Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 4 de 4
Filter
Add more filters










Database
Language
Publication year range
1.
Diabetes Obes Metab ; 16(9): 861-8, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24641271

ABSTRACT

AIM: Glucagon-like peptide-1 (GLP-1) receptor agonists improve islet function and delay gastric emptying in patients with type 2 diabetes mellitus (T2DM). This meta-analysis aimed to investigate the effects of the once-daily prandial GLP-1 receptor agonist lixisenatide on postprandial plasma glucose (PPG), glucagon and insulin levels. METHODS: Six randomized, placebo-controlled studies of lixisenatide 20 µg once daily were included in this analysis: lixisenatide as monotherapy (GetGoal-Mono), as add-on to oral antidiabetic drugs (OADs; GetGoal-M, GetGoal-S) or in combination with basal insulin (GetGoal-L, GetGoal-Duo-1 and GetGoal-L-Asia). Change in 2-h PPG and glucose excursion were evaluated across six studies. Change in 2-h glucagon and postprandial insulin were evaluated across two studies. A meta-analysis was performed on least square (LS) mean estimates obtained from analysis of covariance (ANCOVA)-based linear regression. RESULTS: Lixisenatide significantly reduced 2-h PPG from baseline (LS mean difference vs. placebo: -4.9 mmol/l, p < 0.001) and glucose excursion (LS mean difference vs. placebo: -4.5 mmol/l, p < 0.001). As measured in two studies, lixisenatide also reduced postprandial glucagon (LS mean difference vs. placebo: -19.0 ng/l, p < 0.001) and insulin (LS mean difference vs. placebo: -64.8 pmol/l, p < 0.001). There was a stronger correlation between 2-h postprandial glucagon and 2-h PPG with lixisenatide than with placebo. CONCLUSIONS: Lixisenatide significantly reduced 2-h PPG and glucose excursion together with a marked reduction in postprandial glucagon and insulin; thus, lixisenatide appears to have biological effects on blood glucose that are independent of increased insulin secretion. These effects may be, in part, attributed to reduced glucagon secretion.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Glucagon-Like Peptide 1/agonists , Glucagon/blood , Hypoglycemic Agents/therapeutic use , Insulin/metabolism , Peptides/therapeutic use , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/blood , Gastric Emptying/drug effects , Glucagon/drug effects , Glucagon/metabolism , Glycated Hemoglobin/metabolism , Humans , Insulin/blood , Insulin Secretion , Postprandial Period , Randomized Controlled Trials as Topic
2.
J Biopharm Stat ; 4(2): 165-71, 1994 Jul.
Article in English | MEDLINE | ID: mdl-7951272

ABSTRACT

Suppose, in a clinical trial, the interest is to show that the effectiveness of an experimental therapy is no worse than that of the standard therapy by more than a specified amount, say delta units. Blackwelder (1) discussed this problem in clinical trials where the outcome of interest is dichotomous. The group sequential procedures developed by DeMets and Ware (2) are valid to test Blackwelder's hypothesis for the case delta = 0. In this paper, the asymmetric procedure of DeMets and Ware is modified to handle the case delta > 0. A two-stage procedure is considered in a drug interaction study that focuses on a specific side effect as the event of interest.


Subject(s)
Clinical Trials as Topic/methods , Research Design/statistics & numerical data , Drug Interactions , Drug-Related Side Effects and Adverse Reactions , Humans , Random Allocation , Retrospective Studies
3.
J Clin Pharmacol ; 27(8): 601-9, 1987 Aug.
Article in English | MEDLINE | ID: mdl-3655008

ABSTRACT

Porter et al have reported that pentoxifylline shows statistically significant superiority over placebo in a seven-center, double-blind, parallel group, randomized trial of outpatients with intermittent claudication secondary to chronic occlusive arterial disease. The objective of this report is convey results of the intention-to-treat population, paying careful attention to relevant methodologic issues relating to the analysis of clinical trials. At the same time, a new measure of clinical efficacy, minimum distance walked, is proposed. The rationale for this measure is discussed and results are compared with those for walking distances at each visit. The reanalysis of the Porter et al data by "intention to treat" and by use of the minimum-distance-walked measure confirms the published findings of efficacy of pentoxifylline for treatment of intermittent claudication.


Subject(s)
Intermittent Claudication/drug therapy , Pentoxifylline/therapeutic use , Theobromine/analogs & derivatives , Aged , Aged, 80 and over , Exercise Test , Female , Humans , Male , Middle Aged
4.
J Clin Psychiatry ; 45(4 Pt 2): 78-84, 1984 Apr.
Article in English | MEDLINE | ID: mdl-6370982

ABSTRACT

Twelve parallel group, randomized, double-blind studies of nomifensine's safety and efficacy in the treatment of depressed patients were combined into three pools according to common protocols. This approach permitted evaluation of 1) efficacy results for studies with moderate-sized pools of patients, 2) the degree to which efficacy was generalizable to depressed patients in the general population, and 3) the conditions under which pooled active vs. active (imipramine vs. nomifensine) studies could be regarded as pivotal in support of efficacy. Results showed that nomifensine's superiority over placebo was generalizable to patients with a wide range of characteristics, including age 60 years or older. An appropriate statistical profile of more pronounced nomifensine responders would include patients with a duration of present episode less than 4 months who are acutely depressed, exhibit more severe symptoms, and have been previously hospitalized or treated with other psychotropic medications. A comprehensive assessment and power analysis of the pooled active vs. active studies provided strong evidence for comparability of nomifensine and imipramine.


Subject(s)
Depressive Disorder/drug therapy , Isoquinolines/therapeutic use , Nomifensine/therapeutic use , Adolescent , Adult , Age Factors , Aged , Ambulatory Care , Clinical Trials as Topic , Depressive Disorder/psychology , Double-Blind Method , Female , Hospitalization , Humans , Imipramine/administration & dosage , Imipramine/adverse effects , Imipramine/therapeutic use , Male , Middle Aged , Nomifensine/administration & dosage , Nomifensine/adverse effects , Outcome and Process Assessment, Health Care , Placebos , Psychiatric Status Rating Scales , Random Allocation , Research Design , Time Factors
SELECTION OF CITATIONS
SEARCH DETAIL
...