Incidence Of New-onset Diabetes Mellitus Research Articles

A novel clinical model for risk prediction and stratification of new-onset diabetes mellitus after distal pancreatectomy.

The incidence of new-onset diabetes mellitus (NODM) after distal pancreatectomy (DP) remains high. Few studies have focused on NODM in patients with pancreatic benign or low-grade malignant lesions (PBLML). This study aimed to develop and validate an effective clinical model for risk prediction and stratification of NODM after DP in patients with PBLML. A follow-up survey was conducted to investigate NODM in patients without preoperative DM who underwent DP. Four hundred and forty-eight patients from Peking Union Medical College Hospital (PUMCH) and 178 from Guangdong Provincial People's Hospital (GDPH) met the inclusion criteria. They constituted the training cohort and the validation cohort, respectively. Univariate and multivariate Cox regression, as well as least absolute shrinkage and selection operator (LASSO) analyses, were used to identify the independent risk factors. The nomogram was constructed and verified. Concordance index (C-index), receiver operating characteristic (ROC) curve, calibration curves, and decision curve analysis (DCA) were applied to assess its predictive performance and clinical utility. Accordingly, the optimal cut-off point was determined by maximally selected rank statistics method, and the cumulative risk curves for the high- and low-risk populations were plotted to evaluate the discrimination ability of the nomogram. The median follow-up duration was 42.8 months in the PUMCH cohort and 42.9 months in the GDPH cohort. The postoperative cumulative 5-year incidences of DM were 29.1% and 22.1%, respectively. Age, body mass index (BMI), length of pancreatic resection, intraoperative blood loss, and concomitant splenectomy were significant risk factors. The nomogram demonstrated significant predictive utility for post-pancreatectomy DM. The C-indexes of the nomogram were 0.739 and 0.719 in the training and validation cohorts, respectively. ROC curves demonstrated the predictive accuracy of the nomogram, and the calibration curves revealed that prediction results were in general agreement with the actual results. The considerable clinical applicability of the nomogram was certified by DCA. The optimal cut-off point for risk prediction value was 2.88, and the cumulative risk curves of each cohort showed significant differences between the high- and low-risk groups. The nomogram could predict and identify the NODM risk population, and provide guidance to physicians in monitoring and controlling blood glucose levels in PBLML patients after DP.

New onset diabetes mellitus and cardiovascular outcomes according to statin intensity in patients after drug-eluting stent implantation in Asian patients

We investigated the effect of statin intensity on the development of new onset diabetes mellitus (NODM) in Korean patients after percutaneous coronary intervention (PCI). A total of 1013 consecutive patients without diabetes mellitus were retrospectively analyzed. All study patients received high- or moderate-intensity statin (high-intensity statin; 321 [31.7%], moderate-intensity statin; 692 [68.3%]). The primary endpoint was development of NODM, and the secondary one was the composite of cardiac death, non-fatal myocardial infarction, and any revascularization. In 264 pairs (528 patients) of propensity score-matched patient, NODM developed in 34 patients (6.4%) and composite cardiac events occurred in 73 patients (13.8%) during a median follow-up of 36.7 months. The incidence rate of NODM was significantly higher in patients with high-intensity statin than with moderate-intensity statin (8.3% vs. 4.5%, log-rank P = 0.026). The incidence rate of composite events was not significantly different between the two groups (12.5% vs.15.2%, log-rank P = 0.495). The use of high-intensity statins was associated with NODM after adjustment for multiple risk factors (adjusted hazard ratio, 2.18, 95% confidence interval 1.10‒4.51, P = 0.025). High-intensity statin therapy is associated with a higher incidence of NODM, but not with better cardiovascular outcomes, in Korean patients undergoing PCI. A new cholesterol lowering intensity-based approach rather than stain intensity-based approach to the high-risk patients without diabetes mellitus may be helpful in maximal treatment effect without safety concern of NODM in Asian patients.

Racial disparities in new-onset diabetes mellitus in prostate cancer patients on androgen deprivation therapy: a retrospective analysis of TriNetX data.

Prostate cancer (PCa) is the most common cancer in men in the US and androgen deprivation therapy (ADT) is the most frequently used systemic therapy for PCa. Data suggest that ADT is associated with an increased risk of new-onset diabetes mellitus (NODM) and cardiovascular complications. As the incidence and mortality of PCa are highest among the African American (AA) population, it is important to evaluate the difference in the incidence of NODM and ischemic heart disease (IHD) between AA men compared to Caucasian men. This is a retrospective cohort study utilizing the TriNetX database to assess NODM and IHD risk, risk difference, and risk ratio (RR) after recent ADT initiation in an AA cohort and a Caucasian cohort of patients with PCa. Propensity score matching (PSM) was performed by age, BMI, and confounding comorbidities. After matching, the cohort included 1159 AA patients and 843 Caucasian patients with NODM after ADT initiation. The IHD cohort included 1269 AA patients and 1248 Caucasian patients. The risk of incidence of NODM is higher among AA men at 11.6% risk compared to Caucasian men at 7.4%. The risk difference is 4.1% (95% CI = 3.4, 4.9) p = 0.000. The RR is 1.56 (95% CI = 1.43, 1.70). In contrast, risk difference and risk ratio of IHD was not significant between AA and Caucasian groups. ADT exposure increases the risk of NODM in men with PCa, especially among AA men compared with Caucasian men. Men receiving ADT should be monitored routinely for signs and symptoms of metabolic syndrome and diabetes. Targeted close monitoring of AA men on ADT would be critical to prevent and treat metabolic complications with potential of reducing disparities in PCa morbidity.

1838-PUB: Impact of COVID-19 on New-Onset Pediatric Diabetes Diagnoses

Introduction: Global trends show an increased number of pediatric patients with newly diagnosed diabetes who present in severe diabetic ketoacidosis (DKA) during the COVID-19 pandemic. Methods: Medical records were reviewed for pediatric patients <18 years of age with new onset diabetes mellitus (DM) diagnosed two years pre-pandemic and two years during the COVID pandemic. Data collected included demographic, biochemical, and hospitalization data. Logistic regression was used to investigate the relationship between BMI, hemoglobin A1c, duration of hospital stay, DKA, and pandemic time frame. Results: A total of 175 cases of new onset DM were diagnosed during the study period; 54% post-pandemic. This represents a 16% increase in incident cases in the post-pandemic period. The sample was 55.4% male, 74.9% White/Caucasian, and 33.1% non-Hispanic. Type 1 DM comprised 136 cases. Inpatient diagnoses were the same in both the pre- and post-pandemic periods, n=75. Outpatient diagnoses during the pandemic period (n=19) were significantly higher than in the pre-pandemic period (n=6), X2(1) = 5.83, p < 0.05. The overall logistic regression model was statistically significant, X2(7) =18.35, p < 0.05. Hemoglobin A1c (p < 0.05, OR = 0.756, 95% CI [0.606, 0.945]) and length of hospital stay (p < 0.05, OR = 0.586, 95% CI [0.381, 0.902]) were significantly different between the two time periods, but BMI percentile (p = 0.869) and bicarbonate levels (p = 0.962) were not. Discussion: There was an increased incidence of new onset DM diagnosed in pediatric patients post-COVID. Surprisingly, outpatient cases accounted for the increased number. This study showed that during the pandemic, patients presented with a higher hemoglobin A1c and stayed longer in the hospital than prior to the pandemic. Disclosure K.Simms: None. S.Green: None. M.Shah: None. M.Sareini: None. C.Chin: None.

Clinical utility of resected pancreatic volume ratio calculation for predicting postoperative new-onset diabetes mellitus after distal pancreatectomy-a propensity-matched analysis

BackgroundLimited literature is available on new-onset diabetes mellitus (NODM) after distal pancreatectomy. This study aimed to investigate the correlation between surgery-related factors and the incidence of NODM after distal pancreatectomy. MethodsPatients were divided into the NODM-positive or NODM-negative group according to the diagnosis of NODM. After propensity score matching, the correlation between operation-related factors and the incidence of NODM was analyzed. The diagnostic threshold for predicting NODM was determined using the receiver operating characteristic (ROC) curve and the Youden index. ResultsNo significant correlation was observed between the NODM incidence after distal pancreatectomy and operative blood loss, spleen preservation, surgical method (open or laparoscopy), postoperative ALB and HB (first day after surgery), and postoperative pathology. However, a significant correlation was found between the NODM incidence and the postoperative pancreatic volume or the resected pancreatic volume ratio. Resected pancreatic volume ratio was identified as a predictive risk factor for NODM. Youden index of the ROC curve was 0.548, with a cut off value of 32.05% for resected pancreatic volume ratio. The sensitivity and specificity of the cut off values were 0.952 and 0.595, respectively. ConclusionsThis study demonstrated that the volume ratio of pancreatic resection is a risk factor for the incidence of NODM after distal pancreatectomy. This can be used to predict the incidence of NODM and may have further clinical applications.

Longitudinal Exposure to Tacrolimus and New-Onset Diabetes Mellitus in Renal Transplant Patients

Tacrolimus is an immunosuppressant widely used in transplantations requiring mandatory concentration-controlled dosing to prevent acute rejection or adverse effects, including new-onset diabetes mellitus (NODM). However, no relationship between NODM and tacrolimus exposure has been established. This study aimed to evaluate the relationship between cumulative tacrolimus exposure and NODM occurrence. A total of 452 kidney transplant patients were included in this study. Sixteen patients developed NODM during the first 3 months after transplant. We considered all tacrolimus concentration (C0) values collected until the diagnosis of NODM in these patients and until 3 months after transplant in the others. New tacrolimus cumulative exposure metrics were derived from the time profile of the tacrolimus morning predose concentration, C0: the percentage of C0 values > cutoff, the average of C0 values above the cutoff, and the percentage of the area under C0 versus time curve, AUCC0, above the cutoff. The cutoff chosen was 15 ng/mL, corresponding to the higher end of the therapeutic range for the early post-transplant period. The influence of these metrics on NODM and other clinical and biological characteristics was investigated using the Cox models. The percentage of C0 > 15 mcg/L was statistically different between patients with and without NODM (P = 0.01). Only these tacrolimus C0-derived metrics were significantly associated with an increased risk of NODM [HR: 1.73 (1.43-2.10, P < 0.001)]. This study shows that tacrolimus concentrations >15 mcg/L affect the incidence of NODM.

Clinical profile, etiology, outcome and new-onset diabetes: A SARI case series

Introduction: The world is currently facing the SARS-CoV-2 pandemic with evolving 2nd wave. The COVID-19 patients present most commonly with Severe Acute Respiratory Illness (SARI) in an emergency room with acute onset fever, cough, and breathlessness. However, not all SARI cases as per definition are due to COVID-19 infection, which is well proven in this case series of 113 cases of SARI. This is just the opposite of the other SARI series done in the pre-COVID-19 era. Also, no previous SARI case series data has shown significant association with Diabetes Mellitus, including new-onset diabetes thus figuring out the major Pathophysiological association of COVID-19 with glucose metabolism and has a bearing on the pathogenesis, treatment, and outcome of COVID-19 infection and perpetuity of pandemic of this magnitude. Here we raise concern for the first time about the growing association of an infectious pandemic with the lifestyle disorders which are non-communicable diseases but carry with them the potential of fertile soil for rapidly spreading epidemics. Aim and objective: To find out the etiology, clinical profile, treatment outcome, and mortality rate in different sub-groups of SARI cases in a tertiary care hospital and the incidence of new-onset Diabetes Mellitus in them and to investigate theoretically the hypothesis that maintaining normal glucose metabolism could prevent progression of a mild Flu-like illness (FLI) to a severe form of Severe Acute Respiratory Illness (SARI) and consequent complications such as Cytokine Storm Syndrome and Multi-Organ failure. Design: Retrospective, single-center case series of 113 SARI patients at a tertiary care hospital in Agra India between 1 March- 30 October 2020. Main outcome: The demographics, clinical, pathological, imaging, and treatment outcome data were collected. The SARI cases analyzed were defined as “Severe acute respiratory infections (SARIs) an acute respiratory illness of recent onset (within seven days) manifested by fever (≥ 38 °C), cough and shortness of breath or difficulty in breathing requiring hospitalization and were sub-classified according to the primary etiology producing SARI in them. The findings were compiled and compared. Conclusion: Of the 113 patients of SARI – 32.7% were associated with Diabetes, with 9.74% new-onset Diabetes and 26% previously known Diabetes. This was mainly due to SARS-CoV-2 (24 Diabetics out of 52 COVID-19 cases- 46.1%). The Average hospitalization stay of SARI cases was 10 days with a maximum in SARS-CoV-2 and a minimum stay of 5.22 days in Bacterial Pneumonia and 5.66 days in Koch’s Lungs. The death rate was maximum (4 out of 26) 15.3%. Hospitalized TB/Koch’s Lung patients who presented as SARI and 3.8% in Bacterial Pneumonia, 2.43% in SARS-CoV-2, and &lt; 1% in Sepsis. Those SARI cases who were euglycemic at the time of initial presentation recovered early and carried a good prognosis with less mortality as compared to those who were hyperglycemic on presentation. Also, those FLI cases who maintained euglycemia or did not have any other risk factor which predisposes them to stress (Diabetes, Prolonged fasting, Obesity, major organ disorder, Psychological disorder, and Cancer) did not progress to SARI as the endogenous steroid secretion and sympathetic activation did not occur, the intracellular pH levels remained in the alkaline range. 10.18% of cases developed new-onset diabetes (a total of 11 cases) out of which 10 were in COVID-19. Thus 19.2% incidence of new-onset diabetes in SARS-CoV-2 and a prevalence of 26.9% in SARS-CoV-2, making total diabetes 46.1% in SARS-CoV-2, and out of all SARI cases, 26% of patients developed pulmonary fibrosis with consequent long-term complications. In COVID-19 patients, it was seen only in diabetics SARS CoV-2 male patients, thus no death in non-diabetic females in COVID-19 in this case series.

