. S.A. is a member of the scientific advisory panel for and has received honoraria and/or consulting fees from Takeda/Lilly.Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; FPG, fasting plasma glucose; LOCF, last-observation-carried-forward; ULN, upper limitof normal.A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
Pioglitazone Hydrochloride Monotherapy Improves Glycemic Control in the Treatment of Patients With Type 2 DiabetesA 6-month randomized placebo-controlled dose-response studyOBJECTIVE -To evaluate the efficacy and safety of four doses of pioglitazone monotherapy in the treatment of patients with type 2 diabetes.RESEARCH DESIGN AND METHODS -There were 408 patients randomized in this multicenter double-blind placebo-controlled clinical trial. Patients who had HbA 1c Ն7.0%, fasting plasma glucose (FPG) Ն140 mg/dl, and C-peptide Ͼ1 ng/ml were randomized to receive placebo or 7.5, 15, 30, or 45 mg pioglitazone administered once a day for 26 weeks.RESULTS -Patients treated with 15, 30, or 45 mg pioglitazone had significant mean decreases in HbA 1c (range Ϫ1.00 to Ϫ1.60% difference from placebo) and FPG (Ϫ39.1 to Ϫ65.3 mg/dl difference from placebo). The decreases in FPG were observed as early as the second week of therapy; maximal decreases occurred after 10-14 weeks and were maintained until the end of therapy (week 26). In the 15-, 30-, or 45-mg pioglitazone groups, there were significant mean percent decreases in triglycerides, significant mean percent increases in HDL cholesterol, and only small percent changes in total cholesterol and LDL. The subset of patients naive to therapy had greater improvements in HbA 1c and FPG (difference from placebo of Ϫ2.55% and Ϫ79.9 mg/dl for the 45-mg group) compared with previously treated patients. The overall adverse event profile of pioglitazone was similar to that of placebo. There was no evidence of drug-induced hepatotoxicity or drug-induced elevations of alanine aminotransferase levels in this study.CONCLUSIONS -Pioglitazone monotherapy significantly improves HbA 1c and FPG while producing beneficial effects on serum lipids in patients with type 2 diabetes with no evidence of drug-induced hepatotoxicity.
A simple random survey was conducted in Ireland during 2005 to estimate the ELISA-prevalence of paratuberculosis, commonly called Johne's disease (JD), in the cattle population. Serum samples were collected from all 20,322 females/breeding bulls over 12 months-of-age in 639 herds. All samples were tested using a commercially available absorbed ELISA. The overall prevalence of infected herds, based on the presence of at least one ELISA-positive animal, was 21.4% (95% CI 18.4%-24.9%). Herd prevalence levels amongst dairy herds (mean 31.5%; 95% CI: 24.6%, 39.3%) was higher than among beef herds (mean 17.9%; 95% CI: 14.6%-21.8%). However, the animal level prevalence was similar. The true prevalence among all animals tested, was calculated to be 2.86% (95%CI: 2.76, 2.97) and for animals >= 2 yrs, it was 3.30% (95%CI: 3.17, 3.43). For animals in beef herds, true prevalence was 3.09% (95%CI: 2.93, 3.24), and for those in dairy herds, 2.74% (95%CI: 2.59, 2.90). The majority of herds had only one ELISA-positive infected animal. Only 6.4% (95% CI 4.7%-8.7%) of all herds had more than one ELISA-positive infected animal; 13.3% (CI 8.7%-19.7%) of dairy herds ranging from two to eight ELISA-positive infected animals; and, 3.9% beef herds (CI 2.4%-6.2%) ranging from two to five ELISA-positive infected animals. The true prevalence of herds infected and shedding Mycobacterium avium subspecies paratuberculosis is estimated to be 9.5% for all herd types; 20.6% for dairy herds; and 7.6% for beef herds. If ELISA positive animals <2-years-of-age are excluded, the true herd prevalene reduces to: 9.3% for all herd types; 19.6% for dairy herds; and 6.3% for beef herds based on a test specificity (Sp) of 99.8% and test sensitivity (Se) (i.e., ability to detect culture-positive, infected animals shedding at any level) of 27.8-28.9%.
Little is known about the effectiveness of the cleaning and disinfection methods used on commercial pig farms either in Ireland or worldwide. A National Salmonella Control Programme was implemented in Ireland in August 2002 to monitor and control the infection of pigs with Salmonella species. Commercial pig herds must be categorised according to their Salmonella status as either category 1, 2 or 3, having a serological prevalence of infection with Salmonella serotypes up to 10 per cent, between 10 and 50 per cent or more than 50 per cent, respectively. The aim of this study was to assess the efficacy of washing and disinfecting finisher units on category 1 and category 3 farms in reducing or eliminating the levels of contamination. Counts of Enterobacteriaceae were used as indicators of the contamination of the environment with enteric bacteria, which could include Salmonella species. Samples were taken from the pen floors, feeders and drinkers of seven category 1 and seven category 3 farms, and Enterobacteriaceae and salmonellae were enumerated in each sample. The results suggested that intensive cleaning and disinfection was effective at reducing levels of Enterobacteriaceae on the pen floors of both categories, but that residual contamination remained on the surfaces of the feeders and drinkers on all the farms, particularly on the category 3 farms.
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