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Treatment Comparisons (treatment + comparison)

Distribution by Scientific Domains

Medical Sciences	60%

Selected Abstracts

Establishing the dose of the oral NK1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting

CANCER, Issue 9 2003
Sant P. Chawla M.D.
Abstract BACKGROUND The neurokinin-1 antagonist aprepitant (EMENDÔ; Merck Research Laboratories, West Point, PA) has been shown to reduce chemotherapy-induced nausea and vomiting when it is given with a 5-hydroxytryptamine-3 receptor antagonist and dexamethasone. The current study sought to define the most appropriate dose regimen of oral aprepitant. METHODS This multicenter, randomized, double-blind, placebo-controlled study was conducted in patients with cancer who were receiving initial cisplatin (, 70mg/m2) and standard antiemetic therapy (intravenous ondansetron plus oral dexamethasone). Patients were randomized to receive standard therapy plus either aprepitant 375 mg on Day 1 and 250 mg on Days 2,5, aprepitant 125 mg on Day 1 and 80 mg on Days 2,5, or placebo. Due to an apparent interaction with dexamethasone suggested by pharmacokinetic data obtained while the study was ongoing, the aprepitant 375/250 mg dose was discontinued and replaced with aprepitant 40 mg on Day 1 and 25 mg on Days 2,5, and a new randomization schedule was generated. Patients recorded nausea and emesis in a diary. The primary endpoint was complete response (no emesis and no rescue therapy), which was analyzed using an intent-to-treat approach with data obtained after the dose adjustment. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments, and included all available data. RESULTS The percentages of patients who achieved a complete response in the overall study period were 71.0% for the aprepitant 125/80-mg group (n = 131 patients), 58.8% for the aprepitant 40/25-mg group (n = 119 patients), and 43.7% for the standard therapy group (n = 126 patients; P < 0.05 for either aprepitant regimen vs. standard therapy). Rates for Day 1 were 83.2% for the aprepitant 125/80-mg group, 75.6% for aprepitant 40/25-mg group, and 71.4% for the standard therapy group (P < 0.05 for aprepitant 125/80 mg vs. standard therapy), and rates on Days 2,5 were 72.7% for the aprepitant 125/80-mg group, 63.9% for the aprepitant 40/25-mg group, and 45.2% for the standard therapy group (P < 0.01 for either aprepitant group vs. standard therapy). The efficacy of the aprepitant 375/250-mg regimen was similar to that of the aprepitant 125/80-mg regimen. The overall incidence of adverse events was generally similar across treatment groups: 85% in the aprepitant 375/250-mg group (n = 34 patients), 76% in the aprepitant 125/80-mg group (n = 214 patients), 71% in the aprepitant 40/25-mg group (n = 120 patients), and 72% in the standard therapy group (n = 212 patients), with the exception of a higher incidence of infection in the aprepitant 125/80-mg group (13%) compared with the standard therapy group (4%). CONCLUSIONS When it was added to a standard regimen of intravenous ondansetron and oral dexamethasone in the current study, aprepitant reduced chemotherapy-induced nausea and vomiting and was generally well tolerated, although increases in infection were noted that were assumed to be due to elevated dexamethasone levels as a result of the pharmacokinetic interaction. The aprepitant 125/80-mg regimen had the most favorable benefit:risk profile. Cancer 2003;97:2290,300. © 2003 American Cancer Society. DOI 10.1002/cncr.11320 [source]

Systematic review: standard- and double-dose proton pump inhibitors for the healing of severe erosive oesophagitis , a mixed treatment comparison of randomized controlled trials

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2009
S. J. EDWARDS
Summary Background, No randomized controlled trial (RCT) has compared all European-licensed standard- and double-dose PPIs for the healing of severe erosive oesophagitis. Aim, To compare the effectiveness of licensed doses of PPIs for healing severe erosive oesophagitis (i.e. esomeprazole 40 mg, lansoprazole 30 mg, omeprazole 20 mg and 40 mg, pantoprazole 40 mg and rabeprazole 20 mg). Methods, Systematic review of CENTRAL, EMBASE and MEDLINE for RCTs in patients with erosive oesophagitis (completed October 2008). Endoscopically verified healing rates at 4 and 8 weeks were extracted and re-calculated if not analysed by intention-to-treat. A mixed treatment comparison was used to combine direct treatment comparisons with indirect trial evidence while maintaining randomization. Odds ratios (OR) are reported compared to omeprazole 20 mg. Results, A total of 3021 papers were identified in the literature search; 12 were of sufficient quality to be included in the analysis. Insufficient data were available to included rabeprazole. Esomeprazole 40 mg was found to provide significantly higher healing rates at 4 weeks [OR 1.84, 95% Credible Interval (95% CrI): 1.50 to 2.22] and 8 weeks (OR 1.91, 95% CrI: 1.13 to 2.88). No other PPI investigated had significantly higher healing rates than omeprazole 20 mg. Conclusion, Esomeprazole 40 mg consistently demonstrates higher healing rates compared with licensed standard- and double-dose PPIs. [source]

An evaluation of emerging preference for non-preferred foods targeted in the treatment of food selectivity

BEHAVIORAL INTERVENTIONS, Issue 3 2010
Becky Penrod
Several studies have shown that the acquisition of food consumption does not occur until after escape prevention is implemented. However, the mechanism responsible for the maintenance of food consumption may be due to participants contacting the reinforcing properties of food targeted during intervention such that the food naturally reinforces food consumption. The present study extended the literature on feeding disorders by conducting pre- and post-treatment preference assessments to determine if preference for non-preferred foods (NPFs) had developed after exposure to a treatment comparison of sequential and simultaneous food presentation; presentation methods were implemented alone and combined with escape prevention in the form of a non-removal of the spoon (NRS) procedure. Results for three participants with food selectivity indicated that preference for NPFs developed after being exposed to those foods during either treatment sessions or generalization probes. Copyright © 2010 John Wiley & Sons, Ltd. [source]

A Geometric Approach to Comparing Treatments for Rapidly Fatal Diseases

BIOMETRICS, Issue 1 2006
Peter F. Thall
Summary In therapy of rapidly fatal diseases, early treatment efficacy often is characterized by an event, "response," which is observed relatively quickly. Since the risk of death decreases at the time of response, it is desirable not only to achieve a response, but to do so as rapidly as possible. We propose a Bayesian method for comparing treatments in this setting based on a competing risks model for response and death without response. Treatment effect is characterized by a two-dimensional parameter consisting of the probability of response within a specified time and the mean time to response. Several target parameter pairs are elicited from the physician so that, for a reference covariate vector, all elicited pairs embody the same improvement in treatment efficacy compared to a fixed standard. A curve is fit to the elicited pairs and used to determine a two-dimensional parameter set in which a new treatment is considered superior to the standard. Posterior probabilities of this set are used to construct rules for the treatment comparison and safety monitoring. The method is illustrated by a randomized trial comparing two cord blood transplantation methods. [source]

Systematic review: standard- and double-dose proton pump inhibitors for the healing of severe erosive oesophagitis , a mixed treatment comparison of randomized controlled trials

A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14,237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2008
Alexander Cobitz MD
Abstract Purpose Retrospectively investigate potential associations between rosiglitazone and congestive heart failure (CHF) and, separately, events of myocardial ischemia. Methods Data from 14,237 individuals in 42 short-term, double-blind, randomized studies of rosiglitazone versus placebo or active diabetes medications were analyzed across seven treatment comparisons using an exact logistic regression model, adjusted for number of major cardiovascular risk factors and duration of exposure. Results CHF incidence ranged 0,1.27% (SAEs) and 0.12,2.42% (all AEs) with rosiglitazone versus 0.07,0.75% (SAEs) and 0.25,1.36% (all AEs) with control. Higher odds ratios (95%CI) were observed for CHF SAEs with sulfonylurea- and insulin-containing combinations: rosiglitazone monotherapy versus placebo, 0.25 (<0.01,4.75); rosiglitazone monotherapy versus sulfonylurea/metformin monotherapy, 0.23 (<0.01,2.14); sulfonylurea,+,rosiglitazone versus sulfonylurea monotherapy, 0.95 (0.01,75.20); metformin,+,rosiglitazone versus metformin monotherapy, 0.60 (0.00,8.28); metformin,+,rosiglitazone versus metformin,+,sulfonylurea, 1.04 (0.39,2.86); sulfonylurea,+,metformin,+,rosiglitazone versus sulfonylurea,+,metformin, 3.15 (0.35,150.52); insulin,+,rosiglitazone versus insulin monotherapy, 1.63 (0.52,6.01). Myocardial ischemia incidence ranged 0.75,1.40% (SAEs) and 1.49,2.77% (all AEs) with rosiglitazone versus 0.21,2.04% (SAEs) and 0.56,2.38% (all AEs) with control. Each comparison had an OR >1, with wide confidence intervals generally including unity. With data pooling, more events of myocardial ischemia were observed with rosiglitazone (2.00%) versus control (1.53%) (HR 1.30, 95%CI 1.004,1.69). Conclusions CHF incidence may be greater when rosiglitazone is combined with sulfonylureas or insulin. When data were pooled, more events of myocardial ischemia were observed with rosiglitazone versus control. Final results from RECORD will allow a more rigorous evaluation of the cardiovascular safety profile. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Boost of mucosal secretory immunoglobulin A response by clarithromycin in paediatric influenza

