High Participant Satisfaction Achieved Using Cryolipolysis for Fat Reduction of the Abdomen and Flanks

Background Patient-reported outcome (PRO) data evaluating the physical and psychosocial impact of Cryolipolysis (CoolSculpting) treatment are limited. Objectives Assess multidimensional aspects of satisfaction following cryolipolysis treatment of the flanks and abdomen using a combination of PRO instruments. Methods This was a multi-national, prospective, single cohort, interventional study. The primary endpoint was the proportion of Satisfied or Very Satisfied participants with treatment at 12 weeks post final treatment. Secondary endpoints included satisfaction categorized by treatment area, total number of treatment cycles, baseline body mass index (BMI), and fat volume reduction measured by 3D photography at 12 weeks post final treatment. Exploratory endpoints assessed the physical and psychosocial impacts of treatment. Safety was monitored throughout the study. Results Of 112 participants who were treated, 74.1% were female. The mean age and BMI were 42.5 years and 24.9 kg/mg 2, respectively. Of the 106 evaluable participants, 89.6% were Satisfied or Very Satisfied with treatment results. Satisfaction was high regardless of body area(s), total number of treatment cycles, or baseline BMI. Mean (SD) fat volume reduction was 264.8 mL (411.4). Overall, 90.6% reported Noticeable or Very Noticeable fat reduction, 89.6% were Likely or Very Likely to treat additional areas, and 93.4% would recommend cryolipolysis to a friend. 24 (21.4%) participants reported treatment-emergent adverse events (AEs); 23 (20.5%) reported these as Adverse Device Effects (ADE). No serious device-related or unanticipated adverse effects occurred. Conclusions Cryolipolysis (CoolSculpting) for fat reduction of the flanks and/or abdomen was well-tolerated and associated with high levels of satisfaction across multidimensional PROs.

L3 Skeletal Muscle Index Dynamics in Patients with HCV-Related Compensated Cirrhosis following Sustained Virological Response after Direct Acting Antiviral Treatment

Background and Objectives: Sarcopenia is commonly associated with liver cirrhosis and predicts clinical outcome. Our aim was to identify the changes in skeletal muscle index (SMI) on computed tomography (CT) examination, as a quantitative marker of sarcopenia, in patients with HCV-related cirrhosis after direct acting antivirals (DAAs) treatment and to assess predictive factors for the evolution of SMI. Materials and Methods: This is a single center retrospective study in patients with HCV-related compensated cirrhosis who obtained sustained virological response (SVR) after DAAs. CT examinations were performed in 52 patients before and within 5–24 months after treatment. The total muscle area (TMA) of abdominal muscle at the level of third lumbar vertebra (L3) was measured at baseline and after SVR. The L3-SMI was calculated from TMA divided by body height squared (cm2/m2). We assessed changes in L3-SMI after SVR according to baseline body mass index (BMI) and laboratory data. Predictive factors were assessed by linear regression model. Results: Patients with L3-SMI above the gender-specific cut-off value at baseline had higher values of serum creatinine (median 0.73) compared to patients with low L3-SMI (median 0.68, p = 0.031). After SVR, 14 patients showed increase of L3-SMI, and 38 patients had a decrease of L3-SMI. BMI in the decreased L3-SMI group was significantly lower (median 26.17) than those without decreased L3-SMI (median 28.84, p = 0.021). ALT values in the decreased L3-SMI group (median 66.5) were significantly lower than those without a decrease in L3-SMI (median 88, p = 0.045). Conclusions: Low creatinine serum level correlates with sarcopenia. SMI was partially influenced by the viral clearance. Lower BMI and ALT serum levels at baseline were predictive for no benefit in terms of muscle mass dynamics. Understanding all the mechanisms involved in sarcopenia and identifying the most vulnerable patients could ensure optimal adapted care strategies.

Assessment of Venous Thromboembolism Risk Based on the Khorana Predictive Model and Compliance with Prophylactic Anticoagulation at a Regional Cancer Center- a Quality Improvement Study

Background: Malignancy is an independent risk factor for venous thromboembolism. Factors like site of the primary cancer, associated comorbidities, obesity, and baseline cytopenias play an important role in predicting the risk in cancer patients. Several risk assessments models have been proposed in the literature, however, the Khorana risk predictive model is the most favored tool used in the literature. Patient characteristics like site of primary, baseline hemoglobin/platelets/WBC and BMI are the main components of this scoring system. Patients are classified into low (0), intermediate (1-2) and high (> 3) risk groups. Low dose prophylactic anticoagulation (Apixaban 2.5 mg BID or Rivaroxaban 10 mg daily) for up to 6 months is indicated in patients with score 2 or higher. Methods: 83 patients with a new cancer diagnosis in the years 2018 and 2019 who received chemotherapy and developed a venous thromboembolism (VTE) after the cancer diagnosis were identified from the cancer registry at Edwards Comprehensive Cancer Center. All the components of Khorana score including patient's baseline body mass index (BMI), white blood cell count (WBC), hemoglobin, platelet count and site of the primary were collected. Compliance with prophylactic anticoagulation (Khorana score =/>2) was evaluated. Results: Among 83 patients identified, 61 % and 39 % were female and males, respectively with a mean age of 59 years. The mean duration of onset of VTE was 18 months from the time of cancer diagnosis. The mean Khorana score was 1.1. 34 % of patients(n=28) were found to have a Khorana score of =/> 2 and prophylactic anticoagulation was indicated. Only 7 % of patients (n=2) received prophylactic anticoagulation. The reason for no prophylactic anticoagulation was not documented in all the cases. Conclusion: In patients with a higher risk of VTE, a very low compliance rates for prophylactic anticoagulation were found at our cancer center. Poor documentation and failure to address the risk of VTE are possible reasons for the low compliance rates. Necessary steps needed to improve the compliance rates are warranted including education of the healthcare providers about current available guidelines to decrease risk of VTE in cancer patients. Dedicated lectures and sessions will be organized and educational materials highlighting the importance of VTE risks and prophylactic anticoagulation will be provided to the healthcare providers at the cancer center. Disclosures No relevant conflicts of interest to declare.

Practical efficacy and safety of Konsilar D24 in patients with hypertension: data from the KONSONANS program

Aim. In practice, to evaluate the efficacy, safety and long-term adherence to therapy with a fixed-dose combination of ramipril/indapamide (Konsilar-D24) in patients with grade 1-2 hypertension (HTN) who have not achieved blood pressure (BP) control with prior therapy or have not taken antihypertensive therapy.Material and methods. This multicenter open-label observational program included 524 patients with grade 1-2 HTN who did not take antihypertensive therapy or did not reach the target BP level with mono or dual antihypertensive therapy, as well as patients shifted to Konsilar-D24 therapy no later than two weeks before the start of the program. All patients signed a written informed consent to participate in the program. The safety analysis set includes all patients who have taken at least one dose of a fixed-dose combination of ramipril/indapamide and have visited physician at least once during the program. The effectiveness analysis set included all patients in the safety population who completed the study in accordance with protocol (n=511). Clinical systolic blood pressure (SBP), diastolic BP (DBP) and heart rate were assessed at baseline, as well as at 0,5, 1, 3 and 6 months of treatment. A post hoc subgroup analysis of changes in BP and heart rate was performed depending on age, sex and baseline body mass index.Results. The fixed-dose combination of ramipril with indapamide significantly reduced SBP and DBP after 2-week treatment (-20,9±10,1 mm Hg; pConclusion. Despite the limitations inherent in observational studies, the KONSONANS program has demonstrated high efficacy and safety of fixed-dose combination of ramipril/indapamide taken once a day in hypertensive patients. Ramipril/indapamide fixed-dose combination therapy significantly improved BP control and achieved even lower individual target BP levels in the majority of hypertensive patients.

Changes in metabolic syndrome affect the health-related quality of life of community-dwelling adults

Metabolic syndrome (MetS) is associated with cardiovascular diseases, type 2 diabetes, chronic renal diseases, and all-cause mortality. Furthermore, MetS is associated with poor health-related quality of life (HRQOL). However, the impact of dynamic changes in MetS on changes in the HRQOL was not previously explored. This was an eight-year, prospective cohort study in which 906 middle-aged adults from Shipai, Taipei in northern Taiwan were enrolled during 2009–2010 (baseline). Of those sampled, 427 participants completed the follow-up investigation after 8 years. The HRQOL was measured using the Short Form Health Survey (SF-36). Other variables including age, sex, marital status, level of education, smoking, alcohol consumption, baseline body mass index, and changes in physical activity were adjusted. Compared with adults who never experienced MetS, adults with persistent MetS had a negative change in mental HRQOL (β − 4.20, 95% CI − 7.54 to − 0.86, p = 0.01). The negative changes of persistent MetS on the HRQOL were in the domains of vitality and mental health (β − 4.42, 95% CI − 8.10 to − 0.73 and β − 3.47, 95% CI − 6.90 to − 0.04, respectively). Women and overweight adults were vulnerable to the detrimental effects of persistent MetS. For better HRQOL, more resources should be devoted to reversing MetS in public health.

