Dataset Information

Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.

ABSTRACT: To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine.This was a 12-week, randomized, double-blind, pilot safety study of N?=?238 nondiabetic patients with obesity or overweight with ?1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting???1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ?5% WL are reported.N?=?238 were randomized, and N?=?235 were treated. N?=?94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5?kg/3.3%, 7.0?kg/6.7%, and 7.6?kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P?=?0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P?

SUBMITTER: Smith SR

PROVIDER: S-EPMC5518190 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.

Smith Steven R SR Garvey W Timothy WT Greenway Frank L FL Zhou Sharon S Fain Randi R Pilson Robert R Fujioka Ken K Aronne Louis J LJ

Obesity (Silver Spring, Md.) 20170501 5

<h4>Objective</h4>To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine.<h4>Methods</h4>This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic advers ...[more]

PMID: 28440045

Similar Datasets

Project description:BackgroundTo evaluate effectiveness, safety, and costs of Lorcaserin vs. phentermine among obese non-surgical and surgical patients (post bariatric surgery).MethodsThis retrospective study retrieved charts of all patients (January 2013-June 2016) who received Lorcaserin or phentermine for 3 months. The study assessed anthropometric, glycemic, and lipid changes, as well as side effects and cost of medications among overweight and obese non-surgical (n = 83) and surgical patients (n = 46). These two patient groups were compared using Chi-square (χ2) and unpaired't' test for qualitative and quantitative variables respectively.ResultsAt 3 months, among the non-surgical group, Phentermine patients had greater percentage of total weight loss (TWL%) (7.65 ± 8.26 vs. 2.99 ± 3.72%, P = 0.003), and greater BMI reduction (-3.16 ± 3.63 vs. -1.15 ± 1.53 kg/m2, P = 0.003) than Lorcaserin. Within the surgical group, Lorcaserin patients had significantly smaller TWL% (1.86 ± 5.06 vs. 7.62 ± 9.80%, P = 0.012), and smaller BMI reduction (-0.74 ± 1.80 vs. -3.06 ± 4.08 kg/m2, P = 0.012) than Phentermine. Lorcaserin exhibited significant total cholesterol and LDL improvements only among surgical patients with significant weight reduction (≥5% TW). Both medications were not associated with glycemic improvements among non-surgical and surgical groups. Phentermine had slightly more side effects but was less expensive.ConclusionsAmong both patient groups, phentermine was more effective in achieving weight loss. Lorcaserin showed dyslipidemia improvements only among surgical patients who achieved significant weight reduction. Anti-obesity medications as part of weight management programs can result in weight loss among non-surgical and surgical patients, or halt weight regain among surgical patients. This is the first study to evaluate the effectiveness and safety of two anti-obesity medications (lorcaserin vs. phentermine) among two distinct obese patient groups, non-surgical and surgical patients.

Project description:OBJECTIVES: Linaclotide is a minimally absorbed guanylate cyclase-C agonist. The objective of this trial was to determine the efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C). METHODS: This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period. There were four primary end points, the Food and Drug Administration ’ s (FDA ’ s) primary end point for IBS-C (responder: improvement of ≥ 30 % in average daily worst abdominal pain score and increase by ≥ 1 complete spontaneous bowel movement (CSBM) from baseline (same week) for at least 50 % of weeks assessed) and three other primary end points, based on improvements in abdominal pain and CSBMs for 9 / 12 weeks. Adverse events (AEs) were monitored. RESULTS: The trial evaluated 800 patients (mean age = 43.5 years, female = 90.5 % , white = 76.9 % ). The FDA end point was met by 136 / 405 linaclotide-treated patients (33.6 % ), compared with 83 / 395 placebo-treated patients (21.0 % ) ( P < 0.0001) (number needed to treat: 8.0, 95 % confidence interval: 5.4, 15.5). A greater percentage of linaclotide patients, compared with placebo patients, reported for at least 6 / 12 treatment period weeks, a reduction of ≥ 30 % in abdominal pain (50.1 vs. 37.5 % , P = 0.0003) and an increase of ≥ 1 CSBM from baseline (48.6 vs. 29.6 % , P < 0.0001). A greater percentage of linaclotide patients vs. placebo patients were also responders for the other three primary end points ( P < 0.05). Significantly greater improvements were seen in linaclotide vs. placebo patients for all secondary end points ( P < 0.001). During the RW period, patients remaining on linaclotide showed sustained improvement; patients re-randomized from linaclotide to placebo showed return of symptoms, but without worsening of symptoms relative to baseline. Diarrhea, the most common AE, resulted in discontinuation of 5.7 % of linaclotide and 0.3 % of placebo patients. CONCLUSIONS: Linaclotide significantly improved abdominal pain and bowel symptoms associated with IBS-C for at least 12 weeks; there was no worsening of symptoms compared with baseline following cessation of linaclotide during the RW period.