Different Aspects of Diabetes in Hospitalized Patients with COVID-19.

BackgroundThe novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) causes COVID-19, a recent infectious disease that aggravates the underlying pathophysiology of hyperglycemia in diabetic individuals. This study aimed to detect how diabetes mellitus (DM) affected COVID-19 patients’ morbidity and mortality, and the incidence of neonset DM.Patients and MethodsThe present study was a cross-sectional study done at Aswan Isolation Hospitals, Egypt. It comprised 200 individuals who had been tested positive for COVID-19. They were divided into two groups: group 1 (pre-existing diabetes = 143 patients) and group 2 (new-onset diabetes = 57 patients), and all patients were subjected to general examinations, hospital stay duration, and investigations, such as (complete blood count, urea, creatinine, HBA1c, fasting, postprandial, and random blood sugar, D-Dimer, ferritin, C-reactive protein, PCR for SARS COV-2 RNA, and CT chest.ResultsThe current study consisted of 94 males and 106 females. According to disease severity, they were 96 (48.0%) critical cases, 57 (28.5%) severe cases, and 47 (23.5%) non-severe cases. The incidence of new-onset DM in COVID-19 patients was 28.5% (57 new cases), with a mortality rate of 42.0% (84 cases). Regarding glycemic control, we found a significant difference in fasting blood sugar (FBS) between the two groups, with a significant increase of FBS in the dead group than in the survived group. We also found a significant age difference in critical than in severe and non-severe groups, with a high mortality rate in older patients. Inflammatory markers, such as ferritin, CRP, and D-dimer, were higher in critical than in severe and non-severe groups.ConclusionThe prevalence of new-onset DM is significant among hospitalized COVID-19 patients. Older patients were more prone to disease severity with high mortality rate. Inflammatory markers such as CRP and ferritin were significantly related to the COVID-19 severity and outcome.

Assessing the Incidence of New-onset Diabetes Mellitus with Statin Use: A Systematic Review of the Systematic Reviews and Meta-analyses.

