Baseline Body Mass Index Groups Research Articles

Dynamic Features of Body Mass Index in Late Life Predict Cognitive Trajectories and Alzheimer's Disease: A Longitudinal Study.

The causal relationships of late-life body mass index (BMI) with Alzheimer's disease (AD) remains debated. We aimed to assess the associations of dynamic BMI features (ΔBMIs) with cognitive trajectories, AD biomarkers, and incident AD risk. We analyzed an 8-year cohort of 542 non-demented individuals who were aged ≥65 years at baseline and had BMI measurements over the first 4 years. ΔBMIs were defined as changing extent (change ≤ or >5%), variability (standard deviation), and trajectories over the first 4 years measured using latent class trajectory modeling. Linear mixed-effect models were utilized to examine the influence of ΔBMIs on changing rates of AD pathology biomarkers, hippocampus volume, and cognitive functions. Cox proportional hazards models were used to test the associations with AD risk. Stratified analyzes were conducted by the baseline BMI group and age. Over the 4-year period, compared to those with stable BMI, individuals who experienced BMI decreases demonstrated accelerated declined memory function (p = 0.006) and amyloid-β deposition (p = 0.034) while BMI increases were associated with accelerated hippocampal atrophy (p = 0.036). Three BMI dynamic features, including stable BMI, low BMI variability, and persistently high BMI, were associated with lower risk of incident AD (p < 0.005). The associations were validated over the 8-year period after excluding incident AD over the first 4 years. No stratified effects were revealed by the BMI group and age. High and stable BMI in late life could predict better cognitive trajectory and lower risk of AD.

Efficacy, Safety, and Pharmacokinetics by Body Mass Index Category in Phase 3/3b Long-Acting Cabotegravir Plus Rilpivirine Trials.

Cabotegravir plus rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of human immunodeficiency virus-1 (HIV-1) virologic suppression. This post hoc analysis summarizes CAB + RPV LA results by baseline body mass index (BMI) category among phase 3/3b trial participants. Data from CAB + RPV-naive participants receiving every 4 or 8 week dosing in FLAIR, ATLAS, and ATLAS-2M were pooled through week 48. Data beyond week 48 were summarized by study (FLAIR through week 96 and ATLAS-2M through week 152). HIV-1 RNA <50 and ≥50 copies/mL, confirmed virologic failure (CVF; 2 consecutive HIV-1 RNA ≥200 copies/mL), safety and tolerability, and plasma CAB and RPV trough concentrations were evaluated by baseline BMI (<30 kg/m2, lower; ≥30 kg/m2, higher). Among 1245 CAB + RPV LA participants, 213 (17%) had a baseline BMI ≥30 kg/m2. At week 48, 92% versus 93% of participants with lower versus higher BMI had HIV-1 RNA <50 copies/mL, respectively. Including data beyond week 48, 18 participants had CVF; those in the higher BMI group (n = 8) all had at least 1 other baseline factor associated with CVF (archived RPV resistance-associated mutations or HIV-1 subtype A6/A1). Safety and pharmacokinetic profiles were comparable between BMI categories. CAB + RPV LA was efficacious and well tolerated, regardless of baseline BMI category. NCT02938520, NCT02951052, and NCT03299049.

Pretreatment body mass index affects achievement of target blood pressure with sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus and chronic kidney disease.

Sodium-glucose cotransporter 2 inhibitor (SGLT2-I) shows excellent antihypertensive effects in addition to its hypoglycemic effects. However, whether body mass index (BMI) affects the antihypertensive effect of SGLT2-I remains unknown. We investigated the impact of baseline BMI on the achievement of target blood pressure (BP) with SGLT2-I treatment in Japanese patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). We retrospectively evaluated 447 Japanese patients with T2DM and CKD treated with SGLT2-I for at least 1 year. The primary outcome was achieving the target BP (<130/80 mmHg) after SGLT2-I treatment. Patients were divided into two groups according to a baseline BMI of 29.1 determined by receiver operating characteristic analysis and analyzed in a cohort model with propensity score matching. In each group, 130 patients were compared by propensity score matching. The target BP achievement rate was significantly higher in the BMI < 29.1 group than in the BMI ≥ 29.1 group (34% and 21%, respectively, p = 0.03). The odds ratio for achieving the target BP in the BMI ≥ 29.1 group was 0.50 (95% confidence interval, 0.28-0.90, p = 0.02). The BMI < 29.1 group had significantly lower systolic and diastolic BPs after SGLT2-I treatment than the BMI ≥ 29.1 group. Only the BMI < 29.1 group was showed a significant decrease in the logarithmic albumin-to-creatinine ratio from baseline after SGLT2-I treatment. In patients with T2DM and CKD, baseline BMI was associated with the antihypertensive effects of SGLT2-I. Patients in the lower baseline BMI group were more likely to achieve the target BP after SGLT2-I treatment. Pretreatment BMI affects the antihypertensice effect of SGLT2 inhibirors in patients with T2DM and CKD.

Obesity, antioxidants and negative symptom improvement in first-episode schizophrenia patients treated with risperidone

Negative symptoms remain a main therapeutic challenge in patients with schizophrenia (SZ). Obesity is associated with more severe negative symptoms after the first episode of psychosis. Oxidative stress caused by an impaired antioxidant defense system is involved in the pathophysiology of SZ. Yet, it is unclear regarding the role of obesity and antioxidants in negative symptom improvements in SZ. Therefore, this longitudinal study was designed to assess the impact of obesity on antioxidant defenses and negative symptom improvements in first-episode SZ patients. A total of 241 medication-naive and first-episode patients with SZ were treated with risperidone for 3 months. Outcome measures including symptoms, body weight, and total antioxidant status (TAS) levels were measured at baseline and the end of the third month. We found that after 12 weeks of treatment with risperidone, the body weight increased and clinical symptoms significantly improved. Baseline body mass index (BMI) was negatively correlated with negative symptom improvement after treatment and an increase in TAS was negatively associated with an increase in BMI only in the high BMI group. More importantly, the TAS × BMI interaction at baseline was an independent predictor of negative symptom improvement. Our longitudinal study indicates that the improvement in negative symptoms by risperidone was associated with baseline BMI and TAS levels in patients with SZ. Baseline BMI and TAS may be a predictor for negative improvement in SZ patients after risperidone treatment.

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...

High bodyweight variability and increased risk of atrial fibrillation in patients with type 2 diabetes mellitus

Abstract Background Bodyweight variability is a risk factor for atrial fibrillation (AF), but this has not been studied with a focus on patients with diabetes mellitus (DM). Methods A nationwide population-based cohort of 670,797 patients with type 2 DM from the Korean National Health Insurance Service database without a history of AF and with ≥3 measurements of body weight over a 5-year period were followed up for AF development. Intra-individual bodyweight variability was calculated using variability independent of mean (VIM), and high bodyweight variability was defined as the quintile with the highest variability with the lower four quintiles as reference. Results During a median of 7.0 years of follow-up, 22,019 patients (3.3%) were newly diagnosed with AF. Risk of incident AF was increased in those in the highest quintile of bodyweight variability, after adjustment for baseline body mass index (BMI), age, sex, lifestyle factors, comorbidities, number of oral anti-diabetic medication, insulin use, duration of DM, and fasting glucose (HR 1.16, 95% CI 1.12–1.20). High bodyweight variability was significantly associated with AF development regardless of baseline BMI group and direction of overall weight change. This association was stronger in subjects with lower BMI, those on insulin, and those with a DM duration of greater than 5 years. Conclusions High bodyweight variability was associated with AF development, independently of traditional cardiovascular risk factors and baseline BMI. This association was stronger in underweight patients and in advanced diabetic stage. Funding Acknowledgement Type of funding source: None

ASSOCIATION BETWEEN CLINICAL OUTCOMES AND BASELINE BMI OR ANNUALIZED WEIGHT LOSS IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS ENROLLED IN THE PULMONARY FIBROSIS FOUNDATION PATIENT REGISTRY

SESSION TITLE: Diffuse Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: Low baseline body mass index (BMI) and weight loss have been linked with poor outcomes in patients with idiopathic pulmonary fibrosis (IPF). This analysis investigated the association between clinical outcomes and baseline BMI or annualized change in body weight in patients with IPF enrolled in the Pulmonary Fibrosis Foundation Patient Registry (PFF-PR). METHODS: This analysis examined the relationship between (a) BMI group at enrollment (<25 kg/m2, 25 to <30 kg/m2 or ≥30 kg/m2) or annualized percent change in body weight group (no loss, >0% to <5% or ≥5%) and patient baseline characteristics, (b) BMI group at enrollment and clinical outcomes and (c) annualized percent change in body weight group and clinical outcomes. Outcomes included all-cause mortality at 24 months as well as changes from baseline to 24 months in lung function and exercise capacity, as assessed by percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity for carbon monoxide (%DLCO). Regression analyses were conducted with adjustment for age, sex, smoking history, oxygen use during exertion, pulmonary function, significant comorbidities and medications (pirfenidone, nintedanib and corticosteroids). RESULTS: As of February 14, 2020, 696 patients with IPF from the PFF-PR were eligible for the analysis. At enrollment, pulmonary arterial hypertension (PAH) was the only comorbidity that varied across weight-change categories (P=0.026), with 34 of 36 patients with PAH in the >0% to <5% annualized weight loss category. Logistic regression models did not indicate any difference in all-cause mortality between baseline BMI groups. Compared with patients with no weight loss, increased all-cause mortality was observed in patients with >0% to <5% and with ≥5% weight loss (odds ratios [95% CI], 5.4 [1.5, 34.4] and 5.4 [1.3, 36.9]). In the longitudinal analysis of %FVC and %DLCO, patients with baseline BMI <25 kg/m2 had a greater estimated annualized decline in %FVC than patients with baseline BMI ≥30 kg/m2 (difference [95% CI], 1.74% [0.47%, 3.0%]). A similar trend was also observed with %DLCO. There was no significant difference in annualized change of %FVC or %DLCO between groups defined by annualized percentage change in weight. CONCLUSIONS: Lower all-cause mortality was observed in patients with IPF with no annualized weight loss. Higher baseline BMI was associated with a lesser decline in lung function but not with lower all-cause mortality. CLINICAL IMPLICATIONS: Baseline BMI and annualized weight loss may be associated with clinical outcomes in patients with IPF. DISCLOSURES: Employee relationship with Genentech Please note: >$100000 Added 04/07/2020 by Cindy Burg, source=Web Response, value=Salary No relevant relationships by Elizabeth Freiheit, source=Web Response Consultant relationship with Boehringer Ingelheim Please note: $1001 - $5000 Added 04/07/2020 by Joyce Lee, source=Web Response, value=Consulting fee Consultant relationship with Genentech Please note: $1001 - $5000 Added 04/07/2020 by Joyce Lee, source=Web Response, value=Consulting fee Consultant relationship with Celgene Please note: $1001 - $5000 Added 04/07/2020 by Joyce Lee, source=Web Response, value=Consulting fee Consultant relationship with Galapagos Please note: $1001 - $5000 Added 04/07/2020 by Joyce Lee, source=Web Response, value=Consulting fee Consultant relationship with Eleven P15 Please note: $1001 - $5000 Added 04/07/2020 by Joyce Lee, source=Web Response, value=Consulting fee No relevant relationships by Adam Martin-Schwarze, source=Web Response Employee relationship with Genentech, Inc. Please note: >$100000 Added 04/07/2020 by Ming Yang, source=Web Response, value=Salary

High variability in bodyweight is associated with an increased risk of atrial fibrillation in patients with type 2 diabetes mellitus: a nationwide cohort study

BackgroundBodyweight variability is a risk factor for atrial fibrillation (AF). We aimed to examine the relationship between bodyweight variability and the risk of AF in patients with type 2 diabetes mellitus (DM), and whether this relationship was affected by baseline body mass index (BMI), weight change, or advanced diabetic stage.MethodsA nationwide population-based cohort of 670,797 patients with type 2 DM from the Korean National Health Insurance Service database without a history of AF and with ≥ 3 measurements of bodyweight over a 5-year period were followed up for AF development. Intra-individual bodyweight variability was calculated using variability independent of mean, and high bodyweight variability was defined as the quintile with the highest variability with the lower four quintiles as reference.ResultsDuring a median of 7.0 years of follow-up, 22,019 patients (3.3%) newly developed AF. After multivariate adjustment, those in the highest quintile of bodyweight variability showed a higher risk of incident AF (HR 1.16, 95% CI 1.12–1.20) compared to those in the lower 4 quintiles with reference bodyweight variability, irrespective of baseline BMI group and direction of overall weight change. This association was greater in magnitude in subjects with lower BMI, those on insulin, and those with a DM duration of greater than 5 years. In sensitivity analyses, high bodyweight variability was consistently associated with AF development using other indices of variability and adjusting for glycemic variability.ConclusionsHigh variability in bodyweight was associated with AF development, independently of traditional cardiovascular risk factors and baseline BMI. This association was stronger in underweight patients and with advanced diabetic stage. Weight fluctuation may interfere with the beneficial effects of weight loss and should be avoided when possible in weight control regimens for DM patients.

0681 Comparison Of Upper Airway Stimulation Outcomes Between Regions And Bmi Groups From The Adhere Registry

Abstract Introduction As factors influencing Upper Airway Stimulation (UAS) effectiveness in obstructive sleep apnea (OSA) patients are of interest, we compared changes in apnea hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) based on region and baseline body mass index (BMI). Methods Patients (15≥AHI≤65) of the ADHERE registry with AHI at one-year were grouped by region (Europe (EU) vs United States (US)), and BMI (≤32kg/m2 vs 32-35kg/m2). T-tests and equivalence testing (if the former non-significant) was performed using two-one-sided t-tests. Equivalence margin for AHI was set between -5 and 5 and -2 and 2 for ESS. Results By December 2019, 553 of 1600 patients completed 1-year follow-up. Average age was 60±11, 75% male, BMI 29±4 kg/m2, ESS=11±6. Median AHI decreased from 33 to 10, median ESS decreased from 11 to 6. Response defined by 50% AHI reduction and &amp;lt;20 was 70%. Both regions had similar improvements in median AHI (EU: 33 to 10, US: 34 to 10, p &amp;lt; 0.001 vs baseline), median ESS (EU: 12 to 7; US: 11 to 6, p&amp;lt;0.001 vs baseline), and treatment response (EU: 71%, US: 68%). The mean AHI and ESS difference between regions met the equivalence margin. (AHI: mean difference: 0.34, CI:-1.78, 2.46, ESS: mean difference: 0.57, CI:-0.04, 1.19). Mean change in AHI at 1-year was equivalent in BMI groups (≤32 kg/m2 vs 32-35 kg/m2 respectively) median difference: -19.6 vs. -18.8; mean difference: -0.48, (CI:-3.95, 2.97) However, treatment response ratio was different; 73% vs. 60%, p=0.02, i.e. higher BMI patients were less likely to achieve AHI &amp;lt; 20. ESS scores were equivalent; median: 6 vs. 7; mean difference: -0.33, CI: [-1.16, 0.47]. Conclusion UAS influence on OSA severity defined by AHI and sleepiness was similar irrespective of region and BMI category, however, treatment response defined by 50% AHI reduction and &amp;lt;20 was greater in those with lower BMI. Support The statistical support was provided by Inspire Medical System.

Antihypertensive Effectiveness of Perindopril Arginine and Indapamide Single-Pill Combination According to Body Mass Index: Findings from the FORSAGE Study.

IntroductionOverweight and obesity are increasing worldwide and are associated with an increased risk for cardiovascular disease (CVD). The aim of this study was to examine the burden of CVD risk factors among normal weight, overweight, and obese subjects with hypertension, and to evaluate the effectiveness of switching to a single-pill combination (SPC) of perindopril arginine/indapamide for blood pressure (BP) control in overweight and obese subjects treated in routine clinical practice.MethodsFORSAGE was a 3-month, multicenter, observational, open-label study conducted in Russian patients with uncontrolled arterial hypertension under previous antihypertensive therapy. Subjects were switched to the full-dose perindopril arginine 10 mg/indapamide 2.5 mg SPC. BP was assessed at 2 weeks, 1 month, and 3 months, and serum creatinine and general health status at 3 months. The present post hoc analysis of the FORSAGE study results explored the effectiveness of perindopril arginine/indapamide SPC in patients with arterial hypertension with regard to baseline body mass index (BMI): normal (< 25 kg/m2), overweight (25 ≤ BMI < 30 kg/m2), and obese (≥ 30 kg/m2).ResultsA total of 1969 patients were recruited, but BMI data were available for 1963 patients, two-thirds of whom were women. The distribution of BMI groups was as follows: < 25 kg/m2 (16.7%), overweight (48.7%), and obese (34.7%). Overweight or obese patients had more concomitant diseases such as diabetes mellitus or history of stroke, higher BP levels, serum cholesterol and creatinine, and lower glomerular filtration rates. Switching to perindopril arginine/indapamide SPC was associated with a statistically significant reduction in BP as early as the second week of treatment. At 3 months, systolic blood pressure (SBP)/diastolic blood pressure (DBP) had decreased significantly by 39.3/18.8 mmHg in the normal BMI group, 39.8/18.8 mmHg in overweight, and 39.4/18.7 mmHg in obese groups. The magnitude of the BP reduction was independent of BMI. Achievement of target BP (< 140/90 mmHg) was good in all groups, but lower in obese subjects (70.9%) than in overweight subjects (78.1%) or those with a normal BMI (81.8%) (P < 0.0001 for both comparisons).ConclusionsIn subjects with uncontrolled BP on existing antihypertensive therapy, switching to perindopril arginine 10 mg/indapamide 2.5 mg was associated with statistically significant decreases in BP and higher rates of target BP achievement in all BMI groups, including more than 70% of overweight and obese patients.Trial RegistrationISRCTN ID, ISRCTN14315146 (retrospectively registered 18/11/2019).Electronic supplementary materialThe online version of this article (10.1007/s40119-020-00162-x) contains supplementary material, which is available to authorized users.

Association of baseline body mass index (BMI) with response and survival in patients (Pts) with advanced melanoma (MEL) receiving PD-1 inhibitors.

9579 Background: Obesity promotes PD-1–mediated T cell dysfunction but also improves tumor response to PD-1 blockade. Obesity has been linked with positive outcomes in pts treated with PD-1 blockade. To evaluate the prognostic utility of BMI, we performed a retrospective evaluation of BMI and other covariates in 172 pts with stage IV cutaneous MEL. Methods: Pts with stage IV cutaneous MEL who received anti PD-1 therapy at the University of Pittsburgh between 2014-2018 were included in this analysis. PD-1 blockade was continued until progression or intolerable toxicity. Tumor assessment was performed at baseline and every 12 weeks and response classified per RECIST v1.1. Clinical and demographic data were obtained. BMI was defined based on values at the first treatment date and dichotomized into two groups: ≥30 vs. &lt; 30. Fisher exact test was used to evaluate the correlation between BMI group and ORR. Kaplan Meier method and Cox proportional hazard models were performed to analyzed the time-to-event outcomes (OS and PFS). Results: 172 pts with advanced MEL were evaluated. Greater BMI was associated with greater ORR, PFS and OS across various BMI cutoffs (BMI≥28, BMI≥30 and BMI≥35) although this effect was most obvious at BMI≥30. Pts with BMI≥30 achieved higher ORR than those with BMI &lt; 30 (74% vs. 58%, p-value = 0.04). Concordantly, pts with BMI≥30 had improved PFS and OS: median PFS (BMI≥30 21.1 mos vs. BMI &lt; 30 10.7 mos) and median OS (BMI≥30 35.4 mos vs. BMI &lt; 30 22.8 mos). Higher BMI was independently associated with improved OS (p = 0.018) and PFS (p = 0.047) adjusting for age, Breslow thickness and sex. No significant interaction was observed between the effects of BMI and that of age, sex, or Breslow thickness. Conclusions: Increased BMI was associated with greater ORR in addition to previously reported associations with PFS/OS in a large retrospective series of advanced MEL pts treated with PD-1 blockade. This data was independent of other prognostic factors and underscore the “inflammaging” effects of obesity and age in relation to anti PD-1 therapy in advanced cancer.

Predicting unintentional weight loss in patients with gastrointestinal cancer.

BackgroundUnintentional weight loss is a major problem for patients with gastrointestinal (GI) cancers because it affects treatment, survival outcomes, and quality of life. To date, little is known about the trajectory of weight loss and the relationship between baseline body mass index (BMI), location of the cancer, and outcomes. The aims of this study were to investigate patterns of weight loss over time in patients with GI cancer according to BMI groups (low, normal, and high) and location of cancer.MethodsWe examined de‐identified electronic medical record data of 801 adults (>21 years) with GI cancer using ICD‐9 codes (150–159). Descriptive statistics and linear mixed models were used to examine unintentional weight loss over time by BMI group (low, normal, and high) and to determine the effect of primary cancer site and patient characteristics on weight loss.ResultsThe mean age of patients was 66.5 ± 11.9 years (21–95 years), with 58% male and 86% White. Mean weight loss over 3 years was 21.39 kg. At the first observation point, 7.8% were in the low BMI group, 30.1% were in the normal, and 62% were in the high group. At the end of observation, a majority of deaths (35.5%) occurred in the low BMI group (BMI < 20 kg/m2). Significant weight loss was observed in patients with gastric (t = −5.11, P < 0.001), oesophageal (t = −4.18, P < 0.001), and pancreatic (35.8%, t = −3.58, P < 0.001) cancers. Predictors of weight change were gender (F = 64.93, P < 0.001), cancer stage (F = 7.28, P < 0.001), and site by days (F = 8.24, P < 0.001). Weight loss rates were similar among the three BMI groups, but patterns were different based on primary cancer type as a function of days within each group.ConclusionsWeight loss in patients with GI cancers has implications for survival. Patients with upper GI cancers experienced more weight loss and decreased survival rates compared with patients with lower GI cancers. Patients with a combination of upper GI cancer (oesophagogastric or pancreatic) and low baseline BMI had the fewest survival days and worst patient outcomes. Early intervention for weight management plays a critical role for improving the health outcomes and fatality rates of these patients.

Effect of baseline body mass index on glycemic control and weight change with exenatide monotherapy in Chinese drug-naïve type 2 diabetic patients.

BackgroundThe weight‐reducing effect of exenatide has been proved, but too much weight loss in normal‐weight patients may concern physicians. This study evaluated the effects of exenatide monotherapy on glycemic control and weight change in normal‐weight, overweight, and obese patients with newly diagnosed type 2 diabetes (T2D).MethodsIn this multicenter prospective study, 29 normal‐weight, 54 overweight, and 27 obese newly diagnosed and drug‐naïve patients with T2D were treated with exenatide for 48 weeks. The primary efficacy endpoint was the effect of baseline body mass index (BMI) on glycemic control, measured as the change in HbA1c from baseline to Week 48 compared among different BMI groups. Other endpoints included comparisons of the effects of exenatide on fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body weight, and other metabolic indices.ResultsAfter 48‐week treatment, the estimated mean changes in HbA1c in normal‐weight, overweight, and obese patients were −1.9%, −1.8%, and −1.5%, respectively (P = 0.290 among groups after adjustment for baseline values). There were similar declines in FPG and 0.5‐ and 2‐hour PPG among groups. There were non‐significant trends from normal‐weight to overweight to obese patients for increased weight reduction (decreases of 2.2, 3.9, and 4.0 kg, respectively; P = 0.104) and changes in waist circumference (decreases of 2.2, 3.2, and 5.6 cm, respectively; P = 0.078).ConclusionsBaseline BMI had no effect on glycemic control, weight change, or other metabolic indices with exenatide monotherapy. Normal‐weight patients with T2D would benefit from exenatide as much as overweight or obese patients on glucose control, without increased risk of excess weight loss.

Do patients with higher baseline BMI have improved weight loss with Roux-en-Y gastric bypass versus sleeve gastrectomy?

BackgroundAs sleeve gastrectomy (SG) becomes the most common bariatric procedure, it remains unclear for which patients laparoscopic Roux-en-Y gastric bypass (LRYGB) may be advantageous. Some contend that patients with higher initial body mass index (BMI) achieve better weight loss with LRYGB. ObjectivesThis study evaluates weight loss in SG versus LRYGB patients based on preoperative BMI. SettingCommunity teaching hospital, Baltimore, Maryland. MethodsA convenience cohort of 4935 individuals, undergoing bariatric surgery from 2001 to 2015, was studied to examine 5-year postsurgical trends in weight loss stratified by baseline BMI and procedure. Student t tests compared mean weight loss of baseline BMI groups (<45 versus ≥45; <50 versus ≥50; and <55 versus ≥55) and line graphs and plotted 95% confidence intervals of mean weight loss by year were examined to discern differences in percent excess weight loss (%EWL) by procedure type. ResultsAll patients were more likely to be female (79%) and Caucasian (62.5%). Nearly twice as many patients underwent LRYGB (N = 3236) compared with SG (N = 1699). In patients in the BMI <45, 50, and 55 kg/m2 categories, there was no significant difference in %EWL based on procedure. However, in those patients in the BMI ≥45 and 55 kg/m2 categories, there is significantly higher %EWL in the LRYGB group over SG. ConclusionIn conclusion, patients with lower baseline BMI had improved %EWL regardless of procedure, but those patients with higher baseline BMI who underwent LRYGB did have higher %EWL than those undergoing SG at 2 years follow-up. BMI is one of many key factors when selecting a procedure for an individual patient.

Long-term impact of intensive lifestyle intervention on cognitive function assessed with the National Institutes of Health Toolbox: The Look AHEAD study

IntroductionThis study sought to determine whether 10 years of assignment to intensive lifestyle intervention (ILI) relative to diabetes support and education leads to better cognition. We examine intervention effects overall and among clinical subgroups, and report correlations between computer-administered and interviewer-administered cognitive batteries. MethodsThe Action for Health in Diabetes (Look AHEAD) was a 16-site randomized controlled trial with overweight/obese individuals (aged 45–76) who had type 2 diabetes. The NIH Toolbox Cognition Battery tests developed to measure cognition across the lifespan were used to evaluate cognition. Results were compared with standard paper-and-pencil tests. The Toolbox and paper-and-pencil tests were administered an average of 10.9 years after randomization to 1002 participants. ResultsToolbox measures significantly correlated with interviewer-administered measures, with the strongest correlations between the Toolbox Fluid Cognition Composite and Trails B (r = −0.64, P < .0001) and Digit Symbol Coding (r = 0.63, P < .0001), and between the Toolbox Dimensional Change Card Sort (r = 0.55, P < .0001) and the Digit Symbol Coding test. Overall, ILI and diabetes support and education groups had similar adjusted mean cognitive outcomes (P > .05 for all). Subgroup analyses identified different intervention effects within baseline body mass index groups for Picture Sequence Memory (P = .01), within baseline cardiovascular disease groups for Picture Vocabulary (P = .01) and Fluid Cognition Composite (P = .02) measures, and within baseline age groups for Picture Vocabulary (P = .02). DiscussionCorrelations between Toolbox and interviewer-administered outcomes provide a measure of internal validity. Findings suggest no overall effect of the intervention on cognition and that an ILI resulting in weight loss may have negative implications for cognition in individuals aged ≥60, with previous history of cardiovascular disease, and those with body mass index ≥40.

Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis

This post hoc analysis of ACQUIRE (NCT00559585) explored the effect of baseline body mass index (BMI) on the pharmacokinetics of and clinical response to subcutaneous (SC) or intravenous (IV) abatacept in patients with rheumatoid arthritis (RA). ACQUIRE was a phase 3b, 6-month, double-blind, double-dummy study in which patients with RA were randomized (1:1) to SC (fixed - dose; 125 mg/week) or IV (weight-tiered; ~ 10 mg/kg/month) abatacept plus methotrexate. In this analysis, minimum abatacept plasma concentration (Cmin) was measured at 3 and 6 months, and clinical remission over 6 months was assessed by Disease Activity Score 28 (C-reactive protein; DAS28 [CRP], < 2.6), Simplified Disease Activity Index (SDAI, ≤ 3.3), and Clinical Disease Activity Index (CDAI, ≤ 2.8). Data were stratified by baseline BMI (underweight/normal, < 25 kg/m2; overweight, 25 to < 30 kg/m2; obese, ≥ 30 kg/m2) and administration route. Of the 1456/1457 patients for whom baseline BMIs were available, 526 (36%; SC 265, IV 261) patients were underweight/normal, 497 (34%; SC 249, IV 248) were overweight, and 433 (30%; SC 221, IV 212) were obese. Median Cmin abatacept concentration was ≥ 10 μg/mL (efficacy threshold) at 3 and 6 months in > 90% of patients across BMI groups with both administration routes. DAS28 (CRP), SDAI, and CDAI remission rates at 6 months were similar across BMI groups and 95% confidence intervals overlapped at all time points in both separate and pooled SC/IV analyses. Therapeutic concentrations of abatacept and clinical remission rates using stringent criteria were similar across patient BMIs and administration routes.

The effect of body mass index on clinical response to abatacept as a first-line biologic for rheumatoid arthritis: 6-month results from the 2-year, observational, prospective ACTION study

ObjectiveTo assess the impact of baseline body mass index (BMI) on the efficacy and retention of intravenous abatacept at 6 months in biologic-naïve patients with rheumatoid arthritis (RA). MethodsThis was a 6-month analysis of a 2-year, non-interventional, international, prospective study. Baseline characteristics, clinical response and retention rates were compared by BMI subgroup: underweight/normal, overweight and obese (<25, 25 to <30 and ≥30kg/m2, respectively). ResultsBMI was reported in 643/672 (96%) patients: 264 (41%) were underweight/normal, 224 (35%) overweight and 155 (24%) obese. At baseline, the obese group had more active disease (mean [95% confidence intervals] 28-joint Disease Activity Score [C-reactive protein; derived] 4.6 [4.5, 4.7], 4.8 [4.7, 5.0] and 5.1 [4.9, 5.2] for underweight/normal, overweight and obese groups, respectively), a higher prevalence of metabolic disorders, a greater proportion of women and a lower proportion of patients with rheumatoid factor positivity. There were no significant differences in the percentages of patients achieving a good/moderate European League Against Rheumatism response by BMI group (80.7, 86.1 and 77.0% for underweight/normal, overweight and obese groups, respectively; P=0.178). Overall retention rates at 6 months did not differ across groups (89, 92 and 89% for underweight/normal, overweight and obese groups, respectively; log-rank P=0.382). After adjustment for baseline characteristics, BMI was not significantly associated with risk of discontinuation (reference BMI<25kg/m2; hazard ratio [95% confidence intervals] 0.46 [0.22, 0.99] and 0.69 [0.34, 1.41] for overweight and obese patients, respectively). ConclusionBMI does not impact abatacept clinical response or retention in biologic-naïve patients with RA.

Body mass index and the risk of lung cancer incidence in smokers: a prospective cohort study

To investigate the effect of baseline body mass index (BMI) on the risk of lung cancer incidence in male smokers. All the male employees and retirees of the Kailuan Group were recruited in the Chinese Kailuan Male Cohort Study, and they had been experienced routine physical examinations every two years since May, 2006. Up to 31st December 2011, a total of 3 rounds physical examinations had been completed. A total of 42 718 male smokers candidates from the Chinese Kailuan Male Cohort Study were enrolled in the present study. The date of entering this study was defined as that of taking first check-up, and the date of end-of-observation was defined as that of cancer diagnosis, death or end of follow-up (31 December 2011). Information on demographics, lifestyle such as smoking, alcohol consumption, anthropometries such as height and weight, as well as the information of newly-diagnosed cancer cases, were collected at the baseline investigation. Multivariable Cox proportional hazards regression models were used to investigate the association between levels of the baseline BMI and risk of lung cancer. Of the 42 718 male smokers, there were 181 998.09 person-years of follow-up, taking 4.26 years of average follow-up period. During follow-up, 234 new lung cancer cases were identified among the 42 718 male smokers and the crude incidence density was 128.57/100 000. After the factors adjustment for age, education level, alcohol consumption, physical activity, work environment and cumulative smoking levels (pack-years), compared with subjects of normal BMI group, hazard ratio and 95% confidence intervals of lung cancer for subjects of underweight, overweight, and obesity were 1.63 (0.79-3.37), 0.79 (0.57-1.09) and 0.50 (0.27-0.91), respectively. After the facotors adjustment for age, education level, alcohol consumption, physical activity, work environment and cumulative smoking levels (pack-years), compared with subjects of normal BMI, hazard ratio and 95% confidence intervals of lung cancer for subjects of obesity among subjects who aged 50 years or above, smoked more than 20 pack-years, and exercised less than 4 times per week were 0.33 (0.15-0.71), 0.27 (0.10-0.75), and 0.44 (0.20-0.96), respectively. Obesity subjects who worked above the well had decreased risk of lung cancer (HR=0.38, 95% CI: 0.15-0.96) compared with normal BMI ones who worked above the well. BMI was negatively correlated with the risk of lung cancer in male smokers. As for male smokers, one of the most effective approaches to prevent and control the lung cancer has been shown to quit smoking and keep fit.

Efficacy and Safety of the SGLT2 Inhibitor Luseogliflozin in Japanese Patients With Type 2 Diabetes Mellitus Stratified According to Baseline Body Mass Index: Pooled Analysis of Data From 52-Week Phase III Trials

PurposeLuseogliflozin, a sodium-glucose cotransporter-2 inhibitor, may be beneficial in obese diabetic patients based on its potential to decrease blood glucose and body weight, but there is limited proof. This analysis aimed to investigate the efficacy and safety of luseogliflozin in patients with varying levels of obesity. MethodsA pooled analysis of four 52-week Phase III trials of luseogliflozin 2.5 mg daily (or up to 5 mg daily) in Japanese patients with type 2 diabetes mellitus stratified according to baseline body mass index (BMI) was conducted. Efficacy end points included changes in glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), and body weight. FindingsIn total, 1031 patients were included and stratified into 5 BMI (kg/m2) groups: low-to-medium (<22.5, n = 222); medium (≥22.5 to <25, n = 270); high-level 1 (≥25 to <27.5, n = 262); high-level 2 (≥27.5 to <30, n = 142); and very-high (≥30, n = 135). HbA1c decreased significantly compared with baseline until week 52 in all groups, and a similar trend was observed with FPG and body weight. The reduction in glycemic parameters tended to be slightly smaller in patients with BMI <22.5 kg/m2, and the reduction in body weight tended to be greater in patients with higher BMI, especially those with BMI ≥30 kg/m2. Levels of fasting insulin, C-peptide immunoreactivity, triglyceride, blood pressure, aspartate aminotransferase, alanine aminotransferase, and uric acid decreased significantly at week 52 in all groups (except for aspartate aminotransferase in patients with BMI <22.5 kg/m2). Levels of these parameters tended to be higher at baseline and these enhanced levels resulted in a greater decrease in patients with higher BMI. In safety, the incidence of adverse events was similar between groups, and most of them were mild in severity. ImplicationsHbA1c and body weight decreased significantly in all groups. Decrease in glycemic parameters tended to be smaller in patients with BMI <22.5 kg/m2, while that of body weight was larger in patients with higher BMI. Furthermore, luseogliflozin was especially beneficial in patients with higher BMI in terms of metabolic abnormalities, including insulin secretion and hypertension. Luseogliflozin exhibited a favorable and similar safety profile over 52 weeks in all groups. This agent can be an effective and well-tolerated therapeutic option in patients with a wide range of BMI levels, and it may be more beneficial in patients with higher BMI.

Total Weight Loss as the Outcome Measure of Choice After Roux-en-Y Gastric Bypass.

Currently, there is no agreement on the best method to describe weight loss (WL) after bariatric surgery. The aim of this study is to evaluate short-term outcomes using percent of total body weight loss (%TWL). A single-institution retrospective study of 2420 patients undergoing Roux-en-Y gastric bypass (RYGB) was performed. Suboptimal WL was defined as %TWL < 20% at 12months. Mean preoperative BMI was 46.8 ± 7.8kg/m(2). One year after surgery, patients lost an average 14.1kg/m(2) units of body mass index (BMI), 30.0 ± 8.5%TWL, and 68.5 ± 22.9%EWL. At 6 and 12months after RYGB, mean BMI and percent excess WL (%EWL) significantly improved for all baseline BMI groups (p < 0.01, BMI; p = 0.01, %EWL), whereas mean %TWL was not significantly different among baseline BMI groups (p = 0.9). The regression analysis between each metric outcome and preoperative BMI demonstrated that preoperative BMI did not significantly correlate with %TWL at 1year (r = 0.04, p = 0.3). On the contrary, preoperative BMI was strongly but negatively associated with the %EWL (r = -0.52, p < 0.01) and positively associated with the BMI units lost at 1year (r = 0.56, p < 0.01). In total, 11.3% of subjects achieved <20%TWL at 12months and were considered as suboptimal WL patients. The results of our study confirm that %TWL should be the metric of choice when reporting WL because it is less influenced by preoperative BMI. Eleven percent of patients failed to achieve successful WL during the in the first year after RYGB based on our definition.