Important information to consider about non-systemic cholesterol lowering agents

October 29, 2002

There's been quite a bit of "noise" in the cholesterol category within the past year -- statins being recalled or relabeled due to safety concerns and future "super statins" now being called into question over safety of highest dose. And now a new compound (with no outcomes data as of yet), joins the market. What all of these compounds have in common is that they are absorbed into the blood stream.

Attached here for your review is some information about WelChol® (colesevelam hydrochloride). WelChol is non-systemic (i.e., it is not absorbed and does not travel through the bloodstream.) Thus, patients may avoid systemic side effects that might accompany absorbed cholesterol-lowering drugs.

It's part of the bile acid sequestrant class -- a class that is well studied with a safety record spanning 30 years and proven outcomes data. It is also the only non-absorbed cholesterol-lowering agent FDA approved to be used in combination with any dose of any statin -- and the effects are greater then either therapy alone.

If you are doing a cholesterol story, please review the following and consider for inclusion. And please don't hesitate to contact us for further information. Thank you.

  • WelChol is non-systemic (it is not absorbed and does not travel through the bloodstream). Thus, patients may avoid systemic side effects that might accompany absorbed cholesterol-lowering drugs.

  • WelChol is the only non-systemic cholesterol-lowering agent FDA approved to be used in combination with any dose of any statin. WelChol has been studied with three top selling statins -- Lipitor®, Zocor® and Mevacor®. Results demonstrated that co-administration of WelChol and statins can lower LDL cholesterol levels significantly better than using either therapy alone.

  • The bile acid sequestrant (BAS) class is well studied with a safety record spanning 30 years and proven outcomes data.

  • Demonstrated ability to significantly lower mortality and nonfatal MI by 19%. (p<0.05 vs. placebo)

  • 95% decrease in death and a 79% decrease in cardiovascular events versus usual care when used in combination with statins and niacin.

  • WelChol has not been shown to prevent heart disease or heart attacks.

  • Liver function monitoring is not required with WelChol. In combination with a statin, no additional liver function monitoring is required beyond that for the prescribed statin alone, unlike Zetia® that requires testing upon initiation of combination therapy with a statin.

  • The effects of cholesterol absorption inhibitors including Zetia given alone or in addition to a statin on cardiovascular morbidity and mortality have not been established.

  • In a co-administration study with Lipitor, HDL cholesterol was improved by 11% with WelChol plus Lipitor versus 8% for Lipitor alone.

  • WelChol is not for everyone, especially those with bowel blockage. Tell your doctor if you have trouble swallowing or severe stomach or intestinal problems. Side effects may include constipation, indigestion and gas.
    -end-
    Please see full prescribing information for WelChol (colesevelam HCl).

    For more information on WelChol, call 1-877-4-SANKYO (877-472-6596), visit the WelChol web site at www.welchol.com; or contact Deborah Adams 212-885-0449 or Wendy Lu 212-885-0346.

    Lipitor® (atorvastatin calcium) is a registered trademark of Pfizer Inc. Zocor® (simvastatin) and Mevacor® (lovastatin) are registered trademarks of Merck & Co., Inc. Zetia®(ezetimibe) is a trademark of MSP Marketing Services, LLC

    Hill and Knowlton

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