Lifestyle Factors and Disease Activity over Time in Early Axial Spondyloarthritis - The SPondyloArthritis Caught Early (SPACE) Cohort

Objective Our aim was to study the importance of baseline Body Mass Index (BMI), smoking and alcohol consumption (AC) for disease activity (DA) over one year in early axial spondyloarthritis (axSpA), stratified by sex. Methods In the SPondyloArthritis Caught Early cohort (patients with chronic back pain for ≥3 months, ≤2 years and onset <45 years), ASDAS was recorded at inclusion, 3 and 12 months. All patients included in the analysis had axSpA based on a high physician's level of confidence at baseline. Differences in ASDAS over 1 year by BMI (normal <25, overweight 25-29.9, obese ≥30 kg/m2), smoking history (never/previous/current) and AC (none, 0.1-2, 3-5, ≥6 units/week) at baseline were estimated using mixed linear regression models. Results There were 344 subjects (mean age 30 years; 49% men). In women, obesity was associated with 0.60 (95% CL 0.28, 0.91) higher ASDAS compared to normal BMI. In both sexes, AC tended to be associated with lower DA over one year, with a significant association only in women with the highest AC (mean difference -0.55 (96% CL-1.05, -0.04). Smoking was associated with higher ASDAS over one year compared to never smoking in both sexes, albeit the difference reached statistical significance only in female former smokers. Results were similar in multivariable analysis, adjusted for all lifestyle factors and other confounders. Conclusion In early axSpA, BMI and smoking are associated with higher DA over one year, and AC with lower DA. The magnitude of the modest associations may differ between men and women.

Increased Risk of Nonalcoholic Fatty Liver Disease in Individuals with High Weight Variability

Background: Weight loss through lifestyle modification is recommended for patients with nonalcoholic fatty liver disease (NAFLD). Recent studies have suggested that repeated loss and gain of weight is associated with worse health outcomes. This study aimed to examine the association between weight variability and the risk of NAFLD in patients without diabetes.Methods: We examined the health-checkup data of 30,708 participants who had undergone serial examinations between 2010 and 2014. Weight variability was assessed using coefficient of variation and the average successive variability of weight (ASVW), which was defined as the sum of absolute weight changes between successive years over the 5-year period divided by 4. The participants were classified according to the baseline body mass index and weight difference over 4 years.Results: On dividing the participants into four groups according to ASVW quartile groups, those in the highest quartile showed a significantly increased risk of NAFLD compared to those in the lowest quartile (odds ratio [OR], 1.89; 95% confidence interval [CI], 1.63 to 2.19). Among participants without obesity at baseline, individuals with high ASVW showed increased risk of NAFLD (OR, 1.80; 95% CI, 1.61 to 2.01). Participants with increased weight over 4 years and high ASVW demonstrated higher risk of NAFLD compared to those with stable weight and low ASVW (OR, 4.87; 95% CI, 4.29 to 5.53).Conclusion: Regardless of participant baseline obesity status, high weight variability was associated with an increased risk of developing NAFLD. Our results suggest that further effort is required to minimize weight fluctuations after achieving a desirable body weight.

