The effect of pilates on metabolic control and oxidative stress of diabetics type 2 – A randomized controlled clinical trial

IntroductionThe Pilates method is an approach to body and mind exercises that has as its foundation the gain of stability, strength and flexibility, and the work of muscular control, posture and breathing, which can generate repercussions on oxidative stress and ROS production, it is expected that Pilates can satisfactorily influence glycemic and oxidative stress reduction in elderly diabetes.AimTo analyze the effect of a Pilates protocol on variables indicative of metabolic control and oxidative stress in patients with Type 2 Diabetes Mellitus.MethodRandomized clinical trial in type 2 diabetics enrolled in Hiperdia Parnaíba. A Pilates protocol was performed for 8 weeks, with 2 weekly consultations. The tested variables were: blood glucose, glycated hemoglobin, lipid profile, C-reactive protein and malondialdehyde. ANOVA tests, correlation of Wilcoxon, Friedman and Spearman, were used, with a significance level of 5%.Results44 diabetics participated in the study (intervention group: 22; control: 22), with a mean age of 61.23 ± 8.49years, the majority being female (77.3%), married (59.1%), literate (31.8%), with an average BMI of 26.96 ± 4.35 kg/m². When analyzing the effects of the protocol, there was a significant reduction in glycated hemoglobin (p = 0.002) and oxidative stress (p = 0.004) in the intervention group, however, there were no differences in fasting glucose (p = 0.055) and in the profile lipid, expressed by the total cholesterol (p = 0.654), HDL (p = 0.591), LDL (p = 0.564) and triglycerides (0.192). There was a moderate positive correlation between oxidative stress and glycated hemoglobin (r = 0.44, p = 0.000). Conclusion: The exercise protocol based on the Pilates method produced a reduction in glycated hemoglobin and oxidative stress.     

Association between postprandial lipoprotein subclasses and Framingham cardiovascular disease risk stratification

ObjectiveTo determine the ability of postprandial lipoprotein subclass concentrations to stratify patients with respect to their risk for cardiovascular disease (CVD).MethodsUsing the Framingham cardiovascular disease risk score (FRS) algorithm, a total of 112 consecutive patients referred for community health screening were stratified into two groups: (a) low-risk (FRS < 10%) and (b) intermediate/high-risk (FRS ≥ 10%). Serum lipoprotein subclass concentrations were determined by Vertical Auto Profile (VAP-II).ResultsFasting and postprandial levels of LDL4, HDL2, VLDL1 + 2, VLDL3, and RLP, as well as fasting levels of ApoB and postprandial levels of LDL3 and IDL1, were significantly different in the intermediate/high risk FRS group vs. the low-risk group (P < 0.05). Correlations between Framingham CVD risk and LDL3, LDL4, IDL1, VLDL1 + 2, VLDL3, RLP, and ApoB were positive while negative for HDL2 in both the fasting and postprandial states. Intermediate/high risk for CVD was shown to be significantly associated with both fasting and postprandial levels of VLDL1 + 2 and RLP, as well as with postprandial LDL4 and VLDL3, as determined using forward conditional logistic regression analysis. Postprandial levels of VLDL1 + 2 were better at identifying patients in the intermediate/high-risk FRS group than fasting levels, although the differences were not significant due to overlapping reference intervals. In addition, the association between RLP and VLDL subclasses relative to Framingham CVD risk increased significantly in the postprandial state (ΔR² = 0.023; ΔF = 7.178; ΔP = 0.025) but not in the fasting state.ConclusionsThe use of postprandial lipoprotein subclass concentrations is not inferior to the use of fasting levels in identifying intermediate/high-risk FRS individuals. In addition, changes in RLP and VLDL subclass concentrations in fasting vs. postprandial states may reveal lipid metabolic mechanisms associated with CVD.     

