Objective The aim of this study was to test the effectiveness of the OPTIFAST program (OP), a total meal replacement dietary intervention, compared with a food‐based (FB) dietary plan for weight loss. Methods Participants with BMI 30 to 55 kg/m2, age 18 to 70 years old, were randomized to OP or FB dietary and lifestyle interventions for 26 weeks, followed by a weight‐maintenance phase. Outcomes were percent change in body weight (%WL) from baseline to weeks 26 and 52, associated changes in body composition (using dual energy x‐ray absorptiometry), and adverse events. Primary analysis used repeated‐measures multivariable linear mixed models to compare outcomes between groups in a modified intention‐to‐treat fashion (mITT). Results A total of 273 participants (83% of randomized; 135 OP, 138 FB) made up the mITT population. Mean age was 47.1 ± 11.2 years; 82% were female and 71% non‐Hispanic white. Baseline BMI was 38.8 ± 5.9 kg/m2. At 26 weeks, OP %WL was 12.4% ± 0.6% versus 6.0% ± 0.6% in FB (P < 0.001). At 52 weeks, OP %WL was 10.5% ± 0.6% versus 5.5% ± 0.6% in FB (P < 0.001). Fat mass loss was greater for OP; lean mass loss was proportional to total weight loss. There was no difference in serious adverse event rates between groups. Conclusions Compared with an FB approach, OP was more effective with greater sustained weight loss.
IMPORTANCE There are few nationwide studies comparing the risk of reintervention after contemporary bariatric procedures. OBJECTIVE To compare the risk of intervention after Roux-en-Y gastric bypass (RYGB) vs vertical sleeve gastrectomy (VSG). DESIGN, SETTING, AND PARTICIPANTS This cohort study used a nationwide US commercial insurance claims database. Adults aged 18 to 64 years who underwent a first RYGB or VSG procedure between January 1, 2010, and June 30, 2017, were matched on US region, year of surgery, most recent presurgery body mass index (BMI) category (based on diagnosis codes), and baseline type 2 diabetes. The prematch pool included 4496 patients undergoing RYGB and 8627 patients undergoing VSG, and the final weighted matched sample included 4476 patients undergoing RYGB and 8551 patients undergoing VSG. EXPOSURES Bariatric surgery procedure type (RYGB vs VSG). MAIN OUTCOMES AND MEASURES The primary outcome was any abdominal operative intervention after the index procedure. Secondary outcomes included the following subtypes of operative intervention: biliary procedures, abdominal wall hernia repair, bariatric conversion or revision, and other abdominal operations. Nonoperative outcomes included endoscopy and enteral access. Time to first event was compared using multivariable Cox proportional hazards regression modeling.RESULTS Among 13 027 patients, the mean (SD) age was 44.4 (10.3) years, and 74.1% were female; 13.7% had a preoperative BMI between 30 and 39.9, 45.8% had a preoperative BMI between 40 and 49.9, and 24.2% had a preoperative BMI of at least 50. Patients were followed up for up to 4 years after surgery (median, 1.6 years; interquartile range, 0.7-3.2 years), with 41.9% having at least 2 years of follow-up and 16.3% having at least 4 years of follow-up. Patients undergoing VSG were less likely to have any subsequent operative intervention than matched patients undergoing RYGB (adjusted hazard ratio [aHR], 0.80; 95% CI, 0.72-0.89) and similarly were less likely to undergo biliary procedures (aHR, 0.77; 95% CI, 0.67-0.90), abdominal wall hernia repair (aHR, 0.60; 95% CI, 0.47-0.75), other abdominal operations (aHR, 0.71; 95% CI, 0.61-0.82), and endoscopy (aHR, 0.54; 95% CI, 0.49-0.59) or have enteral access placed (aHR, 0.58; 95% CI, 0.39-0.86). Patients undergoing VSG were more likely to undergo bariatric conversion or revision (aHR, 1.83; 95% CI, 1.19-2.80). (continued) Key Points Question Do patients have greater risk of subsequent operative intervention after Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG)? Findings Among 13 027 patients in this cohort study, compared with matched counterparts undergoing RYGB, patients undergoing VSG had lower overall risk of subsequent operative and nonoperative interventions, including biliary procedures, abdominal wall hernia repair, other abdominal operations, and endoscopy, up to 4 years after surgery. Meaning Patients deciding between RYGB and VSG should consider not only the clinical effectiveness of these 2 procedures but al...
Objective The aim of this work was to study weight loss and risk of cardiovascular disease (CVD) or death associated with longer‐term phentermine use. Methods Using electronic health record data, 13,972 adults were identified with a first phentermine fill in 2010 to 2015, creating exposure categories according to a patient’s duration of use (referent: ≤ 3 months). Multivariable linear models were used to compare percent weight loss across categories at 6, 12, and 24 months, and Cox proportional hazards models were used to compare risk of composite CVD or death, up to 3 years after starting phentermine. Results The cohort was 84% female and 45% white, with a mean (SD) baseline age 43.5 (10.7) years and BMI of 37.8 (7.2) kg/m2. In multivariable models, longer‐term users of phentermine experienced more weight loss; patients using continuously for > 12 months lost 7.4% more than the referent group at 24 months (P < 0.001). The composite CVD or death outcome was rare (0.3%, 41 events), with no significant difference in hazard ratios between groups. Conclusions Greater weight loss without increased risk of incident CVD or death was observed in patients using phentermine monotherapy for longer than 3 months. Despite the limitations of the observational design, this study supports the effectiveness and safety of longer‐term phentermine use for low‐risk individuals.
Objective. To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR).Methods. In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively.Results. The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported.Conclusion. Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.
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