Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01200160
• Collaborator: QUASY (Other)
• Enrollment: 128
• Locations: 22
• Duration (Months): 26.9
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Post-Marketing Observational study of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of observation of 12 months. This includes an enrollment period of 6 months in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on Case Report Forms (CRFs) by the investigator or site staffs according to the protocol.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Drug: Niacin

Detailed Description

This is a Post-Marketing Observational study (PMOS) of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of 12 months. This includes an enrollment period of 6 months and a treatment duration in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on CRFs by the investigator or site staffs according to the protocol.

Prior to enrollment in the study, each subject will be required to give their written informed consent to participate in the study. Written informed consent will include a statement authorizing the use and/or disclosure of their personal and/or health data. The subject will be assured that patient confidentiality will be maintained at all times according to the local regulations, and that data that might identify the patient will not be collected

For patient's consenting to participate in this PMOS study and meeting all of the inclusion and none of the exclusion criteria, at the initial visit or baseline as well at subsequent visits if appropriate , their demographic, medical history, physical examination, vital sign, flushing/adverse event assessments, concomitant medication information, Niaspan dose change/compliance, and lab testing will be documented as per standard medical practice in each country, although not in a protocolized manner.

If Niaspan® treatment is discontinued, subjects will be followed for another 1 month for any adverse event.

Study Design

• Study Type: Observational
• Actual Enrollment: 128 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Lipid abnormalities Niacin	Drug: Niacin; Other Names: Niaspan

Outcome Measures

Primary Outcome Measures

1. Effectiveness of Niaspan [24 weeks regarding baseline visit (visit1)]

   Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels. Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression: percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))*100 Then percent change is calculated at 24 weeks regarding baseline for different variables.

Secondary Outcome Measures

1. Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values [every 4 to 8 weeks for 24 weeks]

   Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score

2. Frequency of Flushing Events [every 4 weeks for 24 weeks]

   evaluate occurrence of such events over time

3. Overall Safety and Tolerability of Niaspan [every 4 weeks for 24 weeks]

   Evaluate overall safety of Niaspan through evaluation of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Male and female subject >18 years-old

• Subjects with primary hyperlipidemia or mixed dyslipidemia with elevated levels of total cholesterol,, LDL-C (low-density lipoprotein-cholesterol), triglycerides and/or decreased levels of HDL-C (high-density lipoprotein-cholesterol) (< 40 mg/dL) and has demonstrated an inadequate response to a lipid-restricted diet and other non-pharmacologic measures alone such as exercise

• Subject has demonstrated persistent dyslipidemic values and/or inadequate response or intolerance to other pharmacologic therapies such as statins, fibrates, resins, etc.

• Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device (IUD), birth control pills or barrier device) during and for 3 months after discontinuation of study treatment.

Exclusion Criteria

• Subject has been treated with any other investigational product in the last 30 days before the day of the screening visit

• Subject exhibits signs of acute illness with clinically relevant findings in the pre-study examination

• Subject has known hypersensitivity to niacin or any component of Niaspan®

• Subject has significant or unexplained hepatic and/or renal dysfunction

• Subject has active peptic ulcer disease

• Subject exhibits active arterial bleeding

• Subject is pregnant or lactating

• The mental condition of the subject renders him/her unable to understand the nature, scope, and possible consequences of the study