Effect of rapid cycle deliberate practice in peripheral intravenous catheters insertion training: A simulation experimental study

Aimto compare the effect of rapid cycle deliberate practice simulation training with skill-training simulation on peripheral intravenous catheter insertion for Licensed Practical Nurses.BackgroundThe use of peripheral intravenous catheters is associated with high rates of complications, although it is widely used in clinical practice. Training strategies to ensure good performance can minimize the risks inherent to this procedure.DesignA randomized simulation experimental pre-post interventional study.MethodsSixty participants were allocated to intervention (n = 30) or control (n = 30) groups. Participants allocated to the intervention group were trained through the Rapid cycle deliberate practice simulation strategy, while participants in the control group were trained through the skill-training simulation strategy. A pre-test was applied before any intervention and a post-test after intervention. The primary outcome was the performance in the peripheral intravenous catheter insertion skill. The comparison of correct performance in the tests was analyzed intergroup and intragroup. The effect size of the interventions was also analyzed. The t-Student and Mann-Whitney tests compared the difference between the groups. The training effect was calculated by Cohen's dm and Glass's Δ measures.ResultsPerformance between the pre-post-test increased from 59.4% to 96% (p < 0.001) in the intervention group and from 57.8% to 93.5% in the control group (p < 0001). There was no statistical difference between the groups after intervention (p = 0225). Cohen's dm measurement was 2.95 and 3.59 in the control and intervention groups, respectively.ConclusionsThe rapid cycle deliberate practice simulation strategy resulted in Licensed Practical Nurses’ performance improvements in peripheral intravenous catheter insertion, evidenced by the increase of correct performance actions in the post-test compared to the pre-test. However, with no statistical difference compared to the skill-training simulation strategy.     

HDL-associated apoCIII plays an independent role in predicting postprandial hypertriglyceridemia

BackgroundThe mechanism for an abnormal pattern of triglyceride (TG) metabolism in response to a meal still needs further investigation. Extensive pieces of evidence have shown that apolipoprotein CIII (apoCIII) is a critical modulator of plasma TG metabolism mostly by inhibiting the hydrolysis of TG. Little is known about the role of apoCIII contained in high density lipoprotein (HDL) in plasma TG metabolism after a meal.MethodsFasting and 4-hour postprandial peripheral venous blood were collected in 91 subjects selected from our hospital. Serum lipid parameters, apoCIII levels and HDL subcomponents were tested by standard laboratory procedures, ELISA, and nuclear magnetic resonance (NMR), respectively. The t-test, and Non-parametric tests were performed to examine differences between groups, Pearson’s correlation and multiple regression analysis were used to assess the correlations between apoCIII (HDL-associated or nonHDL-associated) and postprandial TG.ResultsThere was a significant increase in TG after a meal compared to fasting status [155.40(96.70–251.07) mg/dl.vs.118.53(83.38–173.29)mg/dl, p < 0.001]. However, the total apoCIII levels were unchanged before (11.56(7.89–16.22) mg/dl) and after a meal (11.66(7.75–16.02)mg/dl, p = 0.124), while a significant increase in HDL-associated apoCIII (HDL-apoCIII) was observed from fasting (5.25(3.92–7.83)mg/dl) to post-meal (6.46(4.57–8.76)mg/dl, p = 0.001). Unlike nonHDL-apoCIII, HDL-apoCIII was positively correlated with both fasting and postprandial plasma TG in subjects with baseline plasma TG > 118.53 mg/dl (R = 0.503, p < 0.001 for fasting, R = 0.584, p < 0.001 for postprandial). Besides, in the subjects who had an abnormal TG response to a meal, which was defined as postprandial plasma TG increase of>30% compared to baseline TG levels, postprandial HDL-apoCIII was also increased significantly [5.37(3.52–7.02)mg/dl.vs.6.64(4.61–8.86)mg/dl, p = 0.001]. The enrichment of apoCIII in HDL led to changes of TG, cholesterol, free cholesterol, phospholipid and apoAII contents in HDL particles defined by NMR.ConclusionEnrichment of apoCIII in HDL particles potentially plays an independent role in postprandial hypertriglyceridemia.     

Effect of menthol lozenges after extubation on thirst,nausea, physiological parameters,and comfort in cardiovascular surgery patients: A randomized controlled trial

ObjectivesTo determine the effect of post-extubation oral menthol lozenges on thirst, nausea, physiological parameters, and comfort level in patients undergoing cardiovascular surgery.Research methodology/designThe study was a single-centre, randomized controlled trial.SettingThis study included 119 patients undergoing coronary artery bypass graft surgery in a training and research hospital. Patients in the intervention group (n = 59) received menthol lozenges at 30, 60, and 90 min after extubation. Patients in the control group (n = 60) received standard care and treatment.Main outcome measuresThe primary outcome of the study was the change in post-extubation thirst assessed by Visual Analogue Scale after using menthol lozenges compared to baseline. Secondary outcomes were changes in post-extubation physiological parameters and nausea severity assessed by Visual Analogue Scale compared to baseline, and comfort level assessed with Shortened General Comfort Questionnaire.ResultsBetween-group comparisons showed that the intervention group had significantly lower thirst scores at all time points and nausea at the first assessment (p < 0.05) and significantly higher comfort scores (p < 0.05) than the control group. There were no significant differences between the groups in physiological parameters at baseline or any of the postoperative assessments (p > 0.05).ConclusionIn patients undergoing coronary artery bypass graft surgery, the use of menthol lozenges effectively increased comfort level by reducing post-extubation thirst and nausea, but had no effect on physiological parameters.Implications for clinical practiceNurses should be vigilant for complaints such as thirst, nausea, and discomfort in patients after extubation. Nurses’ administration of menthol lozenges to patients may help reduce post-extubation thirst, nausea, and discomfort.     

A Paradigm Shift in Dyslipidemia Management in Primary Care: A 12-Month Cohort Study

PurposeLDL-lowering therapy is beneficial to reduce the risk of cardiovascular disease (CVD). Higher statin doses lower LDL-C levels and prevent CVD; however, they increase adverse events, such as muscle-related adverse events and new-onset diabetes mellitus (DM). Ezetimibe combined with statin therapy improves LDL-C–lowering levels and tolerability in patients with established CVD. We aimed to analyze the efficacy and safety of a fixed-dose rosuvastatin and ezetimibe (R+E) combination therapy in intermediate-risk patients with hypercholesterolemia and no DM after 12 months of visiting a primary physician.MethodsThis multicenter, open-label, single-arm, prospective observational study involved 5717 patients from 258 primary health care centers in Korea enrolled between 2016 and 2018. Patients had no DM or previous CVD but had cardiovascular risk factors and were taking a statin or a fixed-dose combination of E (10 mg) + R (5, 10, or 20 mg). We analyzed 700 patients using propensity score matching.FindingsA fixed-dose R+E combination therapy significantly reduced LDL-C in 5/10 mg R+E (29.35%), 10/10 mg R+E (36.19%), and 20/10 mg R+E (41.83%) compared with statin monotherapy (19.09%) at 12-month follow-up (P = 0.017). Compared with statin monotherapy, HDL-C levels increased in 5/10 mg R+E (mean change at 12 months; P = 0.004), and triglyceride levels decreased in 10/10 mg R+E (mean change at 12 months; P = 0.033). The fixed-dose R+E combination therapy was associated with fewer adverse events and a neutral effect on glucose deterioration compared with statin monotherapy at 12 months of follow-up.ImplicationsIn a possible paradigm shift, a fixed-dose R+E combination therapy may be beneficial for primary cardiovascular prevention with potent LDL-lowering efficacy and tolerability; however, further large prospective studies are needed.     

Frailty risk in hospitalised older adults with and without diabetes mellitus

Background

Research indicates that diabetes mellitus (DM) may be a risk factor for frailty and individuals with DM are more likely to be frail than individuals without DM; however, there is limited research in hospitalised older adults.

Objectives

To determine the extent of frailty in hospitalised older adults with and without DM using a 16‐item Frailty Risk Score (FRS) and assess the role of frailty in predicting 30‐day rehospitalisation, discharge to an institution and in‐hospital mortality.

Methods

The study was a retrospective, cohort, correlational design and secondary analysis of a data set consisting of electronic health record data. The sample was older adults hospitalised on medicine units. Logistic regression was performed for 30‐day rehospitalisation and discharge location. Cox proportional hazards regression was used to analyse time to in‐hospital death and weighted using propensity scores.

Results

Of 278 hospitalised older adults, 49% had DM, and the mean FRS was not significantly different by DM status (9.6 vs. 9.1, p = 0.07). For 30‐day rehospitalisation, increased FRS was associated with significantly increased odds of rehospitalisation (AOR = 1.24, 95% CI [1.01, 1.51], p = 0.04). Although 81% were admitted from home, 57% were discharged home and 43% to an institution. An increased FRS was associated with increased odds of discharge to an institution (AOR = 1.48, 95% CI [1.26, 1.74], p < 0.001). The FRS was not significantly associated with increased risk of in‐hospital death (p = 0.17), but DM was associated with a 484% increase in the instantaneous risk of death (AHR = 5.84, 95% CI [1.71, 19.9], p = 0.005).

Conclusion

Diabetes mellitus and frailty were highly prevalent; the mean FRS was not significantly different by DM status. Although increased frailty was significantly associated with rehospitalisation and discharge to an institution, only DM was significantly associated with in‐hospital mortality.

Relevance to clinical practice

Frailty assessment may augment clinical assessment and facilitate tailoring care and determining optimal outcomes in patients with and without DM.     

Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter,Randomized, Double-blinded,Parallel, Therapeutic Confirmatory Clinical Trial

PurposeDyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease. The risk for CVD from atherogenic dyslipidemia persists when elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels are not controlled with statin therapy. Therefore, statin/fenofibrate combination therapy is more effective in reducing CVD risk. Here, we assessed the efficacy and tolerability of pitavastatin/fenofibrate combination therapy in patients with mixed dyslipidemia and a high risk for CVD.MethodsThis multicenter, randomized, double-blind, parallel-group, therapeutic-confirmatory clinical trial evaluated the efficacy and tolerability of fixed-dose combination therapy with pitavastatin/fenofibrate 2/160 mg in Korean patients with a high risk for CVD and a controlled LDL-C level (<100 mg/dL) and a TG level of 150–500 mg/dL after a run-in period with pitavastatin 2 mg alone. In the 8-week main study, 347 eligible patients were randomly assigned to receive pitavastatin 2 mg with or without fenofibrate 160 mg after a run-in period. In the extension study, patients with controlled LDL-C and non–HDL-C (<130 mg/dL) levels were included after the completion of the main study. All participants in the extension study received the pitavastatin/fenofibrate combination therapy for 16 weeks for the assessment of the tolerability of long-term treatment.FindingsThe difference in the mean percentage change in non–HDL-C from baseline to week 8 between the combination therapy and monotherapy groups was −12.45% (95% CI, −17.18 to −7.72), and the combination therapy was associated with a greater reduction in non-HDL-C. The changes in lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein from baseline to weeks 4 and 8 were statistically significant with combination therapy compared to monotherapy at all time points. Furthermore, the rates of achievement of non–HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively. The combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy.ImplicationsIn these Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with pitavastatin/fenofibrate was associated with a greater reduction in non–HDL-C compared with that with pitavastatin monotherapy, and a significantly improvement in other lipid levels. Moreover, the combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. Therefore, pitavastatin/fenofibrate combination therapy could be effective and well tolerated in patients with mixed dyslipidemia. ClinicalTrials.gov identifier: NCT03618797.     

Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 Fatty Acids 4 g Fixed-dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-week,Multicenter, Randomized,Double-blind Phase III Study

PurposeResidual cardiovascular risk in patients with hypertriglyceridemia, despite optimal low-density lipoprotein cholesterol levels being achieved with intensive statin treatment, is a global health issue. The purpose of this study was to investigate the efficacy and tolerability of treatment with a combination of high-dose atorvastatin/Ω-3 fatty acid compared to atorvastatin + placebo in patients with hypertriglyceridemia who did not respond to statin treatment.MethodsIn this multicenter, randomized, double-blind, placebo-controlled study, patients who had residual hypertriglyceridemia after a 4-week run-in period of atorvastatin treatment were randomly assigned to receive UI-018 (fixed-dose combination atorvastatin/Ω-3 fatty acid 40 mg/4 g) or atorvastatin 40 mg + placebo (control). The primary efficacy end points were the percentage change from baseline in non–high density lipoprotein cholesterol (non–HDL-C) level at the end of treatment and the adverse events recorded during treatment. A secondary end point was the percentage change from baseline in triglyceride level.FindingsAfter 8 weeks of treatment, the percentage changes from baseline in non–HDL-C (–4.4% vs +0.6%; p = 0.02) and triglycerides (–18.5% vs +0.9%; p < 0.01) were significantly greater in the UI-018 group (n = 101) than in the control group (n = 99). These changes were present in subgroups of advanced age (≥65 years), status (body mass index ≥25 kg/m²), or without diabetes. The prevalences of adverse events did not differ between the 2 treatment groups.ImplicationsIn patients with residual hypertriglyceridemia despite receiving statin treatment, a combination of high-dose atorvastatin/Ω-3 fatty acid was associated with a greater reduction of triglyceride and non–HDL-C compared with atorvastatin + placebo, without significant adverse events.     

