A placebo-controlled, double-blind, randomised trial of magnesium-pyridoxal-5'-phosphate-glutamate for hypercholesterolaemia and other clinical–chemical risk factors of cardiovascular disease in a primary care setting
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Background: Lipid-lowering drugs are extensively used in primary care to reduce the risk of cardiovascular disease (CVD). Apart from high total cholesterol (TC), several other clinical–chemical variables are associated with the risk of CVD. Magnesium-pyridoxal-5'-phosphate-glutamate (MPPG) has been found to have a positive influence on TC levels and other clinical–chemical values in some selected populations. Objective: To assess, in a general practice (GP) setting, the efficacy and clinical effectiveness of MPPG in the treatment of clinical–chemical risk factors for CVD. Design: Randomised double-blind, placebo-controlled, clinical trial, lasting 12 months. Patients: Adults (25–66 years) in an average Dutch village population with serum cholesterol levels between 7.0 mmol/l and 9.9 mmol/l. Intervention: Subjects were assigned at random to treatment with MPPG (3×150 mg daily) or placebo. Clinical–chemical parameters were assessed at 1, 3, 6, 9 and 12 months (t1, t2, t3, t4, t5). Efficacy was measured at t2. Long-term effect (clinical effectiveness) was measured by combining the results at t2, t3, t4 and t5 (t2–5). Outcome measures: TC (primary), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides, apolipoprotein-A1 (Apo-A1), apolipoprotein-B100 (Apo-B), fibrinogen and lipoprotein a [Lp(a), secondary]. Results: No statistically significant differences in the efficacy and effectiveness of TC were found between the MPPG group and the placebo group. The same was demonstrated for the other clinical–chemical values, except for LDL-C (effectiveness, P=0.04). Conclusions: Efficacy and effectiveness of MPPG are too poor to be of relevance for application as a lipid-lowering drug in GP.
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