Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome

NHS Trust

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: placebo; Drug: tredaptive (nicotinic acid/ laropiprant)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01118598

ISRCTN37787683 (Registry Identifier)

R0920 PCOS & Niacin

Details and patient eligibility

About

Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome (PCOS).

Full description

Polycystic ovary syndrome is a common hormone problem in young women and, as a result of it, they can experience irregular periods, reduced fertility, acne and increased body hair. Frequently, increased weight is a feature. Research suggests that they could have a higher risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure, angina, heart attack and stroke.

The fat from the diet is transported from the stomach into the blood and then taken up by the liver, muscles and fat tissues to store or use as an energy source. Delayed removal of fat from the circulation resulting rise of fat after a meal has been known to happen in PCOS. High fats after a meal are a strong risk factor for cardiovascular disease.

Niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol for many years. It has been proved to be effective in reducing risks of heart disease in patients with diabetes. However the effect of niacin on reducing cardiovascular risks and reducing fat level after a meal in PCOS has not been studied and this is why we plan to do this research.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females aged between 18 - 50 years
• Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement

Exclusion criteria

• Pregnancy/trying to conceive/breast feeding
• History of cardiovascular, renal, hepatic and active thyroid disease
• History of gout
• History of alcohol abuse
• History of diabetes
• History of allergy to nicotinic acid/laropiprant or food
• History of bleeding disorders/active peptic ulcers
• Patient on antihypertensive medications
• Patient on anticoagulants
• Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents
• History of smoking more than 15 pack year
• Unwilling for GP to be informed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

placebo arm

Placebo Comparator group

Description:

this group will receive placebo as per protocol

Treatment:

Drug: placebo

tredaptive

Active Comparator group

Description:

tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks

Treatment:

Drug: tredaptive (nicotinic acid/ laropiprant)