Trial Outcomes & Findings for Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females (NCT NCT03615534)
NCT ID: NCT03615534
Last Updated: 2024-01-24
Results Overview
Assessments involve the measurement of serum Triglyceride (TG) level.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
161 participants
Primary outcome timeframe
Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Results posted on
2024-01-24
Participant Flow
Obese females (BMI≥30 kg/m2), within the age of 20-60 years, attending the Obesity research and therapy unit of Al-Kindy College of Medicine, Baghdad, Iraq, throughout the period from 1st October 2014 to 15th March 2015, were screened for preliminary eligibility.
Out of the 161 obese females settled for participation, Atherogenic dyslipidemia (AD) was diagnosed in 69(42.9%) patients, all of whom were enrolled in Therapeutic Lifestyle Changes (TLC) run-in period. AD was averted by TLC in 12(17.4%) patients. The remaining 57(82.6%) non-responding patients were randomly allocated to one of the four study arms.
Participant milestones
| Measure |
Placebo
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
15
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
37.6 years
STANDARD_DEVIATION 2.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
38.9 kg/m^2
STANDARD_DEVIATION 2.1 • n=5 Participants
|
41.5 kg/m^2
STANDARD_DEVIATION 1.7 • n=7 Participants
|
42.0 kg/m^2
STANDARD_DEVIATION 1.7 • n=5 Participants
|
39.7 kg/m^2
STANDARD_DEVIATION 1.8 • n=4 Participants
|
40.6 kg/m^2
STANDARD_DEVIATION 1.8 • n=21 Participants
|
PRIMARY outcome
Timeframe: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.Assessments involve the measurement of serum Triglyceride (TG) level.
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes Serum Triglyceride Levels
Baseline TG levels
|
223.1 mg/dl
Standard Error 23.4
|
241.2 mg/dl
Standard Error 19.1
|
227.0 mg/dl
Standard Error 19.7
|
267.2 mg/dl
Standard Error 20.5
|
|
Changes Serum Triglyceride Levels
Adjusted End line TG levels
|
220.2 mg/dl
Standard Error 12.8
|
133.7 mg/dl
Standard Error 11.4
|
164.0 mg/dl
Standard Error 11.4
|
136.1 mg/dl
Standard Error 12.0
|
PRIMARY outcome
Timeframe: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels. Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC.
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes in Serum Lipoprotein Cholesterol Levels
Baseline TC
|
203.1 mg/dl
Standard Error 11.4
|
190.7 mg/dl
Standard Error 9.3
|
189.1 mg/dl
Standard Error 9.6
|
219.5 mg/dl
Standard Error 10.0
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Baseline HDL-C
|
30.9 mg/dl
Standard Error 2.1
|
32.1 mg/dl
Standard Error 1.7
|
34.2 mg/dl
Standard Error 1.8
|
29.7 mg/dl
Standard Error 1.8
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Baseline d-LDL-C
|
120.0 mg/dl
Standard Error 7.5
|
108.9 mg/dl
Standard Error 6.2
|
120.1 mg/dl
Standard Error 6.4
|
129.3 mg/dl
Standard Error 6.6
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Baseline non HDL-C
|
172.3 mg/dl
Standard Error 11.3
|
158.6 mg/dl
Standard Error 9.2
|
154.9 mg/dl
Standard Error 9.5
|
189.7 mg/dl
Standard Error 9.9
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Baseline RC
|
52.3 mg/dl
Standard Error 8.4
|
49.7 mg/dl
Standard Error 6.8
|
34.9 mg/dl
Standard Error 7.1
|
60.5 mg/dl
Standard Error 7.3
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Adjusted End line TC
|
198.4 mg/dl
Standard Error 7.4
|
171.1 mg/dl
Standard Error 6.7
|
177.3 mg/dl
Standard Error 6.6
|
179.9 mg/dl
Standard Error 6.4
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Adjusted End line HDL-C
|
32.0 mg/dl
Standard Error 1.4
|
37.2 mg/dl
Standard Error 1.3
|
38.3 mg/dl
Standard Error 1.3
|
42.8 mg/dl
Standard Error 1.3
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Adjusted End line d-LDL-C
|
115.7 mg/dl
Standard Error 6.6
|
103.6 mg/dl
Standard Error 5.9
|
103.3 mg/dl
Standard Error 5.9
|
115.0 mg/dl
Standard Error 6.2
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Adjusted End line non HDL-C
|
166.4 mg/dl
Standard Error 7.7
|
134.1 mg/dl
Standard Error 6.9
|
138.7 mg/dl
Standard Error 6.9
|
136.3 mg/dl
Standard Error 7.2
|
|
Changes in Serum Lipoprotein Cholesterol Levels
Adjusted End line RC
|
50.7 mg/dl
Standard Error 4.8
|
30.3 mg/dl
Standard Error 4.3
|
35.7 mg/dl
Standard Error 4.3
|
22.1 mg/dl
Standard Error 4.5
|
PRIMARY outcome
Timeframe: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes in Serum Apolipoprotein Levels
Baseline Apo A1
|
130.8 mg/dl
Standard Error 8.7
|
143.8 mg/dl
Standard Error 7.1
|
150.1 mg/dl
Standard Error 7.4
|
150.0 mg/dl
Standard Error 7.7
|
|
Changes in Serum Apolipoprotein Levels
Baseline Apo B
|
134.1 mg/dl
Standard Error 7.5
|
141.8 mg/dl
Standard Error 6.1
|
123.0 mg/dl
Standard Error 6.3
|
133.1 mg/dl
Standard Error 6.6
|
|
Changes in Serum Apolipoprotein Levels
Adjusted End line Apo A1
|
130.2 mg/dl
Standard Error 10.4
|
155.9 mg/dl
Standard Error 9.3
|
134.2 mg/dl
Standard Error 9.3
|
162.3 mg/dl
Standard Error 9.7
|
|
Changes in Serum Apolipoprotein Levels
Adjusted End line Apo B
|
124.7 mg/dl
Standard Error 6.4
|
106.7 mg/dl
Standard Error 5.7
|
111.1 mg/dl
Standard Error 5.7
|
101.7 mg/dl
Standard Error 6.0
|
SECONDARY outcome
Timeframe: Changes from baseline were assessed at the end eighth week of treatments.Assessments involve the measurement of serum fasting glucose levels.
