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RESULTS With the 50-mg dose , mirabegron Cmax was reduced by 45 % with a high-fat breakfast compared with fasted conditions ( geometric mean ratio [ GMR ] , 54.8 % [ 90 % CI , 43.7 % -68.6 % ] ) and AUC0 - , by 17 % ( GMR , 83.2 % [ 90 % CI , 74.2 % -93.4 % ] ) . |
RESULTS With the 100-mg dose , mirabegron Cmax and AUC0 - were reduced by 39 % ( GMR , 61.3 % [ 90 % CI , 47.8 % -78.7 % ] ) and 18 % ( 82.4 % [ 72.6 % -93.5 % ] ) , respectively , after a high-fat breakfast . |
RESULTS With the 50-mg dose , mirabegron Cmax was decreased by 75 % ( GMR , 25.0 % [ 90 % CI , 19.9 % -31.3 % ] ) and AUC0 - by 51 % ( 48.7 % [ 43.3 % -54.7 % ] ) after a low-fat breakfast . |
RESULTS Corresponding reductions with the 100-mg dose were 64 % ( GMR , 36.3 % [ 90 % CI , 28.2 % -46.8 % ] ) for Cmax and 47 % ( GMR , 53.2 % [ 90 % CI , 46.8 % -60.5 % ] ) for AUC0 - . |
RESULTS The fed/fasted ratios for mirabegron Cmax and AUC0 - were in general independent of dose or sex . |
RESULTS Food delayed Tmax compared with the fasted state , with similar increases with the high - and low-fat meals ( 0.9 hours with 50 mg and 1.5-2 .0 hours with 100 mg ) . |
RESULTS Mirabegron was generally well tolerated , with no apparent difference in AE frequency between the fasted and fed states . |
CONCLUSIONS Mirabegron OCAS tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose ( 50 or 100 mg ) or gender but dependent on meal composition . |
CONCLUSIONS A greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast . |
CONCLUSIONS Based on findings from previous studies , the effects of food observed in this study do not warrant dose adjustment in clinical practice . |
CONCLUSIONS ClinicalTrials.gov identifier : NCT00939757 . |
###16458629 |
OBJECTIVE The purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women . |
METHODS Seventy-one nonobese postmenopausal women were assigned randomly to receive hormone replacement therapy ( conjugated estrogens , 0.625 mg , plus medroxyprogesterone acetate , 2.5 mg ) or placebo daily for 1 year ( 34 women received hormone replacement therapy , and 37 women received placebo ) . |
METHODS At baseline and 12 months , the women received a computed tomography scan at the L4-L5 vertebral disk space , a dual x-ray absorptiometry scan , a euglycemic hyperinsulinemic clamp to measure insulin sensitivity , and a lipid profile . |
METHODS Declining insulin sensitivity was defined as the largest quartile change in insulin sensitivity in the women who received the placebo ( -1.42 mg/min/kg lean body mass ) . |
RESULTS By univariate analysis , we found that significant predictors of worsening insulin sensitivity were the use of hormone replacement therapy , baseline insulin sensitivity , a younger age , and < 10 years since menopause . |
RESULTS By logistic regression , we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity . |
CONCLUSIONS The use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women . |
###24107907 |
BACKGROUND Ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs , resulting in impairment of speech up to the point of unintelligibility . |
BACKGROUND The aim of the present study was the assessment of selected parameters of speech with and without resection prostheses . |
METHODS The speech sounds of 22 patients suffering from maxillary and mandibular defects were recorded using a digital audio tape ( DAT ) recorder with and without resection prostheses . |
METHODS Evaluation of the resonance and the production of the sounds / s / , / sch / , and / ch / was performed by 2 experienced speech therapists . |
METHODS Additionally , the patients completed a non-standardized questionnaire containing a linguistic self-assessment . |
RESULTS After prosthesis supply , the number of patients with rhinophonia aperta decreased from 7 to 2 while the number of patients with intelligible speech increased from 2 to 20 . |
RESULTS Correct production of the sounds / s / , / sch / , and / ch / increased from 2 to 13 patients . |
RESULTS A significant improvement of the evaluated parameters could be observed only in patients with maxillary defects . |
RESULTS The linguistic self-assessment showed a higher satisfaction in patients with maxillary defects . |
CONCLUSIONS In patients with maxillary defects due to ablative tumor surgery , an increase in speech performance and intelligibility is possible by supplying resection prostheses . |
###18366490 |
BACKGROUND Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration . |
OBJECTIVE To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion . |
METHODS A randomised comparative trial where 300 women at 13-20 weeks gestation , requiring medical abortion , were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of 400 microg three-hourly , up to a maximum five doses over 24 h. |
METHODS The same doses were repeated for another 24 h in non-responders . |
METHODS Primary outcome measure was complete abortion rate at 24 and 48 h , and the secondary outcome measures were induction-abortion interval , failure rate , side-effects and patients ' preference to the route . |
RESULTS No statistically significant differences in the complete abortion rates were observed at 24 h ( 64.03 % vs 61.59 % , P = 0.767 ) and at 48 h ( 79.14 % vs 82.01 % , P = 0.651 ) when sublingual and vaginal groups were compared . |
RESULTS Mean induction-abortion intervals in sublingual and vaginal groups were 14.1 and 14.5 h , respectively ( P = 0.066 ) . |
RESULTS Other outcome measures were also more or less similar in both groups . |
RESULTS Differences in the incidence of side-effects were also statistically insignificant when both groups were compared . |
RESULTS Sublingual administration of the drug was preferred by most of the women as compared to vaginal administration ( P < 0.0001 ) . |
CONCLUSIONS Both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients . |
###10676676 |
OBJECTIVE To test the hypothesis that a garlic supplement alters plasma lipoproteins , postprandial lipemia , low-density lipoprotein ( LDL ) size and high-density lipoprotein ( HDL ) subclass distribution differently in 50 moderately hypercholesterolemic subjects classified as LDL subclass pattern A or B. |
BACKGROUND Garlic has been variably reported to reduce or not affect plasma cholesterol values . |
BACKGROUND Low-density lipoprotein pattern B is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with LDL pattern A individuals . |
METHODS A double blind , randomized , placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects ( mean LDL cholesterol = 166 + / - 22 mg/dl ) classified as LDL subclass pattern A ( predominantly large LDL , n = 22 ) or B ( predominantly small LDL , n = 28 ) . |
METHODS Following a two-month stabilization period , subjects were randomly assigned to a placebo or 300 mg three times a day of a standardized garlic tablet for three months . |
RESULTS For all subjects , LDL pattern A and B subjects combined , garlic treatment for three months resulted in no significant change in total cholesterol , LDL cholesterol , HDL cholesterol , HDL subclass distribution , postprandial triglycerides , apolipoprotein B , lipoprotein ( a ) ( Lp [ a ] ) , LDL peak particle diameter or LDL subclass distribution . |
RESULTS There was no significant difference in response for the same parameters among subjects classified as LDL pattern A or B with the exception of significantly greater ( p = 0.01 ) reduction in mean peak particle diameter in pattern A subjects treated with either garlic or placebo . |
RESULTS There was no significant change in LDL subclass distribution . |
CONCLUSIONS This investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further , that it has no impact on HDL subclasses , Lp ( a ) , apolipoprotein B , postprandial triglycerides or LDL subclass distribution . |
CONCLUSIONS Garlic may have a greater effect on LDL particle diameter in LDL pattern A compared with pattern B subjects . |
CONCLUSIONS This difference was not reflected in other plasma lipid measurements . |
###16427930 |
BACKGROUND Ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in 5 % of colonoscopy activity , and the need for training is undefined . |
OBJECTIVE To assess the learning curve and skill-keeping line of ileoscopy . |
METHODS Prospective randomized study . |
METHODS Single GI endoscopy unit . |
METHODS Adult outpatients referred for colonoscopy . |
METHODS Patient randomization to ileocolonoscopy by trainees and seniors . |
METHODS Ileoscopy skill was divided into the following : ileocecal valve ( ICV ) intubation ( success rate , time ) and ileal exploration ( length , time ) . |
METHODS Consecutive blocks of 10 procedures were used to calculate the learning curve and the skill-keeping line . |
METHODS Variables considered to influence ICV intubation were the following : endoscopist experience , ICV morphology , patient age , gender , body mass index , diverticular disease , and preceding abdominal/pelvic surgery . |
RESULTS Learning curve showed that competency in ICV intubation ( 80 % success rate ) and ileal exploration ( 16 cm ) was achieved after 50 procedures . |
RESULTS The skill-keeping line showed that ileoscopy was easy ( 97 % success rate ) , fast ( 1 minute ) , and well accepted up to 45 cm of the ileum . |
RESULTS Thin-lipped and volcanic ICV are the most difficult and easiest to intubate , respectively . |
RESULTS Crohn 's disease and adenomas of the proximal edge of ICV were diagnosed in 2.2 % . |
CONCLUSIONS Training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing ICV intubation to maintain and increase their skill . |
CONCLUSIONS Ileoscopy can be difficult when the ICV is thin lipped or single bulged , and easy when it has a volcanic morphology . |
###16540546 |
OBJECTIVE To estimate minimally important differences ( MIDs ) in scores for the modified Rodnan Skin Score ( mRSS ) and Health Assessment Questionnaire-Disability Index ( HAQ-DI ) in a clinical trial on diffuse systemic sclerosis ( SSc ) . |
METHODS 134 people participated in a 2-year , double-blind , randomised clinical trial comparing efficacy of low-dose and high-dose D-penicillamine in diffuse SSc . |
METHODS At 6 , 12 , 18 and 24 months , the investigator was asked to rate the change in the patient 's health since entering the study : markedly worsened , moderately worsened , slightly worsened , unchanged , slightly improved , moderately improved or markedly improved . |
METHODS Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved . |
RESULTS The MID estimates for the mRSS improvement ranged from 3.2 to 5.3 ( 0.40-0 .66 effect size ) and for the HAQ-DI from 0.10 to 0.14 ( 0.15-0 .21 effect size ) . |
RESULTS Patients who were rated to improve more than slightly were found to improve by 6.9-14 .2 ( 0.86-1 .77 effect size ) on the mRSS and 0.21-0 .55 ( 0.32-0 .83 effect size ) on the HAQ-DI score . |
CONCLUSIONS MID estimates are provided for improvement in the mRSS and HAQ-DI scores , which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc . |
###23169695 |
OBJECTIVE Long-term pharmacological glucocorticoid ( GC ) therapy leads to skeletal muscle atrophy and weakness . |
OBJECTIVE The objective of this study was to investigate whether short-term treatment with GH and testosterone ( T ) can increase lean mass without major impairment of glucose homoeostasis in patients on GC therapy . |
METHODS This was a prospective , open-label , randomised , crossover study . |
METHODS Twelve men ( age 746 years ) on chronic GC treatment participated . |
METHODS The effects of 2 weeks ' treatment with GH , testosterone and the combination of both on lean body mass ( LBM ) , appendicular skeletal muscle mass ( ASMM ) , extracellular water ( ECW ) , body cell mass ( BCM ) and plasma glucose concentrations were investigated . |
RESULTS LBM increased significantly after GH ( 1.71.4 kg ; P = 0.007 ) and GH + testosterone ( 2.41.1 kg ; P = 0.003 ) , but not testosterone alone . |
RESULTS ASMM increased after all three treatment periods ; by 1.00.8 kg after GH ( P = 0.005 ) , 1.70.4 kg after GH + testosterone ( P = 0.002 ) and 0.81.0 kg after testosterone ( P = 0.018 ) . |
RESULTS The increase in ASMM was larger with combined treatment than either GH or testosterone alone ( P < 0.05 ) . |
RESULTS ECW increased significantly after GH + testosterone by 1.52.6 l ( P = 0.038 ) but not after GH or testosterone alone . |
RESULTS BCM increased slightly after single and combined treatments , but the changes were not significant . |
RESULTS Fasting glucose increased significantly after GH ( 0.40.4 mmol/l , P = 0.006 ) while both fasting ( 0.20.3 mmol/l , P = 0.045 ) and post glucose-load ( 1.82.3 mmol/l , P = 0.023 ) plasma glucose concentrations increased after GH + testosterone . |
CONCLUSIONS GH and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose GC treatment . |
CONCLUSIONS In the doses used , combination therapy increases fasting and postprandial glucose concentration . |