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- Fagerberg, Björn, 1943, et al.
(författare)
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Tesaglitazar, a novel dual peroxisome proliferator-activated receptor alpha/gamma agonist, dose-dependently improves the metabolic abnormalities associated with insulin resistance in a non-diabetic population
- 2005
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Ingår i: Diabetologia. - : Springer Science and Business Media LLC. - 0012-186X .- 1432-0428. ; 48:9, s. 1716-25
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Tidskriftsartikel (refereegranskat)abstract
- AIMS/HYPOTHESIS: Insulin resistance is associated with abnormalities in lipid and glucose metabolism, which are major components of metabolic syndrome and risk factors for vascular disease. This study examined the effect of tesaglitazar (Galida), a novel, dual-acting peroxisome proliferator-activated receptor alpha/gamma agonist, on lipid and glucose metabolism in patients with evidence of insulin resistance. METHODS: A 12-week, multicentre, randomised, double-blind, placebo-controlled, dose-finding study compared the efficacy and safety of oral tesaglitazar (0.1, 0.25, 0.5 and 1.0 mg/day) and placebo in 390 non-diabetic patients with hypertriglyceridaemia (plasma triglyceride concentration >1.7 mmol/l) and abdominal obesity (waist-to-hip ratio >0.90 for men and >0.85 for women). RESULTS: A 1.0-mg dose of tesaglitazar reduced fasting triglycerides (the primary endpoint) by 37% (95% CI: -43% to -30%; p<0.0001), non-HDL-cholesterol by 15% (95% CI: -20% to -10%; p<0.0001) and NEFA by 40% (95% CI: -51% to -27%; p<0.0001), and increased HDL-cholesterol by 16% (95% CI: 8 to -24%; p<0.0001). At the end of treatment there was a dose-dependent increase in patients with pattern A LDL particle diameter (40% at baseline vs 87% at 12 weeks for tesaglitazar 1.0 mg). Tesaglitazar produced significant reductions in fasting insulin concentration (-35%; p<0.0001) and plasma glucose concentration (-0.47 mmol/l; p<0.0001). Respiratory infection and gastrointestinal symptoms were the most common adverse events and were similarly frequent in all groups. CONCLUSIONS/INTERPRETATION: Tesaglitazar was well tolerated and produced significant, dose-dependent improvements in lipid and glucose metabolism and insulin sensitivity. Tesaglitazar may have the potential to prevent vascular complications and delay progression to diabetes in these patients.
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- Graff-Iversen, S., et al.
(författare)
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Hormone therapy and mortality during a 14-year follow-up of 14 324 Norwegian women
- 2004
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Ingår i: J Intern Med. - 0954-6820. ; 256:5, s. 437-45
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: We evaluated mortality from cardiovascular disease (CVD), coronary heart disease (CHD) and all causes in relation to use of any hormone therapy (HT) and HT with oestradiol and norethisterone or levonorgestrel. DESIGN: Population-based cohort study. SETTING AND SUBJECTS: Women in three Norwegian counties were invited to a health survey in 1985-88 and 82.8% participated. In all 14 324 post- or perimenopausal women aged 35-62 years, including 702 HT users with a mean age of 48.8 years, were followed for 14 years. RESULTS: Women using HT had mortality from all causes and CVD comparable with that of nonusers. The relative risk (RRs) for CVD mortality amongst all women were 0.69 (95% CI: 0.35-1.33) for users of HT, and 0.96 (95% CI: 0.43-2.17) for users of HT with norethisterone or levonorgestrel. Amongst women free of self-reported cardiovascular health problems at baseline all-cause, CVD and CHD mortality tended to be lower amongst users of HT whilst HT use was linked with increased mortality amongst women with cardiovascular health problems. CONCLUSIONS: In this cohort of women around the usual age of menopause all-cause or CVD mortality amongst users of HT, most often oestradiol combined with norethisterone or levonorgestrel, was not markedly different from that of nonusers. Early CHD events amongst HT users prior to the baseline survey, together with selective inclusion of healthy subjects, may in part explain protective effects of HT on CHD reported from previous observational studies.
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- Graff-Iversen, S., et al.
(författare)
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Use of oral contraceptives and mortality during 14 years' follow-up of Norwegian women
- 2006
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Ingår i: Scand J Public Health. - : SAGE Publications. - 1403-4948 .- 1651-1905. ; 34:1, s. 11-6
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: The aim was to evaluate total and cardiovascular disease (CVD) mortality in relation to use of oral contraceptives (OC) in a cohort of women with a relatively high prevalence of smoking and high serum lipid levels. METHODS: In all 29,053 women aged 20-49 years were invited to a health survey in 1985-88. Of the total 82% attended and 20,282 women free of known CVD were included in this analysis. The relative risk (RR) of mortality during 14 years of follow-up was compared between OC users and non-users by means of proportional hazards regression. RESULTS: About 50% of 827 OC users were daily cigarette smokers, and the mean total cholesterol level in the cohort was 5.9 mmol/l. There were 518 deaths, of which 10 occurred among the women taking OC at baseline. Of three deaths from CVD among OC users, two occurred in the first year of follow-up. Among non-smokers using OC three women died during the follow-up; none of the deaths was due to CVD. Women using OC of any type had no different adjusted total mortality (RR 0.87; 95% CI 0.46-1.65) or CVD mortality (RR 1.41; 95% CI 0.44-4.56) compared with non-users. CONCLUSIONS: The results were consistent with previous evidence which does not indicate that mortality from all causes or CVD is elevated in women using OC.
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- Ruifrok, Anneloes E, et al.
(författare)
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Study protocol : Differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes: Individual patient data (IPD) meta-analysis and health economic evaluation
- 2014
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Ingår i: Systematic Reviews. - : Springer Science and Business Media LLC. - 2046-4053. ; 3
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundPregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women.Methods/designRandomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage weight gain in pregnancy and undertake a value of information analysis to inform future research.
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