Efficacy and Safety of Extended Release Niacin-Fenofibrate Combination and Monotherapy for the Treatment of Atherogenic Dyslipidemia in Obese Females
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Changes Serum Triglyceride Levels
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI≥30 kg/m
- •Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.
排除标准
- •The use of any antilipidemic medication.
- •Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).
- •Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).
- •Clinical or laboratory findings suggestive for thyroid dysfunction.
- •Established diagnosis of Diabetes Mellitus.
- •History of gout, hyperuricemia, or on hypouricemic agents.
- •Active peptic ulcer.
- •Pregnancy, or nursing mothers.
- •Alcohol or tobacco consumption.
研究组 & 干预措施
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.
干预措施: Therapeutic Lifestyle Changes (Other)
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.
干预措施: Placebo (Other)
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.
干预措施: Therapeutic Lifestyle Changes (Other)
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.
干预措施: Fenofibrate (Drug)
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.
干预措施: Therapeutic Lifestyle Changes (Other)
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.
干预措施: Wax Matrix Extended Release Niacin (WMER Niacin) (Dietary Supplement)
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.
干预措施: Therapeutic Lifestyle Changes (Other)
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.
干预措施: Fenofibrate (Drug)
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.
干预措施: Wax Matrix Extended Release Niacin (WMER Niacin) (Dietary Supplement)
结局指标
主要结局
Changes Serum Triglyceride Levels
时间窗: 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.
Changes in Serum Lipoprotein Cholesterol Levels
时间窗: 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.
Changes in Serum Apolipoprotein Levels
时间窗: 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.
次要结局
- Changes in Serum Fasting Glucose Levels.(Changes from baseline were assessed at the end eighth week of treatments.)
- Changes in Estimated Glomerular Filtration Rate (eGFR)(Changes from baseline were assessed at the end of the eighth week of treatments.)
- Changes in Systolic and Diastolic Blood Pressure(Changes from baseline were assessed at the end of the eighth week of treatments.)
- Adverse Events(Changes from baseline were assessed at the end of the eighth week of treatments.)
- Changes in Serum Uric Acid Levels(Changes from baseline were assessed at the end of the eighth week of treatments.)
- Changes in Serum Enzymes Levels(Changes from baseline were assessed at the end of the eighth week of treatments.)
研究者
Lewai Sharki Abdulaziz, MSc PhD
Assistant Professor
Al-Kindy College of Medicine