Lower Baseline Body Mass Index Research Articles

Trajectories of physical activity among participants of six-month mobile app-based disease management program for cardiovascular risk: a group-based trajectory modelling approach

Abstract Background Mobile app-based health promotion is an emerging preventive intervention for cardiovascular disease that allows for the frequent and longitudinal monitoring of physical activity (PA). Previous studies exploring PA trajectories categorized participants in a limited number of follow-up assessments and did not consider dynamic nature with changes that occur over the intervention period. Purpose This study explored the trajectories of PA during mobile app-based disease management programs in adults with cardiovascular risk using group-based trajectory modelling (GBTM). Methods Participants who completed a six-month disease management program using a mobile app were enrolled. The program promoted behavioural changes for the management of cardiovascular risk factors in individuals with one or more of hypertension, diabetes, or dyslipidaemia. Daily step count was measured using a wrist-worn activity tracker (Fitbit devices). Each participant was encouraged to wear a tracker for the monitoring of exercise and physical activity. To analyse relatively physically inactive participants, we included those with baseline step count <8,000 steps/day. GBTM was conducted to identify distinct patterns of longitudinal step count changes of baseline, 3-22 weeks, and 24 weeks. Participants with PA measurements <4 time points were excluded. The baseline characteristics and indicators related to mobile app usage during the first two weeks were compared among the trajectory groups. Results A total of 1,760 participants were included in the analysis (age: median 55 years; 83.8% men; body mass index (BMI): median 27.0 kg/m²; baseline step count: median 6,118 steps/day). GBTM identified four step count trajectory groups: rapid increase (T1, rapid increase in the first three months; 5%), gradual increase (T2, gradual increase in the first three months; 24%), moderate activity (T3, maintained at around 7,000 steps/day; 45%), and physically inactive (T4, around 4,500 steps/day throughout the program; 26%) (Figure 1). The trajectory groups that showed increasing PA patterns were older (T1: median 57 years; T2: 55 years; T3: 55 years; T4: 54 years; p=0.040) with a lower baseline BMI (T1: median 26.6 kg/m²; T2: 26.4 kg/m²; T3: 27.0 kg/m²; T4: 27.7 kg/m²; p<0.001) and were predominantly men (T1: 89.5%; T2: 87.4%; T3: 82.8%; T4: 81.1%; p=0.028). PA increasing patterns were associated with a longer time of mobile app use (T1: median 8.5 min/day; T2: 5.5 min/day; T3: 5.5 min/day; T4: 4.9 min/day; p=0.012) and more login times (T1: median of daily average 3.9/day; T2: 3.0/day; T3: 3.1/day; T4: 2.9/day; p=0.003) during the first two weeks of the program. Conclusions GBTM showed that 30% of participants in the mobile app-based intervention showed significant PA improvement during the first 12 weeks. Results of this study suggest that the response to PA intervention may be associated with lifestyle prior to the program and willingness to use the mobile app.Figure 1.Step count trajectories

Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials

BackgroundCiprofol was approved for use in intensive care unit (ICU) patients requiring sedation during mechanical ventilation in July 2022. A pooled post-hoc analysis of phase 2 and phase 3 trials was conducted primarily to explore hypotension-free outcome in ICU patients who required mechanical ventilation and achieved the target light sedation goal at an early stage after being sedated with ciprofol or propofol.MethodsAll eligible ICU patients who were expected to require sedation for 6–24 h were randomly assigned in a 2:1 ratio to either a ciprofol or propofol group. Ciprofol or propofol was initially infused at loading doses of 0.5 or 1.0 mg/kg followed by maintenance doses of 0.3 or 1.5 mg/kg/h. Ciprofol or propofol dosages were adjusted up or down at rates of 0.05–0.10 mg/kg/h or 0.25–0.50 mg/kg/h, respectively, to achieve the target light sedation (a Richmond Agitation-Sedation Scale of -2 to + 1). The primary post-hoc outcome was the hypotension-free rate in patients who had achieved the target sedation goal after 30-min administration of ciprofol or propofol.ResultsIn total, 174 patients were enrolled for pooled post-hoc analysis, of whom 116 and 58 were assigned to the ciprofol and propofol groups, respectively. The hypotension-free rate was significantly higher in patients who achieved the target sedation goal after 30-min administration of ciprofol (93.0% vs. 81.0%, P = 0.018), and especially in the subgroups of males and patients aged < 65 years. Multivariable analysis revealed that ciprofol treatment, a younger age and lower baseline body mass index were independent favorable predictors for a higher hypotension-free rate in patients who achieved the target sedation goal after 30-min of drug administration. Moreover, hypotension-free patients who reached the target sedation level after 30 min had a more favorable short-term prognosis including a lower incidence of drug-related treatment-emergent adverse events, shorter time to extubation and fewer dose adjustments of ciprofol or propofol (all P < 0.05).ConclusionICU patients undergoing mechanical ventilation and sedated with ciprofol had significantly lower rate of hypotension during the early phase of achieving light sedation during a 6–24 h period, leading to a more favorable short-term prognosis (within 24 h).Trial registrationPhase 2 trial (clinicaltrials.gov, NCT04147416. Registered November 1, 2019, https://classic.clinicaltrials.gov/ct2/show/NCT04147416) and phase 3 trial (clinicaltrials.gov, NCT04620031. Registered November 6, 2020, https://classic.clinicaltrials.gov/ct2/show/NCT04620031).

