HeartPositive: Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00246376
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), Legacy Community Health Center (Other)
• Enrollment: 221
• Location: 1
• Arms: 5
• Duration (Months): 97
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Heart Diseases; HIV Infections; Hyperlipidemia; Hypertriglyceridemia; Insulin Resistance; Atherosclerosis	Behavioral: Diet; Behavioral: Exercise; Drug: Niacin; Drug: Fenofibrate; Other: Placebos	N/A

Detailed Description

BACKGROUND:

HIV lipodystrophy syndrome is associated with both metabolic (e.g., dyslipidemia and insulin resistance) and anthropomorphic (e.g., lipoatrophy and central obesity) abnormalities. These defects are likely to predispose HIV patients on highly active antiretroviral therapy (HAART) to accelerated cardiovascular morbidity. Based on studies of key mechanisms of altered lipid kinetics in these patients, evidence that DE patterns of patients with HIV lipodystrophy are inadequate to manage cardiovascular risk factors, and current recommendations for treatment of atherosclerosis and insulin resistance, the following is hypothesized: 1) an intensive lifestyle intervention with DE will improve the plasma lipid profile, decrease visceral fat mass, and improve hormonal, metabolic, and lipoprotein markers associated with insulin resistance; and 2) adding niacin, fenofibrate, or a combination of the two drugs to the intensive lifestyle intervention will result in further improvement in the cardiovascular risk profile.

DESIGN NARRATIVE:

This randomized, placebo-controlled study of 200 hypertriglyceridemic HIV patients on stable HAART treatment has the following specific aims: 1) to compare the effects of usual care, intensive DE, DE plus niacin, DE plus fenofibrate, and DE plus niacin plus fenofibrate on fasting plasma lipid concentrations (primary endpoint); 2) to compare the effects of the five treatment protocols on body fat distribution; and 3) to compare the effects of the five treatment protocols on hormonal, lipoprotein, and metabolic markers of insulin resistance. The collaborative team has expertise in lipid and lipoprotein metabolism, innovative and effective diet modification programs, intensive exercise programs in HIV patients, and studies of antilipidemic and antiretroviral agents. Therefore, this study will determine the efficacy of DE, with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

Study Design

• Study Type: Interventional
• Actual Enrollment: 221 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Subjects receive lifestyle advice and placebos for Niaspan and Tricor	Other: Placebos; Placebos for Niaspan and Tricor
Experimental: 2 Diet, exercise, and two placebos	Behavioral: Diet; ATP-III diet; Behavioral: Exercise; Supervised exercise in study gym; Other: Placebos; Placebos for Niaspan and Tricor
Experimental: 3 Diet, exercise, Niaspan, and placebo	Behavioral: Diet; ATP-III diet; Behavioral: Exercise; Supervised exercise in study gym; Drug: Niacin; Niaspan, titrated up to 2 grams per day; Other: Placebos; Placebos for Niaspan and Tricor
Experimental: 4 Diet, exercise, placebo, and Tricor	Behavioral: Diet; ATP-III diet; Behavioral: Exercise; Supervised exercise in study gym; Drug: Fenofibrate; Tricor, 120 mg per day; Other: Placebos; Placebos for Niaspan and Tricor
Experimental: 5 Diet, exercise, Niaspan, and Tricor	Behavioral: Diet; ATP-III diet; Behavioral: Exercise; Supervised exercise in study gym; Drug: Niacin; Niaspan, titrated up to 2 grams per day; Drug: Fenofibrate; Tricor, 120 mg per day

Outcome Measures

Primary Outcome Measures

1. Triglycerides [Measured at 24 weeks]

   Triglycerides (mg/dL): Fasting lipid levels

2. Non-HDL-C [Measured at 24 weeks]

   non-HDL-C (mg/dL): Fasting lipid levels

3. HDL-C [Measured at 24 weeks]

   HDL-C (mg/dL): Fasting lipid levels

4. Total Cholesterol [Measured at 24 weeks]

   Total cholesterol (mg/dL): Fasting lipid levels

5. Total Cholesterol : HDL-C Ratio [Measured at 24 weeks]

   Total cholesterol : HDL-C ratio: Fasting lipid levels

Secondary Outcome Measures

1. Insulin Sensitivity [Measured at 24 weeks]

   Adiponectin (micrograms/ml)

2. Body Composition [Measured at 24 weeks]

   Body cell mass (kg) Fat mass (kg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV positive

• On stable HAART regimen for at least 6 months prior to study entry

• T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry

• Fasting triglyceride level greater than 150 mg/dl

• Body mass index (BMI) greater than 18.5 and less than 30

• Uses barrier contraception

Exclusion Criteria:

• Fasting triglyceride level greater than 1000 mg/dl

• BMI less than 18.5 or greater than 30

• Taking diabetic medication or HbA1c less than 7.0

• Use of lipid lowering medication in the 30 days prior to study entry

• Unable to exercise

• T-cell count less than 100

• Current medical condition that makes exercise unadvisable

• History of coronary artery disease (CAD)

• Use of dietary supplements (within 30 days of study entry) that may affect lipid levels including, but not limited to, the following:

1. Omega-3 fatty acids

2. L-Carnitine

3. Soluble fiber supplements

4. Guggul

5. Garlic supplements

6. Niacin greater than 25mg/d

7. Oral liquid supplements

• Use of steroids, hormones, or testosterone (without diagnosis of hypogonadism, testosterone less than 300 ng/dl)

• Irregular periods

• Depo-Provera

• Hypo- or Hyperthyroidism

• Adrenal insufficiency

• Serum alanine or aspartate aminotransferase level greater than 3 times the upper limit of normal

• Alcohol abuse

• Renal insufficiency (creatinine level greater than 1.5 mg/dl)

• Coumadin therapy

• Pregnancy

• Peptic ulcer disease

• Cholelithiasis

• History of hyperuricemia

• History of myositis or rhabdomyolysis

• Known adverse reaction to niacin or fibrates

• Hepatitis C therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77098

Sponsors and Collaborators

• Baylor College of Medicine
• National Heart, Lung, and Blood Institute (NHLBI)
• Legacy Community Health Center

Investigators

• Principal Investigator: Ashok Balasubramanyam, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Samson SL, Pownall HJ, Scott LW, Ballantyne CM, Smith EO, Sekhar RV, Balasubramanyam A. Heart positive: design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/dyslipidemia. Contemp Clin Trials. 2006 Dec;27(6):518-30. Epub 2006 Jul 21.

• Responsible Party: Ashok Balasubramanyam, Principal Investigator, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00246376
• Other Study ID Numbers: H-14105; R01HL073696
• First Posted: Oct 30, 2005
• Last Update Posted: Mar 21, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Lipodystrophy; Insulin Resistance; Hyperlipidemias; Hypertriglyceridemia; Niacin; Fenofibrate

Study Results

Participant Flow

Recruitment Details	Subjects were recruited mainly from the Legacy Community Health Center and Thomas Street Clinic of the Harris County Hospital District and from Houston Area Community Services and private clinics. Recruitment period: January 2004 to September 2009.
Pre-assignment Detail	If potential subjects were taking nutritional supplements or lipid-lowering drugs, these were discontinued for washout for 6 weeks - baseline fasting lipid levels were then measured to determine eligibility prior to randomization.

Arm/Group Title	Group 1: Usual Care	Group 2: Diet / Exercise	Group 3: Diet / Exercise + Fenofibrate	Group 4: Diet / Exercise + Niacin	Group 5: Diet / Exercise + Niacin + Fenofibrate
Arm/Group Description	Subjects receive lifestyle advice and placebos for Niaspan and Tricor	Diet, exercise, and two placebos	Diet, exercise, Fenofibrate, and Niaspan placebo	Diet, exercise, Fenofibrate placebo, and Niaspan	Diet, exercise, Fenofibrate and Niaspan
Period Title: Overall Study
STARTED	41	43	45	47	45
After Dietary run-in at Two Weeks	30	38	41	40	42
COMPLETED	26	24	29	21	28
NOT COMPLETED	15	19	16	26	17

