammatory biomarker in many diseases.
The aim of this study was to examine the association between SIRI and adverse events in patients ...with the acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.
A total of 1724 patients with ACS enrolled from June 2016 to November 2017 at a single centre were included in this study, and SIRI was calculated for each patient. The primary endpoint was the composite of major adverse cardiovascular events (MACE), including overall death, non-fatal myocardial infarction, non-fatal stroke, and unplanned repeat revascularization.
During a median follow-up of 927 days, 355 patients had MACE. Multivariate Cox analysis showed that SIRI was significantly associated with MACE (hazard ratio: 1.127, 95% confidence interval: 1.034-1.229 p = .007). The results were consistent in multiple sensitivity analyses. The addition of SIRI had an incremental effect on the predictive ability of the Global Registry of Acute Coronary Events risk score for MACE (integrated discrimination improvement: 0.007, p = .040; net reclassification improvement: 0.175, p = .020; likelihood ratio test: p < .001). The restricted cubic spline showed a monotonic increase with a greater SIRI value for MACE (p < .001).
SIRI was an independent risk factor for MACE and provided incremental prognostic information in patients with ACS undergoing percutaneous coronary intervention.
KEY MESSAGES
The SIRI is a strong and independent risk factor for adverse outcomes in patients with ACS undergoing percutaneous coronary intervention.
Higher SIRI is associated with a more severe disease status.
The SIRI could increase the prognostic value of the GRACE risk score.
The Heart Failure Association (HFA) of the European Society of Cardiology (ESC) has recently issued a position paper on the role of sodium–glucose co‐transporter 2 (SGLT2) inhibitors in heart failure ...(HF). The present document provides an update of the position paper, based of new clinical trial evidence. Accordingly, the following recommendations are given:
• Canagliflozin, dapagliflozin empagliflozin, or ertugliflozin are recommended for the prevention of HF hospitalization in patients with type 2 diabetes mellitus and established cardiovascular disease or at high cardiovascular risk.
• Dapagliflozin or empagliflozin are recommended to reduce the combined risk of HF hospitalization and cardiovascular death in symptomatic patients with HF and reduced ejection fraction already receiving guideline‐directed medical therapy regardless of the presence of type 2 diabetes mellitus.
Patients with heart failure with reduced ejection fraction and low systolic blood pressure (SBP) have high mortality, hospitalizations, and poorly tolerate evidence-based medical treatment. Omecamtiv ...mecarbil may be particularly helpful in such patients. This study examined its efficacy and tolerability in patients with SBP ≤100 mmHg enrolled in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF).
The GALACTIC-HF enrolled patients with baseline SBP ≥85 mmHg with a primary outcome of time to cardiovascular death or first heart failure event. In this analysis, patients were divided according to their baseline SBP (≤100 vs. >100 mmHg). Among the 8232 analysed patients, 1473 (17.9%) had baseline SBP ≤100 mmHg and 6759 (82.1%) had SBP >100 mmHg. The primary outcome occurred in 715 (48.5%) and 2415 (35.7%) patients with SBP ≤100 and >100 mmHg, respectively. Patients with lower SBP were at higher risk of adverse outcomes. Omecamtiv mecarbil, compared with placebo, appeared to be more effective in reducing the primary composite endpoint in patients with SBP ≤100 mmHg hazard ratio (HR), 0.81; 95% confidence interval (CI), 0.70-0.94 compared with those with SBP >100 mmHg (HR, 0.95; 95% CI, 0.88-1.03; P-value for interaction = 0.051). In both groups, omecamtiv mecarbil did not change SBP values over time and did not increase the risk of adverse events, when compared with placebo.
In GALACTIC-HF, risk reduction of heart failure outcomes with omecamtiv mecarbil compared with placebo was large and significant in patients with low SBP. Omecamtiv mecarbil did not affect SBP and was well tolerated independent of SBP values.
To compare SGLT2 inhibitors and GLP-1 agonists on cardiovascular (CV) outcomes, treatment persistence/discontinuation, healthcare utilization and costs.
This retrospective cohort study utilized ...medical and pharmacy claims to identify new SGLT2 inhibitor or GLP-1 agonist users from January 2015 to June 2017. A total of 5,507 patients were included in each treatment group after 1:1 propensity score matching. Cox proportional hazards models were used to compare CV outcomes and treatment discontinuation. Healthcare utilization and costs were compared using Wilcoxon signed rank test.
No differences in the primary composite CV outcome or secondary CV outcome were observed. Patients using GLP-1 agonists were more likely to discontinue treatment (hazard ratio 1.15, 95% confidence interval 1.10–1.21) and more likely to have an inpatient hospitalization (14.4% vs. 11.9%, P < 0.001) or emergency department visit (27.4% vs. 23.5%, P < 0.001) compared to patients on SGLT2 inhibitors. The average per-person per-month cost difference was +$179 for total cost (P < 0.001), +$70 for medical cost (P < 0.001) and +$108 for pharmacy cost (P < 0.001) for GLP-1 agonists compared to SGLT2 inhibitors.
Differences in composite CV outcomes were not established. However, other findings that favored SGLT2 inhibitors should be weighed against the known risks associated with this therapeutic class.
There has been little progress in reducing health care disparities since the 2003 landmark Institute of Medicine's report Unequal Treatment. Despite the higher burden of cardiovascular disease in ...underrepresented racial and ethnic groups, they have less access to cardiologists and cardiothoracic surgeons, and have higher rates of morbidity and mortality with cardiac surgical interventions. This review summarizes existing literature and highlights disparities in cardiovascular perioperative health care. We propose actionable solutions utilizing multidisciplinary perspectives from cardiology, cardiac surgery, cardiothoracic anesthesiology, critical care, medical ethics, and health disparity experts. Applying a health equity lens to multipronged interventions is necessary to eliminate the disparities in perioperative health care among patients undergoing cardiac surgery.
There has been little progress in reducing health care disparities since the 2003 landmark Institute of Medicine’s report Unequal Treatment. Despite the higher burden of cardiovascular disease in ...underrepresented racial and ethnic groups, they have less access to cardiologists and cardiothoracic surgeons, and have higher rates of morbidity and mortality with cardiac surgical interventions. This review summarizes existing literature and highlights disparities in cardiovascular perioperative health care. We propose actionable solutions utilizing multidisciplinary perspectives from cardiology, cardiac surgery, cardiothoracic anesthesiology, critical care, medical ethics, and health disparity experts. Applying a health equity lens to multipronged interventions is necessary to eliminate the disparities in perioperative health care among patients undergoing cardiac surgery.
Display omitted
•Despite their higher cardiovascular disease burden, underrepresented racial and ethnic groups have less access to cardiovascular and cardiac surgical care, and worse postoperative outcomes.•Various factors, including racism and social determinants of health, contribute to perioperative health care disparities.•Applying a health equity lens to multipronged interventions may reduce disparities and improve cardiovascular outcomes among patients undergoing cardiac surgery.
PDF