Is Obesity a Problem in New Cystic Fibrosis Treatments?

Malnutrition has always been a problem in CF (cystic fibrosis) patients; however, new treatments with CFTR (cystic fibrosis transmembrane conductance regulator protein) modulators have led to weight gain, with some patients at risk of overweight and obesity. Our study aimed to analyze the evolution of BMI (body mass index) after one year of treatment with triple therapy and the factors associated with weight gain in CF patients undergoing treatment with triple therapy with CFTR protein modulators (ETI) (elexacaftor/tezacaftor/ivacaftor). We conducted a prospective, observational, longitudinal, multicenter study in patients diagnosed with cystic fibrosis, aged 18 years or older, with at least one F508del allele and who underwent ETI therapy for at least one year, from 2020 to 2023. One hundred and eight patients from two cystic fibrosis units in Spain, Princess University Hospital of Madrid (74 patients) and Central University Hospital of Asturias (HUCA) (34 patients), were included. Demographic data, anthropometric data, lung function, and exacerbations were collected, comparing the data in the previous year to the start of therapy with the results after one year of treatment. Multivariant models were developed to account for repeated weight and BMI measurements, using a mixed effects model approach and accounting for possible modifying factors Results: One hundred and eight patients were included in the study, 58 men (53.7%) and 50 women (46.3%) with a mean age of 29.5 ± 9.4 years (18-59). Patient weight and BMI were recorded at baseline and at 3-month intervals during the study period. The weight increased from 59.6 kg to 62.6 kg and BMI increased from 21.9 kg/m2 to 23.0 kg/m2 after one year of treatment (p < 0.0001 for both). The proportion of underweight individuals decreased after one year of ETI therapy, from 9.3% to 1.9%, while the proportion of overweight or obese individuals increased from 8.3% to 22.9 % at the same time (p < 0.001). In relation to exacerbations, there is a significant increase in the number of patients who did not have any exacerbations after one year of treatment, which increased from 10.2% to 46.2% (p < 0.001), while the number of patients who had >4 exacerbations decreased significantly, from 40.7% to 1.9% (p < 0.001). FEV1% (forced expiratory volume) increased from 63.9 ± 20.9 to 76.8 ± 21.4 (p < 0.001) and the VR/TLC (residual volume/total lung capacity) value decreased from 45.1 ± 10.9 to 34.9 ± 6.2 (p < 0.001). The proportion with FEV1% > 80% increased from 23.1% before ETI therapy to 49.1% one year after ETI therapy. We performed multivariate mixed models to evaluate the evolution of BMI changes with time, accounting for repeated measures and for possible modifying factors. After the introduction of the triple therapy, patients included in the study had significant weight gain during the 12 months, and when including different covariates in the multivariate mixed model, we found that lower baseline BMI, lower baseline FEV1 and FVC (forced vital capacity), and higher VR/TLC value and higher number of exacerbations were associated with higher BMI changes over the study period. CF patients treated with triple therapy experience significant weight gain, increasing the proportion of overweight patients. CF patients who experienced greater weight gain were those with worse BMI at the start of treatment, as well as patients with worse lung function and a greater number of exacerbations in the year before starting ETI therapy.