Statin use has been linked with new-onset diabetes mellitus (NODM). In the present systematic review, we aimed to determine the incidence of NODM with statin use by assessing and summarizing the data generated by different systematic reviews and metaanalyses published on this topic. We conducted a systematic review of systematic reviews and meta-analyses using a pre-defined study protocol. Two authors independently performed a literature search using PubMed, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) for studies reporting data on statin use and NODM incidence and screened and extracted data for the outcomes of interest. The Assessing the Methodological Auality of Systematic Reviews 2 (AMSTAR 2) checklist was used to evaluate the quality of the included systematic reviews and meta-analyses. The initial search yielded 621 potential records, and 16 relevant systematic reviews and meta-analyses were included in the present systematic review. The included studies showed an increase in the risk of NODM with statin use. In particular, rosuvastatin and atorvastatin were associated with NODM in many systematic reviews or meta-analyses; however, pravastatin and pitavastatin were found to be associated with lower or no risk. We observed a positive trend of development of NODM with statin use became more evident with advancing years as more number of studies were added. Intensive doses of statins and use in older subjects were found to be important risk factors for NODM. Finally, the quality assessment revealed that the included systematic reviews and metaanalyses were of critically low or low quality. We concluded that statin use carries a risk of causing NODM. Statins should not be discouraged in anticipation of NODM. However, glycaemic monitoring should be encouraged with the on-going statin therapy. Furthermore, clinical studies addressing the use of statins and the incidence of NODM as their primary objective should be planned.

Evaluation of glycemic status among hypercholesterolemic patients on atorvastatin in a tertiary care hospital - A retrospective study.

INTRODUCTION:Statins are effective in reducing low-density lipoprotein cholesterol and are favorable in primary and secondary prevention of cardiovascular disease. Recent large trials have linked the use of statins and increased incidence of new-onset diabetes mellitus, the possibility of worsening of glucose level in individuals with diabetes following statin therapy, and this possibility is increased with the use of atorvastatin. This study was undertaken to analyze the possibility of the diabetogenic potential of atorvastatin among hypercholesterolemic patients.MATERIALS AND METHODS:This retrospective cohort study was conducted in the cardiology department from July 2019 to December 2019. Patients on atorvastatin for more than 6 months with normoglycemia on commencement of therapy were included. The occurrence of prediabetes or new-onset diabetes mellitus after atorvastatin therapy is the outcome of the study. Adverse drug effects to atorvastatin were also recorded and WHO-UMC causality assessment was performed. Descriptive statistics were performed for baseline and demographic characteristics.RESULTS:Sixty study participants were included in the study. Eighteen (30%) study participants developed prediabetes with an HbA1c value of 5.97 ± 0.22 and 17 (28%) of participants developed new-onset diabetes mellitus with an HbA1c value of 7.24 ± 0.50. Atorvastatin at dose of 40 mg was found to be the most frequently prescribed dose.CONCLUSION:Atorvastatin has a dose-dependent risk of developing new-onset diabetes mellitus. Hence, the following statin therapy glycemic status should be periodically monitored especially in patients with a large dose of atorvastatin and also in patients with higher risk factors for diabetes.

Incidence and Risk Factors of Diabetes Mellitus (DM) after Distal Pancreatectomy (DP): A Multivariate Analysis

Introduction: The incidence of DM after DP ranges from 11% to 46%. Risk factors are not established. Our objective is identify risk factors for development or worsening of DM after DP of patients in Upper Digestive Surgery Group at Hospital São Rafael / Rede D’Or, Salvador, Bahia. Methods: Data were collected through standardized forms filled out prospectively between 2010 and 2021. Age, gender, comorbidities, surgical complications, tumor’s nature, extension, and thickness of removed pancreas were analyzed. Univariate analysis was performed to identify risk factors to development or worsening of DM in late postoperative period (>30days). Variables with p<0.05 were selected for multivariate analysis by logistic regression. Results: Eigthy-six patients were submitted DP. Mean age was 50.3 ± 16.3 and 71.8% were female. Were previously diabetic 13.8%. The incidence of new onset DM was 31%. In Univariate analysis, sex, age, BMI>30, comorbidities and tumor’s nature were not related to DM. Were statistically significant, the length of resected pancreas (p=0.02) and family history of DM (p=0.0001). In multivariate analysis, only family history of DM (p=0.018; OR 16.896) maintained statistical relevance. Conclusion: In our study family history was related to DM post DP. The length of resected pancreas was not related to DM post DP.

