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Major Study Shows That Lescol(R) XL, A Statin From Novartis, Improves Post-operative Cardiac Outcomes In Patients Undergoing Vascular Surgery

July 03, 2017

Patients undergoing vascular surgery treated perioperatively with Lescol® XL (fluvastatin sodium extended-release tablets) showed a significant improvement in postoperative cardiac outcome within 30 days of having the procedure compared with placebo, according to results of the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) III study published today in the New England Journal of Medicine1.

The study from the Erasmus Medical Center, Rotterdam, the Netherlands, also showed that Lescol XL treatment was associated with significant decreases in total cholesterol, low-density lipoprotein cholesterol (LDL-C), and inflammatory activity reflected by a reduction in high-sensitivity C-reactive protein and interleukin-6 levels1.

"Perioperative cardiac events are the major cause of adverse outcome in high-risk vascular surgery patients, and we need to make greater efforts to reduce them," commented Professor Don Poldermans, Erasmus Medical Centre, Rotterdam, the Netherlands, who conducted the study.

"This study is the first to conclusively demonstrate that a statin, extended-release fluvastatin, improves postoperative cardiac outcome in patients undergoing vascular surgery. Indeed, DECREASE III is the cornerstone study supporting the Class I recommendation in the new European Society of Cardiology (ESC) 'Guidelines for preoperative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery,' to initiate and perioperatively treat high-risk surgery patients with a statin2," he said.

Professor Poldermans also commented, "The improved cardiac outcome shown with extended-release fluvastatin in the DECREASE III study could be at least partly explained by non-lipid or pleiotropic and anti-inflammatory statin effects which may prevent plaque rupture and subsequent myocardial infarction in the perioperative period2,3."

DECREASE III, the largest randomized, double-blind, placebo-controlled statin study in high-risk patients undergoing vascular surgery to date, involved 497 patients scheduled for elective non-cardiac vascular surgery, which included abdominal aortic aneurysm repair, distal aortoiliac reconstruction, lower-limb arterial reconstruction, or carotid-artery endarterectomy. The patients, who had not previously been treated with a statin were randomized to receive, in addition to a beta-blocker, either Lescol XL (80 mg daily) (n=250) or placebo (n=247). Treatment was started at a median of 37 days prior to the surgical procedure, and continued for 30 days after surgery. 27 (10.8%) patients treated with Lescol XL developed myocardial ischaemia within 30 days of the initial surgical procedure, compared with 47 (19.0%) patients given placebo: a risk reduction of 45% with Lescol XL (p=0.01). Furthermore, 12 (4.8%) patients treated with Lescol XL died from cardiovascular causes or suffered a non-fatal myocardial infarction over the same time period, compared with 25 (10.1%) patients given placebo: a risk reduction of 53% with Lescol XL (p=0.03). There was no significant difference in adverse events between Lescol XL and placebo1.

Annually, approximately seven million adults undergo major non-cardiac surgery in Europe. It is estimated that of these patients about 150,000 to 250,000 (2.0 to 3.5%) will suffer a major cardiac complication2. In patients undergoing major non-cardiac vascular surgery the risk of perioperative cardiac complications is particularly high, with rates of perioperative myocardial infarction or cardiac death exceeding five percent2.

References

1. Schouten O, Boersma E, Hoeks SE, Benner R, van Urk H, van Sambeek MRHM, Verhagen HJM, Khan NA, Dunkelgrun M, Bax JJ, and Poldermans D, for the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. Fluvastatin and Perioperative Events in Patients Undergoing Vascular Surgery. N Engl J Med 2009;361:980-9.

2. Poldermans D, Bax JJ, Boersma E, De Hert S, Eeckhout E, Fowkes G, Gorenek B, Hennerici MG, Iung B, Kelm M, Kjeldsen K, Kristensen SD, Lopez-Sendon J, Pelosi P, Philippe F, Pierard L, Ponikowski P, Schmid JP, Sellevold OF, Sicari R, Van den Berghe G, Vermassen F. Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery; the Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Non-cardiac Surgery of the European Society of Cardiology (ESC) and endorsed by the European Society of Anaesthesiology (ESA). Eur Heart J. 2009; epub: doi:10.1093/eurheartj/ehp337.
escardio/guidelines-surveys/esc-guidelines/GuidelinesDocuments/guidelines-perioperative-cardiac-care-FT.pdf

3. Rosenson RS, Tangney CC. Antiatherothrombotic properties of statins: implications for cardiovascular event reduction. JAMA. 1998;279(20):1643-50.

Source
Novartis

View drug information on Lescol XL.