Early Initiation of Evolocumab Treatment in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

PurposeEvolocumab has been shown to improve cardiovascular outcomes in patients with stable atherosclerotic disease. Whether this benefit persists in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) remains undetermined. This study aimed to evaluate the efficacy and safety of the early initiation of evolocumab in Chinese patients with ACS undergoing PCI.MethodsThis retrospective cohort study involved 1564 consecutive patients who had been hospitalized with ACS and underwent PCI, and who had elevated LDL-C levels (≥1.8 mmol/L after receiving high-intensity statin therapy for ≥4 weeks; ≥2.3 mmol/L after receiving low- or moderate-intensity statin; or ≥3.2 mmol/L without statin therapy). Patients who received evolocumab (initiated in-hospital and after 18 months) were included in the evolocumab group (n = 414), and all other patients were included in the control group (n = 1150). The primary outcome at 18 months was a composite of ischemic stroke, cardiovascular death, myocardial infarction, hospitalization for unstable angina, or coronary revascularization. The evolocumab treatment effect on the primary outcome was assessed in all prespecified subgroups.FindingsAt 18 months, evolocumab combined with statins reduced LDL-C levels from baseline levels by 42.48% compared with statins alone. After multivariable adjustment, evolocumab combined with statins significantly reduced the primary outcome (8.2% vs 12.4%; adjusted hazard ratio, 0.65; 95% CI, 0.45–0.95; P = 0.025). In addition, evolocumab consistently reduced the primary outcome across the major subgroups. For the safety outcomes, no significant differences between the groups were observed in any adverse events.ImplicationsAmong Chinese patients who underwent PCI for ACS, the early initiation of evolocumab combined with statin treatment effectively reduced LDL-C levels and lowered the incidence of recurrent ischemic cardiovascular events, with satisfactory tolerability and safety. Chinese Clinical Trial Registry identifier: ChiCTR2100049364.     

A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial

BackgroundHealth behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk.MethodsEligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6 months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics.ConclusionResults of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions.Trial registration: ClinicalTrials.gov identifier NCT01838226     

Impact of antimicrobial stewardship with the Xpert MRSA/SA BC assay at a tertiary hospital in Japan

IntroductionGenetic testing is gaining increasing importance as a part of antimicrobial stewardship (AS). Rapid identification and determination of methicillin susceptibility using the Xpert MRSA/SA BC assay can improve the management of Staphylococcus aureus bacteremia (SAB) and reduce inappropriate antibiotic use. However, few reports have described the effectiveness of this approach.MethodsThe present study aimed to assess the influence of AS using the Xpert MRSA/SA BC assay. Cases were classified into the pre-intervention group (n = 98 patients), in which SAB was identified by traditional culture (November 2017 to November 2019), and the post-intervention group (n = 97 patients), in which the Xpert MRSA/SA BC assay was performed when necessary (December 2019 to December 2021).ResultsPatient characteristics, prognosis, duration of antimicrobial use, and length of hospital stay were compared between the groups. The Xpert assay was performed in 66 patients in the post-intervention group (68.0%). The two groups showed no significant differences in severity and mortality. The rate of cases treated with anti-MRSA agents reduced following the intervention (65.3% vs. 40.4%, p = 0.008). The number of cases involving definitive therapy within 24 h was higher in the post-intervention group (9.2% vs. 24.7%, p = 0.007). The hospitalization rate at >60 days was lower in Xpert implementation cases among MRSA bacteremia cases (28.6% vs. 0%, p = 0.01).ConclusionsThus, the Xpert MRSA/SA BC assay has potential as an AS tool, especially for early definitive treatment to SAB and reduction of long-term hospitalization in MRSA bacteremia cases.     

Does the use of BariBoard™ improve adequacy of chest compressions in morbid obesity? A pilot study using a simulation model

BackgroundObesity is a growing health problem worldwide. Morbid obesity has been associated with significant barriers to effective thoracic cage compression during cardiopulmonary resuscitation.ObjectiveThe BariBoard? purports to improve adequacy of chest compressions in morbidly obese patients. This study uses a simulation model to evaluate this.MethodsThis was a prospective blinded randomised-controlled crossover pilot trial using a simulation model of obesity. Participants, recruited from hospital departments and prehospital services, performed 2 minutes of continuous compressions on mannequins modified to emulate a morbidly obese patient. Participants were randomised by coin toss to a sequence of either control/intervention or intervention/control, with the BariBoard? in the intervention arm. Accelerometers measured chest wall movement during compressions. The primary endpoint was a composite measure of compression adequacy (rate, depth, and recoil). Secondary endpoints comprised the individual components of the composite outcome, as both dichotomous outcomes (adequate vs. inadequate) and continuous variables. All endpoints were adjusted for potential confounders.ResultsOf 205 participants recruited, 201 were analysed. There was a significant difference in the primary outcome between the control and intervention arms (13.4% vs. 4.5%, respectively, p = 0.001) and between the control and intervention arms for the secondary endpoints of adequate compression depth (31.3% vs. 15.9%, p < 0.001) and recoil (63.7% vs. 41.3%, p < 0.001). After adjustment for confounders and interactions, there was no difference in overall efficacy (odds ratio: 0.62, 95% confidence interval: 0.20–1.90, p = 0.40).ConclusionThis pilot study describes the successful assessment of a device using a simulation model of obesity. Within these constraints and after adjustment for confounders, use of the BariBoard ? did not improve efficacy of chest compressions.     

Effectiveness and safety of the Space GlucoseControl system for glycaemia control in caring for postoperative cardiac surgical patients

BackgroundHyperglycaemia is a very common complication in post–cardiac surgical patients, and as such, it must be properly managed. For this purpose, the enhanced Model Predictive Control algorithm for glycaemia control has been implemented into a nurse-led device called Space GlucoseControl (SGC) that aims to achieve a safe and effective blood glucose control in a better way than the traditional “paper-based” protocols.PurposeThe aim of the study was to know the effectiveness and safety of the SGC in glycaemia control in cardiosurgical adult patients in the immediate postoperative period in the intensive care unit.MethodsA prospective before-and-after intervention study was conducted. One hundred sixty cardiosurgical adult patients with hyperglycaemia were selected: 80 in the control group from May to November 2018 and 80 in the intervention group (use of the SGC device) from January to December 2019. The primary outcome was the percentage of time within the target range (140–180 mg/dL in the control group and 100–160 mg/dL in the intervention group).ResultsThe percentage of time within the target range was significantly higher in the SGC group than in the control group (70.5% [58.25–80] vs 54.83% [36.09–75], p < 0.001). The range was also achieved earlier with the SGC (5 [3–6.875] hours vs 7 [4–11] hours; p < 0.05). The first blood glucose value after reaching the target range was higher in the control group, with statistical significance (p < 0.05). There were no hypoglycaemia episodes in the control group. However, during SGC treatment, six episodes of hypoglycaemia occurred, and all of them were nonsevere (mean value = 61 mg/dL).ConclusionThe SGC is useful to achieve a faster tight glycaemic control, with a higher percentage of time within the target range, although episodes of nonsevere hypoglycaemia could be observed.     

Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter,Randomized, Double-blind,Phase IV Study

PurposeResidual cardiovascular risk reduction by fenofibrate in patients with high serum triglyceride (TG) levels despite previous statin monotherapy is not well characterized. The purpose of this study was to evaluate the efficacy and safety of a combination of choline fenofibrate and statin in patients with inadequately controlled TG levels despite previous statin monotherapy.MethodsThis prospective, multicenter, randomized, double-blind study was conducted in Korea. A total of 133 patients with controlled LDL-C but elevated TG levels, already receiving statin monotherapy, were enrolled in the study, which was conducted from July 2018 to December 2019. Patients were randomly assigned to receive combination therapy with choline fenofibrate and statin or statin monotherapy in a 1:1 ratio. After 8 weeks of treatment, the lipid profiles and safety parameters of the patients in the 2 groups were compared.FindingsThe study included 127 patients (64 in the combination group and 63 in the control group) older than 19 years. After 8 weeks of therapy, mean serum TG levels significantly decreased from 269.8 to 145.5 mg/dL (P < 0.0001) in the combination therapy group, whereas no significant changes occurred in the statin monotherapy group (from 271.1 to 280.5 mg/dL). Contrarily, the mean serum HDLC levels significantly increased from 45.0 to 50.4 mg/dL (P = 0.0004) in the combination therapy group, whereas there were no significant changes in the monotherapy group (from 44.3 to 44.7 mg/dL). There were no additional serious adverse events in the combination therapy group compared with the statin monotherapy group.ImplicationsThe combination therapy using choline fenofibrate and statin was found to be effective in serum TG control and likely tolerable in patients with high TG levels despite statin monotherapy. A larger study, conducted for a longer duration, is needed to evaluate the effectiveness of this combination in reducing cardiovascular risk. ClinicalTrials.gov identifier: NCT03874260.     

Osteopathic treatment of patients with shoulder pain. A pragmatic randomized controlled trial

BackgroundShoulder complaints are common in the general population. Typically, the diagnosis of a specific pathology is lacking. The objective of this trial was to evaluate the effectiveness of an osteopathic treatment in patients suffering from shoulder pain.MethodsA pragmatic randomized controlled trial was conducted in patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS). Participants were identified from the general population in Germany and allocated by means of external randomization to an intervention group or a control group. Patients in the intervention group received five osteopathic treatments at intervals of two weeks. Treatment was custom tailored and based on osteopathic principles. Controls received their osteopathic treatment after an 8-week untreated waiting period. Primary outcome parameters were pain intensity and frequency, measured by VAS and Likert Scales. Secondary outcome parameters were shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36).ResultsA total of 70 patients aged 25–70 years (average age 45.6 ± 13.4 years) were included, 36 in the intervention group and 34 in the control group. The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005). The proportion of participants with a low frequency of pain increased in the osteopathic group only (from 7 to 34 vs. 9 to 6 in the control group, p = 0.006), and the number of patients with a high frequency decreased in the osteopathic group only (from 29 to 2 vs. 25 to 28, p < 0.0005). Shoulder specific pain and disability also improved. The follow-up assessment in the intervention group showed further improvements.ConclusionsFive osteopathic treatments over a period of eight weeks led to statistically significant and clinically relevant positive changes of pain and disability in patients suffering from shoulder pain.     

Impact of the pre-illness lipid profile on sepsis mortality

PurposeTo determine if baseline lipid levels contribute to the relationship between lipid levels during sepsis and outcomes.Materials and methodsWe conducted a retrospective cohort study at a tertiary-care academic medical center. Multivariable logistic regression models were used to adjust for confounders. Both Systemic Inflammatory Response Syndrome (SIRS) and Sequential Organ Failure Assessment (SOFA) score-based definitions of sepsis were analyzed.Measurements and main resultsAfter adjusting for patient characteristics and severity of illness, baseline values for both low density lipoprotein (LDL) cholesterol and triglycerides were associated with mortality (LDL cholesterol odds ratio [OR] 0.44, 95% confidence interval [CI] 0.23–0.84, p = .013; triglyceride OR 0.54, 95% CI 0.37–0.78, p = .001) using a SIRS based definition of sepsis. An interaction existed between these two variables, which resulted in increased mortality with higher baseline low density lipoprotein (LDL) cholesterol values for individuals with triglycerides below 208 mg/dL and the opposite direction of association above this level (interaction OR 1.48, 95% CI 1.02–2.16, p = .039). When using a SOFA score-based definition, only triglycerides remained associated with the mortality (OR 0.55, 95% CI 0.35–0.86, p = .008).ConclusionsBaseline lipid values, particularly triglyceride concentrations, are associated with hospital mortality in septic patients.