Risk of Liver and Kidney Damage Pose Big Concern to Patients When Managing Cholesterol Levels

Despite Recent News Coverage About Statin Side Effect Concerns, Doctors

Still Keep Patients in the Dark About Risks

May 03, 2004, 01:00 ET from Sankyo Pharma Inc.

    PARSIPPANY, N.J., May 3 /PRNewswire/ -- A new nationwide survey shows that
 adults with high cholesterol are highly concerned about possible side effects
 that are associated with prescription cholesterol-lowering medications,
 however, many say their doctors are not talking to them about these risks.
 Patients are further adding to the lack of communication because a majority
 (55 percent) who use cholesterol-lowering food products or over-the-counter
 medications to manage their cholesterol are not telling their doctor that they
 are using these products in addition to their cholesterol-lowering
 prescription medications.  Today, about 104 million American adults (50.7
 percent of the population) have total blood-cholesterol levels that put them
 at serious risk for cardiovascular disease.(1)
     Conducted by Roper with 400 adults with high cholesterol, the survey found
 that a majority are concerned about the possibility that prescription
 cholesterol medications will damage their liver (80 percent), kidneys (75
 percent) or cause muscle aches and pains (64 percent).  More than four in
 10 people (44 percent) with high cholesterol have not discussed the risks or
 side effects of their cholesterol-lowering medications with their doctors.
 While almost all (94 percent) say that a change in diet and exercise would be
 their preferred way to lower their cholesterol, 89 percent recognize that a
 combination of diet, exercise and prescription medications is the most
 effective way to lower cholesterol.
     Those surveyed also tend to have other cardiovascular risk factors
 including hypertension (46 percent) and diabetes (18 percent).  Two-thirds of
 these patients (66 percent) are concerned about the possibility of their
 cholesterol-lowering medication having a negative interaction with other
 medications they are taking.
     The survey also indicates that the majority of people with high
 cholesterol (81 percent) do not know their LDL (bad) cholesterol level.  More
 than half (54 percent) do not believe their LDL cholesterol level is a serious
 risk to their health, and less than one in 10 (6 percent) consider it life
 threatening.  The survey was sponsored by Sankyo Pharma Inc.
     "This survey demonstrates the critical need for patients and their
 physicians to communicate more actively with each other about any medication
 concerns patients may have," said Lori Mosca, M.D., M.P.H, Ph.D., Director,
 Preventive Cardiology, New York Presbyterian Hospital and Associate Professor
 of Medicine, Columbia University.  "Further, we need to be more proactive in
 educating our patients with high cholesterol about what their cholesterol
 levels and goals are so they have a better understanding of why we have
 prescribed a cholesterol-lowering therapy."
     When asked about the characteristics of a cholesterol-lowering medication
 that would be important, a majority of those surveyed said a drug that does
 not go through the liver or the kidneys (81 percent), does not require blood
 work to monitor for liver function (77 percent), and does not enter the
 bloodstream (63 percent) are important.  After learning that a non-systemic
 cholesterol-lowering drug is one that is not absorbed into the bloodstream and
 because of this is less likely to affect the liver or kidneys, 41 percent
 expressed interest in taking a non-systemic option.
     The leading class of non-systemic cholesterol-lowering medications is the
 bile acid sequestrant class (BAS).  The branded leader of that class,
 WelChol(R) (colesevelam HCI), is an effective and well-tolerated option for
 patients with high cholesterol.  WelChol is different from most other
 cholesterol-lowering drugs on the market because it is non-systemic, meaning
 that the body does not absorb it and it is eliminated without traveling to the
 liver, kidneys or any other target organs.  Systemic medications, which
 include the statin class, are those that are absorbed from the intestine into
 the bloodstream and travel throughout the body.
     "Having a safe and effective therapy, such as WelChol, that can minimize
 the risk of systemic drug-drug interactions, is a great option to have in our
