New Data Demonstrate Welchol (colesevelam HCl) Significantly Improved Lipid and Glycemic Measures in Patients With High LDL Cholesterol and Prediabetes
PARSIPPANY, N.J., April 23 /PRNewswire/ -- Results of a new
study showed that Welchol® (colesevelam HCl) 3.75 g/d
significantly improved lipid and glycemic measures in patients with
high LDL cholesterol and prediabetes (impaired fasting glucose
and/or impaired glucose tolerance). The randomized,
placebo-controlled, double-blind study was presented today at the
American Association of Clinical Endocrinologists (AACE) 19th
Annual Meeting and Clinical Congress in Boston.(1) These data are
consistent with previous studies that have shown Welchol to be safe
and effective in lowering A1C, fasting plasma glucose and
low-density lipoprotein cholesterol (LDL-C) in adult patients with
type 2 diabetes.(2)
"These new findings are important because they provide valuable
information on the effects of Welchol to significantly reduce LDL
cholesterol, fasting plasma glucose, and A1C levels in patients at
high risk for developing type 2 diabetes," said Yehuda Handelsman,
MD, FACP, FACE, Medical Director of the Metabolic Institute of
America in Tarzana, Calif. and investigator of the study. "The
evaluation of Welchol in this high risk population underscores
recent guidelines established by AACE, which recommended physicians
target and treat underlying disorders such as high cholesterol and
elevated glucose levels in people with prediabetes."(3)
Approximately 57 million adults in the U.S. have impaired
fasting glucose and/or impaired glucose tolerance, which puts them
at a three to 10 times higher risk of developing type 2 diabetes
and a 1.5 times greater risk of cardiovascular disease.(3,4,5) A
recent position statement from the American Diabetes Association
(ADA) stated that individuals with an A1C level of 5.7 to 6.4
percent are considered to have prediabetes and are at high risk for
developing type 2 diabetes.(6) In patients diagnosed with type 2
diabetes, more than 50 percent also have elevated LDL
cholesterol.(7)
About the Study
Poster #403 - Colesevelam HCI to Treat Hypercholesterolemia and
Improve Glycemia in Prediabetes: A Randomized, Prospective
Study(1,8)
This 16-week, randomized, placebo-controlled, double-blind, multinational study evaluated patients aged 18 to 79 years with high LDL cholesterol and prediabetes, who met the following criteria: LDL cholesterol levels >/=100 mg/dL; triglycerides <500 mg>/=140 mg/dL to <200 mg>/=110 to
The study found that after 16 weeks of treatment, Welchol
compared with placebo resulted in a statistically significant mean
reduction of LDL cholesterol levels (-13.9 vs. +1.7 percent; mean
treatment difference of -15.6 percent), mean non-HDL cholesterol
levels (-8.4 vs. +0.7 percent; mean treatment difference of -9.1
percent), and mean apoliproprotein B levels (-7.5 vs. +0.6 percent;
mean treatment difference of -8.1 percent), respectively,
p<0.001. Welchol also improved glycemic levels compared with
placebo, with a significant mean reduction in A1C levels (-0.12 vs.
-0.03 percent; mean treatment difference of -0.10 percent; p=0.02)
and significant reduction in median fasting plasma glucose levels
(-4.0 mg/dL vs. -2.0 mg/dL; median treatment difference of -2.0
mg/dL; p=0.02). Treatment with Welchol increased triglyceride
levels relative to placebo (median treatment difference: 14.3
percent; p<0.001).
Significantly more patients attained target levels for LDL cholesterol with Welchol compared with placebo at week 16: LDL cholesterol <100 mg>
About Welchol
Approved in 2000 to lower LDL cholesterol and in 2008 as add-on
therapy for glycemic control in adults, Welchol is approved by the
U.S. Food and Drug Administration (FDA) as an adjunct to diet and
exercise to reduce elevated LDL-C and improve glycemic control in
adults with primary hyperlipidemia and type 2 diabetes, two chronic
health conditions. Welchol should not be used for the treatment of
type 1 diabetes or for the treatment of diabetic ketoacidosis.
Welchol has not been studied in type 2 diabetes as monotherapy or
in combination with a dipeptidyl peptidase 4 inhibitor and has not
been extensively studied in combination with thiazolidinediones.
Welchol has not been studied in Fredrickson Type I, III, IV, and V
dyslipidemias. Welchol has not been studied in children younger
than 10 years of age or in pre-menarchal girls. Welchol is
available in two formulations, Welchol tablets and Welchol® for
Oral Suspension.
In clinical studies of adult patients with type 2 diabetes,
Welchol lowered A1C, fasting plasma glucose and LDL-C, important
risk factors for cardiovascular disease.* In clinical studies of
patients with elevated LDL-C, Welchol lowered LDL-C when used as
monotherapy, when added to statin therapy, or as initial
combination with statin therapy.(2)
*The effect of Welchol on cardiovascular morbidity and mortality
has not been determined.
IMPORTANT INFORMATION ABOUT WELCHOL (colesevelam HCl)
Indications
Welchol is indicated as an adjunct to diet and exercise to:
-- reduce elevated low-density lipoprotein cholesterol (LDL-C) in
patients with primary hyperlipidemia (Fredrickson Type IIa) as
monotherapy or in combination with an hydroxymethyl-glutaryl-coenyme
(HMG CoA) reductase inhibitor
-- reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of
age, with heterozygous familial hypercholesterolemia, as monotherapy
or in combination with a statin after failing an adequate trial of
diet therapy
-- improve glycemic control in adults with type 2 diabetes mellitus
Important Limitations of Use
-- Welchol should not be used for the treatment of type 1 diabetes or for
the treatment of diabetic ketoacidosis
-- Welchol has not been studied in type 2 diabetes as monotherapy or in
combination with a dipeptidyl peptidase 4 inhibitor and has not been
extensively studied in combination with thiazolidinediones
-- Welchol has not been studied in Fredrickson Type I, III, IV, and V
dyslipidemias
-- Welchol has not been studied in children younger than 10 years of age
or in premenarchal girls
Contraindications
Welchol is contraindicated in individuals with bowel
obstruction, those with serum triglyceride (TG) concentrations of
>500 mg/dL, or with a history of hypertriglyceridemia-induced
pancreatitis.
Warnings and Precautions
The effect of Welchol on cardiovascular morbidity and mortality
has not been determined.
Welchol can increase serum TG concentrations particularly when
used in combination with sulfonylureas or insulin. Caution should
be exercised when treating patients with TG levels >300
mg/dL.
Welchol may decrease the absorption of fat-soluble vitamins A,
D, E and K. Patients on vitamin supplements should take their
vitamins at least 4 hours prior to Welchol. Caution should be
exercised when treating patients with a susceptibility to vitamin K
or fat-soluble vitamin deficiencies.
Caution should also be exercised when treating patients with
gastroparesis, gastrointestinal motility disorders, major
gastrointestinal tract surgery, and when treating patients with
dysphagia and swallowing disorders.
Welchol reduces gastrointestinal absorption of some drugs. Drugs
with a known interaction with colesevelam, especially those with a
narrow therapeutic index, should also be administered at least 4
hours prior to Welchol. Drugs that have not been tested for
interaction with colesevelam, especially those with a narrow
therapeutic index, should also be administered at least 4 hours
prior to Welchol. Alternatively, the physician should monitor drug
levels of the coadministered drug.
To avoid esophageal distress, Welchol for Oral Suspension should
not be taken in its dry form.
Due to tablet size, Welchol for Oral Suspension is recommended
for, but not limited to, use in the pediatric population as well as
in any patient who has difficulty swallowing tablets.
Phenylketonurics: Welchol for Oral Suspension contains 48 mg
phenylalanine per 3.75 gram dose.
Adverse Reactions
In clinical trials, the adverse reactions observed in >/=2%
of patients, and more commonly with Welchol than placebo,
regardless of investigator assessment of causality seen in:
-- Adults with Primary Hyperlipidemia were: constipation (11.0% vs 7.0%),
dyspepsia (8.3% vs 3.5%), nausea (4.2% vs 3.9%), accidental injury
(3.7% vs 2.7%), asthenia (3.6% vs 1.9%), pharyngitis (3.2% vs 1.9%),
flu syndrome (3.2% vs 3.1%), rhinitis (3.2% vs 3.1%) and myalgia (2.1%
vs 0.4%).
-- Pediatric patients with heFH primary hyperlipidemia were:
nasopharyngitis (6.2% vs 4.6%), headache (3.9 vs 3.1%), fatigue (3.9%
vs 1.5%), creatine phosphokinase increase (2.3% vs 0.0%), rhinitis
(2.3% vs 0.0%) and vomiting (2.3% vs 1.5%).