Efficacy and Safety of Tacrolimus-Based Maintenance Regimens in De Novo Kidney Transplant Recipients: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

BackgroundTacrolimus is an established component of immunosuppressive regimens for kidney transplant recipients (KTRs); however, data comparing long-term outcomes between formulations are lacking. We conducted a systematic literature review and network meta-analysis assessing tacrolimus (primarily Advagraf [once-daily] and Prograf [twice-daily])-based maintenance regimens.Material/MethodsEmbase, MEDLINE, and Cochrane databases and congress proceedings were searched to identify studies of adult de novo KTRs who received tacrolimus-based therapy in phase II/III randomized controlled trials. Outcomes were acute rejection, graft/patient survival, and incidence of new-onset diabetes mellitus after transplantation (NODAT) and cytomegalovirus (CMV) infection. Bayesian network meta-analysis was used to analyze treatment effects on graft/patient survival.ResultsSixty-eight publications (61 primary) were included. Of 21 publications reporting graft rejection following Advagraf or Prograf treatment in ≥1 study arm, 12-month biopsy-proven acute rejection (BPAR) ranged from 3.3% with Prograf to 55.0% with mycophenolic acid (MPA)+corticosteroids (CS); >24 month BPAR ranged from 0% to 58.7% (the latter with bleselumab-based therapy). Fourteen publications reported graft loss following Advagraf (0–9.6%) or Prograf (0–7.5%). Patient mortality ≤24 months after transplantation (14 publications) ranged from 0% to 8.1% with Advagraf or Prograf. Advagraf+MPA+CS and reference treatment, Prograf+MPA+CS, were associated with a similar risk of graft loss (odds ratio 1.19; 95% credible-interval 0.51, 3.06) and mortality (odds ratio 1.21; 95% credible-interval 0.1557, 9.03). Incidence of NODAT and CMV varied by treatment arm.ConclusionsGraft loss and patient mortality rates were generally comparable between Advagraf- and Prograf-based regimens. Further prospective studies are needed to evaluate longer-term outcomes.

Abstract 11193: Incremental Diabetogenic Effect of Statin According to Its Intensity in Acute Myocardial Infarction Patients Following Successful Percutaneous Coronary Intervention

Introduction: Although statin therapy is strongly recommended in acute myocardial infarction (AMI) patients, there has been consistent concern regarding the development of new onset diabetes mellitus (NODM). Currently, there has been no data whether diabetogenic effect of statin is intensity dependent. In this study, we investigated the impact of different statin intensity on incidence of NODM up to 3 years. Methods: Among 13,104 AMI patients enrolled in the Korea AMI Registry (KAMIR) between November 2011 and May 2015, we enrolled the 5,906 patients without diabetes mellitus and successful percutaneous coronary intervention (PCI). There were 22.8% (1,349/5,906) of patients received high intensity stain and 76.0% (4,488/5,906) patients received moderate intensity, and only 1.2% (69/5,906) patients received low intensity statin. The incidence of NODM were investigated among three different intensity of statins up to 3 years. Results: At baseline, high intensity statin group showed higher baseline LDL cholesterol level, body mass index, and abdominal circumference compared to other groups. In Kaplan-Meier curve, the cumulative incidence of NODM was significantly higher in high intensity group than mild and moderate intensity group (7.8% vs. 1.5% vs. 5.9% respectively, Log rank p-value = 0.002, Figure 1A). The incremental diabetogenic tendency was observed in each individual statin in dose-dependant manner (Figure 1B). In Cox regression, the intensity of statin was statistically significant prognostic factor of NODM after adjusting age, and other metabolic variables, such as body mass index, abdominal circumstance, and level of serum triglyceride. Conclusions: Among the AMI patients underwent successful PCI, higher intensity statin was associated with higher incidence of NODM, showing the diabetogenic effect of statin intensity.

Angiotensin-converting enzyme inhibitors versus angiotensin receptor blockers: New-onset diabetes mellitus stratified by statin use.

Regardless of statin use, which is known to induce hyperglycaemia, comparative studies on the risk of new-onset diabetes mellitus (NODM) with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) are needed. This study evaluated the effects of ACEIs and ARBs on NODM in the clinical setting. This retrospective cohort study utilized electronic medical record data from Seoul St. Mary's Hospital and Seoul National University Hospital from 2009 to 2012. Patients who were prescribed ACEIs or ARBs for the first time (irrespective of concomitant statin use) were followed up for 5years. A total of 11,703 patients were included, 24.9% (n=2916) were taking ACEIs and 75.1% (n=9189) were taking ARBs. Patients on ACEIs had a significantly lower incidence of NODM both with statin use (HR=0.13, p<0.001) and without (HR=0.15, p=0.009) than patients on ARBs. Age ≥60years (HR=1.49, p=0.010), BMI ≥25 (HR=1.96, p<0.010), use of calcium channel blockers (HR=1.47, p=0.010), and diuretics (HR=1.48, p=0.010) were risk factors for NODM with statin use. Patients taking ACEIs are less likely to develop NODM than patients taking ARBs, irrespective of statin use. Patients' conditions, including the risk of NODM, should be considered before prescribing ACEIs or ARBs. Future randomized clinical trials are needed to clarify further the relationship between ACEIs and ARBs and their effect on NODM.

