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- Mann, D. L., et al.
(författare)
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Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL)
- 2004
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Ingår i: Circulation. - 1524-4539. ; 109:13, s. 1594-602
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Studies in experimental models and preliminary clinical experience suggested a possible therapeutic role for the soluble tumor necrosis factor antagonist etanercept in heart failure. METHODS AND RESULTS: Patients with New York Heart Association class II to IV chronic heart failure and a left ventricular ejection fraction < or =0.30 were enrolled in 2 clinical trials that differed only in the doses of etanercept used. In RECOVER, patients received placebo (n=373) or subcutaneous etanercept in doses of 25 mg every week (n=375) or 25 mg twice per week (n=375). In RENAISSANCE, patients received placebo (n=309), etanercept 25 mg twice per week (n=308), or etanercept 25 mg 3 times per week (n=308). The primary end point of each individual trial was clinical status at 24 weeks. Analysis of the effect of the 2 higher doses of etanercept on the combined outcome of death or hospitalization due to chronic heart failure from the 2 studies was also planned (RENEWAL). On the basis of prespecified stopping rules, both trials were terminated prematurely owing to lack of benefit. Etanercept had no effect on clinical status in RENAISSANCE (P=0.17) or RECOVER (P=0.34) and had no effect on the death or chronic heart failure hospitalization end point in RENEWAL (etanercept to placebo relative risk=1.1, 95% CI 0.91 to 1.33, P=0.33). CONCLUSIONS: The results of RENEWAL rule out a clinically relevant benefit of etanercept on the rate of death or hospitalization due to chronic heart failure.
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- Wolever, T M S, et al.
(författare)
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Determination of the glycaemic index of foods: interlaboratory study.
- 2003
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Ingår i: European Journal of Clinical Nutrition. - : Springer Science and Business Media LLC. - 1476-5640 .- 0954-3007. ; 57:3, s. 475-482
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Practical use of the glycaemic index (GI), as recommended by the FAO/WHO, requires an evaluation of the recommended method. Our purpose was to determine the magnitude and sources of variation of the GI values obtained by experienced investigators in different international centres. Design: GI values of four centrally provided foods (instant potato, rice, spaghetti and barley) and locally obtained white bread were determined in 8-12 subjects in each of seven centres using the method recommended by FAO/WHO. Data analysis was performed centrally. Setting: University departments of nutrition. Healthy subjects (28 male, 40 female) were studied. Results: The GI values of the five foods did not vary significantly in different centres nor was there a significant centre´food interaction. Within-subject variation from two centres using venous blood was twice that from five centres using capillary blood. The s.d. of centre mean GI values was reduced from 10.6 (range 6.8-12.8) to 9.0 (range 4.8-12.6) by excluding venous blood data. GI values were not significantly related to differences in method of glucose measurement or subject characteristics (age, sex, BMI, ethnicity or absolute glycaemic response). GI values for locally obtained bread were no more variable than those for centrally provided foods. Conclusions: The GI values of foods are more precisely determined using capillary than venous blood sampling, with mean between-laboratory s.d. of approximately 9.0. Finding ways to reduce within-subject variation of glycaemic responses may be the most effective strategy to improve the precision of measurement of GI values.
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