 arsenal of cholesterol-lowering medications," said Dr. Mosca.  "Because it can
 be used alone or in combination with statins, it can greatly improve patients'
 success rates in meeting target cholesterol levels."
     About WelChol
     WelChol, a non-systemic lipid-lowering agent approved by the U.S. Food and
 Drug Administration (FDA) for marketing in May 2000, is the top selling
 branded drug in the bile acid sequestrant class (BAS).
     WelChol is indicated, alone or in combination with a statin, as an adjunct
 to diet and exercise for the reduction of elevated LDL (bad) cholesterol in
 patients with primary hypercholesterolemia (Fredrickson Type IIa) when the
 response to diet and exercise has been inadequate.  Liver-function monitoring
 is not required with WelChol when used as monotherapy, and in combination with
 a statin, no additional liver-function monitoring is required beyond that for
 the prescribed statin alone.
     In clinical trials, when WelChol was given alone in addition to a low-fat
 diet and exercise, it was shown to reduce LDL (bad) cholesterol by an average
 of 15 to 18 percent.
     When WelChol is given in combination with a statin, the combination can
 more dramatically lower cholesterol levels than using either therapy alone.
 In a study where WelChol was taken with Zocor(R) (a statin), WelChol 3.8 g
 provided a 16 percent (32 mg/dL) additional average LDL cholesterol reduction
 in combination therapy beyond that of Zocor 10 mg alone.  WelChol is the only
 non-systemic cholesterol-lowering agent FDA approved to be used in combination
 with any dose of any statin.  It has been studied with three commonly
 prescribed statins -- Lipitor,(R) Zocor and Mevacor.(R)
     WelChol is not for everyone, especially those with bowel blockage.
 Caution should be exercised when treating patients who have trouble swallowing
 or severe stomach or intestinal problems.  Side effects may include
 constipation, indigestion and gas.
     WelChol has not been studied in combination with all medications or
 supplements.  Patients should always tell their doctor about all medications
 and supplements they are taking before starting any new therapy, including
     For more information on WelChol, call 877-4-SANKYO (877-472-6596), or go
 to the WelChol web site at www.WelChol.com.
     About the Survey
     Roper conducted telephone interviews with 400 adults age 20 or older who
 were doctor-diagnosed as having high cholesterol levels and were taking
 prescription medications, over-the-counter medications and/or eating
 cholesterol-lowering food products in addition to changes in diet and exercise
 to lower or manage their cholesterol level.  Responses were weighted by
 demographic factors to ensure a reliable and accurate representation of the
 survey universe.  The margin of sampling error is +/-5 percentage points for
 the total sample of 400.
     About Sankyo Pharma
     Sankyo Pharma Inc. is dedicated to developing and marketing important
 pharmaceutical products for the U.S. market.  A national sales force of 530
 representatives promotes WelChol, and they are supported by dedicated managed
 care personnel.  Sankyo Pharma also markets medications for the treatment of
 hypertension with its co-promote partner Forest Laboratories, Inc.
     Sankyo Pharma launched WelChol(R) (colesevelam HCI), a non-systemic
 lipid-lowering agent, in September 2000.  Currently, WelChol is the number one
 prescribed branded agent in its category with 2003 sales in excess of $100
 million dollars.
     Sankyo Pharma's parent company, Sankyo Co. Ltd. of Tokyo, is one of
 Japan's largest pharmaceutical companies, with annual worldwide sales of $4.5
 billion.  Sankyo has a long history of discovering new classes of drugs,
 including the statin class of lipid-lowering drugs, with its discovery of the
 first statin, mevastatin, and the co-discovery of lovastatin, the first statin
 to be marketed.  Additionally, Sankyo discovered, co-developed and
 manufactures pravastatin sodium.
     Please see package insert for full prescribing information
     Zocor(R)(simvastatin) and Mevacor(R)(lovastatin) are registered
      trademarks of Merck & Co., Inc.
     Lipitor(R)(atorvastatin calcium) is a registered trademark of Pfizer Inc
     WelChol(R)(colesevelam HCI) is a registered trademark of Sankyo Pharma
      (1) American Heart Association. 2004 Heart and Stroke Statistical
          Update.  Dallas, Tex: American Heart Association, 2003. Page 28.

SOURCE Sankyo Pharma Inc.