LOPID (gemfibrozil tablets, USP) is a lipid regulating agent which decreases serum
triglycerides and very low density lipoprotein (VLDL) cholesterol, and increases high
density lipoprotein (HDL) cholesterol. While modest decreases in total and low density
lipoprotein (LDL) cholesterol may be observed with LOPID therapy, treatment of
patients with elevated triglycerides due to Type IV hyperlipoproteinemia often results in
a rise in LDL-cholesterol. LDL-cholesterol levels in Type IIb patients with elevations of
both serum LDL-cholesterol and triglycerides are, in general, minimally affected by
LOPID treatment; however, LOPID usually raises HDL-cholesterol significantly in this
group. LOPID increases levels of high density lipoprotein (HDL) subfractions HDL2 and
HDL3, as well as apolipoproteins AI and AII. Epidemiological studies have shown that
both low HDL-cholesterol and high LDL-cholesterol are independent risk factors for
coronary heart disease.
In the primary prevention component of the Helsinki Heart Study (refs. 1,2), in which
4081 male patients between the ages of 40 and 55 were studied in a randomized, double
blind, placebo-controlled fashion, LOPID therapy was associated with significant
reductions in total plasma triglycerides and a significant increase in high density
lipoprotein cholesterol. Moderate reductions in total plasma cholesterol and low density
lipoprotein cholesterol were observed for the LOPID treatment group as a whole, but the
lipid response was heterogeneous, especially among different Fredrickson types. The
study involved subjects with serum non-HDL-cholesterol of over 200 mg/dL and no
previous history of coronary heart disease. Over the five-year study period, the LOPID
group experienced a 1.4% absolute (34% relative) reduction in the rate of serious
coronary events (sudden cardiac deaths plus fatal and nonfatal myocardial infarctions)
compared to placebo, p=0.04 (see Table I). There was a 37% relative reduction in the rate
of nonfatal myocardial infarction compared to placebo, equivalent to a treatment-related
difference of 13.1 events per thousand persons. Deaths from any cause during the double-blind portion of the study totaled 44 (2.2%) in the LOPID randomization group and 43
(2.1%) in the placebo group.