The Novartis Pharmaceutical Corporation investigational compound Lescol® XL (fluvastatin sodium extended release tablets) shows significant reductions in LDL-C and excellent increases in HDL-C, according to study results presented today at the 12th International Symposium on Atherosclerosis in Stockholm. The Phase III study data demonstrated a median decrease of 38 percent in LDL-C (low density lipoprotein cholesterol) and a mean increase of up to 18.7 percent in HDL-C (high density lipoprotein cholesterol) with Lescol® XL in patients with dyslipidemia. These results mean that Lescol® XL effectively manages dyslipidemia since a previous meta analysis showed that a mean LDL-C reduction of 30 percent or less is sufficient to bring more than 90 percent patients to the treatment goal.
Almost 70 percent of coronary heart disease patients have low HDL-C. These patients carry an increased risk of cardiovascular events of almost 40 percent. Hence the increase of up to 18.7 percent in HDL-C yielded by Lescol® XL is clinically meaningful.
The data confirmed that Lescol® XL 80 mg provides significantly improved efficacy with a similar safety profile when compared to Lescol® (fluvastatin sodium) 40 mg. In phase II and III trials in a total of 900 patients treated with Lescol® XL, no cases of myopathy and rhabdomyolysis have been reported to date.
To learn more about Lescol® XL, contact Anna Frable, 973-781-5388, anna.frable@pharma.novartis.com of Novartis or Stacey Collins, 212-601-8360, scollins@pharma.novartis.com of Porter Novelli.