-- Adult patients with Type 2 Diabetes were: constipation (8.7% vs 2.0%),
nasopharyngitis (4.1% vs 3.6%), dyspepsia (3.9% vs 1.4%), hypoglycemia
(3.0% vs 2.3%), nausea (3.0% vs 1.4%) and hypertension (2.8% vs 1.6%).
Post-marketing experience: Due to the voluntary nature of these
reports it is not possible to reliably estimate frequency or
establish a causal relationship.
-- Increased seizure activity or decreased phenytoin levels have been
reported in patients receiving phenytoin concomitantly with Welchol.
-- Reduced International Normalized Ratio (INR) has been reported in
patients receiving warfarin concomitantly with Welchol.
-- Elevated thyroid-stimulating hormone (TSH) in patients receiving
thyroid hormone replacement therapy.
Pregnancy
Welchol is Pregnancy Category B.
Please visit http://www.welchol.com/pdf/Welchol_PI.pdf for
full Prescribing Information on Welchol.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
For more information on Welchol, call 877-4-DSPROD
(877-437-7763), or go to the Welchol website at
www.Welchol.com.
For patients having difficulty affording their Welchol
(colesevelam HCl) medication, please call the Daiichi Sankyo Open
Care Patient Assistance Program at 1-866-268-7327 for more
information or visit www.dsi.com.
About Daiichi Sankyo
In keeping with its vision of becoming a "Global Pharma
Innovator," the Daiichi Sankyo Group is dedicated to the creation
and supply of innovative pharmaceutical products to address the
diversified, unmet medical needs of customers in both developed and
emerging markets. While maintaining its portfolio of marketed
pharmaceuticals for hypertension, hyperlipidemia, and bacterial
infections, the Group is engaged in the development of treatments
for thrombotic disorders and focused on the discovery of novel
oncology and cardiovascular-metabolic therapies. Furthermore, the
Daiichi Sankyo Group has created a "Hybrid Business Model," which
will respond to market and customer diversity and optimize growth
opportunities across the value chain. For more information, please
visit www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey,
is the U.S. subsidiary of Daiichi Sankyo Company, Ltd. For more
information on Daiichi Sankyo, Inc., please visit
www.dsi.com.
References
1. Handelsman Y et al. Colesevelam HCL to Treat Hypercholesterolemia and
Improve Glycemia in Prediabetes: A Randomized, Prospective Study.
Poster at the American Association of Clinical Endocrinologists (AACE)
19th Annual Meeting and Clinical Congress , Boston (April 21-25, 2010).
2. Welchol Product Information. Available at:
http://www.welchol.com/utilities/product_info.html.
3. Garber AJ, Handelsman Y, Einhorn D, et al. Diagnosis and management of
prediabetes in the continuum of hyperglycemia: when do the risks of
diabetes begin? A consensus statement from the American College of
Endocrinology and the American Association of Clinical
Endocrinologists. Endocrine Practice 2008; 14: 933-946.
4. Centers for Disease Control and Prevention. National Diabetes Fact
Sheet: general information and national estimates on diabetes in the
United States, 2007. In: US Department of Health and Human Services,
ed. Atlanta, GA, 2008.
5. American Diabetes Association. Pre-diabetes FAQs. Available at:
http://www.diabetes.org/diabetes-basics/prevention/pre-diabetes/pre-dia
betes-faqs.html.
6. American Diabetes Association. Diagnosis and classification of diabetes
mellitus. Diabetes Care. 2010; 33: S62-S69.
7. Cheung BMY et al. Diabetes Prevalence and Therapeutic Target
Achievement in the United States, 1999 to 2006. The American Journal of
Medicine. 2009; 122: 443-453.
8. Daiichi Sankyo, Inc. Data on File.
Copyright 2010, Daiichi Sankyo, Inc. all rights reserved: [DSWC10000961].
Source: Daiichi Sankyo
CONTACT: Jennifer Brennan of Daiichi Sankyo, Inc., Office,
+1-973-944-2511, Cell, +1-201-709-9309, jbrennan@dsi.com;
or Kristen Drake of
WCG, Office, +1-212-301-7215, Cell, +1-917-647-6223, kdrake@wcgworld.com, for
Daiichi Sankyo
Web Site: http://www.daiichisankyo.com/
Posted: April 2010
