To determine whether 8 weeks of Niaspan treatment increases cholesterol efflux in male
subjects with low HDL-C cholesterol when compared to no treatment.
To determine whether 8 weeks of Niaspan treatment increases fecal cholesterol excretion when
compared to no treatment.
To determine whether 8 weeks of Niaspan treatment increases the rate of global reverse
cholesterol transport when compared to no treatment.
Inclusion Criteria:
Subjects meeting the following criteria at the Screening Visit will be eligible to
participate:
- Provide written informed consent
- Male
- Age 18 to 70 years
- BMI 18. 5-40 kg/m2
- HDL-C values <40 mg/dL
- Triglyceride value 150-500 mg/dL.
- Good health based on medical history, physical examination and laboratory safety
tests performed at the screening visit or prior to initial dose of study medication.
- No clinically significant abnormality on ECG performed at the screening visit or
prior to initial dose of study medication.
- Non-smoker and no other use of nicotine containing products for at least 6 months and
does not plan to begin smoking during the course of the study.
- Dietary or nutritional remedies including plant sterol containing products (i. e.
Benecol, SmartBalance, etc) of any sort for at least 2 weeks prior to and throughout
the study.
- Willing to avoid the use of lipid modifying medications (excluding statins) such as
the fibrates, cholestyramine, fish oil, and ezetimibe within 8 weeks prior to and
during the study.
- Avoidance of extreme change of physical activity from screening through the follow-up
period.
Exclusion Criteria:
Subjects are excluded from participation in the study if any of the following criteria
apply:
- History of intolerance to Niacin or Niaspan.
- Treatment with Niacin or Niaspan in the past 3 months (Multivitamin use with
non-pharmacologic doses of Niacin - less than 500mg per day - is allowed).
- History of stroke, chronic seizures, or major neurological disorder.
- Significant emotional problems or a history of clinically significant psychiatric
disorder.
- Bleeding diathesis or intolerance to aspirin.
- Anemia as defined as a hematocrit < 25%.
- History of gastritis, bleeding gastric or duodenal ulcers.
- History Type 1 or Type 2 diabetes, or fasting plasma glucose >125 mg/dL at screening
or 75 gm OGTT with 2 hour glucose >140mg/dL.
- History of illness that, in the opinion of the investigator, might confound the
results of the study or pose an additional risk through participation.
- History of ileal bypass, gastric bypass, or other condition associated with
malabsorption.
- Abnormal thyroid function tests.
- AST or ALT > 1. 5x the upper limit of normal.
- Active or recent gastrointestinal condition such as gastroenteritis, irritable bowel
syndrome, chronic constipation, or diarrhea which may affect bowel movements.
- History of plant sterol storage disease or a history of intolerance to plant sterols
or plant sterol containing products.
- History of neoplastic disease (i. e. leukemia, lymphoma, malignant melanoma), or
myeloproliferative disease, regardless of the time since treatment. Exceptions
include adequately treated non-melanomatous skin carcinoma, and other malignancies
that may have been treated successfully >10 years prior to the screening visit with
no evidence of recurrence.
- Excessive alcohol consumption defined as > three glasses of alcoholic beverages or
distilled spirits per day. *** Must avoid excessive alcohol consumption throughout
study.
- Currently using psyllium or other fiber based laxatives, phytosterol margarines,
and/or over the counter (OTC) treatments that are known to affect serum lipids and
has NOT been treated with a stable regimen for > 6 weeks prior to screening (Visit 1)
or the subject DOES NOT agree to continue this regimen for the duration of the
clinical trial.
- Regular user of illicit drugs or history of drug abuse (including alcohol) within the
previous 2 years.
- Use of anabolic agents.
- Any condition or therapy which, in the opinion of the investigator, poses a risk to
the subject
- Use of any investigational drug within 30 days before screening
