Fluid-filled intragastric balloons are an effective and safe weight loss option across BMI and age ranges.

INTRODUCTION: Obesity is an expanding public health problem, resulting in more than half a billion adults worldwide. Intragastric balloon (IGB) placement is a weight loss alternative for obese patients with an inadequate weight loss response to diet and exercise. The aim of this study is to examine the efficacy and safety of the single-chamber fluid-filled IGB for weight loss and compare its results across different age groups. METHODS: We performed a database review of 239 consecutive patients from two outpatient GI clinics who underwent placement of an IGB. Our final analysis composed of 239 IGB placements in 232 patients (mean age, 44.5 ± 10.3 years; 67% female; baseline BMI 42.0 ± 9.0). Efficacy outcomes included the percentage of the total (%TWL) and excess weight loss (%EWL). Safety outcomes were measured as the number of patients who required early IGB removal (before 6 months). RESULTS: %TWL at 3 months was 10.1% and 14.4% at 6 months. Overall, 92%, 74%, and 47% of patients lost 5%, 10%, and 15% of total weight at 6 months, respectively. %EWL was 22.1% and 30.7% at 3 and 6 months post-IGB placement, respectively. The balloon was safely removed at six months after placement in most patients, whereas in 13.0% of cases early removal was performed at an average of 12.0 weeks after placement (range, 2 days-23 weeks). CONCLUSION: The use of a single-chamber fluid-filled IGB is successful in inducing a significant amount of weight loss in almost three-fourths of patients six months after its placement. This beneficial effect is seen across different BMI ranges and age groups at a similar level. IGBs should be considered an effective and safe alternative for obese patients who fail lifestyle interventions and conservative measures, fulfilling the unmet needs of many who are unwilling or unable to undergo bariatric surgery.

Off-label direct oral anticoagulants dosing in atrial fibrillation and venous thromboembolism is associated with higher mortality.

BACKGROUND: Direct oral anticoagulants (DOAC) off-label use data is lacking. Our study aimed to assess the clinical outcomes in a racially mixed population treated for atrial fibrillation (AF) and venous thromboembolism (VTE). METHODS: We retrospectively evaluated six months of DOAC prescriptions for AF or VTE treatment. Prescriptions were classified as off-label or appropriate following FDA labeling. The off-label group was sub-classified as under or overdosing. RESULTS: Of the 1,087 DOAC prescriptions, 67% were for AF. African Americans and Caucasians were equally represented. There were 171 (16%) inappropriate prescriptions, with 106 (62%), being underdosed. The off-label group had a higher 30-day readmissions risk (OR = 1.69, 95% CI:1.11-2.54, p = 0.012) and 1-year all-cause mortality (OR = 1.90, 95% CI:1.02-3.37, p = 0.032). There was no difference in major bleeding (OR = 1.27, 95% CI:0.63-2.37, p = 0.480) or new thromboembolism (OR = 1.27, 95% CI:0.73-2.13, p = 0.369) between the groups. Underdosing carried a higher risk of new thromboembolism (OR = 3.15, 95% CI:1.09-9.15, p = 0.024). CONCLUSIONS: One in every six patients received off-label DOACs dosing. Off-label use had increased 30-day readmissions and 1-year all-cause mortality. Underdosing was associated with a higher risk of new thromboembolism.