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Study Consisting (study + consisting)
Selected AbstractsA Comparative Pharmacokinetic Study in Healthy Volunteers of the Effect of Carbamazepine and Oxcarbazepine on Cyp3a4EPILEPSIA, Issue 3 2007Astrid-Helene Andreasen Summary:,Purpose: Carbamazepine (CBZ) and oxcarbazepine (OXCZ) are well-known inducers of drug metabolism via CYP3A4. Indirect interaction studies and clinical experience suggest that CBZ has a stronger potential in this regard than OXCZ. However this has never been subject to a direct comparative study. We performed a study in healthy volunteers to investigate the relative inductive effect of CBZ and OXCZ on CYP3A4 activity using the metabolism of quinidine as a biomarker reaction. Methods: Ten healthy, male volunteers participated in an open, randomized crossover study consisting of two periods separated by a 4-week wash-out period. The subjects received 1200 mg oral OXCZ daily for 17 days and 800 mg oral CBZ for 17 days. A single 200 mg oral dose of quinidine was administered at baseline and following administration of CBZ and OXCZ. Outcome parameters were the formation clearance of 3-hydroxyquinidine dose and the ratio of the AUCs of 3-hydroxyquinidine to quinidine. Results: Formation clearance of 3-hydroxyquinidine was increased by means of 89% (CI: 36,164; p = 0.0022) and 181% (CI: 120,260, p < 0.0001) after treatment with OXCZ and CBZ, respectively, compared to baseline. The relative inductive effect of CBZ was 46% higher than for OXCZ. AUC ratio increased by means of 161% (CI: 139,187, p < 0.0001) (OXCZ) and 222% (CI: 192,257, p < 0.0001) (CBZ). Quinidine Cmax decreased by means of 29% (CI: 16,40, p = 0.0018) (OXCZ) and 33% (CI: 18,45, p = 0.0020) (CBZ). T½ decreased by means of 12% (CI: 6,17, p < 0.0014) (OXCZ) and 32% (CI: 25,38, p < 0.0001) (CBZ). tmax was not changed in either period. Conclusion: We confirm a clinically significant inductive effect of both OXCZ and CBZ. The inductive effect of CBZ was about 46% higher than that of OXCZ, a difference that may be of clinical relevance. [source] Glutathione S -transferase M3 (A/A) genotype as a risk factor for oral cancer and leukoplakia among Indian tobacco smokersINTERNATIONAL JOURNAL OF CANCER, Issue 1 2004Nilabja Sikdar Abstract Polymorphism in glutathione S -transferase (GST) genes, causing variations in enzyme activities, may influence susceptibility to oral cancer and leukoplakia in smokers and/or smokeless tobacco users. In this case-control study consisting of 109 leukoplakia and 256 oral cancer patients and 259 controls, genotype frequencies at GSTM1, GSTT1, GSTM3 and GSTP1 loci were determined by polymerase chain reaction-restriction fragment length polymorphism methods and analyzed by multiple logistic regression to determine the risks of the diseases. There were no significant differences in the distributions of GSTM1, GSTM3 and GSTT1 genotypes in patients and controls when all individuals were compared. In contrast, frequencies of ile/ile genotype at codon 105 and variant val-ala haplotype of GSTP1 was significantly higher (OR = 1.5; 95% CI = 1.0,2.0) and lower (OR = 1.4; 95% CI = 1.0,1.9) in oral cancer patients compare to controls, respectively. The impacts of all genotypes on risks of oral cancer and leukoplakia were also analyzed in patients with different tobacco habits and doses. Increased risks of cancer and leukoplakia were observed in tobacco smokers with GSTM3 (A/A) genotype (OR = 2.0, 95% CI = 1.0,4.0; OR = 2.0, 95% CI = 1.0,4.4, respectively). So, GSTM3 (A/A) genotype could become one of the markers to know which of the leukoplakia would be transformed into cancer. Heavy tobacco chewing (> 124 chewing-year) increased the risk of cancer in individuals with GSTT1 homozygous null genotype (OR = 3.0; 95% CI = 1.0,9.8). Furthermore, increased lifetime exposure to tobacco smoking (> 11.5 pack-year) increased the risk of leukoplakia in individuals with GSTM1 homozygous null genotype (OR = 2.4; 95% CI = 1.0,5.7). It may be suggested that polymorphisms in GSTP1, GSTM1, GSTM3 and GSTT1 genes regulate risk of cancer and leukoplakia differentially among different tobacco habituals. © 2003 Wiley-Liss, Inc. [source] Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE studyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2009M. T. Rosenberg Summary Objective:, The ENDURANCE study evaluated the efficacy of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED), by measuring the duration of erection leading to successful intercourse using a stopwatch as the assessment instrument. Methods:, This was a randomised, multicentre, double-blind, placebo-controlled, crossover study consisting of a 4-week treatment-free run-in phase after which patients were randomised to either fixed-dose vardenafil 10 mg or placebo (to be administered 60 min prior to intercourse) and entered the first of the two 4-week double-blind treatment periods, separated by a 1-week washout. The primary efficacy end-point was the stopwatch-assessed duration of erection, which was defined as the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina leading to successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP-3). Secondary efficacy end-points included SEP-2 and SEP-3 success rates, the erectile function domain of the International Index of Erectile Function, global assessment questionnaire, change from baseline in duration of erection and duration of erection not leading to successful intercourse. Safety was assessed by adverse events (AEs), laboratory samples, vital signs and ECGs. Results:, Of the 191 men included in the safety population, 40% had moderate ED and 33% had severe ED at baseline. The duration of erection (least squares mean ± SE) leading to successful intercourse was longer with vardenafil than with placebo (12.81 ± 1.00 min vs. 5.45 ± 1.00 min; p < 0.001). The differences recorded for all secondary end-points were statistically significant in favour of vardenafil compared with placebo (p < 0.001), with the exception of duration of erection not leading to successful intercourse. Vardenafil was well tolerated in this study; the majority of AEs being mild-to-moderate in intensity. Conclusion:, Vardenafil 10-mg therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED compared with placebo. [source] Improving glycaemic control self-efficacy and glycaemic control behaviour in Chinese patients with Type 2 diabetes mellitus: randomised controlled trialJOURNAL OF CLINICAL NURSING, Issue 3-4 2010Qifang Shi Aims and objectives., To examine the effect of a hospital-based clinic intervention on glycaemic control self-efficacy and glycaemic control behaviour of Chinese patients with type 2 diabetes mellitus (DM). Background., Self-efficacy expectations are related to self-management of diabetes and, in conjunction with environmental support, are better predictors of behaviour than are knowledge and skills. Enhancing self-efficacy in patients with DM has been shown to have a positive effect on behavioural change and positively influence long-term glycaemic control. Design., A randomised controlled trial study consisting of two-group pretest-post-test. Methods., One hundred and fifty-seven patients with type 2 DM were randomly divided into two groups: (1) the experimental group (77 patients) receiving one-month hospital-based clinic intervention and (2) the control group (80 patients) receiving usual care. Data collection instruments used in this study were Diabetes Management Self-Efficacy Scale and Summary of Diabetes Self-Care Activities Measure. Outcomes were determined by changes in glycaemic control self-efficacy and glycaemic control behaviour of patients with type 2 DM. Results., The findings revealed that the experimental group showed statistically significant improvement in glycaemic control self-efficacy and glycaemic control behaviour immediately and four months after the intervention (F = 26·888, df = 1, 155, p < 0·05 and F = 18·619, df = 1, 155, p < 0·05, respectively). Conclusions., One-month hospital-based clinic intervention could be useful in improving glycaemic control self-efficacy and glycaemic control behaviour. Relevance to clinical practice., Nurses can learn and use the sources of self-efficacy to enhance patients' self-efficacy on their glycaemic control in clinical care. The health education is most important in nursing care and should be considered while organising the hospital-based clinic intervention. [source] G Protein ,3 Subunit Gene Variants and Essential Hypertension in