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Effect of mean HbA1c on the association of HbA1c variability and all-cause mortality in patients with type 2 diabetes

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (4)

Aim To evaluate the effect of mean HbA1c on the correlation between HbA1c variability and all-cause mortality, and the risks associated with different levels of HbA1c and glycaemic control status in patients with type 2 diabetes. Materials and Methods Patients with type 2 diabetes and at least three HbA1c measurements within 12-24 months were included. HbA1c variability score, coefficient of variation (CV) and standard deviation (SD) were used to evaluate variability. A variability score of 50 was set as a cutoff to define low and high variability. Results A total of 4216 patients were included, of whom 1196 died during the observation period (11.1 +/- 3.2 years). All-cause mortality increased with HbA1c variability score and the quartiles of HbA1c CV and SD. The strength of this association was attenuated after adjustment for mean HbA1c, and the risks associated with HbA1c variability and glycaemic control status were similar. The highest associated risk was observed with an HbA1c variability score of >50 and mean HbA1c of >= 7.5%. Mortality risk was significantly higher with a mean HbA1c of <= 6.0% and >8.5% and of <= 6.0% and >8.0% for low and high HbA1c variability, respectively. Conclusions Mean HbA1c contributed to the correlation between HbA1c variability and all-cause mortality. The risks associated with HbA1c variability and glycaemic control status were similar. The relationship between mean HbA1c and mortality presented a J-shaped distribution for both low and high HbA1c variability.

Real-world data reveal unmet clinical needs in insulin treatment in Asian people with type 2 diabetes: the Joint Asia Diabetes Evaluation (JADE) Register

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (4)

Aims To explore the pattern of insulin use and glycaemic control in Asian people with type 2 diabetes, stratified by gender, young-onset diabetes (YOD; diagnosed before age 40 years), and diabetic kidney disease (DKD; estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m(2)). Materials and methods We conducted a cross-sectional analysis of 97 852 patients from 11 Asian countries/regions (2007-2017) included in the prospective Joint Asia Diabetes Evaluation (JADE) Register. Results Among 18 998 insulin users (47% women, mean +/- SD age 59.2 +/- 11.7 years, diabetes duration 13.2 +/- 8.3 years, glycated haemoglobin [HbA1c] 72 +/- 21.4 mmol/mol [8.74 +/- 1.95%], median total daily insulin dose [TDD] 0.27-0.82 units/kg), 25% and 29.5% had YOD and DKD, respectively. Premixed (44%) and basal-only (42%) insulin were the most common regimens. Despite being more commonly treated with these two regimens with higher insulin dosages, patients with YOD had worse HbA1c levels than their late-onset peers (73 +/- 20.5 vs. 71 +/- 21.2 mmol/mol [8.82 +/- 1.87% vs. 8.66 +/- 1.94%]; P < 0.001). Fewer women than men attained an HbA1c level < 53 mmol/mol (7%; 15.7% vs 17.1%; P = 0.018). Adjusting for age, diabetes duration, TDD, HbA1c, eGFR, and use of oral glucose-lowering drugs at baseline, the odds of self-reported hypoglycaemia were higher in women (vs. men: adjusted odds ratio [aOR] 1.16, 95% confidence interval [CI] 1.05-1.28) and in patients with DKD treated with a premixed regimen (1.81 [95% CI 1.54-2.13] vs. 1.34 [95% CI 1.16-1.54] in non-DKD; P-interaction < 0.001). Compared to basal-only regimens, premixed and basal-bolus regimens had similar HbA1c reductions but were independently associated with increased odds of hypoglycaemia (1.65 [95% CI 1.45-1.88] and 1.88 [95% CI 1.58-2.23], respectively). Conclusions In this Asian population, there were varying patterns of insulin regimens with suboptimal glycaemic control, despite relatively high TDDs, which were influenced by gender, DKD, and YOD status.

Higher versus standard starting dose of insulin glargine 100 U/mL in overweight or obese Chinese patients with type 2 diabetes: Results of a multicentre, open-label, randomized controlled trial (BEYOND VII)

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (5)

Aim To determine the safety of a higher starting dose of basal insulin in overweight/obese patients with type 2 diabetes (T2D). Materials and methods This 16-week, randomized, multicentre, open-label trial enrolled adults with T2D (body mass index 25-40 kg/m(2)) and suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7.5-11.0% [58-97 mmol/mol] and fasting plasma glucose [FPG] >9.0 mmol/L) with two to three oral anti-hyperglycaemic drugs at 51 centres in China. Patients were randomized (1:1) to a higher (0.3 U/kg) or standard (0.2 U/kg) starting dose of insulin glargine 100 U/mL, which was then titrated to achieve a self-monitored fasting blood glucose (FBG) of 4.4 to 5.6 mmol/L. The primary endpoint was the percentage of patients with >= 1 episode of overall confirmed hypoglycaemia (<= 3.9 mmol/L or severe). Results At the end of study (n = 866), 11.0% patients treated with the 0.3 U/kg starting insulin dose experienced overall confirmed hypoglycaemia versus 8.6% of patients treated with 0.2 U/kg (estimated difference 2.1%, 95% confidence interval - 1.68, 5.89). The proportions of patients with symptomatic (9.8% vs 7.0%; P = 0.128) and nocturnal hypoglycaemia (2.7% vs 1.2%; P = 0.102) were similar in the two groups. There were no events of severe hypoglycaemia or FBG <3.0 mmol/L during the 16-week treatment, and achievement of HbA1c <7.0% (53 mmol/mol) (37.1% vs 37.1%) or FPG <5.6 mmol/L (15.9% vs 16.3%), <6.1 mmol/L (27.6% vs 26.1%), or < 7.0 mmol/L (48.8% vs 48.3%) without hypoglycaemia were comparable in the two groups. Moreover, the mean time was shorter (4.53, 3.95 and 2.74 weeks vs 5.51, 5.21 and 3.64 weeks) and number of titrations was lower (3.5, 3.0 and 2.0 vs 4.3, 4.0 and 2.8) to achieve self-monitored FBG targets of <5.6, <6.1 and <7.0 mmol/L in the higher versus the standard insulin dose group (all P < 0.01). Conclusions Among overweight/obese patients with T2D, a higher insulin starting dose was as safe as the standard starting dose, and self-monitored FBG targets were achieved earlier with the higher versus the standard dose.

Association between uric acid levels and cardio-renal outcomes and death in patients with type 2 diabetes: A subanalysis of EMPA-REG OUTCOME

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (7)

In the EMPA-REG OUTCOME trial, we explored the association between pre-randomization uric acid level tertile (<309.30 mu mol/L; 309.30 to <387.21 mu mol/L; >= 387.21 mu mol/L) and cardiovascular (CV) death, hospitalization for heart failure (HHF), HHF or CV death, all-cause mortality, three-point major adverse CV events (MACE), and incident or worsening nephropathy. Patients with type 2 diabetes and CV disease received empagliflozin or placebo. The median baseline plasma uric acid level was 344.98 mu mol/L, and patients' baseline characteristics were mainly balanced across tertiles. Baseline uric acid levels were associated with cardio-renal outcomes: in the placebo group, for the highest versus lowest tertile, the multivariable hazard ratios for three-point MACE, HHF or CV death, and incident or worsening nephropathy were 1.22 (95% confidence interval [CI] 0.89-1.67; P = 0.2088), 1.51 (95% CI 1.02-2.23; P = 0.0396) and 1.77 (95% CI 1.33-2.34; P < 0.0001), respectively. When tested as a continuous variable, baseline uric acid was associated with all outcomes in the placebo group. Empagliflozin improved all cardio-renal outcomes across tertiles, with all interaction P values >0.05. Further investigation of these relationships is required.

Effectiveness of sodium-glucose co-transporter-2 inhibitors on ischaemic heart disease

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (7)

Aim To compare the cardiovascular risks between users and non-users of sodium-glucose co-transporter-2 (SGLT2) inhibitors based on electronic medical record data from a large integrated healthcare system in South Louisiana. Materials and methods Demographic, anthropometric, laboratory and medication prescription information for patients with type 2 diabetes who were new users of SGLT2 inhibitors, either as initial treatments or as add-on treatments, were obtained from electronic health records. Mediation analysis was performed to evaluate the association of use of SGLT2 inhibitors and changes of metabolic risk factors with the risk of incident ischaemic heart disease. Results A total of 5338 new users of SGLT2 inhibitors were matched with 13 821 non-users. During a mean follow-up of 3.26 years, 2302 incident cases of ischaemic heart disease were defined. After adjusting for multiple confounding factors, patients using SGLT2 inhibitors had a lower risk of incident ischaemic heart disease compared to patients not using SGLT2 inhibitors (hazard ratio [HR] 0.63, 95% confidence interval [CI] 0.54-0.73). Patients using SGLT2 inhibitors also had a lower risk of incident ischaemic heart disease within 6 months (HR 0.36, 95% CI 0.25-0.44), 12 months (HR 0.40, 95% CI 0.32-0.49), 24 months (HR 0.53, 95% CI 0.43-0.60) and 36 months (HR 0.65, 95% CI 0.54-0.73), respectively. Reductions in systolic blood pressure partly mediated lowering risk of ischaemic heart disease among patients using SGLT2 inhibitors. Conclusions The real-world data in the present study show the contribution of SGLT2 inhibitors to reducing risk of ischaemic heart disease, and their benefits beyond glucose-lowering.

Age-specific associations of glycated haemoglobin variability with cardiovascular disease and mortality in patients with type 2 diabetes mellitus: A 10-year cohort study

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (8)

Aims To investigate the associations of increased variability in glycated haemoglobin (HbA1c) with cardiovascular disease (CVD) and mortality risk in patients with diabetes. Materials and Methods This prospective cohort study included 147 811 patients aged 45 to 84 years with type 2 diabetes mellitus, without CVD and with at least three HbA1c values recorded before baseline in the period 2008 to 2010. HbA1c variability was evaluated using a mixed effects model to reduce regression dilution bias. Age-specific associations (45- 54, 55- 64, 65- 74 and 75- 84 years) between HbA1c variability and risk of CVD and mortality were assessed by Cox regression, adjusted for patient characteristics and usual HbA1c. Results After a median follow-up of 7.4 years(1.02 million person-years), an overall incidence of 40 785 events including CVD (incidence 27 793) and all-cause mortalities (incidence 23 175) were identified. Positive log-linear associations between HbA1c variability and CVD and mortality were identified in all age groups. The hazard ratios (HRs) for the composite of CVD and all-cause mortality showed that age was inversely associated with HbA1c variability, with a 28% higher risk per 1% increase in HbA1c variability in the age group 45 to 54 years (all composite outcomes: HR 1.28, 95% confidence interval [CI] 1.21, 1.35), whereas only a 14% higher risk in the 75- 84 age group (all composite outcomes: HR 1.14, 95% CI 1.11, 1.17). Subgroup analysis showed the risk in patients with usual HbA1c <53mmol/mol was about eight times higher than in those with usual HbA1c >= 64mmol/mol. Conclusions HbA1c variability was strongly related to CVD and mortality in patients with diabetes across all age groups. Whilst pursuing optimal HbA1c targets, attention should be given to patients with high HbA1c variability, especially younger patients with good HbA1c control.

A pragmatic study of mid-mixture insulin and basal insulin treatment in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic medications: A lesson from real-world experience

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (8)

Background Chinese guidelines for the treatment of type 2 diabetes (T2D) recommend basal or premixed insulins as insulin starters after failed oral antihyperglycaemic medication (OAM). This pragmatic study compared effectiveness and safety of add-on basal insulin analog (BI) and mid-mixture insulin analog (MMI; 50:50 premixed insulin) as starter insulin regimens in Chinese patients with T2D in a real-world setting. Materials and Methods This was a multicentre, open-label, randomized, parallel, pragmatic trial. Patients receiving OAMs were randomized 1:1 to BI (n = 410) or MMI (n = 404) for 24 weeks. Insulin titration and OAM adjustment were determined by investigators following usual standard-of-care. The primary outcome was change in glycated haemoglobin (HbA1c) from baseline. Results Least-squares mean changes in HbA1c from baseline to week 24 were -2.00% and -2.15% for BI and MMI groups, respectively (P = .13). The MMI group demonstrated a greater reduction in concomitant OAM therapies used than BI group (53.8% vs. 35.3%, respectively; P < .001). Very limited daily insulin dose increments were observed from baseline to week 24 in both BI and MMI groups (2.5 U/day and 1.8 U/day, respectively). Although both insulin analogs were well-tolerated without severe hypoglycaemia, small weight gains were seen with both treatments. Higher total hypoglycaemia rates were noticed with the MMI group, while nocturnal hypoglycaemia events were comparable. Conclusions In real-world settings, BI and MMI provided similar improvement in glucose control without conceding hypoglycaemia. The BI group received a greater number of OAMs in real-world settings. Limited insulin dose titration was observed, while more adjustments occurred with OAM usage.

COVID-19 infection may cause ketosis and ketoacidosis

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (10)

The present study included 658 hospitalized patients with confirmed COVID-19. Forty-two (6.4%) out of 658 patients presented with ketosis on admission with no obvious fever or diarrhoea. They had a median (interquartile range [IQR]) age of 47.0 (38.0-70.3) years, and 16 (38.1%) were men. Patients with ketosis were younger (median age 47.0 vs. 58.0 years; P = 0.003) and had a greater prevalence of fatigue (31.0% vs. 10.6%; P < 0.001), diabetes (35.7% vs. 18.5%; P = 0.007) and digestive disorders (31.0% vs. 12.0%; P < 0.001). They had a longer median (IQR) length of hospital stay (19.0 [12.8-33.3] vs. 16.0 [10.0-24.0] days; P < 0.001) and a higher mortality rate (21.4% vs. 8.9%; P = 0.017). Three (20.0%) out of the 15 patients with diabetic ketosis developed acidosis, five patients (26.7%) with diabetic ketosis died, and one of these (25.0%) presented with acidosis. Two (7.4%) and four (14.3%) of the 27 non-diabetic ketotic patients developed severe acidosis and died, respectively, and one (25.0%) of these presented with acidosis. This suggests that COVID-19 infection caused ketosis or ketoacidosis, and induced diabetic ketoacidosis for those with diabetes. Ketosis increased the length of hospital stay and mortality. Meanwhile, diabetes increased the length of hospital stay for patients with ketosis but had no effect on their mortality.

Sodium-glucose co-transporter-2 inhibitors and the risk of diabetic ketoacidosis in patients with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (9)

Aim To assess the effects of sodium-glucoseco-transporter-2 (SGLT2) inhibitors on diabetic ketoacidosis (DKA) in patients with type 2 diabetes. Materials and Methods We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and from inception to 13 June 2019 for randomized controlled trials (RCTs) that compared SGLT2 inhibitors with control in patients with type 2 diabetes. Paired reviewers independently screened citations, assessed the risk of bias and extracted data. Peto's method was used as the primary approach to pool the effect of SGLT2 inhibitors on DKA. Sensitivity analyses with the alternative effect measure (risk ratio) or pooling method (Mantel-Haenszel), the use of continuity correction of 0.5 for zero-event trials or a generalized linear mixed model were conducted. Six preplanned subgroup analyses were performed to explore heterogeneity. The grading of recommendations assessment, development and evaluation (GRADE) approach was used to rate the quality of evidence. Results A total of 39 RCTs were included, involving 60 580 patients and 85 DKA events. SGLT2 inhibitors were statistically associated with an increased risk of DKA versus control (SGLT2 inhibitors: 62/34 961 [0.18%] vs. control: 23/25 211 [0.09%], Peto odds ratio [OR] 2.13, 95% confidence interval [CI] 1.38 to 3.27, I-2 = 8%; RD 1.7 more events, 95% CI 0.6 more to 3.4 more events per 1000 over 5 years; high-quality evidence). Sensitivity analyses showed similar results. The subgroup analyses by mean age (interaction P = 0 .02) and length of follow-up (interaction P = 0 .03) showed a larger relative effect among older patients (aged >= 60 years) and those with longer use of SGLT2 inhibitors (>52 weeks). Conclusions High-quality evidence suggests that SGLT2 inhibitors may increase the risk of DKA in patients with type 2 diabetes. The apparent differences in treatment effects among patients of a different age or follow-up were probable, suggesting the advisability of caution in patients with long-term use of SGLT2 inhibitors or in older patients.

Positive association of serum uric acid with new-onset diabetes in Chinese women with hypertension in a retrospective analysis of the China Stroke Primary Prevention Trial

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (9)

Aims To investigate the association of baseline serum uric acid (UA) with new-onset diabetes, and to explore the possible effect modifiers in Chinese adults with hypertension. Materials and methods A total of 14 943 hypertensive patients with available UA measurements and without diabetes at baseline were included from the China Stroke Primary Prevention Trial (CSPPT). Participants were randomly assigned to a double-blind daily treatment with 10 mg enalapril and 0.8 mg folic acid or 10 mg enalapril alone. The primary outcome was new-onset diabetes, defined as physician-diagnosed diabetes or use of glucose-lowering drugs during follow-up, or fasting glucose >= 7.0 mmol/L at the exit visit. Results Over a median follow-up of 4.5 years, 1623 participants (10.9%) developed diabetes. Overall, there was a positive association between baseline UA and new-onset diabetes in women (per SD increment; adjusted odds ratio [OR] 1.14, 95% confidence interval [CI] 1.07, 1.23), but not in men (adjusted OR 1.01, 95% CI 0.92, 1.10). Moreover, a stronger positive association between baseline UA and new-onset diabetes was found among women with lower time-averaged on-treatment systolic blood pressure during the treatment period (P-interaction = 0.024), higher baseline body mass index (P-interaction = 0.012), or higher baseline waist circumference (P-interaction = 0.032). Conclusions Our study suggested that higher baseline UA was significantly associated with increased risk of new-onset diabetes in hypertensive Chinese women, but not in men. Further prospective studies are required to validate the differential association by sex.

The clinical characteristics and outcomes of patients with diabetes and secondary hyperglycaemia with coronavirus disease 2019: A single-centre, retrospective, observational study in Wuhan

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (8)

Aim To explore whether coronavirus disease 2019 (COVID-19) patients with diabetes and secondary hyperglycaemia have different clinical characteristics and prognoses than those without significantly abnormal glucose metabolism. Materials and methods We retrospectively analysed 166 COVID-19 patients at Tongji Hospital (Wuhan) from 8 February to 21 March 2020. Clinical characteristics and outcomes (as of 4 April 2020) were compared among control (group 1), secondary hyperglycaemia (group 2: no diabetes history, fasting plasma glucose levels of >= 7.0 mmol/L once and HbA1c values <6.5%) and patients with diabetes (group 3). Results Compared with group 1, groups 2 and 3 had higher rates of leukocytosis, neutrophilia, lymphocytopenia, eosinopenia and levels of hypersensitive C-reactive protein, ferritin and d-dimer (P < .05 for all). Group 2 patients had higher levels of lactate dehydrogenase, prevalence of liver dysfunction and increased interleukin-8 (IL-8) than those in group 1, and a higher prevalence of increased IL-8 was found in group 2 than in group 3 (P < .05 for all). The proportions of critical patients in groups 2 and 3 were significantly higher compared with group 1 (38.1%, 32.8% vs. 9.5%,P < .05 for both). Groups 2 and 3 had significantly longer hospital stays than group 1, which was nearly 1 week longer. The composite outcomes risks were 5.47 (1.56-19.82) and 2.61 (0.86-7.88) times greater in groups 2 and 3 than in group 1. Conclusions Hyperglycaemia in both diabetes and secondary hyperglycaemia patients with COVID-19 may indicate poor prognoses. There were differences between patients with secondary hyperglycaemia and those with diabetes. We recommend that clinicians pay more attention to the blood glucose status of COVID-19 patients, even those not diagnosed with diabetes before admission.

Evaluation of the safety of sodium-glucose co-transporter-2 inhibitors for treating patients with type 1 diabetes

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (10)

Aim To conduct an overall safety assessment of sodium-glucose co-transporter-2 (SGLT-2) inhibitors used for the treatment of patients with type 1 diabetes (T1D), including ketoacidosis, genital infection, volume depletion, liver and kidney injury events, cardiovascular events, diarrhea and severe hypoglycaemia. Materials and Methods We searched three databases (Pubmed, Embase and the Cochrane Library) for randomized controlled trials that treated T1D by using SGLT-2 inhibitors from 2000 to 5 March 2020. Results Of the 1653 articles identified that fit our search criteria, 22 studies included qualitative-based results, eight of which were randomized clinical trials that included quantitative-based results. Compared with the control group, the SGLT-2 inhibitors treatment group was found to have had an increased incidence of ketoacidosis (P< .00001, OR 4.34, 95% CI [2.37, 7.96], I-2= 18%), events leading to discontinuation (P< .0001, OR 1.76, 95% CI [1.34, 2.31], I-2= 0%), genital infection (P< .00001, OR 3.64, 95% CI [2.82, 4.70], I-2= 0%), volume depletion (P= .006, OR 2.10, 95% CI [1.23, 3.59], I-2= 4%) and diarrhoea (P= .008, OR 1.64, 95% CI [1.14, 2.36], I-2= 0%). However, according to subgroup analysis, the risk of diarrhoea was dose-related. The incidence of urinary tract infection, cardiovascular events, renal events, liver injury and fracture was not significantly different for the treatment group compared with the control group. Conclusions Despite showing some promise as a treatment approach, the application of SGLT-2 inhibitors for patients with T1D should be considered with caution.

Greater variability in lipid measurements associated with cardiovascular disease and mortality: A 10-year diabetes cohort study

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (10)

Aim To examine the associations between variability in lipids and the risk of cardiovascular disease (CVD) and mortality in patients with type 2 diabetes based on low-density lipoprotein-cholesterol (LDL-C), the total cholesterol (TC) to high-density lipoprotein-cholesterol (HDL-C) ratio and triglycerides (TG). Materials and methods A retrospective cohort study included 125 047 primary care patients with type 2 diabetes aged 45-84 years without CVD during 2008-2012. The variability of LDL-C, TC to HDL-C and TG was determined using the standard deviation of variables in a mixed effects model to minimize regression dilution bias. The associations between variability in lipids and CVD and mortality risk were assessed by Cox regression. Subgroup analyses based on patients' baseline characteristics were also conducted. Results A total of 19 913 CVD events and 15 329 mortalities were recorded after a median follow-up period of 77.5 months (0.8 million person-years), suggesting a positive linear relationship between variability in lipids and the risk of CVD and mortality. Each unit increase in the variability of LDL-C (mmol/L), the TC to HDL-C ratio and TG (mmol/L) was associated with a 27% (HR: 1.27 [95% CI: 1.20-1.34]), 31% (HR:1.31 [95% CI: 1.25-1.38]) and 9% (HR: 1.09 [95% CI: 1.04-1.15]) increase in the risk of composite endpoint of CVD and mortality, respectively. Age-specific effects were also found when comparing LDL-C variability, with patients aged 45-54 years (HR: 1.70 [95% CI: 1.42-2.02]) exhibiting a 53% increased risk for the composite endpoints than those aged 75-84 years (HR: 1.11 [95% CI: 1.01-1.23]). Similar age effects were observed for both the TC to HDL-C ratio and TG variability. Significant associations remained consistent among most of the subgroups. Conclusions Variability in respective lipids are significant factors in predicting CVD and mortality in primary care patients with type 2 diabetes, with the strongest effects related to LDL-C and the TC to HDL-C ratio and most significant in the younger age group of patients aged 45-54 years. Further study is warranted to confirm these findings.

