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1.  Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial 
Background
Consistent with its effect on gastric emptying, exenatide, an injectable treatment for type 2 diabetes, may slow the absorption rate of concomitantly administered oral drugs resulting in a decrease in maximum concentration (Cmax). This study evaluated the drug interaction potential of exenatide when administered adjunctively with oral contraceptives, given their potential concomitant use.
Methods
This trial evaluated the effect of exenatide co-administration on single- and multiple-dose pharmacokinetics of a combination oral contraceptive (ethinyl estradiol [EE] 30 μg, levonorgestrel [LV] 150 μg [Microgynon 30®]). Thirty-two healthy female subjects participated in an open-label, randomised, crossover trial with 3 treatment periods (oral contraceptive alone, 1 hour before exenatide, 30 minutes after exenatide). Subjects received a single dose of oral contraceptive on Day 8 of each period and QD doses on Days 10 through 28. During treatment periods of concomitant usage, exenatide was administered subcutaneously prior to morning and evening meals at 5 μg BID from Days 1 through 4 and at 10 μg BID from Days 5 through 22. Single- (Day 8) and multiple-dose (Day 22) pharmacokinetic profiles were assessed for each treatment period.
Results
Exenatide did not alter the bioavailability nor decrease daily trough concentrations for either oral contraceptive component. No substantive changes in oral contraceptive pharmacokinetics occurred when oral contraceptive was administered 1 hour before exenatide. Single-dose oral contraceptive administration 30 minutes after exenatide resulted in mean (90% CI) Cmax reductions of 46% (42-51%) and 41% (35-47%) for EE and LV, respectively. Repeated daily oral contraceptive administration 30 minutes after exenatide resulted in Cmax reductions of 45% (40-50%) and 27% (21-33%) for EE and LV, respectively. Peak oral contraceptive concentrations were delayed approximately 3 to 4 hours. Mild-to-moderate nausea and vomiting were the most common adverse events observed during the trial.
Conclusions
The observed reduction in Cmax is likely of limited importance given the unaltered oral contraceptive bioavailability and trough concentrations; however, for oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before exenatide injection.
Trial registration
ClinicalTrials.gov: NCT00254800.
doi:10.1186/1472-6904-12-8
PMCID: PMC3378442  PMID: 22429273
exenatide twice daily; pharmacokinetics; oral contraceptive
2.  Effects of Exenatide and Lifestyle Modification on Body Weight and Glucose Tolerance in Obese Subjects With and Without Pre-Diabetes 
Diabetes Care  2010;33(6):1173-1175.
OBJECTIVE
To assess the effects of exenatide on body weight and glucose tolerance in nondiabetic obese subjects with normal or impaired glucose tolerance (IGT) or impaired fasting glucose (IFG).
RESEARCH DESIGN AND METHODS
Obese subjects (n = 152; age 46 ± 12 years, female 82%, weight 108.6 ± 23.0 kg, BMI 39.6 ± 7.0 kg/m2, IGT or IFG 25%) were randomized to receive exenatide (n = 73) or placebo (n = 79), along with lifestyle intervention, for 24 weeks.
RESULTS
Exenatide-treated subjects lost 5.1 ± 0.5 kg from baseline versus 1.6 ± 0.5 kg with placebo (exenatide − placebo, P < 0.001). Placebo-subtracted difference in percent weight reduction was −3.3 ± 0.5% (P < 0.001). Both groups reduced their daily calorie intake (exenatide, −449 cal; placebo, −387 cal). IGT or IFG normalized at end point in 77 and 56% of exenatide and placebo subjects, respectively.
CONCLUSIONS
Exenatide plus lifestyle modification decreased caloric intake and resulted in weight loss in nondiabetic obesity with improved glucose tolerance in subjects with IGT and IFG.
doi:10.2337/dc09-1203
PMCID: PMC2875418  PMID: 20332357
3.  Correction and Use of Biomedical Literature Affected by Scientific Misconduct 
The purpose of this study was to identify and describe published research articles that were named in official findings of scientific misconduct and to investigate compliance with the administrative actions contained in these reports for corrections and retractions, as represented in PubMed. Between 1993 and 2001, 102 articles were named in either the NIH Guide for Grants and Contracts (“Findings of Scientific Misconduct”) or the U.S. Office of Research Integrity annual reports as needing retraction or correction. In 2002, 98 of the 102 articles were indexed in PubMed. Eighty-five of these 98 articles had indexed corrections: 47 were retracted; 26 had an erratum; 12 had a correction described in the “comment” field. Thirteen had no correction, but 10 were linked to the NIH Guide “Findings of Scientific Misconduct”, leaving only 3 articles with no indication of any sort of problem. As of May 2005, there were 5,393 citations to the 102 articles, with a median of 26 citations per article (range 0–592). Researchers should be alert to “Comments” linked to the NIH Guide as these are open access, and the “Findings of Scientific Misconduct’ reports are often more informative than the statements about the retraction or correction found in the journals.
PMCID: PMC2796981  PMID: 17703606
bibliometric analysis; biomedical publishing; publication ethics; scientific misconduct; retraction of publication
4.  Racial Similarities in Response to Standardized Offer of Influenza Vaccination 
BACKGROUND
Despite known benefits of influenza vaccination and coverage by Medicare Part B, elderly minority patients are less likely to receive influenza vaccination than whites.
OBJECTIVES
To test whether a nonphysician-initiated standardized offer of influenza vaccination to all elderly primary care patients would result in similar proportions of African-American and white patients accepting vaccine.
DESIGN
In 7 metropolitan Detroit primary care practices during the 2003 influenza vaccination season, medical assistants assessed influenza immunization status of all patients 65 years and older and collected limited demographic data. Eligible patients were offered vaccination.
MEASUREMENTS
Proportion of patients accepting influenza vaccination by race and predictors of vaccine acceptance.
RESULTS
Four hundred and fifty-four eligible patients with complete racial information were enrolled: 40% African American, 52% white, 8% other race/ethnicity. Similar proportions of African Americans and whites had already received the 2003 vaccine (11.6% and 11.0%, respectively) or stated vaccination as the reason for visit (23.8% and 30.5%, respectively). Among the remainder, there also were similar proportions who accepted vaccination: 68.9% white and 62.1% African-American patients. History of previous vaccination was the only statistically significant predictor of vaccine acceptance (odds ratio [OR] 8.64, 95% confidence interval [CI] 4.17, 17.91, P <.001). After adjusting for history of previous vaccination, age, gender, and education, the odds of vaccine acceptance were no different for whites and African Americans (OR 1.20, 95% CI 0.63, 2.29, P = .57).
CONCLUSIONS
Vaccination acceptance differed little between African-American and white elderly patients. Using nonphysician personnel to identify and offer influenza vaccine to eligible patients is easily accomplished in primary care offices and has the potential to eliminate racial disparities in influenza vaccination.
doi:10.1111/j.1525-1497.2006.00401.x
PMCID: PMC1484713  PMID: 16686810
health care delivery; influenza; vaccination; race/ethnicity; underserved populations; disparities

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