Bone Mineral Density Trends During the First Year After Laparoscopic Sleeve Gastrectomy—a Cohort Study on 241 Patients

Purpose Laparoscopic sleeve gastrectomy (LSG) is an effective weight loss procedure, but detrimental effects on bone health have been described. We aimed to assess the dynamics of regional and total bone mineral density (BMD) in a cohort of patients undergoing LSG and to capture gender differences in terms of evolution. Materials and Methods We conducted a retrospective study on 241 patients who underwent LSG to determine the regional and total BMD changes at 6 and 12 months after the intervention. Results One hundred ten males and 140 females (97 pre-, 43 postmenopausal) were included. Mean baseline body mass index (BMI) was 44.16 ± 6.11 kg/m2 in males and 41.60 ± 5.54 kg/m2 in females, reaching 28.62 ± 4.26 kg/m2 and 27.39 ± 4.2 kg/m2, respectively, at 12 months. BMD showed a continuous decline, with significant loss from 6 months postoperatively. There was a positive correlation between BMD and BMI decline at 12 months (r = 0.134, p < 0.05). Total BMD loss at 12 months was significantly greater in males than premenopausal females, independent of BMI variation and age. During the first 6 months, men lost significantly more bone mass than premenopausal and postmenopausal women (BMD variation was 2.62%, 0.27%, 1.58%, respectively). The second period (6–12 months) was similar in all three groups, revealing a further steady (~ 1.4%) BMD decline. Conclusions Our results are consistent with previous findings that LSG negatively impacts BMD, stressing the importance of bone health-oriented measures in postoperative care. Moreover, the impact that seems more significant in males warrants future exploration, as it might change clinical practice. Graphical abstract

Legacy of a 10-Year Multidomain Lifestyle Intervention on the Cognitive Trajectories of Individuals with Overweight/Obesity and Type 2 Diabetes Mellitus

<b><i>Introduction:</i></b> Weight loss and increased physical activity interventions are commonly recommended for individuals with type 2 diabetes (T2D) and overweight or obesity. We examined the impact of randomization to an intensive lifestyle intervention (ILI) on trajectories of cognitive function over 10 years in a cohort of participants in a randomized clinical trial who had T2D and overweight/obesity at baseline. <b><i>Methods:</i></b> Participants aged 45–76 years were enrolled in 2001–2004 and were randomized to the ILI or a diabetes support and education (DSE) condition. Cognitive function was assessed in 3,938 participants at up to 4 time points 8–18 years after randomization. General linear mixed effects models examined cognitive trajectories over time. Subgroup analyses focused on sex, individuals with baseline body mass index &#x3e;30, those carrying the <i>APOE</i> ε4 allele, and those with a baseline history of cardiovascular disease (CVD). <b><i>Results:</i></b> Overall, there were no differences in the rate of cognitive decline by intervention arm. Subgroup analyses showed that participants who had a baseline history of CVD and were randomized to the ILI arm of the study performed significantly worse on the Stroop Color Word Test than those in the DSE arm. <b><i>Discussion/Conclusions:</i></b> The ILI did not result in preserved cognitive function or slower rates of cognitive decline in this cohort of individuals who had T2D and were overweight or obese at baseline.

Lixisenatide is effective and safe as add-on treatment to basal insulin in Asian individuals with type 2 diabetes and different body mass indices: a pooled analysis of data from the GetGoal Studies

IntroductionThis analysis aims to investigate the efficacy and safety of once-daily lixisenatide add-on treatment to basal insulin in Asian individuals with type 2 diabetes, by baseline body mass index (BMI).Research design and methodsData from all Asian participants in the placebo-controlled GetGoal-Duo 1, GetGoal-L, and GetGoal-L-C Studies were pooled and categorized according to the following BMI subgroups:<25 kg/m2, 25–<30 kg/m2 and ≥30 kg/m2. Efficacy and safety of lixisenatide versus placebo were evaluated among BMI subgroups. Multivariable regression analyses were also conducted to explore the potential influence of BMI on efficacy outcomes after adjusting for baseline characteristics.Results555 participants were included (mean age 53.9 years, 52.4% men). No significant differences in treatment effect between the BMI subgroups were observed for the changes from baseline to 24 weeks in glycated hemoglobin (HbA1c), fasting plasma glucose, postprandial glucose (PPG), PPG excursion, body weight, BMI, and basal insulin dose with lixisenatide, as well as the change in basal insulin dose at study endpoint and the proportion of participants achieving an HbA1c <7% at 24 weeks (all p values for interaction >0.15). In the multivariable regression analysis, participants in the lowest BMI group had a smaller reduction in body weight over the 24-week treatment period relative to the highest BMI group (p=0.023).ConclusionsThis post hoc analysis indicates that lixisenatide improved glycemic control regardless of baseline BMI and was well tolerated in Asian individuals unable to achieve their HbA1c target on basal insulin±oral antidiabetic drugs.