Comparison of Coenzyme A and Pantethine Capsule for Safety and Efficacy On Patients With Hyperlipidemia
Condition: Hyperlipoproteinemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the lipid lowering effects and clinical safety of a
      natural hypolipidemic compound, coenzyme A capsule with a marketed drug, Pantethine Capsule,
      in Chinese patients with moderate dyslipidemia.
    

Detailed description: 
      Hyperlipidemia plays important roles in the development and progression of atherosclerosis.
      Modulating lipid levels has been shown to reduce the development of atherosclerosis and
      incidence of cardiovascular disease. The HMG-CoA reductase inhibitors (also known as statins)
      are the most effective agents available in the management of hyperlipidemia and prevention of
      major cardiovascular events. Although statin based therapy is commonplace in primary and
      secondary prevention, several economical, clinical and safety issues have been raised, so
      that there is ongoing research into new, safer and more effective agents to be used alone or
      in combination with existing cardiovascular drugs.

      Coenzyme A (CoA) is a ubiquitous essential cofactor that plays a central role in the
      metabolism of carboxylic acids, including short- and long-chain fatty acids, as well as
      carbohydrate and protein. In the metabolic pathway of lipid, CoA participates in fatty acid
      β-oxidation, promoting triglyceride (TG) catabolism. Previous research revealed that
      insufficiency of CoA in vivo influenced fatty acid β-oxidation catabolism and impaired
      clearance of TG from plasma, which was supposed to be one plausible reason resulting in type
      Ⅱb and Ⅳ hyperlipoproteinemia. In addition, epidemiological studies showed the prevalence of
      serum lipids level increased with age, which may be related to the reduction of CoA synthesis
      in aging individuals. Moreover, studies on animals have given evidence to prove that
      supplement of CoA had normalizing activity on plasma lipids in dyslipidemia.

      Pantethine is a versatile and very well tolerated hypolipidemic agent that can decrease serum
      triglycerides, LDL cholesterol, and apolipoprotein B, while increasing HDL cholesterol and
      apolipoprotein A-I. Pantethine is the disulfide of pantetheine which per se occurs naturally
      as a product of coenzyme A catabolism. Theoretically, antihyperlipidemia effect of CoA should
      be more directly and effectively than pantethine. Researches on rabbits and rats models prove
      that high dose CoA orally can relieve fasting hyperlipidemia and insulin resistance induced
      by high fat diet. So far there has not been sufficient clinical research data to support the
      efficacy of CoA in dyslipidemia patients. The present study compares the safety and
      effectiveness of oral CoA and Pantetheine.
    

Intervention name(s): Coenzyme A; Pantethine
Intervention type(s): Drug; Drug
Intervention description(s): Coenzyme A 400mg per day.; Pantethine 600mg per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment