Linked Life Data

21293451

Source:http://linkedlifedata.com/resource/pubmed/id/21293451

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
7
pubmed:dateCreated
2011-6-27
pubmed:abstractText
Three double-blind, placebo-controlled, three-parallel-group, multicenter phase 3 trials were conducted to assess the efficacy and safety of CP-945,598 for weight loss and weight-loss maintenance. Two trials were designed to be 2 years in duration (in obese and overweight patients) and one as a 1-year study (in obese and overweight patients with type 2 diabetes). However, the 2-year trials and the CP-945,598 development program were terminated before completion due to changing regulatory perspectives of CB1 receptor-related drugs. In total, 1,253 and 2,536 participants in the two 2-year multinational and North American studies were randomized to 10-mg CP-945,598 (n = 360; 718); 20-mg CP-945,598 (n = 534, 1,084) and placebo (n = 359, 734), respectively; and 975 participants were randomized to 10-mg CP-945,598 (n = 318); 20-mg CP-945,598 (n = 320); and placebo (n = 337) in the 1-year multinational diabetes trial. Baseline demographics were similar between treatment groups within each trial. One year of treatment with CP-945,598 resulted in a dose-related mean percentage reduction from baseline body-weight in all trials. A significant proportion of all participants also achieved 5% and 10% weight loss after 1 year. In participants with mainly well-controlled type 2 diabetes, the combination of lifestyle and CP-945,598 induced substantial improvements in glycemic control. The most frequent adverse events (AEs) for CP-945,598 were: diarrhea, nausea, nasopharyngitis, and headache. Self-reported experiences of anxiety and suicidal thoughts were higher with CP-945,598 than placebo, as were the incidence of depression and depressed mood. However, the reported increases in psychiatric symptoms were not consistently dose dependent.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
1930-7381
pubmed:author
pubmed:issnType
Print
pubmed:volume
19
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1404-14
pubmed:meshHeading
pubmed-meshheading:21293451-Adolescent, pubmed-meshheading:21293451-Adult, pubmed-meshheading:21293451-Aged, pubmed-meshheading:21293451-Anti-Obesity Agents, pubmed-meshheading:21293451-Diabetes Mellitus, Type 2, pubmed-meshheading:21293451-Dose-Response Relationship, Drug, pubmed-meshheading:21293451-Double-Blind Method, pubmed-meshheading:21293451-Drugs, Investigational, pubmed-meshheading:21293451-Early Termination of Clinical Trials, pubmed-meshheading:21293451-Female, pubmed-meshheading:21293451-Humans, pubmed-meshheading:21293451-Male, pubmed-meshheading:21293451-Middle Aged, pubmed-meshheading:21293451-Obesity, pubmed-meshheading:21293451-Overweight, pubmed-meshheading:21293451-Patient Dropouts, pubmed-meshheading:21293451-Piperidines, pubmed-meshheading:21293451-Purines, pubmed-meshheading:21293451-Receptor, Cannabinoid, CB1, pubmed-meshheading:21293451-Recurrence, pubmed-meshheading:21293451-Weight Loss, pubmed-meshheading:21293451-Young Adult
pubmed:year
2011
pubmed:articleTitle
Efficacy and safety of CP-945,598, a selective cannabinoid CB1 receptor antagonist, on weight loss and maintenance.
pubmed:affiliation
Weill Cornell Medical College, Cornell University, New York, New York, USA.
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase III