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ITT Analysis (itt + analysis)
Selected AbstractsImprovement in behavioural symptoms in patients with moderate to severe Alzheimer's disease by memantine: a pooled data analysisINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 5 2008S. Gauthier Abstract Introduction Behavioural disturbances are a common and distressing aspect of Alzheimer's disease (AD). This pooled analysis evaluated the specific benefits of memantine on behavioural disturbances in patients with moderate to severe AD. Methods Data were pooled from six 24/28-week, randomised, placebo-controlled, double-blind studies. Of the 2,311 patients included in these studies, 1,826 patients with moderate to severe AD (MMSE <20) were included in this analysis, corresponding to the extended indication for memantine in Europe. In this subgroup, 959 patients received memantine 20,mg/day and 867 received placebo. Behavioural symptoms were rated using the Neuropsychiatric Inventory (NPI) total and single-item scores at weeks 12 and 24/28. Results At weeks 12 and 24/28, ITT analysis demonstrated that memantine treatment produced statistically significant benefits over placebo treatment in NPI total score (p,=,0.001 and p,=,0.008), and in NPI single items: delusions (p,=,0.007,week 12, p,=,0.001,week 24/28), hallucinations (p,=,0.037,week 12), agitation/aggression (p,=,0.001,week 12, p,=,0.001,week 24/28), and irritability/lability (p,=,0.005,week 24/28), LOCF population. Analysis of the patients without symptoms at baseline indicated reduced emergence of agitation/aggression (p,=,0.002), delusions (p,=,0.047), and disinhibition (p,=,0.011), at week 12, and of agitation/aggression (p,=,0.002), irritability/lability (p,=,0.004), and night-time behaviour (p,=,0.050) at week 24/28 in those receiving memantine. OC analyses yielded similar results. Conclusions The data suggest that memantine is effective in treating and preventing the behavioural symptoms of moderate to severe AD. Specific persistent benefits were observed on the symptoms of delusions and agitation/aggression, which are known to be associated with rapid disease progression, increased caregiver burden, early institutionalisation, and increased costs of care. Copyright © 2007 John Wiley & Sons, Ltd. [source] Clinical trial: effects of botulinum toxin on levator ani syndrome , a double-blind, placebo-controlled studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009S. S. C. RAO Summary Background, Levator ani syndrome is characterized by anorectal discomfort/pain, treatment of which is unsatisfactory. We hypothesized that Botulinum toxin relieves spasm and improves symptoms. Aim, To perform a randomized, placebo-controlled, crossover study to examine the efficacy and safety of botulinum toxin in patients with levator ani syndrome. Methods, Twelve patients with levator ani syndrome (,1 year) received anal intra sphincteric injections of 100 units of botulinum toxin A and placebo at 90-day intervals using EMG guidance. Daily frequency, severity, duration and intensity of pain (VAS) were recorded. Anorectal manometry, balloon expulsion and pudendal nerve latency tests were performed to examine the physiological changes and adverse effects. Results, Seven patients (male/female = 4/3) completed the study and three had incomplete data, but all 10 underwent in an ITT analysis; two others dropped out. After administration of botulinum toxin, the mean frequency, intensity and duration of pain were unchanged (P = 0.31) compared with baseline. The 90-day mean VAS pain score was 6.79 ± 0.27 vs. baseline score of 7.08 ± 0.29 (P = 0.25). Anal sphincter pressures, rectal sensory thresholds, pudendal nerve latency and balloon expulsion times were unchanged after drug or placebo administration. Conclusions, Injection of botulinum toxin into anal sphincter is safe, but it does not improve anorectal pain in levator ani syndrome. [source] Cure of Helicobacter pylori infection in elderly patients: comparison of low versus high doses of clarithromycin in combination with amoxicillin and pantoprazoleALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2001A. Pilotto Background: Advancing age may influence clarithromycin's pharmacokinetics. No studies have yet compared the effects of different dosages of clarithromycin in combination with a proton pump inhibitor and amoxicillin in elderly patients. Aim: To compare the efficacy and tolerability of clarithromycin 250 mg vs. clarithromycin 500 mg twice daily (b.d.) in combination with pantoprazole and amoxicillin in elderly patients. Methods: One hundred and fifty-four elderly patients with H. pylori -associated ulcer disease or chronic gastritis were consecutively randomized to receive pantoprazole 40 mg daily plus amoxicillin 1 g, and either clarithromycin 250 mg b.d. (PAC 250) or clarithromycin 500 mg b.d. (PAC 500). Two months after therapy, endoscopy and gastric biopsies were repeated. Results: The cure rates of H. pylori infection in the PAC 250 and PAC 500 groups were, respectively, 83% and 79% (ITT analysis) and 94% and 88% (PP analysis) (P=N.S.). Significant decreases in chronic gastritis activity both in the body (P < 0.00001) and the antrum (P < 0.0001) of the stomach were found in H. pylori -cured patients, independently of clarithromycin dosage. Four patients in PAC 250 (5%) and seven in PAC 500 (9%) reported adverse events (P=N.S.). One patient in PAC 250 (25%) and three in PAC 500 (43%) discontinued the study because of these drug-related side-effects (P=N.S.). Conclusions: In elderly patients, 1-week triple therapy with a proton pump inhibitor, amoxicillin and clarithromycin is a highly effective and well tolerated anti- H. pylori treatment. With this combination, clarithromycin at the lower dose of 250 mg b.d. achieved excel- lent cure rates and minimized adverse events and costs. [source] Is a percentage a percentage?THE CLINICAL RESPIRATORY JOURNAL, Issue 1 2010Systematic review of the effectiveness of Scandinavian behavioural modification smoking cessation programmes Abstract Introduction:, Tobacco smoke is the leading preventable cause of death in the world. A total of 50% of all smokers will die from a smoking-related disease with a major impact upon quality of life and health-care costs. Tobacco-controlling