Cardiovascular Diseases
Conditions
Keywords
Low-Density Lipoprotein Cholesterol, Hypertriglyceridemia, Latin America, Cardiovascular Diseases, Cholesterol, Sedentary Lifestyle, High-Density Lipoprotein Cholesterol
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.
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.
Interventions
DRUGNiacin
Sponsors
QUASY
Abbott
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Frequency of Flushing Events | every 4 weeks for 24 weeks | evaluate occurrence of such events over time |
| Overall Safety and Tolerability of Niaspan | every 4 weeks for 24 weeks | Evaluate overall safety of Niaspan through evaluation of adverse events |
Countries
Colombia, Mexico, Venezuela
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lipid Abnormalities | 128 |
| Total | 128 |
Baseline characteristics
| Characteristic | Lipid Abnormalities |
|---|---|
| Age, Categorical <=18 years | 0 participants |
| Age, Categorical >=65 years | 31 participants |
| Age, Categorical Between 18 and 65 years | 96 participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 13 |
| Region of Enrollment Colombia | 15 participants |
| Region of Enrollment Mexico | 53 participants |
| Region of Enrollment Venezuela | 60 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
Primary
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.
Time frame: 24 weeks regarding baseline visit (visit1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HDL-Cholesterol | Effectiveness of Niaspan | 41.9755 mg/dL | Standard Deviation 7.56248 |
Secondary
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
Time frame: every 4 to 8 weeks for 24 weeks
Secondary
Frequency of Flushing Events
evaluate occurrence of such events over time
Time frame: every 4 weeks for 24 weeks
Secondary
Overall Safety and Tolerability of Niaspan
Evaluate overall safety of Niaspan through evaluation of adverse events
Time frame: every 4 weeks for 24 weeks