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.
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.


METHODS
Randomised double-blind, placebo-controlled, clinical trial, lasting 12 months.


METHODS
Adults (25-66 years) in an average Dutch village population with serum cholesterol levels between 7.0 mmol/l and 9.9 mmol/l.


METHODS
Subjects were assigned at random to treatment with MPPG (3 x 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).


METHODS
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.
Schuitemaker
G E
GE
University of Maastricht, Department of General Practice and Research Institute for Extramural and Transmural Health Care, Maastricht, The Netherlands.
van der Pol
G A
GA
Aretz
C P
CP
Dinant
G J
GJ
D000328:Adult; D000368:Aged; D001054:Apolipoproteins A / Q000097:blood; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005973:Glutamine / Q000627:therapeutic use*; D006801:Humans; D006937:Hypercholesterolemia / Q000150:complications / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011732:Pyridoxal Phosphate / Q000627:therapeutic use*; D012016:Reference Values
D001054:Apolipoproteins A; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D005973:Glutamine; D011732:Pyridoxal Phosphate; C047672:magnesium-pyridoxal-5'-phosphate glutamate