the Northern Chinese Han PopulationANNALS OF HUMAN GENETICS, Issue 4 2005Biao Li Summary Recently a novel C825T polymorphism in the G protein ,3 subunit gene was identified that showed an association with hypertension in a German population; the results of studies in other populations have been inconsistent. To examine the contribution of GNB3 polymorphisms to the development of hypertension in the northern Chinese Han population, we conducted a case-control study consisting of 501 hypertensive cases and 503 controls using the G(-350)A, C825T and C1429T polymorphisms. Genotypes of samples were determined by PCR and restriction digestion. Single locus analysis showed a significant association between G(-350)A and hypertension (P = 0.01) but no association for C825T or C1429T. The three polymorphisms were in tight linkage disequilibrium (D,=,1 for G(-350)A-C825T, D,= 0.92 for C825T-C1429T) and a total of 7 haplotypes were observed in the entire population. Haplotype A-C-C was found to be significantly related to hypertension (P = 0.032) and A-C-C carriers had a more than two-fold higher risk of hypertension than non-carriers, after adjustment for BMI and glucose. In conclusion, our study suggests that G(-350)A is a potential functional polymorphism that may be related to hypertension, whereas the C825T and C1429T polymorphisms are not associated with hypertension in the northern Chinese Han population. [source] Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizuresACTA NEUROLOGICA SCANDINAVICA, Issue 5 2009A. Gil-Nagel Objectives ,,, To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures. Material and methods ,,, Double-blind, placebo-controlled, parallel-group, multicenter study consisting of an 8-week baseline period, after which patients were randomized to placebo (n = 87) or once-daily ESL 800 mg (n = 85) or 1200 mg (n = 80). Patients received half dose during 2 weeks preceding a 12-week maintenance period. Results ,,, Seizure frequency over the maintenance period was significantly (P < 0.05) lower than placebo in both ESL groups. Responder rate was 23% (placebo), 35% (800 mg), and 38% (1200 mg). Median relative reduction in seizure frequency was 17% (placebo), 38% (800 mg), and 42% (1200 mg). The most common adverse events (AEs) (>10%) were dizziness, somnolence, headache, and nausea. The majority of AEs were of mild or moderate severity. Conclusions ,,, Once-daily treatment with ESL 800 and 1200 mg was effective and generally well tolerated. [source] Emergency Department Utilization in the United States and Ontario, CanadaACADEMIC EMERGENCY MEDICINE, Issue 6 2007DrPH, Guohua Li MD Objectives:The current crisis in the emergency care system is characterized by worsening emergency department (ED) overcrowding. Lack of health insurance is widely perceived to be a major contributing factor to ED overcrowding in the United States. This study aimed to compare ED visit rates in the United States and Ontario, Canada, according to demographic and clinical characteristics. Methods:This was a cross sectional study consisting of a nationally representative sample of 40,253 ED visits included in the 2003 National Hospital Ambulatory Medical Care Survey in the United States, and all ED visits recorded during 2003 by the National Ambulatory Care Reporting System in Ontario, Canada. The main outcome was the number of ED visits per 100 population per year. Results:The annual ED visit rate in the United States was 39.9 visits (95% confidence interval = 37.2 to 42.6) per 100 population, virtually identical to the rate in Ontario, Canada (39.7 visits per 100 population). In both the United States and Ontario, Canada, those aged 75 years and older had the highest ED visit rate and women had a slightly higher ED visit rate than men. The most common discharge diagnosis was injury/poisoning, accounting for 25.6% of all ED visits in the United States and 24.7% in Ontario, Canada. Overall, 13.9% of ED patients in the United States were admitted to hospitals, compared with 10.5% in Ontario, Canada. Conclusions:ED visit rates and patterns are similar in the United States and Ontario, Canada. Differences in health insurance coverage may not have a substantial impact on the overall utilization of emergency care. [source] | ||||||||||