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes in Serum Fasting Glucose Levels.
Baseline serum fasting glucose
|
93.5 mg/dl
Standard Error 3.9
|
98.9 mg/dl
Standard Error 3.2
|
94.6 mg/dl
Standard Error 3.3
|
94.7 mg/dl
Standard Error 3.4
|
|
Changes in Serum Fasting Glucose Levels.
Adjusted End line serum fasting glucose
|
91.3 mg/dl
Standard Error 2.3
|
91.7 mg/dl
Standard Error 2.0
|
100.1 mg/dl
Standard Error 2.1
|
87.3 mg/dl
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Changes from baseline were assessed at the end of the eighth week of treatments.Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) .
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes in Estimated Glomerular Filtration Rate (eGFR)
Baseline eGFR
|
89.8 ml/min per 1.73 m^2
Standard Error 4.8
|
86.5 ml/min per 1.73 m^2
Standard Error 3.9
|
91.0 ml/min per 1.73 m^2
Standard Error 4.1
|
85.2 ml/min per 1.73 m^2
Standard Error 4.2
|
|
Changes in Estimated Glomerular Filtration Rate (eGFR)
Adjusted End line eGFR
|
83.1 ml/min per 1.73 m^2
Standard Error 3.4
|
83.2 ml/min per 1.73 m^2
Standard Error 3.1
|
82.9 ml/min per 1.73 m^2
Standard Error 3.2
|
79.2 ml/min per 1.73 m^2
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Changes from baseline were assessed at the end of the eighth week of treatments.Assessments involve the measurement of serum uric acid levels
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes in Serum Uric Acid Levels
Baseline serum uric acid
|
4.45 mg/dl
Standard Error 0.30
|
5.21 mg/dl
Standard Error 0.24
|
4.87 mg/dl
Standard Error 0.25
|
5.28 mg/dl
Standard Error 0.26
|
|
Changes in Serum Uric Acid Levels
Adjusted End line serum uric acid
|
4.80 mg/dl
Standard Error 0.25
|
4.0 mg/dl
Standard Error 0.22
|
5.6 mg/dl
Standard Error 0.23
|
3.9 mg/dl
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Changes from baseline were assessed at the end of the eighth week of treatments.Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels.
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes in Serum Enzymes Levels
Baseline CK
|
28.0 IU/L
Standard Error 4.7
|
29.1 IU/L
Standard Error 3.8
|
26.9 IU/L
Standard Error 4.0
|
28.0 IU/L
Standard Error 4.1
|
|
Changes in Serum Enzymes Levels
Baseline AST
|
17.1 IU/L
Standard Error 1.6
|
18.8 IU/L
Standard Error 1.3
|
17.0 IU/L
Standard Error 1.4
|
18.9 IU/L
Standard Error 1.4
|
|
Changes in Serum Enzymes Levels
Baseline ALT
|
13.1 IU/L
Standard Error 1.4
|
16.3 IU/L
Standard Error 1.2
|
16.0 IU/L
Standard Error 1.2
|
17.8 IU/L
Standard Error 1.2
|
|
Changes in Serum Enzymes Levels
Adjusted End line AST
|
18.9 IU/L
Standard Error 0.8
|
17.3 IU/L
Standard Error 0.8
|
18.0 IU/L
Standard Error 0.8
|
19.6 IU/L
Standard Error 0.8
|
|
Changes in Serum Enzymes Levels
Adjusted End line ALT
|
15.4 IU/L
Standard Error 0.6
|
14.4 IU/L
Standard Error 0.5
|
16.4 IU/L
Standard Error 0.5
|
16.2 IU/L
Standard Error 0.6
|
|
Changes in Serum Enzymes Levels
Adjusted End line CK
|
27.3 IU/L
Standard Error 4.7
|
34.9 IU/L
Standard Error 4.2
|
27.4 IU/L
Standard Error 4.4
|
28.2 IU/L
Standard Error 4.5
|
SECONDARY outcome
Timeframe: Changes from baseline were assessed at the end of the eighth week of treatments.Assessments involve the measurement of systolic and diastolic blood pressure. Patients were allowed to rest for 15 minutes in sitting position, and Walgreens Homedics WGNBPA-540 upper arm blood pressure monitor (Walgreens, China), was used for the measurement of blood pressure. Three consecutive readings were taken at 1 minute interval, and systolic and diastolic blood pressure were calculated as the mean of the last two readings.
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Changes in Systolic and Diastolic Blood Pressure
Baseline diastolic blood pressure
|
80.7 mmHg
Standard Error 2.6
|
83.5 mmHg
Standard Error 2.1
|
76.1 mmHg
Standard Error 2.3
|
77.3 mmHg
Standard Error 2.4
|
|
Changes in Systolic and Diastolic Blood Pressure
Baseline systolic blood pressure
|
120.7 mmHg
Standard Error 3.9
|
125.4 mmHg
Standard Error 3.1
|
118.5 mmHg
Standard Error 3.4
|
119.5 mmHg
Standard Error 3.5
|
|
Changes in Systolic and Diastolic Blood Pressure
Adjusted End line diastolic blood pressure
|
79.5 mmHg
Standard Error 1.0
|
78.6 mmHg
Standard Error 0.9
|
80.3 mmHg
Standard Error 1.1
|
80.9 mmHg
Standard Error 1.1
|
|
Changes in Systolic and Diastolic Blood Pressure
Adjusted End line systolic blood pressure
|
118.3 mmHg
Standard Error 2.1
|
117.4 mmHg
Standard Error 1.8
|
117.8 mmHg
Standard Error 2.2
|
118.8 mmHg
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Changes from baseline were assessed at the end of the eighth week of treatments.Assessments comprise the total number of participants complicating and reporting muscle pain,flushing, nausea, vomiting, and dizziness. As part of the complete safety profile of each arm,other specific reported adverse event are presented in the Adverse Event Module.
Outcome measures
| Measure |
Placebo
n=12 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 Participants
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Adverse Events
Muscle Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Flushing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events
Nausea/Vomiting
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Adverse Events
Dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fenofibrate Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WMER Niacin Monotherapy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Combination Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Placebo
|
Fenofibrate Monotherapy
n=15 participants at risk
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
|
WMER Niacin Monotherapy
n=14 participants at risk
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Wax Matrix Extended Release Niacin (WMER Niacin)
|
Combination Therapy
n=13 participants at risk
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Fenofibrate
Wax Matrix Extended Release Niacin (WMER Niacin)
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
0.00%
0/12 • Up to the end of the eighth week of treatments.
|
0.00%
0/15 • Up to the end of the eighth week of treatments.
|
0.00%
0/14 • Up to the end of the eighth week of treatments.
|
7.7%
1/13 • Up to the end of the eighth week of treatments.
|
|
General disorders
Flushing
|
0.00%
0/12 • Up to the end of the eighth week of treatments.
|
0.00%
0/15 • Up to the end of the eighth week of treatments.
|
7.1%
1/14 • Up to the end of the eighth week of treatments.
|
0.00%
0/13 • Up to the end of the eighth week of treatments.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/12 • Up to the end of the eighth week of treatments.
|
0.00%
0/15 • Up to the end of the eighth week of treatments.
|
21.4%
3/14 • Up to the end of the eighth week of treatments.
|
7.7%
1/13 • Up to the end of the eighth week of treatments.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Up to the end of the eighth week of treatments.
|
0.00%
0/15 • Up to the end of the eighth week of treatments.
|
0.00%
0/14 • Up to the end of the eighth week of treatments.
|
7.7%
1/13 • Up to the end of the eighth week of treatments.
|
|
Renal and urinary disorders
eGFR˂ 60ml/min per 1.73 m^2
|
0.00%
0/12 • Up to the end of the eighth week of treatments.
|
0.00%
0/15 • Up to the end of the eighth week of treatments.
|
0.00%
0/14 • Up to the end of the eighth week of treatments.
|
0.00%
0/13 • Up to the end of the eighth week of treatments.
|
|
Hepatobiliary disorders
ALT or AST >3ULN
|
0.00%
0/12 • Up to the end of the eighth week of treatments.
|
0.00%
0/15 • Up to the end of the eighth week of treatments.
|
0.00%
0/14 • Up to the end of the eighth week of treatments.
|
0.00%
0/13 • Up to the end of the eighth week of treatments.
|
|
Metabolism and nutrition disorders
Uric acid > 6 mg/dl
|
0.00%
0/12 • Up to the end of the eighth week of treatments.
|
0.00%
0/15 • Up to the end of the eighth week of treatments.
|
21.4%
3/14 • Up to the end of the eighth week of treatments.
|
0.00%
0/13 • Up to the end of the eighth week of treatments.
|
Additional Information
Lewai Sharki Abdulaziz
Al-Kindy College of Medicine, ////university of Baghdad
Phone: 750 659 0024
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place