Lisdexamfetamine Pharmacokinetic Comparison Between Patients Who Underwent Roux-en-Y Gastric Bypass and Nonsurgical Controls.

INTRODUCTION/PURPOSE: The objective of this research was to characterize the impact of Roux-en-Y gastric bypass (RYGB) on the pharmacokinetic properties of the pro-drug lisdexamfetamine and its active metabolite, d-amphetamine. MATERIALS AND METHODS: A case-control design was used where patients who had undergone RYGB 9-24 months prior were matched on sex, age, and body mass index (BMI) to nonsurgical controls who had no history of weight loss surgery. Each participant received a single 50 mg dose of lisdexamfetamine, and plasma samples were collected over a 24-h period following dosing. Noncompartmental analyses were used to compare pharmacokinetic measures between groups. RESULTS: There were no significant differences between the RYGB (n = 10) and NSC groups (n = 10) on sex (70% female), age (40.9 ± 9.6 vs. 41.3 ± 8.9 years), BMI (30.3 ± 5.2 vs. 31 ± 5.9 kg/m2), or ethnicity (100% vs. 80% White). The pharmacokinetic parameters between the RYGB and NCS groups were found to be equivalent for lisdexamfetamine and d-amphetamine, including maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC(0-∞)). CONCLUSION: These data suggest that there is no need to routinely adjust lisdexamfetamine dosing following RYGB. However, given the potential for inter-individual differences, patients who undergo RYGB should be clinically monitored and individualized dosing strategies should be considered for concerns surrounding efficacy or toxicity.

The relationship between childhood maltreatment and psychopathology in adults undergoing bariatric surgery.

BACKGROUND: A history of childhood maltreatment and psychopathology are common in adults with obesity. OBJECTIVES: To report childhood maltreatment and to evaluate associations between severity and type of childhood maltreatment and lifetime history of psychopathology among adults with severe obesity awaiting bariatric surgery. SETTING: Four clinical centers of the Longitudinal Assessment of Bariatric Surgery Research Consortium. METHODS: The Childhood Trauma Questionnaire, which assesses presence/severity (i.e., none, mild, moderate, severe) of physical abuse, mental abuse, physical neglect, mental neglect, and sexual abuse, was completed by 302 female and 66 male bariatric surgery patients. Presurgery lifetime history of psychopathology and suicidal ideation/behavior were assessed with the Structured Clinical Interview for DSM-IV and the Suicidal Behavioral Questionnaire-Revised, respectively. Presurgery lifetime history of antidepressant use was self-reported. RESULTS: Two thirds (66.6%) of females and 47.0% of males reported at least 1 form of childhood trauma; 42.4% and 24.2%, respectively, at greater than or equal to moderate severity. Among women, presence/greater severity of childhood mental or physical abuse or neglect was associated with a higher risk of history of psychopathology (i.e., major depressive disorder, posttraumatic stress disorder, other anxiety disorder, alcohol use disorder, binge eating disorder), suicidal ideation/behavior and antidepressant use (P for all ≤ .02). These associations were independent of age, race, education, body mass index, and childhood sexual abuse. Childhood sexual abuse was independently associated with a history of suicidal ideation/behavior and antidepressant use only (P for both ≤ .05). Statistical power was limited to evaluate these associations among men. CONCLUSION: Among women with obesity, presence/severity of childhood trauma was positively associated with relatively common psychiatric disorders.

Conception rates and contraceptive use after bariatric surgery among women with infertility: Evidence from a prospective multicenter cohort study.

BACKGROUND: Lack of prospective trials have resulted in a dearth of information regarding postbariatric surgery conception rates in women with a preoperative history of infertility. OBJECTIVE: To examine associations between preoperative history of infertility and postbariatric surgery conception. SETTING: A multicenter cohort study at 10 United States hospitals (2006-2009). METHODS: Participants completed a preoperative reproductive health questionnaire, with annual postoperative assessments for up to 7 years until January 2015. This report was restricted to women 18- to 44-years old with no history of menopause, hysterectomy, or hormone replacement therapy. The primary outcomes were postoperative (0 to <90 mo) conception rate, early conception rate (0 < 18 mo), and postoperative unprotected intercourse with a male partner while not trying to conceive. RESULTS: Of 740 eligible women, 650 (87.8%) provided required responses. Median interquartile range (IQR) preoperative age was 34 (30-39) years and follow-up was 6.5 (5.9-7.0) years. Nulliparous women with a preoperative history of infertility represented 8.0% (52/650) of the total cohort, 63.5% (33/52) of whom had never conceived. Compared with women without this history, these women had a higher postoperative conception rate (121.2 [95% confidence interval (CI), 102.3-143.5]/1000 versus 47.0 [95%CI, 34.2-62.9]/1000 woman-yr; P < .001), early conception rate (115.4 [95%CI, 96.1-138.5]/1000 versus 33.9 [95%CI, 23.6-47.1]/1,000 woman-yr; P < .01), and a higher risk of unprotected intercourse (ARR 1.48 [95% CI, 1.14-1.90], P = 0.003). CONCLUSION: After bariatric surgery, preoperative history of infertility and nulliparity was associated higher conception rates and unprotected intercourse.

