Findings of the naftidrofuryl in quality of life (NIQOL) european study program

Background. We report in this paper the findings of a pooled analysis of 3 previously published studies undertaken in Germany, France and Belgium to assess the effects of naftidrofuryl on the quality of life of patients with intermittent claudication. Methods, A total of 754 patients were randomised in the 3 studies, 709 of whom (358 naftidrofuryl, 351 placebo) were available for the primary intention-to-treat analysis. The primary outcome variable was the change in the disease-related limitation of the quality of life as measured by the CLAU-S questionnaire. This instrument which has been validated in an international study, comprises 47 questions covering 5 dimensions: ''daily living'', ing'', ''pain'', ''social life'', ''disease specific anxiety''and ''mood''. Results. A multivariate analysis of covariance adjusted for baseline values, study effect and first order study treatment interaction, demonstrated the global superiority of naftidrofuryl over placebo (p<0.001). A separate covariance analysis for the 5 dimensions showed highly significant differences for ''daily living'', ''pain'', ''social life'' and ''mood'' (all p<0.01). Conclusions. In conclusion, this pooled analysis has shown that naftidrofuryl can significantly improve the quality of life of patients with intermittent claudication. These findings, taken together with evidence from previous studies that it improves treadmill walking distances, suggest that naftidrofuryl can play a useful role in the treatment of this condition

First results on the Effects of metformin on endothelial function and inflammatory activity in type 2 diabetes mellitus: the HOME study, a randomized placebo-controlled trial

From the Study HOME, the first results on the Effects of metformin on endothelial function and inflammatory activity in type 2 diabetes mellitus: the HOME study is a randomized placebo-controlled trial. Abstract 1, Klinische Endocrinologiedagen, Doorwerth, February 2004

Effects of short-term treatment with metformin on markers of endothelial function and inflammatory activity in type 2 diabetes mellitus: a randomized placebo-controlled trial

The Effects of short-term treatment with metformin on markers of endothelial function and inflammatory activity in type 2 diabetes mellitus were studied in a randomized placebo-controlled trial

Naftidrofuryl for Intermittent Claudication, a Meta Analysis

Objectives: Assessing the efficacy of a pharmaceutical agent throughout an Individual Patient Data Meta-analysis IPD-MA. Of 7 available studies, 6 were considered as acceptable, for a total of 1266 randomized patients. We were able to match all the Previous results of original publications. The geometric mean ratio of CD improvement naftidrofuryl/placebo was 1.41 (95%CI 1.32-1.51, p<0.001), and the Number Needed to Treat 5, with results robust to sensitivity analysis. The difficulties and potential of bias of performing IPD in the pharmaceutical sector will be discussed. The implications of the evidence that naftidrofuryl has a clinically meaningful effect in improvement of claudication distance will be discussed in the light of subjective outcomes and hard endpoints.L'objectif de cette étude est la mise den évidence de l'efficacité du naftidrofuryl dans l'augmentation du perimetre de marche. Dans ce but, une meta-analyse de 6 essais a été réalisées à parti des données patients (IPD). La ratio des moyennes géometriques fut de 1.41 (95%CI 1.32-1.51, p<0.001), and le nombre nécessaire à traiter de 5. Ces résultats confirment l'eficacité du traitement étudié dans cette pathologie

The Efficacy of Acamprosate in Enhancing Abstinence in Alcohol Dependence: A Meta-Analysis Evaluating Continuous and Controlled Abstinence, Women and Alcoholism: An Individual Patient Data (IPD) Meta-Analysis of Outcome Predictors Based on 935 Female Pati

Acamprosate is an FDA-approved medication that enhances abstinence in alcohol-dependent patients. A meta-analysis was carried out to compare acamprosate with placebo on TA and CA. 21 randomized, placebo-controlled trials (RCTs) that fulfilled predetermined selection criteria were identified. Primary outcome measures were percent days of TA (defined as zero drinks during the treatment interval) and CA (defined as <5 standard drinks/day during the treatment interval). TA and CA rates were also significantly higher with patients treated with acamprosate vs. placebo (40.5% vs. 27.2%; RR, 0.653; 95% CI, .569-.749; P<.001) with an NNT=6.8. Acamprosate can provide a significant benefit by reducing alcohol consumption during relapse.Acamprosate est un médicament approuvé par la FDA qui augmente l'abstinence pour les patients alcool-dépendants. Les mesures primaires de résultats étaient des jours de pour cent du TA (défini en tant que abstinence totale pendant l'intervalle de traitement) et du CA (Abstinence contrôlée donc moins de 5 drinks/jour).Une méta-analyse a été effectuée pour comparer l'acamprosate au placebo sur le TA et le CA. 21 ont randomisé, les épreuves placebo-commandées (RCTs) qui ont accompli des critères prédéterminés de choix ont été identifiées. TA and CA rates sont superieurs pour les patients sous acamprosate(40.5% vs. 27.2%; RR, 0.653; 95% CI, .569-.749; P<.001) with an NNT=6.8. Acamprosate fournit un effet significatif de reduction de consommation alcoolique

New results in the study of Effects of short-term treatment with metformin on markers of endothelial function and inflammatory activity in type 2 diabetes mellitus: a randomized placebo-controlled trial

The Effects of short-term treatment with metformin on markers of endothelial function and inflammatory activity in type 2 diabetes mellitus were studied in a randomized placebo-controlled trial