P1019CANAGLIFLOZIN AND RISK OF SKIN AND SOFT TISSUE INFECTIONS IN PEOPLE WITH DIABETES MELLITUS AND KIDNEY DISEASE - A POST-HOC ANALYSIS OF THE CREDENCE TRIAL

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Amy Kang ◽  
Brendan Smyth ◽  
Brendon Neuen ◽  
Hiddo Lambers Heerspink ◽  
Gian Luca Di Tanna ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Soft Tissue ◽  
Kidney Disease ◽  
Skin Infections ◽  
Soft Tissue Infections ◽  
Post Hoc Analysis ◽  
Intention To Treat ◽  
Post Hoc ◽  
Treat Population

Abstract Background and Aims The skin’s hypertonic microenvironment has a hypothesized protective antimicrobial function that may be disrupted by SGLT2i. The association between sodium glucose cotransporter inhibitors (SGLT2i) and genital mycotic infections is well established, but it is not known if these agents increase the risk of other skin and soft tissue infections (SSTI). We aimed to describe SSTI in the CREDENCE trial, and determine whether canagliflozin affects the risk of skin and soft tissue infections (SSTIs) overall and in subgroups. Method We performed a post-hoc analysis of the CREDENCE trial that randomised people with type 2 diabetes and albuminuric stage 2 and 3 chronic kidney disease to either canagliflozin 100mg daily or placebo. Infections reported as adverse events were assessed by two blinded authors following predetermined criteria for SSTI with discrepancies resolved by consensus. We analysed the risks of SSTIs in the on-treatment population as the more conservative approach, with a sensitivity analysis conducted in the intention-to-treat population. Univariable time-to first-event regression models were assessed. Results Overall 373/4397 (8.5%) participants experienced 478 events comprising 252 bacterial skin infections (including 2 episodes of necrotising fasciitis), 94 fungal skin infections, 109 other skin infections and 23 soft tissue infections. Of these, 136/478 (28%) were serious. Drug was continued in 290/373 (78%) of first events, with similar frequency of subsequent events between groups (31/133 (23%) and 33/157 (21%) for those continuing canagliflozin and placebo respectively). In both cases of necrotising fasciitis, drug was withdrawn and the participants recovered.Canagliflozin did not increase the risk of SSTI (HR 0.85 [95% Confidence Interval (CI) 0.69-1.04] p=0.11) (Figure 1). Results were similar in the intention-to-treat population (HR 0.88 [95% CI 0.73-1.07] p=0.20), in analyses confined to serious SSTI (HR 0.83 [95% CI 0.58-1.21] p=0.33), and in the predefined subgroups. Conclusion Although other studies suggest that SGLT2i may reduce the sodium content of the skin, we found that canagliflozin does not increase the risk of skin and soft tissue infections, overall or in any subgroup, in people with type 2 diabetes mellitus and albuminuric chronic kidney disease.

Abstract #295 GLP-1 Receptor Agonists and Death From Any Cause in Elderly Patients with Type 2 Diabetes Mellitus: A Post-Hoc Analysis

2018 ◽  
Vol 24 ◽  
pp. 80-81
Author(s):  
Konstantinos Toulis ◽  
Krishna Gokhale ◽  
G. Neil Thomas ◽  
Wasim Hanif ◽  
Krishnarajah Nirantharakumar ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Elderly Patients ◽  
Post Hoc Analysis ◽  
Receptor Agonists ◽  
Post Hoc

Management of superficial and deep-seated Staphylococcus aureus skin and soft tissue infections in sub-Saharan Africa: a post hoc analysis of the StaphNet cohort

Infection ◽  
2018 ◽  
Vol 46 (3) ◽  
pp. 395-404 ◽  
Author(s):  
Abraham Alabi ◽  
Theckla Kazimoto ◽  
Marthe Lebughe ◽  
Delfino Vubil ◽  
Patrick Phaku ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Soft Tissue ◽  
Sub Saharan Africa ◽  
Soft Tissue Infections ◽  
Post Hoc Analysis ◽  
Sub Saharan ◽  
Post Hoc

scholarly journals FP152EFFECT OF BARDOXOLONE METHYL TREATMENT ON URINARY ALBUMIN IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE - POST-HOC ANALYSIS FROM BEAM AND BEACON

2018 ◽  
Vol 33 (suppl_1) ◽  
pp. i27-i27
Author(s):  
Peter Rossing ◽  
Geoffrey Block ◽  
Glenn Chertow ◽  
Melanie Chin ◽  
Angie Goldsberry ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Urinary Albumin ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Effects of canagliflozin on hyperkalaemia and serum potassium in people with diabetes and chronic kidney disease: insights from the CREDENCE trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
B L Neuen ◽  
M Oshima ◽  
V Perkovic ◽  
C Arnott ◽  
G Bakris ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Serum Potassium ◽  
Sglt2 Inhibitor ◽  
Renin Angiotensin System ◽  
Renin Angiotensin ◽  
Post Hoc Analysis ◽  
Intention To Treat ◽  
Potassium Binders ◽  
Post Hoc

