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| Name | Class |
|---|---|
| Al-Kindy College of Medicine | OTHER |
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Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and type 2 diabetes mellitus and has emerged as an important marker for the increased cardiovascular disease (CVD) risk observed in these populations.
Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent studies have focused on optimizing treatment for AD and compare the efficacy and tolerability of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach has not yet been established.
The present study was intended to evaluate the restorative efficacy of Extended Release Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their safety and tolerability in females with obesity-induced AD.
Study Setting:
The present study is a single blinded placebo-controlled randomized clinical trial, in which target individuals were 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, University of Baghdad (Baghdad, Iraq), throughout the period from 1st October 2014 to 15th March 2015.
Study Protocol:
Target individuals with fulfill devoid of exclusion criteria, were further screened and only candidates with conventional diagnosis of AD, as confirmed by a fasting serum TG >150 mg/dl coincide with an HDL-C of less than 50 mg/dl, were considered to be enrolled. Finally, and successive to a comprehensible concise for the expected benefits and side effects on top of the commitment to the entire protocol, eligible candidates settled for participation were provided with a written informed consent.
Enrollment:
Discontinuation of Treatment:
Although the absence of published consensus on drug discontinuation in the face of laboratory abnormalities has permitted a spectrum of indefinite decisions, mainly driven by clinical experience, clinical status and tolerability of the patient. For the present study discontinuation of treatment is considered if:
Assessment of Treatments Responses:
Responses to the different treatments arms, in terms of efficacy and safety, are assessed by analyzing clinical and laboratory data collected at each visit over the entire course of the study, including a thorough medical history and previous medication records.
Statistical Analysis:
All statistical analyses were executed via the statistical package SPSS version 17.0 (SPSS, Inc.). Prior to analysis, Shapiro-Wilk test was used for assessing the normality of distributions for continuous variables, with the data expressed as the mean ± standard error (SE). Analysis of variance (ANOVA) was applied to compare the means of baseline characteristics among different treatments groups. Comprising the influence of the baseline level as a covariate, analysis of covariance (ANCOVA), embracing the least significant difference (LSD) for pair-wise comparison, was applied to assess treatment effects and safety profiles among different arms. Results were evaluated in terms of adjusted end line levels and percent changes from baseline levels. Multivariate Analysis of Covariance (MANCOVA), on the other hand, with further adjustments for relevant covariates was conducted whenever needed. Probability of less than 0.05 was considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Fenofibrate Monotherapy | Active Comparator | 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. |
|
| WMER Niacin Monotherapy | Active Comparator | 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. |
|
| Combination Therapy | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Lifestyle Changes | Other | Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes Serum Triglyceride Levels | Assessments involve the measurement of serum Triglyceride (TG) level. | 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. |
| Changes in Serum Lipoprotein Cholesterol Levels | 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. | 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. |
| Changes in Serum Apolipoprotein Levels | Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Serum Fasting Glucose Levels. | Assessments involve the measurement of serum fasting glucose levels. | Changes from baseline were assessed at the end eighth week of treatments. |
| Changes in Estimated Glomerular Filtration Rate (eGFR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewai S Abdulaziz, MSc PhD | Al-Kindy college of Medicine, University of Baghdad | Study Chair |
| May S Al-Sabbagh, MSc | College of Pharmacy, University of Baghdad | Study Chair |
| Marwah S Attar, MSc | College of Pharmacy, University of Baghdad | Study Director |
| Faris A Khazaal, FRCP | Al-Kindy college of Medicine, University of Baghdad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Kindy College of Medicine, University of Baghdad | Baghdad | 10045 | Iraq | |||
| Lewai S Abdulaziz |
Individual participant data that underlie the results reported in this article, after deidentification (table, figures, and appendices).
Beginning 6 months and ending 24 months following article publication
Anyone who wishes to access the data, to achieve aims in the approved proposal or for meta-analysis. The data will be available in our college's data warehouse up to 24 months following article publication.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Other |
|
| Fenofibrate | Drug |
|
|
| Wax Matrix Extended Release Niacin (WMER Niacin) | Dietary Supplement |
|
|
Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) .
| Changes from baseline were assessed at the end of the eighth week of treatments. |
| Changes in Serum Uric Acid Levels | Assessments involve the measurement of serum uric acid levels | Changes from baseline were assessed at the end of the eighth week of treatments. |
| Changes in Serum Enzymes Levels | Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels. | Changes from baseline were assessed at the end of the eighth week of treatments. |
| Changes in Systolic and Diastolic Blood Pressure | 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. | Changes from baseline were assessed at the end of the eighth week of treatments. |
| Adverse Events | 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. | Changes from baseline were assessed at the end of the eighth week of treatments. |
| Baghdad |
| 10045 |
| Iraq |
| FG001 |
| 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 |
| FG002 | 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) |
| FG003 | 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) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Weight (in Kilograms) and Height (in Meters) were measured using a portable stadiometer with movable head piece typically mounted on balanced beam scale (Segma, Germany). Body mass index (BMI) is the relative weight for height and it was calculated according to formula bellow: BMI=Weight (Kg) / Height2 (m) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes Serum Triglyceride Levels | Assessments involve the measurement of serum Triglyceride (TG) level. | Posted | Mean | Standard Error | mg/dl | 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. |
|
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|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Changes in Serum Lipoprotein Cholesterol Levels | 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. | Posted | Mean | Standard Error | mg/dl | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Changes in Serum Apolipoprotein Levels | Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels. | Posted | Mean | Standard Error | mg/dl | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Serum Fasting Glucose Levels. | Assessments involve the measurement of serum fasting glucose levels. | Posted | Mean | Standard Error | mg/dl | Changes from baseline were assessed at the end eighth week of treatments. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Estimated Glomerular Filtration Rate (eGFR) | Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) . | Posted | Mean | Standard Error | ml/min per 1.73 m^2 | Changes from baseline were assessed at the end of the eighth week of treatments. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Serum Uric Acid Levels | Assessments involve the measurement of serum uric acid levels | Posted | Mean | Standard Error | mg/dl | Changes from baseline were assessed at the end of the eighth week of treatments. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Serum Enzymes Levels | Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels. | Posted | Mean | Standard Error | IU/L | Changes from baseline were assessed at the end of the eighth week of treatments. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Systolic and Diastolic Blood Pressure | 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. | Posted | Mean | Standard Error | mmHg | Changes from baseline were assessed at the end of the eighth week of treatments. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events | 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. | Posted | Count of Participants | Participants | Changes from baseline were assessed at the end of the eighth week of treatments. |
|
Up to the end of the eighth week of treatments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | 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) | 0 | 14 | 0 | 14 | 7 | 14 |
| EG003 | 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) | 0 | 13 | 0 | 13 | 3 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flushing | General disorders | Systematic Assessment |
| ||
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| eGFR˂ 60ml/min per 1.73 m^2 | Renal and urinary disorders | Systematic Assessment |
| ||
| ALT or AST >3ULN | Hepatobiliary disorders | Systematic Assessment |
| ||
| Uric acid > 6 mg/dl | Metabolism and nutrition disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lewai Sharki Abdulaziz | Al-Kindy College of Medicine, ////university of Baghdad | 750 659 0024 | +964 | lewaisharki@kmc.uobaghdad.edu.iq |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
Not provided
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| Male |
|
| Adjusted End line TG levels |
|
| Superiority |
| 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) |
| OG003 | 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) |
|
|
|
| OG003 | 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) |
|
|
|
| OG003 | 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) |
|
|
|
| OG003 | 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) |
|
|
|
| OG003 | 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) |
|
|
|
| OG003 | 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) |
|
|
|
| OG002 |
| 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) |
| OG003 | 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) |
|
|
|
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)
| OG003 | 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) |
|
|