The effect of canagliflozin on amputation risk in theCANVASprogram and theCREDENCEtrial

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (10)

Aim To determine whether there was an explanation as to why the effects of the sodium-glucose co-transporter-2 (SGLT2) inhibitor canagliflozin on amputation risk vary between the CANVAS program and the CREDENCE trial. Methods We performed a pooled analysis of patient-level data from the CANVAS program and the CREDENCE trial. Patient characteristics associated with amputation risk were assessed in univariable and multivariable regression models and compared between studies. Effects of canagliflozin on amputation risk were determined from Cox proportional hazards models and compared between studies, subgroups and for a range of amputation outcomes. Effects over time were explored by cumulative event curves. Results In the CANVAS program (n = 10 142; median follow-up 2.4 years) and CREDENCE trial (n = 4401; median follow-up 2.5 years), 2.3% and 5.3% of participants, respectively, reported baseline amputation history. Key differences at baseline were the proportions with nephropathy (CREDENCE higher, 100% vs. 17.5%) and cardiovascular disease (CANVAS higher, 66% vs. 50%). There were 133 amputations in CREDENCE (3.0% annual event rate) and 187 amputations in CANVAS (1.8% annual event rate), with prior amputation being the strongest predictor of future amputation in both groups. Effects of canagliflozin on amputation risk were significantly different between trials (P-heterogeneity.02, I-2= 82%), but this was not explained by participant or trial differences. There was no evidence that foot disease management protocols instituted during CREDENCE ameliorated amputation risk. Conclusions We identified no explanation for the difference in amputation risk between the CREDENCE trial and the CANVAS program. In the context of null effects of SGLT2 inhibition on amputation in CREDENCE and all other large trials, there is a possibility that the finding in CANVAS was the result of chance.

Newly diagnosed diabetes is associated with a higher risk of mortality than known diabetes in hospitalized patients withCOVID-19

期刊: DIABETES OBESITY & METABOLISM, 2020; 22 (10)

Aim To evaluate the association between different degrees of hyperglycaemia and the risk of all-cause mortality among hospitalized patients with COVID-19. Materials and Methods In a retrospective study conducted from 22 January to 17 March 2020, 453 patients were admitted to Union Hospital in Wuhan, China, with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection. Patients were classified into four categories: normal glucose, hyperglycaemia (fasting glucose 5.6-6.9 mmol/L and/or HbA1c 5.7%-6.4%), newly diagnosed diabetes (fasting glucose >= 7 mmol/L and/or HbA1c >= 6.5%) and known diabetes. The major outcomes included in-hospital mortality, intensive care unit (ICU) admission and invasive mechanical ventilation (IMV). Results Patients with newly diagnosed diabetes constituted the highest percentage to be admitted to the ICU (11.7%) and require IMV (11.7%), followed by patients with known diabetes (4.1%; 9.2%) and patients with hyperglycaemia (6.2%; 4.7%), compared with patients with normal glucose (1.5%; 2.3%), respectively. The multivariable-adjusted hazard ratios of mortality among COVID-19 patients with normal glucose, hyperglycaemia, newly diagnosed diabetes and known diabetes were 1.00, 3.29 (95% confidence interval [CI] 0.65-16.6), 9.42 (95% CI 2.18-40.7) and 4.63 (95% CI 1.02-21.0), respectively. Conclusion We showed that COVID-19 patients with newly diagnosed diabetes had the highest risk of all-cause mortality compared with COVID-19 patients with known diabetes, hyperglycaemia and normal glucose. Patients with COVID-19 need to be kept under surveillance for blood glucose screening.

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