Trial Outcomes & Findings for Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America (NCT NCT01200160)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

128 participants

Primary outcome timeframe

24 weeks regarding baseline visit (visit1)

Results posted on

2014-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Lipid Abnormalities 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.
Overall Study STARTED	128
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	62

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lipid Abnormalities n=128 Participants
Age, Categorical <=18 years	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	96 participants n=5 Participants
Age, Categorical >=65 years	31 participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants
Region of Enrollment Mexico	53 participants n=5 Participants
Region of Enrollment Venezuela	60 participants n=5 Participants
Region of Enrollment Colombia	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HDL-Cholesterol n=53 Participants
Effectiveness of Niaspan	41.9755 mg/dL Standard Deviation 7.56248

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every 4 weeks for 24 weeks

evaluate occurrence of such events over time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every 4 weeks for 24 weeks

Evaluate overall safety of Niaspan through evaluation of adverse events

Outcome measures

Outcome data not reported

Adverse Events

Lipid Abnormalities

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lipid Abnormalities n=128 participants at risk Those with the condition and exposed to the study drug
Skin and subcutaneous tissue disorders Flushing	24.2% 31/128 • Number of events 35 • 24 weeks

Additional Information

Carlos A Gonzalez MD, PhD

Abbott Laboratories de México

Phone: (5255) 5809-

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER