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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.