Statin Therapy Greatly Reduces Harmful Inflammation and Cholesterol

Newswise — Research conducted at the Methodist DeBakey Heart Center in Houston shows that a combination statin therapy already proven to lower bad cholesterol by a dramatic 70 percent, now has the added benefit of reducing life-threatening inflammation that can lead to heart disease.

The new results show 46 percent reduction in C-reactive protein (CRP), a marker for inflammation, in patients treated with 40 mg of rosuvastatin and 10 mg ezetimibe.

"Inflammation can lead to serious complications such as heart attack and stroke, and high levels of CRP can predict these risks years before they actually occur," said Dr. Christie Ballantyne, cardiologist at the Methodist DeBakey Heart Center and principle investigator for the study. "Physicians have long relied on blood cholesterol as a key indicator of cardiovascular risk, but recent research suggests that high risk patients who achieved a low CRP level combined with a low LDL-c level had the fewest cardiovascular events."

The study looked at data from 465 patients in five different countries. A combination treatment regimen of 40 mg of rosuvastatin (Crestor®) and 10 mg of ezetimibe (Zetia®) demonstrated a 46 percent reduction in levels of CRP in high-risk patients. In six weeks, the combination regimen also helped 58 percent of patients achieve dual goals1 of lowering CRP and LDL-c (bad cholesterol). These post-hoc analysis findings from the EXPLORER** study will be presented for the first time this week at the World Congress of Cardiology in Barcelona. Previous EXPLORER results released at ISA in June showed high-risk patients achieved an unprecedented 70 percent reduction in LDL-c using combination therapy.2 "The highly effective reductions in both LDL-c and CRP seen in the EXPLORER study provide a new opportunity for high-risk patients to achieve optimal reduction in both factors with combination therapy," Ballantyne said.

Key findings from EXPLORER: 1, 3? Significantly more patients (58% vs. 24%) achieved an LDL-C <100 mg/dL or <70 mg/dL (depending on risk category) and CRP <2 mg/L at six weeks with Crestor 40mg and Zetia 10mg compared with Crestor 40 mg monotherapy.

? Crestor and Zetia reduced CRP levels by 46% compared with 29% with Crestor monotherapy.

? Crestor and Zetia also reduced mean LDL-C by an unprecedented 70%.

? Significantly (p<0.001) more patients achieved their NCEP ATP III LDL-C goal of <100 mg/dL (94% vs 79%) at six weeks with Crestor and Zetia compared with Crestor monotherapy.

? Both CRESTOR monotherapy and CRESTOR combined with ezetimibe produced similar increases in HDL-C ("good" cholesterol) (8.5% vs. 10.8%).

? CRESTOR and ezetimibe were both well tolerated.

** EXPLORER (Examination of Potential Lipid modifying effects Of Rosuvastatin in combination with Ezetimibe versus Rosuvastatin alone) was a 12-week, randomized trial of 469 patients with LDL-C 160-<250 mg/dL (4.1-<6.5 mmol/L) designed to evaluate whether adding ezetimibe to CRESTOR would enable more patients with severely high cholesterol to achieve guideline lipid goals compared with CRESTOR monotherapy. Patients participated in a six-week dietary lead-in followed by six weeks of randomized treatment with rosuvastatin 40 mg alone or in combination with ezetimibe 10 mg.

About the Methodist DeBakey Heart CenterThe Methodist DeBakey Heart Center is a world-renowned organization that is continuing the ground-breaking work begun by famed heart care pioneer, Dr. Michael E. DeBakey, and his associates, who developed many of today's life-saving techniques, tools and procedures at The Methodist Hospital.

Located in Houston, the Methodist DeBakey Heart Center combines research, prevention, diagnostic care, surgery and rehabilitation services in a coordinated multi-disciplinary program with one focus: delivering compassionate, effective care and treatment to patients with heart disease. Patient care teams provide the full range of cardiac care, ensuring high-quality care and satisfaction to those served.Experience, combined with the latest advances in technology and research, allows patients to access the best possible care and treatment in a caring, spiritual environment.

References: 1. Ballantyne C, Sosef F, Duffield E. Rosuvastatin Plus Ezetimibe for Achievement of Low-Density Lipoprotein Cholesterol and C-Reactive Protein Goals: Results From the EXPLORER Study. Poster presented at: World Congress of Cardiology; 6 September, 2006; Barcelona, Spain. 2. Ballantyne C, Sosef F, Duffield E. Efficacy and Safety of Rosuvastatin Plus Ezetimibe in High-Risk Patients: Results from the EXPLORER Study. Paper presented at: International Symposium on Atherosclerosis; 22 June, 2006; Rome, Italy.3. Ballantyne C, Sosef F, Duffield E. Efficacy and Safety of Rosuvastatin Plus Ezetimibe in High-Risk Patients: Results from the EXPLORER Study. Atherosclerosis Supplements 2006;7(3):552 Abs Th-P16:270.