Achieving normoglycaemia with tirzepatide: Post hoc exploratory analysis of the SURPASS J-mono and J-combo studies.

Normoglycaemia was achieved in a significant proportion of Japanese participants with type 2 diabetes in two phase 3 studies of tirzepatide. This post hoc exploratory analysis aimed to identify predictive factors associated with normoglycaemia achievement. SURPASS J-mono and SURPASS J-combo study data were pooled for this analysis. Characteristics of participants in whom normoglycaemia [glycated haemoglobin (HbA1c) <5.7%] was achieved were summarized. Logistic regression analyses were performed with HbA1c <5.7% achievement as the target variable. Of 912 participants, normoglycaemia was achieved in 553 (60.6%) following 52 weeks of tirzepatide treatment. Overall, the mean (SD) age was 56.7 (10.6) years and mean diabetes duration was 7.7 (6.0) years, and 76% of participants were men. Mean (SD) change from baseline in HbA1c and bodyweight was -2.87% (0.95) versus -2.47% (1.1) and -10.30 (5.8) kg versus -3.75 (4.3) kg for participants in whom normoglycaemia was and was not reached, respectively. Multivariate regression analyses showed that lower baseline body mass index, shorter disease duration and lower baseline HbA1c were significantly associated with higher rates of normoglycaemia achievement (p = 0.009, p = 0.008, p < 0.001, respectively) as was a tirzepatide dose of 10 or 15 mg compared with 5 mg (p < 0.001). The highest percentage of participants in whom normoglycaemia (94%) was achieved were those with lower baseline HbA1c (<8%) and the greatest weight reduction (≥15%). Baseline HbA1c and body mass index, disease duration and the tirzepatide treatment group were shown to be predictive factors for achieving normoglycaemia. A lower baseline HbA1c was most strongly associated with normoglycaemia achievement.

Lack of weight gain and increased mortality during and after treatment among adults with drug-resistant tuberculosis in Georgia, 2009-2020.

While low body mass index (BMI) is associated with poor tuberculosis (TB) treatment outcomes, the impact of weight gain during TB treatment is unclear. To address this knowledge gap, we assessed if lack of weight gain is associated with all-cause mortality during and after TB treatment. We conducted a retrospective cohort study among adults with newly diagnosed multi- or extensively drug-resistant (M/XDR) pulmonary TB in Georgia between 2009-2020. The exposure was a change in BMI during the first 3-6 months of TB treatment. All-cause mortality during and after TB treatment was assessed using the National Death Registry. We used competing-risk Cox proportional hazard models to estimate adjusted hazard ratios (aHR) between BMI change and all-cause mortality. Among 720 adult participants, 21% had low BMI (<18.5 kg/m2) at treatment initiation and 9% died either during (n=16) or after treatment (n=50). During the first 3-6 months of TB treatment, 17% lost weight and 14% had no weight change. Among 479 adults with normal baseline BMI ( ≥18.5-24.9 kg/m2), weight loss was associated with an increased risk of death during TB treatment (aHR=5.25; 95%CI: 1.31-21.10). Among 149 adults with a low baseline BMI, no change in BMI was associated with increased post-TB treatment mortality (aHR=4.99; 95%CI: 1.25-19.94). Weight loss during TB treatment (among those with normal baseline BMI) or no weight gain (among those with low baseline BMI) was associated with increased rates of all-cause mortality. Our findings suggest that scaling up weight management interventions among those with M/XDR TB may be beneficial.

Body mass index and weight loss as risk factors for poor outcomes in patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis

Objective The association between nutritional status and prognosis of idiopathic pulmonary fibrosis (IPF) remains unclear. This systematic review and meta-analysis aimed to explore the effect of body mass index (BMI) and weight loss on the prognosis of IPF patients. Methods We accumulated studies on IPF, BMI, and weight loss from databases including PubMed, Embase, Web of science, Scopus, Ovid and Cochrane Library up to 4 August 2023. Using Cox proportional hazard regression model for subgroup analysis, hazard ratio (HR) and 95% confidence intervals (CI) for BMI in relation to mortality, acute exacerbation (AE), and hospitalization in IPF patients were calculated, and HR, odds ratio (OR), and 95% CI for weight loss corresponding to IPF patient mortality were assessed. Sensitivity analysis was peformed by eliminating every study one by one, and publication bias was judged by Egger’s test and trim-and-fill method. Results A total of 34 eligible studies involving 18,343 IPF patients were included in the meta-analysis. The pooled results by univariate Cox regression analysis showed that baseline BMI was a predictive factor for IPF mortality (HR = 0.93, 95%CI = [0.91, 0.94]). Furthermore, the results by the multivariable regression model indicated that baseline BMI was an independent risk factor for predicting IPF mortality (HR = 0.94, 95%CI = [0.91, 0.98]). Weight loss was identified as a risk factor for IPF mortality (HR = 2.74, 95% CI = [2.12, 3.54]; OR = 4.51, 95% CI = [1.72, 11.82]) and there was no predictive value of BMI for acute exacerbation (HR = 1.00, 95% CI= [0.93, 1.07]) or hospitalization (HR = 0.95, 95% CI = [0.89, 1.02]). Conclusion Low baseline BMI and weight loss in the course of IPF may indicate a high risk of mortality in patients with IPF, so it is meaningful to monitor and manage the nutritional status of IPF patients, and early intervention should be conducted for low BMI and weight loss.

P1044 Mirikizumab Pharmacokinetics and Exposure-Response in a Phase 2 Study in Patients With Moderately to Severely Active Crohn’s Disease

Abstract Background Mirikizumab (miri) is a humanized anti–interleukin-23-p19 monoclonal antibody approved for the treatment of ulcerative colitis (UC) and under development for Crohn’s disease (CD). This analysis characterises miri pharmacokinetics (PK) and the relationship between miri exposure and efficacy response using data from a phase 2 trial in adults with moderately to severely active CD. Methods AMAG was a randomised, double-blind, placebo-controlled trial conducted in 14 countries. Patients received placebo, miri 200 mg, 600 mg, or 1000 mg as induction regimens administered intravenously (IV) every 4 weeks (Q4W) through Week 12, followed by 36 weeks of maintenance treatment with continuous treatment of miri 200 mg, 600 mg, or 1000 mg IV or miri 300 mg administered subcutaneously (SC) Q4W. PK parameters were analysed by non-linear mixed-effects modelling. Covariate effects on miri exposure were evaluated using simulation-based estimations. Exposure-response (ER) for patients achieving endoscopic response by Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Weeks 12 and 52 were assessed using logistic regression models. Results 186 patients were included. The estimated systemic clearance (CL), central volume of distribution (V), and SC bioavailability (F) were 0.022 L/hr, 3.31 L, and 33.4%, respectively. Lower baseline values for SES-CD (indicative of a less severe CD) were associated with reduced CL. Lower body weight and higher albumin levels were also associated with reduced CL. Higher body weight was associated with higher V and lower baseline body mass index correlated with higher SC F. Impacts on PK parameters were small relative to random variability and not considered clinically relevant. The model-based ER analyses for endoscopic response probability at Week 12 detected a significant treatment effect relative to placebo (p&amp;lt;0.001) and a significant ER (p=0.001) in a dose range of 200-1000 mg. The ER analyses indicated near maximal efficacy for IV dose between 600 mg and 1000 mg during the Induction Period. There was no significant relationship between miri exposure and the probability of achieving endoscopic response by SES-CD at Week 52, indicating exposures produced by the maintenance doses provided similar efficacy. Conclusion Miri PK characteristics in adults with active CD were consistent with miri UC studies. Overall, none of the covariates identified as being significantly correlated with miri PK parameters were considered clinically relevant. No patient factors evaluated in this analysis justify dose adjustment. These findings support the miri induction dose 900 mg IV Q4W and maintenance dose 300 mg SC Q4W selected for phase 3 CD study.

Group-Based Trajectory Modeling to Identify Patterns of Antipsychotic-Associated Weight Gain Among Children and Adolescents.

