Principal investigator:Rury Holman
Sponsor:Bayer PLC (UK)
The Lipids in Diabetes Study (LDS) was a prospective, randomised, placebo-controlled, clinical outcome trial which commenced recruitment in April 1999. The principal objective of the trial was to determine whether lipid reduction with a statin (cerivastatin) or a fibrate (fenofibrate) could substantially reduce cardiovascular related morbidity and mortality in subjects with type 2 diabetes (non-insulin dependent diabetes).
4191 people with type 2 diabetes but not known coronary heart disease (CHD) and who were not thought to require lipid lowering therapy were randomised to lipid-lowering therapy with cerivastatin (Lipobay) and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical sites before cerivastatin was withdrawn. Secondary objectives were to assess the effects of the two study drugs on predefined major clinical events, progression of microalbuminuria, changes in digital electrocardiographic parameters and the lipid profile.
Following the withdrawal of cerivastatin by Bayer in August 2001, the Lipids in Diabetes Study (LDS) was put on hold and the 4191 randomised subjects asked to stop all study medication temporarily. In light of this, and the release of the Heart Protection Study (HPS) results, major efforts were made to restart the LDS using a modified design....[Read more...]