March 2007: Research conducted at the Methodist DeBakey Heart Center in Houston shows that a combination statin therapy lowers bad cholesterol by an unprecedented 70 percent, and has the added benefit of reducing life-threatening inflammation that can lead to heart disease and stroke.
The results published in the American Journal of Cardiology, also 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.
"A seventy percent drop is the largest reduction in bad cholesterol ever seen in a statin clinical trial. Cardiologists have long recognized the challenge in helping high-risk patients reach their target cholesterol levels, to ultimately prevent heart attack and stroke," said Dr. Christie Ballantyne, cardiologist at the Methodist DeBakey Heart Center and principal investigator for the study. "These results offer hope for these patients."
In addition, 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, Ballantyne said. 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 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.
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Key findings from EXPLORER** study:
- Crestor and Zetia 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.
- Crestor and Zetia reduced CRP levels by 46% compared with 29% 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) and coronary heart disease (CHD) or CHD risk equivalent 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.
Reference: 1. Ballantyne CM, Weiss R, Moccetti T, Vogt A, Eber B, Sosef F, Duffield E, for the EXPLORER Study Investigators. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol 2007;99:673-680.
Source: Methodist Hospital, Houston, Newswise
