Hypercholesterolemia, Mixed Dyslipidemia
Conditions
Keywords
Usual practice re-examination
Brief summary
This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration.
Interventions
Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who are treated with TREDAPTIVE tablet within current local label for the first time * Participants with primary hypercholesterolemia or mixed dyslipidemia * Participants who are treated with TREDAPTIVE for more than or equal to 24 weeks will be included in long-term surveillance * Special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected.
Exclusion criteria
* Participant who is treated with TREDAPTIVE tablet before contract and out of enrollment period * Participant who has a contraindication to TREDAPTIVE tablet according to the current local label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Cholesterol at Week 24 | Baseline and Week 24 | Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE |
| Percentage of Participants With Any Adverse Experience | From start of treatment through 14 days after the last dose (Up to 26 weeks) | An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event. |
| Percentage of Participants With Adverse Drug Reactions | From start of treatment through 14 days after the last dose (Up to 26 weeks) | An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event. |
| Change From Baseline in Total Cholesterol at Week 12 | Baseline and Week 12 | Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE |
| Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 | Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE |
| Change From Baseline in Triglycerides at Week 12 | Baseline and Week 12 | Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Baseline and Week 24 | Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE |
| Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Baseline and Week 24 | Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE |
| Change From Baseline in Triglycerides at Week 24 | Baseline and Week 24 | Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE |
| Investigator's Overall Efficacy Evaluation at Week 12 | Baseline and Week 12 | The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline. |
| Investigator's Overall Efficacy Evaluation at Week 24 | Baseline and Week 24 | The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline. |
Participant flow
Recruitment details
1,166 participants who were currently using niacin (+) laropiprant (TREDAPTIVE) for treatment of primary hypercholesterolemia or mixed dyslipidemia were enrolled and their case report forms were collected. Enrollment was stopped early due to termination of all studies involving TREDAPTIVE.
Pre-assignment details
A completer was considered a participant eligible for safety population. Efficacy population was a sub-population of the safety population
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) | 862 |
| Total | 862 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Dose Violation | 70 |
| Overall Study | Duplicate enrollment | 1 |
| Overall Study | Missing pre-treatment data | 72 |
| Overall Study | Triglyceride Entry Criteria Not Met | 152 |
| Overall Study | Violation of Entry Criterion | 9 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 59.03 years STANDARD_DEVIATION 10.92 |
| Sex: Female, Male Female | 268 Participants |
| Sex: Female, Male Male | 594 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 65 / 862 |
| serious Total, serious adverse events | 7 / 862 |
Outcome results
Primary
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 12
Population: Participants in safety population whose case report form contained baseline and Week 12 data for HDL-C levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | 7.06 mg/dL | Standard Deviation 9.53 |
Primary
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24
Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 24
Population: Participants in safety population whose case report form contained baseline and Week 24 data for HDL-C levels and had received TREDAPTIVE for 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 | 6.25 mg/dL | Standard Deviation 8.7 |
Primary
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 12
Population: Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -6.81 mg/dL | Standard Deviation 29.2 |
Primary
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 24
Population: Participants in safety population whose case report form contained baseline and Week 24 data for LDL-C levels and had received TREDAPTIVE for 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | -14.82 mg/dL | Standard Deviation 30.09 |
Primary
Change From Baseline in Total Cholesterol at Week 12
Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 12
Population: Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Total Cholesterol at Week 12 | -12.52 mg/dL | Standard Deviation 32.44 |
Primary
Change From Baseline in Total Cholesterol at Week 24
Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 24
Population: Participants in safety population whose case report form contained baseline and Week 24 data for total cholesterol levels and had received TREDAPTIVE for 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Total Cholesterol at Week 24 | -20.01 mg/dL | Standard Deviation 35.08 |
Primary
Change From Baseline in Triglycerides at Week 12
Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 12
Population: Participants in safety population whose case report form contained baseline and Week 12 data for triglyceride levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Triglycerides at Week 12 | -106.32 mg/dL | Standard Deviation 208.38 |
Primary
Change From Baseline in Triglycerides at Week 24
Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Time frame: Baseline and Week 24
Population: Participants in safety population whose case report form contained baseline and Week 24 data for triglyceride levels and had received TREDAPTIVE for 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Triglycerides at Week 24 | -137.87 mg/dL | Standard Deviation 153.24 |
Primary
Investigator's Overall Efficacy Evaluation at Week 12
The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline.
Time frame: Baseline and Week 12
Population: Participants in safety population whose case report form contained the investigator's overall assessment after 12 weeks of treatment with TREDAPTIVE
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Investigator's Overall Efficacy Evaluation at Week 12 | Improved | 68.23 Percentage of Participants |
| All Participants | Investigator's Overall Efficacy Evaluation at Week 12 | Unchanged | 25.86 Percentage of Participants |
| All Participants | Investigator's Overall Efficacy Evaluation at Week 12 | Worsened | 5.91 Percentage of Participants |
Primary
Investigator's Overall Efficacy Evaluation at Week 24
The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline.
Time frame: Baseline and Week 24
Population: Participants in safety population whose case report form contained the investigator's overall assessment after 24 weeks of treatment with TREDAPTIVE
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Investigator's Overall Efficacy Evaluation at Week 24 | Worsened | 6.87 Percentage of Participants |
| All Participants | Investigator's Overall Efficacy Evaluation at Week 24 | Improved | 72.52 Percentage of Participants |
| All Participants | Investigator's Overall Efficacy Evaluation at Week 24 | Unchanged | 20.61 Percentage of Participants |
Primary
Percentage of Participants With Adverse Drug Reactions
An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks)
Population: Safety population: all enrolled participants who met entry criteria regarding safety data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Adverse Drug Reactions | 15.20 Percentage of Participants |
Primary
Percentage of Participants With Any Adverse Experience
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks)
Population: Safety population: all enrolled participants who met entry criteria regarding safety data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Any Adverse Experience | 19.61 Percentage of participants |