Baseline Characteristics

Arm/Group Title	Group 1: Usual Care	Group 2: Diet / Exercise	Group 3: Diet / Exercise + Fenofibrate	Group 4: Diet / Exercise + Niacin	Group 5: Diet / Exercise + Niacin + Fenofibrate	Total
Arm/Group Description	Subjects receive lifestyle advice and placebos for Niaspan and Tricor	Diet, exercise, and two placebos	Diet, exercise, Fenofibrate, and Niaspan placebo	Diet, exercise, Fenofibrate placebo, and Niaspan	Diet, exercise, Fenofibrate and Niaspan	Total of all reporting groups
Overall Participants	41	43	45	47	45	221
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	40 97.6%	43 100%	45 100%	47 100%	45 100%	220 99.5%
>=65 years	1 2.4%	0 0%	0 0%	0 0%	0 0%	1 0.5%
Sex: Female, Male (Count of Participants)
Female	4 9.8%	4 9.3%	9 20%	5 10.6%	7 15.6%	29 13.1%
Male	37 90.2%	39 90.7%	36 80%	42 89.4%	38 84.4%	192 86.9%
Region of Enrollment (participants) [Number]
United States	41 100%	43 100%	45 100%	47 100%	45 100%	221 100%

Outcome Measures

1. Primary Outcome

Title	Triglycerides
Description	Triglycerides (mg/dL): Fasting lipid levels
Time Frame	Measured at 24 weeks

Outcome Measure Data

Analysis Population Description

All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Arm/Group Title	Group 1 - Usual Care	Group 2 - Diet/Exercise Only	Group 3 - Diet/Exercise + Fenofibrate	Group 4 - Diet/Exercise + Niacin	Group 5 - Diet/Exercise + Fenofibrate + Niacin
Arm/Group Description	These subjects did not participate in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.	These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.	These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Measure Participants	30	38	41	40	42
Mean (Standard Error) [mg/dL]	199 (24.9)	216.9 (28.6)	155.1 (18.5)	177.6 (24.2)	135.6 (16.9)

2. Secondary Outcome

Title	Insulin Sensitivity
Description	Adiponectin (micrograms/ml)
Time Frame	Measured at 24 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed 24 weeks.

Arm/Group Title	Group 1 - Usual Care	Group 2 - Diet/Exercise Only	Group 3 - Diet/Exercise + Fenofibrate	Group 4 - Diet/Exercise + Niacin	Group 5 - Diet/Exercise + Fenofibrate + Niacin
Arm/Group Description
Measure Participants	26	24	29	21	28
Fasting insulin	8.7 (2)	6.7 (1.6)	9.5 (1.6)	11.9 (3)	10.3 (2.5)
HOMA-IR	1.92 (0.47)	1.38 (0.36)	2.02 (0.47)	2.76 (0.75)	2.38 (0.62)
Insulin sensitvity index	3.54 (0.73)	4.95 (1.1)	3.81 (0.76)	2.88 (0.67)	2.38 (0.62)
Adiponectin	7.12 (1.09)	6.04 (0.98)	5.24 (0.76)	11.01 (1.87)	10.34 (1.67)

3. Secondary Outcome

Title	Body Composition
Description	Body cell mass (kg) Fat mass (kg)
Time Frame	Measured at 24 weeks

Outcome Measure Data

Analysis Population Description

The number corresponds to the number of subjects who completed the study (see Participant flow)

Arm/Group Title	Group 1 - Usual Care	Group 2 - Diet/Exercise	Group 3 - Diet/Exercise + Fenofibrate	Group 4 - Diet/Exercise + Niacin	Group 5 - Diet/Exercise + Fenofibrate + Niacin
Arm/Group Description
Measure Participants	26	24	29	21	28
Body cell mass	59.6 (2.3)	67.3 (2)	66.6 (1.8)	67.1 (2.1)	68.2 (2)
Fat mass	36.8 (1.9)	37.5 (1.6)	35.8 (1.5)	37.7 (1.8)	36.2 (1.7)

4. Primary Outcome

Title	Non-HDL-C
Description	non-HDL-C (mg/dL): Fasting lipid levels
Time Frame	Measured at 24 weeks

Outcome Measure Data

Analysis Population Description

All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Arm/Group Title	Group 1 - Usual Care	Group 2 - Diet/Exercise Only	Group 3 - Diet/Exercise + Fenofibrate	Group 4 - Diet/Exercise + Niacin	Group 5 - Diet/Exercise + Fenofibrate + Niacin
Arm/Group Description	These subjects did not participate in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.	These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.	These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Measure Participants	30	38	41	40	42
Mean (Standard Error) [mg/dl]	162.2 (7.8)	165.4 (8.1)	145.8 (7.4)	154 (8.3)	137.1 (7.7)

5. Primary Outcome

Title	HDL-C
Description	HDL-C (mg/dL): Fasting lipid levels
Time Frame	Measured at 24 weeks

Outcome Measure Data

Analysis Population Description

All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Arm/Group Title	Group 1 - Usual Care	Group 2 - Diet/Exercise Only	Group 3 - Diet/Exercise + Fenofibrate	Group 4 - Diet/Exercise + Niacin	Group 5 - Diet/Exercise + Fenofibrate + Niacin
Arm/Group Description	These subjects did not participate in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.	These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.	These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Measure Participants	30	38	41	40	42
Mean (Standard Error) [mg/dl]	37.1 (1.8)	38.7 (1.9)	40.7 (1.8)	41.8 (2.2)	44.8 (2.1)

6. Primary Outcome

Title	Total Cholesterol
Description	Total cholesterol (mg/dL): Fasting lipid levels
Time Frame	Measured at 24 weeks

Outcome Measure Data

Analysis Population Description

All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Arm/Group Title	Group 1 - Usual Care	Group 2 - Diet/Exercise Only	Group 3 - Diet/Exercise + Fenofibrate	Group 4 - Diet/Exercise + Niacin	Group 5 - Diet/Exercise + Fenofibrate + Niacin
Arm/Group Description	These subjects did not participate in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.	These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.	These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Measure Participants	30	38	41	40	42
Mean (Standard Error) [mg/dL]	195.6 (7.7)	200.1 (8.3)	184 (6.9)	190.8 (8.2)	178.4 (7)

7. Primary Outcome

Title	Total Cholesterol : HDL-C Ratio
Description	Total cholesterol : HDL-C ratio: Fasting lipid levels
Time Frame	Measured at 24 weeks

Outcome Measure Data

Analysis Population Description

All those who underwent the 2-week (first follow-up) measurement and continued in the study.

Arm/Group Title	Group 1 - Usual Care	Group 2 - Diet/Exercise Only	Group 3 - Diet/Exercise + Fenofibrate	Group 4 - Diet/Exercise + Niacin	Group 5 - Diet/Exercise + Fenofibrate + Niacin
Arm/Group Description	These subjects did not participate in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took placebos.	These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.	These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.	These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
Measure Participants	30	38	41	40	42
Mean (Standard Error) [ratio]	5.2 (0.3)	5.1 (0.3)	4.5 (0.2)	4.6 (0.3)	4 (0.2)

