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

Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Colombia
  • Cali, Colombia, 101-102
    • Site Reference ID/Investigator# 48183
  • Cali, Colombia
    • Site Reference ID/Investigator# 48182
• Mexico
  • Aguascalientes, Mexico, 20129
    • Site Reference ID/Investigator# 42108
  • Aguascalientes, Mexico, 20234
    • Site Reference ID/Investigator# 42110
  • Guadalajara, Jalisco, Mexico, 44657
    • Site Reference ID/Investigator# 42103
  • Metepec, Estado de Mexico, Mexico, 52140
    • Site Reference ID/Investigator# 42105
  • Mexico City DF, Mexico, 03920
    • Site Reference ID/Investigator# 42102
  • Mexico City DF, Mexico, 06359
    • Site Reference ID/Investigator# 42107
  • Mexico City DF, Mexico, 11560
    • Site Reference ID/Investigator# 42109
  • Mexico City DF, Mexico, 11850
    • Site Reference ID/Investigator# 42106
  • Mexico D.F., Mexico, C.P. 11650
    • Site Reference ID/Investigator# 26348
  • Tijuana, Baja California Norte, Mexico, 11650
    • Site Reference ID/Investigator# 42104
  • Tijuana, Baja California Norte, Mexico, 22420
    • Site Reference ID/Investigator# 42112
  • Tuxtla Gutierrez, Chiapas, Mexico, 29000
    • Site Reference ID/Investigator# 42111
  • Tuxtla Gutierrez, Chiapas, Mexico, 29030
    • Site Reference ID/Investigator# 42114
  • Zacatecas, Mexico, 98608
    • Site Reference ID/Investigator# 42113
  • Zapopan, Jalisco, Mexico, 45200
    • Site Reference ID/Investigator# 42115
• Venezuela
  • Bolivar, Venezuela, 8050
    • Site Reference ID/Investigator# 44202
  • Caracas, Venezuela, 1010
    • Site Reference ID/Investigator# 26350
  • Caracas, Venezuela, 1010
    • Site Reference ID/Investigator# 44206
  • Caracas, Venezuela, 1060
    • Site Reference ID/Investigator# 44203
  • Estado Carabobo, Venezuela, 2001
    • Site Reference ID/Investigator# 44204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Niaspan	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.	24 weeks regarding baseline visit (visit1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values	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	every 4 to 8 weeks for 24 weeks
Frequency of Flushing Events	evaluate occurrence of such events over time	every 4 weeks for 24 weeks
Overall Safety and Tolerability of Niaspan	Evaluate overall safety of Niaspan through evaluation of adverse events	every 4 weeks for 24 weeks

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: QUASY
• Investigators: Principal Investigator: Enrique C Morales Villegas, MD, Centro de investigacion Cardiometabolica

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): June 6, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Cholesterol; Cardiovascular Diseases; Sedentary Lifestyle; Hypertriglyceridemia; Latin America; Low-Density Lipoprotein Cholesterol; High-Density Lipoprotein Cholesterol
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Niacin
• Other Study ID Numbers: P12-055