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."
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
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.