WelChol, in Combination With Zocor, Works Better Than Zocor Alone

New Study Shows That 2 Cholesterol-Lowering Drugs Taken

In Combination Cut LDL-Cholesterol Levels by 42%



Apr 30, 2001, 01:00 ET from Sankyo Pharma

    PARSIPPANY, N.J., April 30 /PRNewswire/ -- WelChol(TM) (colesevelam HCl)
 and Zocor(R) (simvastatin), taken in combination, can lower LDL-cholesterol
 levels by 42% in patients with moderately high cholesterol -- a reduction
 superior to either therapy alone -- according to a new study published in the
 April 1st issue of American Journal of Medicine.  The additional reduction of
 LDL-cholesterol levels from this combination of WelChol* (3.8 grams) and Zocor
 (10 milligrams), compared to Zocor (10 milligrams) alone, was twice the
 magnitude seen with doubling the dose of Zocor.(1)
     "This study demonstrates that combination therapy is a safe and effective
 approach to cholesterol management," said Howard H. Knapp, MD, PhD, principal
 study investigator and executive director, Deaconess Billings Clinic Research
 Division, Billings, Montana.  There is no change in the adverse event profile
 with the coadministration of atorvastatin (Lipitor(R)), simvastatin (Zocor) or
 lovastatin (Mevacor(R)).
     These results are consistent with other clinical trials that demonstrate
 that co-administration with WelChol reduces LDL-cholesterol levels more
 dramatically than either therapy alone.  New data from a study to be published
 later this year, showed that WelChol 3.8 grams per day combined with Lipitor
 10 milligrams a day resulted in a 48% average reduction in LDL-cholesterol.(2)
 The study showed that patients taking this combination achieved
 LDL-cholesterol reductions that were not statistically significantly different
 from taking 80 milligrams of Lipitor (8 times the commonly prescribed Lipitor
 dose).(3)
     WelChol, available by prescription only, effectively lowers
 LDL-cholesterol (or "bad" cholesterol) and is the only lipid-lowering agent
 that is FDA-approved for combination use with a statin.  Administered alone or
 in combination with a statin, WelChol is indicated as adjunctive therapy to
 diet and exercise for the reduction of elevated cholesterol in patients with
 primary hypercholesterolemia when diet and exercise alone are not adequate.
 
     WelChol/Zocor Study
     In a six-week multicenter, randomized, double-blind placebo-controlled
 trial, patients suffering from hypercholesterolemia were monitored to
 determine the efficacy and safety of WelChol when coadministered with starting
 doses of Zocor.  Study investigators found that WelChol taken in combination
 with Zocor offers a novel therapeutic alternative to achieve recommended goals
 of lipid-lowering and may be particularly beneficial for high-risk patients
 who require the greatest reductions in LDL-cholesterol levels.
     In this trial, 258 patients with hypercholesterolemia (LDL-cholesterol
 level greater than 160 mg/dL and triglyceride level less than or equal to 300
 mg/dL) were randomly assigned to a daily treatment regimen of placebo,
 WelChol, and Zocor.  All patients received equal numbers of capsules and
 tablets to ensure blinding.  Patient compliance was measured by pill count.
 At 2-week intervals, fasting plasma lipid profiles were conducted.
     At the end of the trial, the mean LDL-cholesterol levels declined by 4% in
 the placebo group.  Treatment with WelChol (3.8 grams daily) decreased
 LDL-cholesterol levels by 16%, and Zocor (10 milligrams daily) reduced mean
 LDL-cholesterol levels by 26%; the combination appeared to be additive, with a
 42% reduction.
     Because WelChol is not absorbed into the blood stream, it has few side
 effects.  The most common side effects (>5%) versus placebo (sugar pill) are
 gas (12% vs. 14%), constipation (11% vs. 7%), infection (10% vs. 13%), upset
 stomach (8% vs. 3%), and headache (6% vs. 8%).  WelChol should not be taken by
 patients who have bowel obstruction.
     As with all medications, patients should always let their healthcare
 provider know about the medications and supplements they are taking.  Also,
 liver-function monitoring is not required with WelChol, and in combination
 with a statin, no additional liver-function monitoring is required beyond that
 for the prescribed statin alone.
     For more information on WelChol, call 877-4-SANKYO (877-472-6596), or go
 to the WelChol web site at http://www.welchol.com.
 