Abstract Background Hyperkalaemia is a common complication of type 2 diabetes mellitus (T2DM) and limits the optimal use of agents that block the renin-angiotensin aldosterone system (RAAS), particularly in patients with chronic kidney disease (CKD). In patients with CKD, sodium glucose cotransporter 2 (SGLT2) inhibitors provide cardiorenal protection, but whether they affect the risk of hyperkalaemia remains uncertain. Purpose We sought to assess the effect of canagliflozin on hyperkalaemia and other potassium-related outcomes in people with T2DM and CKD by conducting a post-hoc analysis of the CREDENCE trial. Methods The CREDENCE trial randomized 4401 participants with T2DM and CKD to the SGLT2 inhibitor canagliflozin or matching placebo. In this post-hoc analysis using an intention-to-treat approach, we assessed the effect of canagliflozin on a composite outcome of time to either investigator-reported hyperkalaemia or the initiation of potassium binders. We also analysed effects on central laboratory-determined hyper- and hypokalaemia (serum potassium ≥6.0 and <3.5 mmol/L, respectively) and change in serum potassium. Results At baseline the mean serum potassium in canagliflozin and placebo arms was 4.5 mmol/L; 4395 (99.9%) participants were receiving renin angiotensin system blockade. Canagliflozin reduced the risk of investigator-reported hyperkalaemia or initiation of potassium binders (HR 0.78, 95% CI 0.64–0.95, p=0.014; Figure 1). The incidence of laboratory-determined hyperkalaemia was similarly reduced (HR 0.77, 95% CI 0.61–0.98, p=0.031; Figure 2); the risk of hypokalaemia (HR 0.92, 95% CI 0.71–1.20, p=0.53) was not increased. Mean serum potassium over time with canagliflozin was similar to that of placebo. Conclusion Among patients treated with RAAS inhibitors, SGLT2 inhibition with canagliflozin may reduce the risk of hyperkalaemia in people with T2DM and CKD without increasing the risk of hypokalaemia. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

scholarly journals Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Chao Gao ◽  
Mariusz Tomaniak ◽  
Kuniaki Takahashi ◽  
Hideyuki Kawashima ◽  
Rutao Wang ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Primary Endpoint ◽  
Composite Endpoint ◽  
Bleeding Events ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Type 3 ◽  
Q Wave

Abstract Background Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD) are a subpopulation characterized by ultrahigh ischemic and bleeding risk after percutaneous coronary intervention. There are limited data on the impact of ticagrelor monotherapy among these patients. Methods In this post hoc analysis of the GLOBAL-LEADERS trial, the treatment effects of the experimental (one-month dual-antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin alone) were analyzed according to DM/CKD status. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years. The patient-oriented composite endpoint (POCE) was defined as the composite of all-cause death, any stroke, site-reported MI and any revascularization, whereas net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events. Results At 2 years, the DM + /CKD + patients had significantly higher incidences of the primary endpoint (9.5% versus 3.1%, adjusted HR 2.16; 95% CI [1.66–2.80], p < 0.001), BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE, compared with the DM-/CKD- patients. Among the DM + /CKD + patients, after adjustment, there were no significant differences in the primary endpoints between the experimental and reference regimen; however, the experimental regimen was associated with lower rates of POCE (20.6% versus 25.9%, HR 0.74; 95% CI [0.55–0.99], p = 0.043, pinteraction = 0.155) and NACE (22.7% versus 28.3%, HR 0.75; 95% CI [0.56–0.99], p = 0.044, pinteraction = 0.310), which was mainly driven by a lower rate of all revascularization, as compared with the reference regimen. The landmark analysis showed that while the experimental and reference regimen had similar rates of all the clinical endpoints during the first year, the experimental regimen was associated with significantly lower rates of POCE (5.8% versus 11.0%, HR 0.49; 95% CI [0.29–0.82], p = 0.007, pinteraction = 0.040) and NACE (5.8% versus 11.2%, HR 0.48; 95% CI [0.29–0.82], p = 0.007, pinteraction = 0.013) in the second year. Conclusion Among patients with both DM and CKD, ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE. These findings should be interpreted as hypothesis-generating. Clinical Trial Registration: ClinicalTrials.gov (NCT01813435).

Impact of Race/Ethnicity on the Efficacy and Safety of Commonly Used Insulin Regimens: A Post Hoc Analysis of Clinical Trials in Type 2 Diabetes Mellitus

2010 ◽  
Vol 16 (5) ◽  
pp. 818-828 ◽  
Author(s):  
Jaime Davidson ◽  
Lyndon Lacaya ◽  
Honghua Jiang ◽  
Cory Heilmann ◽  
Jamie Scism-Bacon ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Type 2 Diabetes Mellitus ◽  
Efficacy And Safety ◽  
Post Hoc Analysis ◽  
Race Ethnicity ◽  
Post Hoc
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