Lipids in Diabetes Study
OVERVIEW
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and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical sites before cerivastatin was withdrawn.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.
The LDS Study Ends
The Lipids in Diabetes Study (LDS) ended prematurely when Bayer unexpectedly withdrew their cholesterol lowering drug, cerivastatin, in August 2001.
LDS Close out
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. A revised approach with no placebo group, which compared a different statin with micronised fenofibrate and also with a combination of both agents, received world-wide approval. Although alternative pharmaceutical funding was agreed in principle for the amended design, a sudden reversal by the company involved has meant that the LDS has now had to be closed out permanently.