RESPIROLOGY, Issue 8 2009
Takako SAWABUCHI
ABSTRACT Background and objective: The antiviral neuraminidase inhibitor oseltamivir (OSV) is used to treat influenza. The macrolide clarithromycin (CAM) is used to treat bacterial infections and has anti-inflammatory and immunomodulatory activities. This retrospective study investigated the immunomodulatory effects of CAM in children presenting with influenza A. Methods: The study recruited 40 children with acute influenza, and grouped them according to the treatment received: 5-day treatment with OSV (n = 14), CAM (n = 8), OSV + CAM (n = 12) and untreated (n = 6). The before and after treatment comparisons were made of the level of secretory IgA (sIgA) against influenza A virus (H3N2) and (H1N1), total sIgA, viral RNA copy numbers in nasopharyngeal aspirates and disease symptoms. Results: Infection induced anti-viral mucosal sIgA in the nasopharyngeal aspirates of most patients of all treatment groups. Particularly prominent increases in the levels were found in the CAM and OSV + CAM groups. Low induction of anti-viral sIgA was observed in the OSV group, but the addition of CAM to OSV augmented sIgA production and restored local mucosal sIgA levels. The frequency of residual cough in the OSV + CAM group was significantly lower than in the other groups including the group treated with OSV. Conclusions: CAM boosted the nasopharyngeal mucosal immune response in children presenting with influenza A, even in those treated with OSV who had low production of mucosal anti-viral sIgA, and alleviated the symptoms of influenza. [source]

Construction of Resolvable Spatial Row,Column Designs

BIOMETRICS, Issue 1 2006
E. R. Williams
Summary Resolvable row,column designs are widely used in field trials to control variation and improve the precision of treatment comparisons. Further gains can often be made by using a spatial model or a combination of spatial and incomplete blocking components. Martin, Eccleston, and Gleeson (1993, Journal of Statistical Planning and Inference34, 433,450) presented some general principles for the construction of robust spatial block designs which were addressed by spatial designs based on the linear variance (LV) model. In this article we define the two-dimensional form of the LV model and investigate extensions of the Martin et al. principles for the construction of resolvable spatial row,column designs. The computer construction of efficient spatial designs is discussed and some comparisons made with designs constructed assuming an autoregressive variance structure. [source]

Principal Stratification in Causal Inference

BIOMETRICS, Issue 1 2002
Constantine E. Frangakis
Summary. Many scientific problems require that treatment comparisons be adjusted for posttreatment variables, but the estimands underlying standard methods are not causal effects. To address this deficiency, we propose a general framework for comparing treatments adjusting for posttreatment variables that yields principal effects based on principal stratification. Principal stratification with respect to a posttreatment variable is a cross-classification of subjects defined by the joint potential values of that posttreatment variable under each of the treatments being compared. Principal effects are causal effects within a principal stratum. The key property of principal strata is that they are not affected by treatment assignment and therefore can be used just as any pretreatment covariate, such as age category. As a result, the central property of our principal effects is that they are always causal effects and do not suffer from the complications of standard posttreatment-adjusted estimands. We discuss briefly that such principal causal effects are the link between three recent applications with adjustment for posttreatment variables: (i) treatment noncompliance, (ii) missing outcomes (dropout) following treatment noncompliance, and (iii) censoring by death. We then attack the problem of surrogate or biomarker endpoints, where we show, using principal causal effects, that all current definitions of surrogacy, even when perfectly true, do not generally have the desired interpretation as causal effects of treatment on outcome. We go on to formulate estimands based on principal stratification and principal causal effects and show their superiority. [source]