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PubMed · 11635732

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C Koninckx. [Not Available].. https://pubmed.ncbi.nlm.nih.gov/11635732/

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A randomized, double-blind study of gemfibrozil for the treatment of protease inhibitor-associated hypertriglyceridaemia.

BACKGROUND: Hypertriglyceridaemia is common in patients with HIV, especially those taking protease inhibitors or with lipodystrophy, frequently observed at levels associated with accelerated cardiac disease. This study aimed to explore the efficacy and safety of gemfibrozil for hypertriglyceridemia in patients with HIV infection. METHODS: A 16-week, randomized, double-blind, comparative study of low saturated fat diet versus low saturated fat diet with gemfibrozil 600 mg twice daily in patients with triglycerides > or = 3mmol/l receiving protease inhibitor therapy. Following a 4-week period of dietary intervention alone, patients were randomized to gemfibrozil or matching placebo. The primary outcome was the difference in mean change in fasting triglycerides at week 16 between the two groups. RESULTS: 37 men were randomized (17 gemfibrozil, 20 placebo) with median fasting triglycerides 5.6 mmol/l. Mean changes in triglycerides from week 4 to week 16 were -1.22 mmol/l and +0.35 mmol/l for the gemfibrozil and placebo groups respectively (between-group mean difference of 1.57 mmol/l; 95% confidence interval, -6.7 to 3.5; = 0.08). Only one patient treated had triglycerides return to a desirable range (< or = 2.00 mmol/l). No significant changes in the other metabolic parameters were observed. Gemfibrozil was well tolerated, did not appear to induce additional protease inhibitor toxicity, and did not induce changes in CD4 lymphocyte counts or HIV RNA load. CONCLUSIONS: Gemfibrozil is safe and demonstrated at most, modest efficacy for hypertriglyceridemia in HIV-infected patients receiving protease inhibitors. Given the level of response, however, it is unclear whether these reductions will confer clinical benefit, at least in the presence of continued protease inhibitor use.

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Prevalence and determinants of hormone replacement therapy in German women 1984-1995.

OBJECTIVES: To describe trends in prevalence and determinants of hormone replacement therapy (HRT) in German women. METHODS: Three representative samples of women in Augsburg, Germany were examined in the MONICA surveys in 1984/85 (45-64 years; N=1013), 1989/90 and 1994/95 (both 45-74 years; N=1496 and 1475) by interview and anthropometry, and all drugs taken during the previous week were documented. The prevalence of HRT use was calculated by survey, age group and HRT type, and various characteristics were evaluated as determinants for any systemic HRT use by logistic regression. RESULTS: The prevalence of HRT use in women aged 45-64 years in 1984/85, 1989/90 and 1994/95 was 3, 9% (age 45-74, 6%) and 23% (17%), respectively. In 1994/1995, positive determinants of HRT use were daily consumption of salad and vegetables, having quit smoking (vs. current smoking), regular exercise, ever having taken oral contraceptives, body mass index <25 kg/m(2) and age, and negative determinants were not drinking alcohol and education for <9 years (all P-value <0.10 in multivariate model). After multiple adjustment, HRT users were five times more likely to have participated in cancer screening and to have visited a gynaecologist >or=5 times during the previous year, and were less likely not to have seen a general practitioner or gynaecologist (all P-values <0.001). CONCLUSION: HRT use increased substantially in Germany between 1984 and 1995. Women with characteristics associated with lower morbidity and mortality were more likely to use HRT, which agrees with the healthy-user phenomenon described in other countries.

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