Project description:BackgroundAvocados contain fiber, lutein, and vitamin E, and they are a rich source of MUFAs. The effect of including an avocado daily as part of a hypocaloric weight-loss diet on weight loss is not known.ObjectiveThe aim of this study was to determine the effect of daily avocado consumption as part of a hypocaloric diet on weight loss, body composition, satiety, biomarkers of inflammation, and intestinal microbiota composition.MethodsIn this randomized, parallel-controlled, open-label, 2-arm intervention study, 51 healthy overweight/obese women and men were assigned to a hypocaloric diet with 1 Hass avocado daily (AVO; n = 24) or a hypocaloric diet (CTRL; n = 27) without daily avocado for 12 wk. Serum markers and intestinal microbiota were analyzed at baseline and week 12.ResultsBoth groups experienced significant weight loss, decrease in BMI (in kg/m2), total body fat, and visceral adipose tissue, respectively (AVO: -2.3 ± 2 kg, -0.8 ± 0.8, -1.1% ± 2%, and -81.2 ± 118 g; CTRL: -2.6 ± 3.6 kg, -0.9 ± 1, -1.5% ± 2%, and -87.4 ± 216 g). We observed a significant decrease in serum glucose over time in the control group compared with the AVO group. There was no change between the groups in serum triglyceride, but a significant decrease from baseline to 12 wk was observed in the AVO group. Serum hepatic growth factor (HGF) and relative proportion of bacterial phyla (Firmicutes and Bacteroidetes), family (Bacteroidaceae and Erysipelotrichaceae), and genus (Bacteroides, Clostridium, Methanosphaera, and Candidatus Soleaferrea) were significantly altered in the AVO group compared with the CTRL group. A trend to decrease in serum inflammatory factors IL-1β (P = 0.07) and C-reactive protein (P = 0.074) was observed in the AVO group compared with CTRL.ConclusionsDaily Hass avocado consumption as part of a hypocaloric diet supported weight loss, a decrease in serum HGF, and an increase in the abundance of bacteria involved in plant polysaccharide fermentation. This trial was registered at clinicaltrials.gov as NCT02953158.

Project description:BackgroundImplementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States).MethodsIn a 12-month trial, families of children (age 7-12 years; body mass index ≥85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n = 360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions.ResultsThe mean body mass index Z-score declined in both arms (P < 0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P = 0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P = 0.05), low-density lipoprotein cholesterol (P = 0.04), aspartate aminotransferase (P = 0.02), and alanine transaminase (P = 0.03) concentrations.ConclusionsSafety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters.Trial registrationClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.

Project description:BackgroundYouth with disabilities are at high risk of unemployment compared with youth without disabilities. They often encounter challenges in accessing vocational programs that meet their needs. One promising approach that could help to address barriers that youth encounter while also enhancing social support is through electronic mentoring (e-mentoring). Although there is an increase in e-mentoring for youth with disabilities, little is known about its impact for youth with physical disabilities.ObjectiveThis study aimed to assess the acceptability and initial impact of a Web-based peer electronic mentor employment intervention for youth with physical disabilities.MethodsThe Empowering Youth Towards Employment intervention was evaluated using a pilot randomized controlled trial (RCT). Youth, aged 15-21 years, with physical disabilities were randomly assigned to an intervention (ie, mentored) or control (ie, not mentored) group. Trained mentors (ie, near peers) with a physical disability led the online discussion forums and provided peer support and resources for 12 modules (1 topic per week over 12 weeks). Primary outcomes focused on self-determination, career maturity, and social support. We also explored program adherence and dosage, participant satisfaction, and areas for improvement.ResultsA total of 13 youth (mean age 17.3 years, SD 1.88; 54%, 7/13 female) completed the RCT. In the intervention group (n=9), 56% (5/9) of the youth were females, and in the control group (n=4), 50% (2/4) of the youth were female. Participants reported satisfaction with the program and that it was feasible and acceptable. Participants' mean engagement level with the program was 5.22 (SD 2.48) for the intervention group and 5.40 (SD 4.56) for controls. Participants in the intervention group demonstrated significant improvements in self-determination (t12=2.49; P<.04) compared with the control group. No adverse events were reported.ConclusionsThe Empowering Youth Towards Employment is a promising intervention that enhances self-determination among youth with physical disabilities.Trial registrationClinicalTrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc).International registered report identifier (irrid)RR2-10.2196/resprot.8034.

Dataset Information

Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.

Publications

Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets