Meta-analysis: In a meta-analysis of 5 landmark studies (ACCORD, FIELD, BIP, VA-HIT
and HHS) involving 4726 patients, fibrates have been found to reduced CV events significantly by 35% in patients with high TG [greater than or equal to] 204 mg/dL and low HDL [less than or equal to] 34 mg/dL (atherogenic dyslipidaemia).
In the VA-HIT
trial (55), NMR-measured concentrations of total and small HDL particles were independent predictors of recurrent cardiovascular disease.
Rubins HB, Robins SJ, Collins D, et al, for the VA-HIT
Study Group: Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol.
Certain statements in this press release, including statements relating to Niaspan, the results of the COMPELL study and other studies, including but not limited to the HATS, VA-HIT
, ARBITER 2 and ARBITER 3 studies, the growing emphasis on the treatment of HDL cholesterol, the potential increase in market growth for cholesterol combination therapies, the growth prospects of the markets in which the Company's products compete, the Company's strong and growing research and development pipeline and future sales growth are forward-looking and are subject to risks and uncertainties which may cause actual results to differ materially from those projected in a forward-looking statement.
, the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial: >2500 men with established CHD and low HDL (of which a quarter had diabetes) were randomized to gemfibrozil 600 mg twice daily or placebo and followed for approximately 5 years.