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| Ironwood Pharmaceuticals is advancing novel cholesterol absorption inhibitors (CAIs) for the treatment of hypercholesterolemia (high cholesterol), a risk factor for coronary heart disease, heart attack, and stroke. |
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| We are developing next-generation CAIs to serve both as stand-alone and combination therapies for the treatment of hypercholesterolemia. |
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| Clinical proof of concept data H2 ‘08 |
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| Cardiovascular disease is the leading cause of death in the developed world and hypercholesterolemia is a key risk factor. Drug therapies that lower LDL-cholesterol have shown significant improvements in patient outcomes. The cholesterol product sector generates more than $25 billion in annual sales and continues to show significant growth, fueled by multiple published clinical studies that show the benefits of more aggressive cholesterol-lowering. These studies led to the introduction of new, more aggressive cholesterol management guidelines by the National Cholesterol Education Program (NCEP). The most significant element of these recommendations is the lowering of LDL target levels from 100 mg/dl to 70 mg/dl for patients most at risk for a cardiovascular event. This change dramatically increases the pool of patients in the U.S. who may benefit from cholesterol-lowering therapies to an estimated 50 million. Only half of the patients currently receiving cholesterol-lowering drugs achieve LDL levels of 100 mg/dl, meaning that more aggressive therapies should be considered to achieve the new target levels. |
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| Statins are the dominant therapeutic class for treating dyslipidemia. However, not all patients treated with a statin alone achieve LDL goals, even at the highest dose levels. In addition, there are a significant number of patients who are “statin intolerant” and require alternative interventions. Addressing this clinical dilemma is an emerging class of therapeutics that block intestinal absorption of cholesterol (CAIs). The addition of a CAI to statin therapy offers the potential to safely achieve greater LDL reductions. CAIs can also be used alone or in combination with other non-statin lipid-lowering medications. |