Adverse Events

Time Frame	Throughout duration of study (5 years)
Arm/Group Title	Group 1: Usual Care		Group 2: Diet / Exercise		Group 3: Diet / Exercise + Fenofibrate		Group 4: Diet / Exercise + Niacin		Group 5: Diet / Exercise + Niacin + Fenofibrate
Arm/Group Description	Subjects receive lifestyle advice and placebos for Niaspan and Tricor		Diet, exercise, and two placebos		Diet, exercise, Fenofibrate, and Niaspan placebo		Diet, exercise, Fenofibrate placebo, and Niaspan		Diet, exercise, Fenofibrate and Niaspan
All Cause Mortality
	Group 1: Usual Care		Group 2: Diet / Exercise		Group 3: Diet / Exercise + Fenofibrate		Group 4: Diet / Exercise + Niacin		Group 5: Diet / Exercise + Niacin + Fenofibrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: Usual Care		Group 2: Diet / Exercise		Group 3: Diet / Exercise + Fenofibrate		Group 4: Diet / Exercise + Niacin		Group 5: Diet / Exercise + Niacin + Fenofibrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/30 (23.3%)		10/38 (26.3%)		6/41 (14.6%)		4/40 (10%)		5/42 (11.9%)
Cardiac disorders
Chest pain / angina	1/30 (3.3%)	1	1/38 (2.6%)	1	1/41 (2.4%)	1	1/40 (2.5%)	1	0/42 (0%)	0
Hepatobiliary disorders
Transaminases elevated >3 times upper normal limit	1/30 (3.3%)	1	1/38 (2.6%)	1	0/41 (0%)	0	1/40 (2.5%)	1	2/42 (4.8%)	2
Elevated Bilirubin	3/30 (10%)	3	5/38 (13.2%)	5	4/41 (9.8%)	4	0/40 (0%)	0	2/42 (4.8%)	2
Metabolism and nutrition disorders
Triglycerides > 1000mg/dl	1/30 (3.3%)	1	3/38 (7.9%)	3	0/41 (0%)	0	1/40 (2.5%)	1	0/42 (0%)	0
Renal and urinary disorders
Serum creatining > 1.5 mg/dL	1/30 (3.3%)	1	0/38 (0%)	0	1/41 (2.4%)	1	1/40 (2.5%)	1	1/42 (2.4%)	1
Other (Not Including Serious) Adverse Events
	Group 1: Usual Care		Group 2: Diet / Exercise		Group 3: Diet / Exercise + Fenofibrate		Group 4: Diet / Exercise + Niacin		Group 5: Diet / Exercise + Niacin + Fenofibrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/30 (56.7%)		11/38 (28.9%)		12/41 (29.3%)		33/40 (82.5%)		25/42 (59.5%)
Cardiac disorders
Acute myocardial infarction	0/30 (0%)	0	1/38 (2.6%)	1	0/41 (0%)	0	0/40 (0%)	0	0/42 (0%)	0
Ear and labyrinth disorders
Dizziness	1/30 (3.3%)	1	1/38 (2.6%)	1	0/41 (0%)	0	1/40 (2.5%)	1	1/42 (2.4%)	1
Gastrointestinal disorders
Diarrhea	3/30 (10%)	3	1/38 (2.6%)	1	2/41 (4.9%)	2	2/40 (5%)	2	0/42 (0%)	0
Nausea/Vomiting	2/30 (6.7%)	2	1/38 (2.6%)	1	4/41 (9.8%)	4	0/40 (0%)	0	3/42 (7.1%)	3
Abdominal pain	1/30 (3.3%)	1	2/38 (5.3%)	2	0/41 (0%)	0	1/40 (2.5%)	1	0/42 (0%)	0
General disorders
Fatigue	2/30 (6.7%)	2	0/38 (0%)	0	1/41 (2.4%)	1	1/40 (2.5%)	1	2/42 (4.8%)	2
Loss of appetite	1/30 (3.3%)	1	1/38 (2.6%)	1	0/41 (0%)	0	0/40 (0%)	0	1/42 (2.4%)	1
Hepatobiliary disorders
Acute cholecystitis	0/30 (0%)	0	0/38 (0%)	0	0/41 (0%)	0	1/40 (2.5%)	1	0/42 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/30 (0%)	0	0/38 (0%)	0	0/41 (0%)	0	2/40 (5%)	2	1/42 (2.4%)	1
Headache	5/30 (16.7%)	5	0/38 (0%)	0	0/41 (0%)	0	2/40 (5%)	2	0/42 (0%)	0
Body ache	0/30 (0%)	0	1/38 (2.6%)	1	0/41 (0%)	0	1/40 (2.5%)	1	2/42 (4.8%)	2
Leg cramps	0/30 (0%)	0	1/38 (2.6%)	1	0/41 (0%)	0	0/40 (0%)	0	1/42 (2.4%)	1
Psychiatric disorders
Suicide attempt	0/30 (0%)	0	0/38 (0%)	0	0/41 (0%)	0	1/40 (2.5%)	1	0/42 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/30 (0%)	0	0/38 (0%)	0	0/41 (0%)	0	1/40 (2.5%)	1	0/42 (0%)	0
Kidney stone	0/30 (0%)	0	0/38 (0%)	0	1/41 (2.4%)	1	0/40 (0%)	0	0/42 (0%)	0
Polyuria	0/30 (0%)	0	0/38 (0%)	0	1/41 (2.4%)	1	1/40 (2.5%)	1	0/42 (0%)	0
Skin and subcutaneous tissue disorders
Rash/Itching	1/30 (3.3%)	1	0/38 (0%)	0	0/41 (0%)	0	3/40 (7.5%)	3	2/42 (4.8%)	2
Flushing	1/30 (3.3%)	1	2/38 (5.3%)	2	3/41 (7.3%)	3	16/40 (40%)	16	12/42 (28.6%)	12

Limitations/Caveats

High dropout rate, especially by loss to follow-up (with no explanation). Flushing was common among patients taking niacin, and this (with transportation and socio-economc problems) could have contributed to the high drop-out rate.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.