Antipsychotic-associated weight gain (AAWG) is a common adverse effect of second-generation antipsychotic (SGA) medications among children and adolescents. This study applied group-based trajectory modeling to identify latent trajectories of AAWG among children and adolescents and associated risk factors. This was a retrospective analysis of the IQVIA Ambulatory EMR-US database from 2016 to 2021. The cohort consisted of patients aged 6 to 19 years who were SGA naive and received at least 90 days of continuous SGA prescriptions. Group-based trajectory modeling was used to identify latent trajectories of AAWG development during a 24-month period since SGA initiation, and multinomial logistic regression analysis was conducted to examine the risk factors associated with the identified AAWG trajectories. A total of 16,262 patients were included. Group-based trajectory modeling identified the following 4 distinctive AAWG trajectories: persistent severe weight gain (4.2%), persistent moderate weight gain (20.1%), minor weight change (69.6%), and gradual weight loss (6.1%). Compared with the minor weight change group, younger age (12-17 vs 5-11: odds ratio [OR], 0.634; 95% confidence interval [CI], 0.521-0.771), lower baseline body mass index z -score (OR, 0.216; 95% CI, 0.198-0.236), and receiving olanzapine as the initial SGA (olanzapine vs aripiprazole: OR, 1.686; 95% CI, 1.673-1.699) were more likely to follow severe weight gain trajectories. The area under the receiver operating characteristic curves for comparing severe weight gain versus minor weight change groups and moderate weight vs minor weight change groups in the multinomial regression model were 0.91 and 0.8, respectively. A quarter of pediatric SGA recipients experienced persistent weight gain during the SGA treatment. The risk of having persistent AAWG can be predicted using patient characteristics collected before SGA initiation and the initial SGA agent.

Weight Gain and Increased Body Mass Index in Patients with Hepatitis C after Eradication Using Direct-Acting Antiviral Therapy in Taiwan.

Few studies have reported weight gain in patients with hepatitis C virus (HCV) infection treated with direct-acting antiviral agents (DAAs). This retrospective cohort study identified factors associated with substantial weight gain after DAA treatment in Taiwan. This study involved patients treated using DAAs at the Chiayi and Yunlin branches of Chang Gung Memorial Hospital from 1 January 2017 to 31 October 2020. Body weight data were collected at the start of DAA therapy and 2 years after the confirmation of a sustained virologic response. We performed multiple logistic regression to evaluate the clinical and laboratory parameters associated with a large body mass index (BMI) increase (≥5%). The mean BMI was 25.56 ± 4.07 kg/m2 at baseline and 25.77 ± 4.29 kg/m2 at the endpoint (p = 0.005). A considerable reduction in fibrosis-4 (FIB-4) score was a significant predictor of a large BMI increase (OR: 1.168; 95% CI: 1.047-1.304, p = 0.006). By contrast, older age (OR: 0.979; 95% CI: 0.963-0.996, p = 0.013) and a higher baseline BMI (OR: 0.907; 95% CI: 0.863-0.954, p < 0.001) were associated with a reduced risk of a large increase in BMI at the endpoint. In summary, a larger BMI increase was closely associated with a younger age, lower baseline BMI, and higher FIB-4 score reduction. Notably, differences in DAA regimens did not affect outcomes. Future studies are needed to elucidate the long-term effects and metabolic outcomes associated with this body weight change and investigate the exact underlying mechanisms.

Risk Factors for Eribulin-induced Severe Neutropenia in Patients With Recurrent Breast Cancer.

Eribulin is an effective chemotherapeutic agent for advanced and metastatic breast cancer. However, severe neutropenia occurs in 30-40% of patients and interferes with the recommended treatment schedule. Neutropenia is a major cause of treatment interruptions, delays, or even relative dose reductions. This study aimed to examine the risk factors for severe neutropenia after eribulin treatment. We retrospectively evaluated 263 patients with metastatic breast cancer who had received eribulin therapy. Risk factors for severe neutropenia in the first cycle were evaluated. Severe neutropenia in cycle 1 occurred in 50% of the patients. Multivariate analysis suggested six risk factors for severe neutropenia: low baseline neutrophil count and body mass index, high aspartate aminotransferase and bilirubin levels, creatinine clearance (CrCl) less than 50 ml/min, and eribulin dose of 1.4 mg/m2 Conclusion: This is one of the few studies to simultaneously examine both hepatic and renal functions in relation to severe neutropenia induced by eribulin. We have provided important information to support the close monitoring of patients with these risk factors and subsequent dosage adjustments, if necessary.

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.

Early Initiation of Adalimumab Significantly Diminishes Postoperative Crohn's Disease Endoscopic Recurrence and Is Superior to 6-Mercaptopurine Therapy: An Open-Label, Randomized Controlled Study.

Postoperative recurrence (POR) is the rule in patients with Crohn's disease (CD), mitigated with prophylactic therapy. The evidence for therapeutic choice and timing of intervention is lacking. We aimed to compare the rates of POR in patients treated early with prophylactic 6-mercaptopurine (6-MP) or adalimumab. We conducted a prospective single-center randomized open-label clinical study in which patients in surgical remission following their first ileocecectomy were randomized to receive early treatment with 6-MP or adalimumab. Patients were followed up clinically every 3 months and underwent endoscopy at weeks 32 and 58 postoperatively. The primary endpoint was endoscopic recurrence (ePOR) at 1 year (week 58), defined as a Rutgeerts score ≥ i2. We enrolled 35 patients (25 males, mean age 35 ± 1.4 years, median disease duration 5 ± 6.1 years) following ileocecectomy. Of these, seven (20%) were current smokers and nine (26%) biologics-experienced. Patients allocated to adalimumab had significantly less ePOR than patients treated with 6MP at week 32 (21% vs. 69%, p = 0.004) and 58 (47% vs. 75%), (p = 0.03, HR = 0.39, 95% CI = 0.16-0.93). POR was associated with an increased diameter of the resected small bowel surgical specimen, lower baseline body mass index (BMI), increased week 18 fecal calprotectin, increased week 18 serum alanine aminotransferase and decreased week 18 hemoglobin level. Adalimumab was more effective than 6-MP in preventing ePOR. Increased operative small bowel diameter and lower postoperative BMI were associated with ePOR. At eighteen weeks, serum hemoglobin, ALT and fecal calprotectin levels were predictive of endoscopic disease recurrence. (ClinicalTrials.gov ID NCT01629628).

Changes in Body Mass Index and Incident Mild Cognitive Impairment Among African American Older Adults.

Previous research suggests a decline in body mass index (BMI) among older adults is associated with negative health outcomes, including mild cognitive impairment (MCI) and incident dementia. However, no studies have examined the effects of education or developing MCI on BMI trajectories over time. The purpose of this investigation was to characterize trajectories of change in BMI among older adults who develop MCI. Participants were from the Minority Aging Research Study (MARS), a longitudinal cohort study of cognitive decline and Alzheimer's disease in older African Americans living in the greater Chicago, Illinois, area. The study included annual clinical evaluations of cognitive status, as well as measurements of height and weight for BMI calculation. Older African American participants without cognitive impairment at baseline were included in the present analysis (N = 436, 78% women, mean baseline age = 72 [SD = 5.7], mean education = 15 [SD = 3.5]). In piecewise linear mixed-effects models that included a random intercept and 2 random slopes, BMI declined over time (B = -0.20, SE = 0.02, p < .001), with a faster decline after MCI diagnosis (additional decline, B = -0.15, SE = 0.06, p = .019). Older age was associated with lower baseline BMI (B = -0.19, SE = 0.05, p < .001), as was higher education (B = -0.34, SE = 0.09, p < .001). Further, higher education was associated with a slower decline in BMI before MCI (B = 0.02, SE = 0.006, p = .001), but a faster decline after MCI (B = -0.06, SE = 0.022, p = .003). These results suggest an accelerated decline in BMI following an MCI diagnosis, with higher education related to an even faster BMI decline.

Dose‐related clozapine‐induced weight gain

Weight gain is a known adverse drug reaction associated with the use of antipsychotic medications, potentially leading to obesity and/or other long‐term metabolic complications such as type II diabetes, hypertension, and cardiovascular disease. Reported risk factors associated with antipsychotic‐induced weight gain include young age, female sex, and low baseline body mass index (Correll et al., 2017). Among the approaches used to reverse or reduce weight gain associated with antipsychotics are non‐pharmacological interventions around diet and exercise and pharmacological strategies involving either switching to a different antipsychotic, adding metformin or other weight‐lowering drugs, or reducing the dose of the current antipsychotic.

Predictors of Psoriasis Area and Severity Index 100 response in Korean patients with moderate-to-severe plaque psoriasis receiving biologics.

The Psoriasis Area and Severity Index (PASI) 100 response rate after treatment with biologics is reportedly lower in Asians than non-Asians. Large-scale studies evaluating predictors of PASI100 response in Korean patients with psoriasis are yet to be conducted. To identify predictors of patients achieving PASI100 response after 48-52 weeks of treatment with a biological agent. We retrospectively reviewed the medical records of 145 patients with psoriasis treated with a single biological agent for over one year. Clinical features were compared between super-responders (defined as achieving PASI100 at 48-52 weeks) and non-super-responders. Among the patients included in the study, 61 (42.1%) were super-responders. No statistical difference in demographics and face, scalp, or nail involvement was observed. However, the mean body mass index (BMI) and baseline PASI were lower in super-responders (24.3kg/m2, 14.3) than in non-super-responders (26.1kg/m2, 16.2). There were more biologically naïve patients among the super-responders (85.2%) than the non-super-responders (67.9%). In Korean patients with moderate-to-severe psoriasis, a better PASI100 response is expected for patients who are biologically naïve with a relatively lower baseline BMI and PASI.

Incident sarcopenia in hospitalized older people: A systematic review.

Hospitalization has been associated with the development of sarcopenia. This study aimed to examine the new incidences of hospital sarcopenia, associated risk factors and health outcomes, as defined by internationally recognized diagnostic criteria in hospitalized older people. Pre-defined search terms were run through five databases. Six studies that assessed sarcopenia on two separate time points during hospitalization on older inpatients were included. Prevalence of sarcopenia varied from 14.1% to 55% depending on diagnostic criteria and cut-off points used. New sarcopenia occurred between 12% to 38.7% patients following hospitalization. Risk factors were older age, longer duration of bed rest, lower baseline body mass index, cognitive impairment and activities of daily living disability. None of the studies reported health outcomes associated with newly developed sarcopenia in hospital.

1393-P: Remission Incidence and Associated Clinical Factors in New-Onset Type 2 Diabetes under Standard Medical Care—A Population-Based Study

The natural history of type 2 diabetes (T2D) is mostly progressive and patients often die from diabetes-related complications. However, T2D can sometimes improve enough to discontinue medications, and this phenomenon remains poorly understood. Using health examination data from the Korean National Health Insurance Service (KNHIS) for a new-onset T2D cohort, we investigated the incidence of diabetes remission and associated clinical factors. Remission was defined as normal fasting blood glucose levels &amp;lt; 126 mg/dL, an alternative criterion for remission based on expert consensus; patients who reached normal fasting blood glucose levels measured at 2-year intervals after discontinuation of treatment were defined as achieving remission. New-onset T2D patients (N=114,874) from 2009 to 2012 were followed until 2017, and 2,429 patients (2.1%) experienced remission during the study period. No significant difference in age was reported between the remission and non-remission groups. Compared to the non-remission group, the remission group had lower baseline body mass index (25.4 kg/m2 vs. 25.7 kg/m2), lower baseline fasting glucose levels (157.7 mg/dL vs. 177.1mg/dL), and a lower prevalence of hypertension (47.7% vs. 52.2%) and hyperlipidemia (44.4% vs. 48.2%). When investigating treatment methods, the remission rate was lower in patients who used more than three oral hypoglycemic agents including sulfonylurea (5.43% vs. 14.4%), while the rate of insulin users was higher in the remission group (10.5% vs. 8.0%). When weight change within 2 years before and after remission was reviewed through health examination results, the group that succeeded in weight loss of 5% or more had a significantly higher rate of remission. In summary, remission was observed at rates as low as 2.1% in patients in standard medical care settings. Weight loss and insulin therapy in early T2D patients are thought to lead a favorable prognosis in terms of remission. Disclosure K. Song: None. J. Kim: None. K. Han: None. H. Kwon: None. Funding National Research Foundation of Korea (2021R1A2C2013890)

Weight change and risk of obesity-related complications: A retrospective population-based cohort study of a UK primary care database.

To examine associations between weight loss/gain and risk of developing 13 obesity-related complications (ORCs), stratified by baseline body mass index (BMI). In this retrospective cohort study, we included adults with obesity (>30 kg/m2 ) from the UK Clinical Practice Research Datalink GOLD database with weight change (-50% to +50%) between Years 1 and 4 (N = 418 774 [median follow-up: 7 years]). Associations between weight change, baseline BMI and risk of developing ORCs during follow-up were assessed using Cox proportional hazard models. The impact of weight change on ORCs was generally dependent on baseline BMI. Four clear patterns were seen across the 13 outcomes. Pattern 1 showed greatest weight loss benefit for people with low baseline BMI (type 2 diabetes, sleep apnoea, hypertension and dyslipidaemia); Pattern 2 showed most weight loss benefit at lower baseline BMI but no significant weight loss effect at higher baseline BMI (asthma, hip/knee osteoarthritis and polycystic ovary syndrome); Pattern 3 showed benefit in most cardiovascular diseases with weight loss (chronic kidney disease, heart failure, atrial fibrillation and venous thromboembolism), but no additional benefit with >10% weight loss; Pattern 4 showed no clear relationship between weight change and unstable angina/myocardial infarction and depression. We found similar but opposite patterns for weight gain. Weight loss benefit is dependent on weight loss magnitude and initial BMI, and weight gain is associated with a similar risk increase. Four patterns of association were identified between degree of weight change, baseline BMI and 13 ORCs.