An Analysis of the Risk Factors for New-Onset Diabetes Mellitus After Liver Transplantation.

ObjectiveTo investigate the risk factors related to new-onset diabetes mellitus (NODM) and the significance of IL-6.MethodsA retrospective analysis was conducted on clinical data from 64 patients who received either a living donor liver transplantation or a donation after circulatory death from September 2013 to October 2020 and attended regular follow-up visits for six or more months. During follow-up, patients were randomized into groups and followed up until the completion of the study or the death of the patient.ResultsThe incidence of NODM was 31.25% (n = 20). The median age in the NODM group was 52.15 years (p < 0.01). Age (OR = 1.089; 95% CI: 0.0211–0.1495, p = 0.003) and elevated preoperative IL-6 (OR = 1.122; 95% CI: 0.0619–0.1677, p = 0.029) were found to be independent risk factors for NODM. HBV-induced liver cirrhosis, warm ischemia time (WIT), body mass index (BMI), and high preoperative fasting blood glucose (FBG) were also found to be risk factors for NODM. The recipient had a higher risk of NODM if the donor had a high BMI and poor hepatic function. The concentrations of IL-6, procalcitonin (PCT), FBG, and tacrolimus (TAC) in the first month postoperatively were significantly higher in the NODM group than in the NO-NODM group. The survival rate of the patients was not affected by NODM.ConclusionHBV-induced liver cirrhosis, WIT, BMI, and high preoperative FBG levels are risk factors for NODM, and age and preoperative IL-6 levels are independent risk factors. To a certain extent, higher BMI and poor hepatic function had reference significance for the incidence of NODM. Patients with a high concentration of FBG, IL-6, and TAC in the first month postoperatively had an increased risk of suffering from NODM.

Atrophy of remnant pancreas after pancreatoduodenectomy: Risk factors and effects on quality of life, nutritional status, and pancreatic function.

Factors aggravating remnant pancreas atrophy following pancreatoduodenectomy and the effects of atrophy have not been extensively studied. This study aimed to evaluate the clinical factors affecting remnant pancreas atrophy and assess the effects of atrophy on quality of life, nutritional status, and pancreatic exocrine and endocrine functions. Data collected prospectively from 122 patients who completed 12months of follow-up, including computed tomography and the quality-of-life questionnaire, were analyzed. Pancreas volume was measured using a computed tomography volumetry program. Endocrine and exocrine functions were evaluated. Malignancy and adjuvant chemoradiotherapy were associated with severity of atrophy. At 12 postoperative months, quality-of-life scores and nutritional indexes were mostly not associated with atrophy, but stool elastase level decreased significantly and incidence of new-onset diabetes mellitus was higher in the severe atrophy group. Postprandial 2-hour blood glucose and glycosylated hemoglobin levels were also higher in this group. Remnant pancreas atrophy was more severe in patients with malignant disease who received adjuvant chemoradiotherapy and was associated with pancreatic exocrine and endocrine functions. More careful monitoring and active management of exocrine and endocrine deficiencies are necessary for patients who underwent pancreatoduodenectomy for malignant disease and received chemoradiotherapy.

Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial.

Background: One in every four patients with a first episode of non-gallstone-related acute pancreatitis (AP) develops recurrent disease. Recurrent episodes of AP or acute flares of chronic pancreatitis (CP) are associated with decreased quality of life and progression of the disease. Besides removing the etiology of pancreatitis (which sometimes is not possible), there are no effective measures to prevent recurrence. Meta-analyses of randomized controlled trials, as well as epidemiological and cohort studies, suggest that statins may be protective against the development of index AP.Methods: The SIMBA study is a triple-blind randomized placebo-controlled, parallel-group multicenter trial. Patients with recurrent AP or with acute flares of CP (at least two episodes in the last 12 months) will be randomized to receive simvastatin 40 mg daily or placebo. During a 3-year study period, 144 patients (72 per arm of treatment) from 26 centers will be enrolled. The patients will receive the study treatment for 1 year. The primary aim is to compare the recurrence of AP or acute flares in CP. Secondary endpoints include the incidence of new-onset diabetes mellitus, new-onset exocrine pancreatic insufficiency (EPI), new-onset imaging signs of CP, frequency of all-cause hospital admissions, severity of AP, adherence to treatment, and frequency of adverse events.Discussion: The SIMBA trial will ascertain whether simvastatin, a safe, widely used and inexpensive drug, can change the natural course of recurrent pancreatitis.Trial Registration: ClinicalTrials.gov Identifier: NCT04021498

New onset diabetes mellitus and cardiovascular events in Korean patients with acute myocardial infarction receiving high-intensity statins

BackgroundHigh-intensity statin therapy is typically used in patients with acute myocardial infarction (AMI) for secondary prevention. However, there have been consistent concerns regarding its association with diabetes mellitus. We investigated the effect of high-intensity atorvastatin and rosuvastatin on new-onset diabetes mellitus (NODM) and cardiovascular outcomes over a 3-year follow-up period.MethodsData from the Korea Acute Myocardial Infarction Registry were collected from November 2011 to October 2015, and 13,104 patients with AMI were enrolled from major cardiovascular centers. Among them, 2221 patients without diabetes who had been administered with high-intensity atorvastatin (40–80 mg) and rosuvastatin (20 mg) were investigated. The atorvastatin and rosuvastatin groups were evaluated for the incidence of NODM and major adverse cardiac events (MACE) including death, myocardial infarction, and revascularization cases in the following 3 years.ResultsBaseline characteristics were comparable between the two groups. Event-free survival rate of NODM was not significantly different between the atorvastatin and rosuvastatin groups (92.5% vs. 90.8%, respectively; Log-rank P-value = 0.550). The event-free survival rate of MACE was also not significantly different between atorvastatin and rosuvastatin groups (89.0% vs. 89.6%, respectively; Log rank P-value = 0.662). Multivariate Cox analysis revealed that statin type was not a prognostic factor in the development of NODM and MACE.ConclusionsAdministering high-intensity atorvastatin and rosuvastatin in patients with AMI produced comparable effects on NODM and clinical outcomes, suggesting their clinical equivalence in secondary prevention.

Safety and Tolerability of PCSK9 Inhibitors: Current Insights.

The current era of preventive cardiology continues to emphasize on low-density lipoprotein cholesterol (LDL-C) reduction to alleviate the burden of atherosclerotic cardiovascular disease (ASCVD). In this regard, the pharmacological inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) enzyme via monoclonal antibodies has emerged as a novel lipid-lowering therapy, leading to a marked reduction in circulating LDL-C levels and subsequent improvement of cardiovascular outcomes. As these agents are increasingly used in current clinical practice, mounting scientific and clinical evidence supports that PCSK9 inhibitors offer an excellent safety and tolerability profile with a low incidence of adverse events. Notably, the most frequently reported side effects are injection-site reactions. In contrast to statins, PCSK9 inhibitors do not appear to exert a detrimental effect on glycemic control or to increase the incidence of new-onset diabetes mellitus. Accumulating evidence also indicates that PCSK9 inhibitors are a safe, well-tolerated and effective therapeutic strategy for patients with statin intolerance. On the other hand, as PCSK9 inhibitors reduce LDL-C to unprecedented low levels, a large body of current research has examined the effects of their long-term administration on neurocognition and on levels of vitamin E and other fat-soluble vitamins, providing encouraging results. This review aims to present and discuss the current clinical and scientific evidence pertaining to the safety and tolerability of PCSK9 inhibitors.

Risk factors for new-onset diabetes mellitus after distal pancreatectomy

IntroductionSeveral previous studies have reported the incidence of new-onset diabetes mellitus (NODM) after pancreatectomy. Nevertheless, the results were inconsistent. The true rate of NODM after distal pancreatectomy (DP) is still...