• April 21, 2014

Cholesterol control: Know all your treatment options

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Posted: Monday, February 3, 2014 6:00 pm | Updated: 2:32 am, Tue Feb 11, 2014.

(BPT) - If you’ve been diagnosed with high LDL or “bad” cholesterol, know that you are not alone. It is estimated that 71 million Americans have high LDL or “bad” cholesterol, putting them at greater risk of having a heart attack or stroke. Despite this, less than half of these adults with high “bad” cholesterol have been treated and even less actually have their cholesterol under control.

“It’s important for each patient to work with their doctor to discuss the most effective treatment plan for their high cholesterol,” says Dr. Vivian Fonseca, professor of medicine and pharmacology at Tulane University Health Sciences Center. “In some cases, dietary changes and increased exercise is all that is needed for cholesterol control. For others, medication also is needed.”

Defining “high” cholesterol

Cholesterol is a waxy, fat-like substance, and some cholesterol is needed for your body to function normally. However, having too much “bad” cholesterol and not enough “good” cholesterol can cause plaque to build up on the walls of your arteries, putting you at elevated risk for heart disease and stroke.

Since high “bad” cholesterol doesn’t cause many symptoms, a great deal of people may not realize their levels are too high, underscoring the importance of getting cholesterol levels checked. Doctors recommend adults have their cholesterol levels screened every five years (sooner if you already have been diagnosed with high cholesterol). A blood test can determine your cholesterol levels.

Controlling your weight, staying physically active and making healthful food choices can help lower “bad” cholesterol. For many people, however, heredity plays a role and even with lifestyle changes, their “bad” cholesterol may continue to be too high. In those cases, a doctor may prescribe medication to help reduce the “bad” cholesterol.

Treating “bad” cholesterol

When more than diet and exercise is needed to treat high cholesterol, most people are treated with a class of medications called “statins.” If the use of a statin by itself is not getting cholesterol under control, another type of medicine called Welchol® (colesevelam hydrochloride) may be added to further lower “bad” cholesterol levels.

Welchol is a bile acid sequestrant that lowers "bad" cholesterol differently from statins. While statins work in the liver, Welchol works in the intestines. Bile acids are needed to help digest fat from foods that are eaten. Welchol attaches to these bile acids and bile and removes some of them from the body. When levels of bile acids are reduced, the liver needs to make more and takes cholesterol from the bloodstream to do so, thereby lowering "bad" cholesterol. Tell your healthcare provider if you have stomach or intestinal problems, including gastroparesis (when the stomach takes too long to empty its contents), abnormal contractions of the digestive system, a history of major gastrointestinal tract surgery, if you have trouble swallowing, or if you have vitamin A, D, E, or K deficiencies. The most common side effects seen in patients taking Welchol include constipation, indigestion and nausea.

If you’re not sure about your cholesterol levels, see your doctor to schedule a blood test. Since high cholesterol typically has no symptoms, if you wait to see a doctor until you feel sick, it could be too late to prevent serious health problems. For more information on high cholesterol, visit www.heart.org. To learn more about Welchol, visit www.welchol.com or speak to your doctor.

What is Welchol (colesevelam HCl)?

Welchol, along with diet and exercise, lowers LDL or “bad” cholesterol. It can be taken alone or with other cholesterol-lowering medications known as statins.

Welchol lowers LDL cholesterol in boys, and in girls who have had a menstrual period, ages 10 to 17 years, with a condition known as heterozygous familial hypercholesterolemia (a genetic disorder that causes high cholesterol) alone or with other cholesterol-lowering medications known as statins after inadequate control with diet alone.

Welchol, along with diet and exercise, also lowers blood sugar levels in adult patients with type 2 diabetes mellitus when added to other anti-diabetes medications (metformin, sulfonylureas, or insulin).

Welchol should not be used to treat type 1 diabetes or diabetic ketoacidosis.

Welchol has not been studied with all anti-diabetes medications.

Welchol has not been studied in children younger than 10 years old or in girls who have not had a menstrual period.

Important Safety Information About Welchol (colesevelam HCl)

Welchol is available by prescription only. Ask your HCP if Welchol is right for you.

Welchol is not for everyone, especially those with:

  • a history of intestinal blockage,
  • blood triglyceride levels of greater than 500 mg/dL, or
  • a history of pancreatitis (inflammation of the pancreas) due to high triglyceride levels.

Welchol has not been shown to prevent heart disease or heart attacks.

Tell your health care provider (HCP) if you have high triglycerides (greater than 300 mg/dL).

Tell your HCP if you have stomach or intestinal problems, including gastroparesis (when the stomach takes too long to empty its contents), abnormal contractions of the digestive system, a history of major gastrointestinal tract surgery, if you have trouble swallowing, or if you have vitamin A, D, E, or K deficiencies.

Welchol has known interactions with cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, certain birth control pills, olmesartan medoxomil, and metformin extended release (ER). Welchol has not been studied with all combinations of drugs and supplements. Please tell your HCP about all medications and supplements you may be taking before beginning Welchol, as your HCP may tell you to take your other medications and supplements 4 hours before taking Welchol.

Remember to tell your HCP if you are pregnant, plan to become pregnant, or are breastfeeding.

Welchol (colesevelam HCl) for Oral Suspension should not be taken in its dry form.

Welchol for Oral Suspension is recommended for, but not limited to, use in appropriate pediatric patients as well as any patient who has difficulty swallowing.

Phenylketonurics: Welchol for Oral Suspension contains 27 mg phenylalanine per 3.75 gram dose.

In clinical trials, the adverse reactions observed in ≥2% of patients, and more commonly with Welchol than placebo (“sugar pill”), regardless of investigator assessment of causality seen in:

  • Adult patients with high LDL (“bad” cholesterol) were: constipation, indigestion, nausea, accidental injury, weakness, sore throat , flu-like symptoms, runny nose, and muscle aches
  • Pediatric patients with high “bad” cholesterol were: inflamed nasal passages and throat, headache, fatigue, creatine phosphokinase (a muscle enzyme) increase, runny nose, and vomiting
  • Adult patients with type 2 diabetes, when added to other anti-diabetes medications, were: constipation, inflamed nasal passages and throat, indigestion, low blood sugar, nausea, and high blood pressure
  • Adult patients with type 2 diabetes, when taken alone (monotherapy), were: back pain, headache, diarrhea, low blood sugar, C-reactive protein increased, constipation, upper respiratory tract infection, high blood sugar, high blood pressure, blood creatinine phosphokinase increased, gastroesophageal reflux disease (GERD), and tooth abscess

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 patients having difficulty affording their Daiichi Sankyo medication, please call the Daiichi Sankyo Patient Assistance Program at 1-866-268-7327 for more information or visit www.dsi.com/news/patientassistance.html.

Please click here for full Prescribing Information for Welchol. For more information about Welchol, visit www.welchol.com.

DSWC13102814

01/14

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