A multi-center, randomized, parallel-group study to compare the efficacy of enhanced cognitive behavior therapy (CBT-E) with treatment as usual (TAU) for anorexia nervosa: study protocol

BackgroundThe superiority of Enhanced Cognitive Behavior Therapy (CBT-E) with regard to weight gain and improvement of psychopathology of eating disorders for patients with anorexia nervosa (AN) over other psychotherapies and treatment as usual (TAU) has not been demonstrated in randomized controlled trials (RCTs). However, a previous RCT showed that patients with AN whose baseline body mass index (BMI) was less than 17.5 kg/m2 gained more weight when treated with CBT-E than with other psychotherapies. The aim of the study is to compare the efficacy of CBT-E and TAU for patients with AN. It was hypothesized that CBT-E would be superior to TAU, at least in terms of weight gain, as most patients with AN are likely to have a BMI lower than 17.5 kg/m2.Methods/designA randomized parallel-group multicenter trial will be conducted in three teaching hospitals in Japan between January 2023 and March 2026. Patients with DSM-5 AN, aged 16 years and older, with a BMI equal to or above 14.0 and below 18.5 will be eligible to participate. 56 patients will be randomly and evenly assigned to two intervention groups (CBT-E and TAU). Those assigned to CBT-E will be offered 25–40 sessions in accordance with their initial BMI. Patients assigned to TAU will have at least one session every 2 weeks, with the number of sessions and treatment period not fixed in advance. The primary outcome is BMI at 40 weeks after treatment initiation. The secondary outcomes are the results from the Japanese version of the Eating Disorder Examination Questionnaire and Clinical Impairment Assessment questionnaire to measure eating disorder psychopathology and psychological impairment. The follow-up assessment will be performed 6 months after the 40-week assessment.DiscussionThis multi-center randomized controlled study will probably evaluate the efficacy of CBT-E compared with TAU for patients with more severe AN than in previous studies since Japanese patients are likely to have a lower BMI than those in Western countries. While it may be difficult to generalize the results of a study conducted in Japan, it would be valuable to clarify the efficacy of CBT-E as a treatment package.Trial registrationUMIN, UMIN000048847. Registered 12 Sep 2022.

Low body mass index is associated with poor treatment outcome following radiotherapy in esophageal squamous cell carcinoma.

We aimed to determine whether patients with esophageal cancer with a low baseline body mass index (BMI) have a poor prognosis following radiotherapy (RT). We retrospectively analyzed data from 50 patients with esophageal cancer to determine whether a low starting BMI (before RT) was associated with a poor outcome. All study participants were diagnosed with non-metastatic esophageal squamous cell carcinoma (SCC). The number of patients at each T stage were as follows: 7 (14%) patients at T1, 18 (36%) at T2, 19 (38%) at T3, and 6 (12%) at T4. Based on BMI, 7 (14%) patients were defined as underweight. A low BMI was common in patients with T3/T4 stage esophageal cancer (7/43, p = 0.01). Overall, the 3-year progression-free survival (PFS) and overall survival (OS) rates were 26.3% and 69.2%, respectively. In univariate analysis, clinical factors associated with poor PFS included being underweight (BMI <18.5 kg/m2; p = 0.011) and a positive N status (p = 0.017). Univariate analysis also revealed that being underweight was associated with a decrease in OS (p = 0.003). However, being underweight was not an independent prognostic factor for PFS and OS. Patients with esophageal SCC with a low starting BMI (BMI <18.5 kg/m2) are more prone to have a negative survival outcome following RT than patients who are considered to be normal weight or overweight. For this reason, it is important that clinicians pay more attention to BMI when treating patients with esophageal SCC.