• Subject is unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 48183	Cali		Colombia	101-102
2	Site Reference ID/Investigator# 48182	Cali		Colombia
3	Site Reference ID/Investigator# 42108	Aguascalientes		Mexico	20129
4	Site Reference ID/Investigator# 42110	Aguascalientes		Mexico	20234
5	Site Reference ID/Investigator# 42103	Guadalajara, Jalisco		Mexico	44657
6	Site Reference ID/Investigator# 42105	Metepec, Estado de Mexico		Mexico	52140
7	Site Reference ID/Investigator# 42102	Mexico City DF		Mexico	03920
8	Site Reference ID/Investigator# 42107	Mexico City DF		Mexico	06359
9	Site Reference ID/Investigator# 42109	Mexico City DF		Mexico	11560
10	Site Reference ID/Investigator# 42106	Mexico City DF		Mexico	11850
11	Site Reference ID/Investigator# 26348	Mexico D.F.		Mexico	C.P. 11650
12	Site Reference ID/Investigator# 42104	Tijuana, Baja California Norte		Mexico	11650
13	Site Reference ID/Investigator# 42112	Tijuana, Baja California Norte		Mexico	22420
14	Site Reference ID/Investigator# 42111	Tuxtla Gutierrez, Chiapas		Mexico	29000
15	Site Reference ID/Investigator# 42114	Tuxtla Gutierrez, Chiapas		Mexico	29030
16	Site Reference ID/Investigator# 42113	Zacatecas		Mexico	98608
17	Site Reference ID/Investigator# 42115	Zapopan, Jalisco		Mexico	45200
18	Site Reference ID/Investigator# 44202	Bolivar		Venezuela	8050
19	Site Reference ID/Investigator# 26350	Caracas		Venezuela	1010
20	Site Reference ID/Investigator# 44206	Caracas		Venezuela	1010
21	Site Reference ID/Investigator# 44203	Caracas		Venezuela	1060
22	Site Reference ID/Investigator# 44204	Estado Carabobo		Venezuela	2001

Sponsors and Collaborators

• Abbott
• QUASY

Investigators

• Principal Investigator: Enrique C Morales Villegas, MD, Centro de Investigación Cardiometabólica

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01200160
• Other Study ID Numbers: P12-055
• First Posted: Sep 13, 2010
• Last Update Posted: Jun 6, 2014
• Last Verified: May 1, 2014

• Keywords provided by Abbott: Low-Density Lipoprotein Cholesterol; Hypertriglyceridemia; Latin America; Cardiovascular Diseases; Cholesterol; Sedentary Lifestyle; High-Density Lipoprotein Cholesterol
• Additional relevant MeSH terms: Cardiovascular Diseases; Niacin

Study Results

Participant Flow

Arm/Group Title	Lipid Abnormalities
Arm/Group Description	No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients. This study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject's was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol. Typically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country.
Period Title: Overall Study
STARTED	128
COMPLETED	66
NOT COMPLETED	62

Baseline Characteristics

Arm/Group Title	Lipid Abnormalities
Arm/Group Description
Overall Participants	128
Age (participants) [Number]
<=18 years	0 0%
Between 18 and 65 years	96 75%
>=65 years	31 24.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (13)
Sex: Female, Male (Count of Participants)
Female	53 41.4%
Male	75 58.6%
Region of Enrollment (participants) [Number]
Mexico	53 41.4%
Venezuela	60 46.9%
Colombia	15 11.7%

Outcome Measures

1. Primary Outcome

Title	Effectiveness of Niaspan
Description	Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels. Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression: percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))*100 Then percent change is calculated at 24 weeks regarding baseline for different variables.
Time Frame	24 weeks regarding baseline visit (visit1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HDL-Cholesterol
Arm/Group Description
Measure Participants	53
Mean (Standard Deviation) [mg/dL]	41.9755 (7.56248)

2. Secondary Outcome

Title	Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values
Description	Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score
Time Frame	every 4 to 8 weeks for 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Frequency of Flushing Events
Description	evaluate occurrence of such events over time
Time Frame	every 4 weeks for 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Overall Safety and Tolerability of Niaspan
Description	Evaluate overall safety of Niaspan through evaluation of adverse events
Time Frame	every 4 weeks for 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	24 weeks
Arm/Group Title	Lipid Abnormalities
Arm/Group Description	Those with the condition and exposed to the study drug
All Cause Mortality
	Lipid Abnormalities
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lipid Abnormalities
	Affected / at Risk (%)	# Events
Total	0/128 (0%)
Other (Not Including Serious) Adverse Events
	Lipid Abnormalities
	Affected / at Risk (%)	# Events
Total	31/128 (24.2%)
Skin and subcutaneous tissue disorders
Flushing	31/128 (24.2%)	35

Limitations/Caveats

Expected sample size was not achieved due to supply issues with the new formulation in Mexico and the local decision in Colombia to cancel marketing the product in the country.

More Information

Certain Agreements

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

An agreement is in place that includes a clause of keeping Abbott´s information confidential and that any publication would be performed under agreement with Abbott.