policies, including smoking cessation, have increasingly been implemented across European countries. Reported effectiveness data on smoking cessation interventions are important for decision making. Objective:, This study aimed to conduct a literature review on how the effectiveness (quit rates) of behavioural modification smoking cessation programmes (BMSCPs) , counselling, quitlines and quit-and-win contests , were analysed in Denmark, Sweden and Norway. Methods:, A systematic review was carried out by using the search engines Medline (U.S. National Library of Medicine, Bethesda, MD, USA), Cinahl (CINAHL Information Systems, EBSCO Industries, Ipswich, MA, USA), Embase (Elsevier, New York, NY, USA) and the grey literature. Following the Russell Standards, studies were selected according to design, analysis of data [intention-to-treat (ITT)/per protocol (PP)], documentation of abstinence and length of follow-up. Cochrane reviews of pharmacological studies were used as the benchmark. Results:, Although ITT analysis is the standard scientific approach advocated, most studies of BMSCPs reviewed were analysed by using the PP approach and were based on self-reported point prevalence estimates. This resulted in the reported 1-year quit rates between 16%,45% (PP) and 9%,23% (ITT). In contrast, pharmacological studies are conservative, as they are randomised, use ITT analysis and have continuous quit rates with biochemical verification of abstinence. Conclusion:, This literature review reveals that quit rates of smoking cessation interventions are not always comparable. Scandinavian BMSCPs reported optimistic quit rates, confirmed by Cochrane literature review criteria. Care should be exercised when comparing smoking cessation interventions. Please cite this paper as: Poulsen PB, Dollerup J and Møller AM. Is a percentage a percentage? Systematic review of the effectiveness of Scandinavian behavioural modification smoking cessation programmes. The Clinical Respiratory Journal 2009; DOI:10.1111/j.1752-699X.2009.00144.x. [source] Golimumab, a human anti,tumor necrosis factor , monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: Twenty-four,week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis,ARTHRITIS & RHEUMATISM, Issue 8 2009Paul Emery Objective To assess the safety and efficacy of golimumab in methotrexate (MTX),naive patients with active rheumatoid arthritis (RA). Methods MTX-naive patients with RA (n = 637) were randomized to receive placebo plus MTX (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus MTX (group 3), or golimumab 100 mg plus MTX (group 4). Subcutaneous injections of golimumab or placebo were administered every 4 weeks. The dosage of MTX/placebo capsules started at 10 mg/week and escalated to 20 mg/week. The primary end point, the proportion of patients meeting the American College of Rheumatology 50% improvement criteria (achieving an ACR50 response) at week 24, required significant differences between groups 3 and 4 combined (combined group) versus group 1 and significant differences in a pairwise comparison (group 3 or group 4 versus group 1). Results An intent-to-treat (ITT) analysis of the ACR50 response at week 24 did not show a significant difference between the combined group and group 1 (38.4% and 29.4%, respectively; P = 0.053), while a post hoc modified ITT analysis (excluding 3 untreated patients) of the ACR50 response showed statistically significant differences between the combined group and group 1 (38.5% versus 29.4%; P = 0.049) and between group 3 (40.5%; P = 0.038) but not group 4 (36.5%; P = 0.177) and group 1. Group 2 was noninferior to group 1 for the ACR50 response at week 24 (33.1%; 95% confidence interval lower bound ,5.2%; predefined delta value for noninferiority ,10%). The combination of golimumab plus MTX demonstrated a significantly better response compared with placebo plus MTX in most other efficacy parameters, including response/remission according to the Disease Activity Score in 28 joints. Serious adverse events occurred in 7%, 3%, 6%, and 6% of patients in groups 1, 2, 3, and 4, respectively. Conclusion Although the primary end point was not met, the modified ITT analysis of the primary end point and other prespecified efficacy measures demonstrated that the efficacy of golimumab plus MTX is better than, and the efficacy of golimumab alone is similar to, the efficacy of MTX alone in reducing RA signs and symptoms in MTX-naive patients, with no unexpected safety concerns. [source] Probiotics in pregnant women to prevent allergic disease: a randomized, double-blind trialBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2010C.K. Dotterud Summary Background, Previous reports have suggested that certain probiotics given to mothers and children at risk of atopy halves the incidence of atopic dermatitis (AD) at 2 years of age. Objectives, To examine if probiotics given to pregnant women in a nonselected population could prevent atopic sensitization or allergic diseases during the child's first 2 years. Methods, In a randomized, double-blind trial of children from a nonselected maternal population (ClinicalTrials.gov identifier: NCT00159523), women received probiotic milk or placebo from 36 weeks of gestation to 3 months postnatally during breastfeeding. The probiotic milk contained Lactobacillus rhamnosus GG, L. acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12. Children with an itchy rash for more than 4 weeks were assessed for AD. At 2 years of age, all children were assessed for atopic sensitization, AD, asthma and allergic rhinoconjunctivitis. The intention-to-treat (ITT) analysis was enabled by multiple imputations. Results, Four hundred and fifteen pregnant women were computer randomized. At 2 years, 138 and 140 children in the probiotic and the placebo groups, respectively, were assessed. In the ITT analysis, the odds ratio (OR) for the cumulative incidence of AD was 0·51 in the probiotic group compared with the placebo [95% confidence interval (CI) 0·30,0·87; P = 0·013]. There were no significant effects on asthma (OR 0·68, 95% CI 0·26,1·80; P = 0·437) or atopic sensitization (OR 1·52, 95% CI 0·74,3·14; P = 0·254). Conclusions, Probiotics given to nonselected mothers reduced the cumulative incidence of AD, but had no effect on atopic sensitization. [source] | ||||||||||