Loss of Control Eating and Binge Eating in the 7 Years Following Bariatric Surgery.

BACKGROUND: Although bariatric surgery is an effective intervention for severe obesity, a subset of patients demonstrates suboptimal weight outcomes. Postoperative loss of control eating (LOCE) and binge eating may influence weight outcomes, though research has not examined differences by surgical procedure, or factors that predict postoperative LOCE. This study aimed to [1] characterize LOCE and binge eating disorder (BED) over a 7-year period following bariatric surgery; [2] examine concurrent, prospective, and cumulative relationships between LOCE and weight loss; [3] assess whether these associations are moderated by surgery type; and [4] evaluate predictors of LOCE. METHODS: Participants were 2156 patients who underwent laparoscopic adjustable gastric banding (LAGB) or Roux-n-Y gastric bypass (RYGB) in the multi-center Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study. Generalized linear mixed models examined relationships between LOCE and percent weight loss and predictors of LOCE. RESULTS: LOCE and BED initially declined then increased after surgery, with a notable number of de-novo cases (25.6% and 4.8%, respectively). LOCE was related to less concurrent but not prospective or cumulative percent weight loss. Self-monitoring of eating, higher daily eating frequency, older age, male gender, and higher self-esteem were associated with a lower likelihood of LOCE. CONCLUSIONS: Results suggest that LOCE and binge eating are clinically relevant behaviors that may impede weight loss, and findings highlight the importance of ongoing assessment of maladaptive eating following surgery.

Contraception and Conception After Bariatric Surgery.

OBJECTIVE: To examine contraceptive practices and conception rates after bariatric surgery. METHODS: The Longitudinal Assessment of Bariatric Surgery-2 is a multicenter, prospective cohort study of adults undergoing first-time bariatric surgery as part of routine clinical care at 10 U.S. hospitals. Recruitment occurred between 2005 and 2009. Participants completed preoperative and annual postsurgical assessments for up to 7 years until January 2015. This report was restricted to women 18-44 years old with no history of menopause, hysterectomy, or estrogen and progesterone therapy. Primary outcomes were self-reported contraceptive practices, overall conception rate, and early (less than 18 months) postsurgical conception. Contraceptive practice (no intercourse, protected intercourse, unprotected intercourse, or tried to conceive) was classified based on the preceding year. Conception rates were determined from self-reported pregnancies. RESULTS: Of 740 eligible women, 710 (95.9%) completed follow-up assessment(s). Median (interquartile range) preoperative age was 34 (30-39) years. In the first postsurgical year, 12.7% (95% CI 9.4-16.0) of women had no intercourse, 40.5% (95% CI 35.6-45.4) had protected intercourse only, 41.5% (95% CI 36.4-46.6) had unprotected intercourse while not trying to conceive, and 4.3% (95% CI 2.4-6.3) tried to conceive. The prevalence of the first three groups did not significantly differ across the 7 years of follow-up (P for all >.05); however, more women tried to conceive in the second year (13.1%, 95% CI 9.3-17.0; P<.001). The conception rate was 53.8 (95% CI 40.0-71.1) per 1,000 woman-years across follow-up (median [interquartile range] 6.5 [5.9-7.0] years); 42.3 (95% CI 30.2-57.6) per 1,000 woman-years in the 18 months after surgery. Age (adjusted relative risk 0.41 [95% CI 0.19-0.89] per 10 years, P=.03), being married or living as married (adjusted relative risk 4.76 [95% CI 2.02-11.21], P<.001), and rating future pregnancy as important preoperatively (adjusted relative risk 8.50 [95% CI 2.92-24.75], P<.001) were associated with early conception. CONCLUSIONS: Postsurgical contraceptive use and conception rates do not reflect recommendations for an 18-month delay in conception after bariatric surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT00465829.

Eating disorders after bariatric surgery: a case series.

OBJECTIVE: A significant number of post-bariatric surgery (BS) patients present with eating disorders (EDs) symptoms that require specialized treatment. These cases are thought to be underreported due to their frequent sub-syndromal presentation. This article describes ED syndromes that develop subsequent to BS. METHOD: The clinical charts of 12 individuals who were hospitalized on a specialized inpatient EDs unit were reviewed. RESULTS: Based on the new DSM-5 proposed criteria, six patients would meet criteria for an anorexia nervosa (AN) diagnosis: three with binge eating/purge AN subtype and three with restrictive AN subtype. An additional four met criteria for atypical AN, since they were at a normal weight, and two patients met criteria for bulimia nervosa. DISCUSSION: Several similarities to the classical EDs were found. The findings that most distinguished these patients from those with classical EDs were their ages, and the age of onset of the ED for some patients.