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
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 WelChol. 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 Inc. (1) American Heart Association. 2004 Heart and Stroke Statistical Update. Dallas, Tex: American Heart Association, 2003. Page 28.
SOURCE Sankyo Pharma Inc.
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