     Sankyo Pharma is dedicated to developing and marketing innovative
 pharmaceuticals for the U.S. market.  Sankyo Pharma has operations in New York
 and New Jersey with a Research Institute in California.  A national sales
 force of 350 people, including a dedicated managed care sales force, promotes
 Sankyo Pharma products.
     Sankyo Pharma's parent company, Sankyo Co. Ltd. of Tokyo, is the
 second-largest pharmaceutical company in Japan and one of the leading
 pharmaceutical companies in the world.  Sankyo is a global innovator and a
 primary source of new therapeutic agents including drugs for hypertension and
 cardiovascular disease.  Sankyo played an important role in establishing the
 HMG-CoA reductase inhibitor (or "statin") class of lipid-lowering agents.
 Sankyo originated the statin class in 1971 with the discovery of mevastatin,
 although mevastatin was not commercialized.  Sankyo also co-discovered
 lovastatin (Mevacor), the first statin therapy to be marketed.  It discovered,
 co-developed and manufactures pravastatin.  Sankyo independently markets
 pravastatin throughout the world and through its licensee, Bristol-Myers
 Squibb.  Pravastatin is marketed as Pravachol(R) in the United States.
 
     *Please see package insert for full prescribing information.
 
     Mevacor(R) and Zocor(R) are registered trademark of Merck & Co., Inc.;
 Lipitor(R) is a registered trademark of Pfizer Inc.; Pravachol(R) is a
 registered trademark of Bristol-Myers Squibb.
 
     References:
     (1) Knapp, Howard et al. Efficacy and Safety of Combination Simvastatin
         and Colesevelam in Patients with Primary Hypercholesterolemia.
         American Journal of Medicine.  April 1, 2001; 110:352-360.
     (2) IMS National Prescription Audit Basic Data Report.
         January-March 2000.
     (3) Data on file, Sankyo Pharma, Parsippany, New Jersey.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X36734752
 
 

SOURCE Sankyo Pharma
    PARSIPPANY, N.J., April 30 /PRNewswire/ -- WelChol(TM) (colesevelam HCl)
 and Zocor(R) (simvastatin), taken in combination, can lower LDL-cholesterol
 levels by 42% in patients with moderately high cholesterol -- a reduction
 superior to either therapy alone -- according to a new study published in the
 April 1st issue of American Journal of Medicine.  The additional reduction of
 LDL-cholesterol levels from this combination of WelChol* (3.8 grams) and Zocor
 (10 milligrams), compared to Zocor (10 milligrams) alone, was twice the
 magnitude seen with doubling the dose of Zocor.(1)
     "This study demonstrates that combination therapy is a safe and effective
 approach to cholesterol management," said Howard H. Knapp, MD, PhD, principal
 study investigator and executive director, Deaconess Billings Clinic Research
 Division, Billings, Montana.  There is no change in the adverse event profile
 with the coadministration of atorvastatin (Lipitor(R)), simvastatin (Zocor) or
 lovastatin (Mevacor(R)).
     These results are consistent with other clinical trials that demonstrate
 that co-administration with WelChol reduces LDL-cholesterol levels more
 dramatically than either therapy alone.  New data from a study to be published
 later this year, showed that WelChol 3.8 grams per day combined with Lipitor
 10 milligrams a day resulted in a 48% average reduction in LDL-cholesterol.(2)
 The study showed that patients taking this combination achieved
 LDL-cholesterol reductions that were not statistically significantly different
 from taking 80 milligrams of Lipitor (8 times the commonly prescribed Lipitor
 dose).(3)
     WelChol, available by prescription only, effectively lowers
 LDL-cholesterol (or "bad" cholesterol) and is the only lipid-lowering agent
 that is FDA-approved for combination use with a statin.  Administered alone or
 in combination with a statin, WelChol is indicated as adjunctive therapy to
 diet and exercise for the reduction of elevated cholesterol in patients with
 primary hypercholesterolemia when diet and exercise alone are not adequate.
 
     WelChol/Zocor Study
     In a six-week multicenter, randomized, double-blind placebo-controlled
 trial, patients suffering from hypercholesterolemia were monitored to
 determine the efficacy and safety of WelChol when coadministered with starting
 doses of Zocor.  Study investigators found that WelChol taken in combination
 with Zocor offers a novel therapeutic alternative to achieve recommended goals
 of lipid-lowering and may be particularly beneficial for high-risk patients
 who require the greatest reductions in LDL-cholesterol levels.
     In this trial, 258 patients with hypercholesterolemia (LDL-cholesterol
 level greater than 160 mg/dL and triglyceride level less than or equal to 300
 mg/dL) were randomly assigned to a daily treatment regimen of placebo,
 WelChol, and Zocor.  All patients received equal numbers of capsules and
 tablets to ensure blinding.  Patient compliance was measured by pill count.
 At 2-week intervals, fasting plasma lipid profiles were conducted.
     At the end of the trial, the mean LDL-cholesterol levels declined by 4% in
 the placebo group.  Treatment with WelChol (3.8 grams daily) decreased
 LDL-cholesterol levels by 16%, and Zocor (10 milligrams daily) reduced mean
 LDL-cholesterol levels by 26%; the combination appeared to be additive, with a
 42% reduction.
     Because WelChol is not absorbed into the blood stream, it has few side
 effects.  The most common side effects (>5%) versus placebo (sugar pill) are
 gas (12% vs. 14%), constipation (11% vs. 7%), infection (10% vs. 13%), upset
 stomach (8% vs. 3%), and headache (6% vs. 8%).  WelChol should not be taken by
 patients who have bowel obstruction.
     As with all medications, patients should always let their healthcare
 provider know about the medications and supplements they are taking.  Also,
 liver-function monitoring is not required with WelChol, and in combination
 with a statin, no additional liver-function monitoring is required beyond that
 for the prescribed statin alone.
     For more information on WelChol, call 877-4-SANKYO (877-472-6596), or go
 to the WelChol web site at http://www.welchol.com.
 
     Sankyo Pharma is dedicated to developing and marketing innovative
 pharmaceuticals for the U.S. market.  Sankyo Pharma has operations in New York
 and New Jersey with a Research Institute in California.  A national sales
 force of 350 people, including a dedicated managed care sales force, promotes
 Sankyo Pharma products.
     Sankyo Pharma's parent company, Sankyo Co. Ltd. of Tokyo, is the
 second-largest pharmaceutical company in Japan and one of the leading
 pharmaceutical companies in the world.  Sankyo is a global innovator and a
 primary source of new therapeutic agents including drugs for hypertension and
 cardiovascular disease.  Sankyo played an important role in establishing the
 HMG-CoA reductase inhibitor (or "statin") class of lipid-lowering agents.
 Sankyo originated the statin class in 1971 with the discovery of mevastatin,
 although mevastatin was not commercialized.  Sankyo also co-discovered
 lovastatin (Mevacor), the first statin therapy to be marketed.  It discovered,
 co-developed and manufactures pravastatin.  Sankyo independently markets
 pravastatin throughout the world and through its licensee, Bristol-Myers
 Squibb.  Pravastatin is marketed as Pravachol(R) in the United States.
 
     *Please see package insert for full prescribing information.
 
     Mevacor(R) and Zocor(R) are registered trademark of Merck & Co., Inc.;
 Lipitor(R) is a registered trademark of Pfizer Inc.; Pravachol(R) is a
 registered trademark of Bristol-Myers Squibb.
 
     References:
     (1) Knapp, Howard et al. Efficacy and Safety of Combination Simvastatin
         and Colesevelam in Patients with Primary Hypercholesterolemia.
         American Journal of Medicine.  April 1, 2001; 110:352-360.
     (2) IMS National Prescription Audit Basic Data Report.
         January-March 2000.
     (3) Data on file, Sankyo Pharma, Parsippany, New Jersey.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X36734752
 
 SOURCE  Sankyo Pharma