LOPID (gemfibrozil tablets, USP) is indicated as adjunctive therapy to diet for:
1. Treatment of adult patients with very high elevations of serum triglyceride levels
(Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not
respond adequately to a determined dietary effort to control them. Patients who
present such risk typically have serum triglycerides over 2000 mg/dL and have
elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V
hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides
below 1000 mg/dL are unlikely to present a risk of pancreatitis. LOPID therapy may
be considered for those subjects with triglyceride elevations between 1000 and 2000
mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of
pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000
mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern
with massive triglyceride elevations accompanying fasting chylomicronemia, but the
influence of LOPID therapy on the risk of pancreatitis in such situations has not been
adequately studied. Drug therapy is not indicated for patients with Type I
hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides,
but who have normal levels of very low density lipoprotein (VLDL). Inspection of
plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V
hyperlipoproteinemia (ref. 5).
2. Reducing the risk of developing coronary heart disease only in Type IIb patients
without history of or symptoms of existing coronary heart disease who have had an
inadequate response to weight loss, dietary therapy, exercise, and other
pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to
reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid
abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol
and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL
PHARMACOLOGY). The National Cholesterol Education Program has defined a
serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an
independent risk factor for coronary heart disease (ref. 6). Patients with significantly
elevated triglycerides should be closely observed when treated with gemfibrozil. In
some patients with high triglyceride levels, treatment with gemfibrozil is associated
with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL
TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE,
ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER
ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING
THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN
WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG,
CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING
TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS
NOT LIKELY TO OUTWEIGH THE RISKS. LOPID IS ALSO NOT INDICATED
FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS
THEIR ONLY LIPID ABNORMALITY.
In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-
cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious
coronary events was similar for gemfibrozil and placebo subgroups (see Table I).
The initial treatment for dyslipidemia is dietary therapy specific for the type of
lipoprotein abnormality. Excess body weight and excess alcohol intake may be important
factors in hypertriglyceridemia and should be managed prior to any drug therapy.
Physical exercise can be an important ancillary measure, and has been associated with
rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as
hypothyroidism or diabetes mellitus should be looked for and adequately treated.
Estrogen therapy is sometimes associated with massive rises in plasma triglycerides,
especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation
of estrogen therapy may obviate the need for specific drug therapy of
hypertriglyceridemia. The use of drugs should be considered only when reasonable
attempts have been made to obtain satisfactory results with nondrug methods. If the
decision is made to use drugs, the patient should be instructed that this does not reduce
the importance of adhering to diet.