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PubMed1983

Elevation of high density lipoprotein cholesterol (cHDL) and reduction of the total cholesterol/cHDL index in the treatment of hyperlipoproteinaemias IIb and IV with bezafibrate.

A study was carried out in 21 patients with Type IIb or Type IV hyperlipoproteinaemia to evaluate the effect of treatment with 600 mg bezafibrate per day over a period of 3 months. The results of the lipid parameters studied showed that there were significant reductions after 1 and 3-months' treatment, respectively, of 19% and 16% total cholesterol, 55% and 57% triglycerides, 19% and 15% calculated cLDL, and 55% and 58% calculated cVLDL. Over the same times, there was a significant increase in cHDL of 35% and 41%, respectively. The cT/cHDL index decreased significantly from a mean basal value of 7.81 +/- 1.44 to 4.76 +/- 0.96 after 1 month and to 4.75 +/- 0.90 after 3 months, corresponding to a 39% reduction in both instances. This index was reduced to 5.0 or less in 76% of the patients. At the end of the trial there was normalization of hyperlipoproteinaemia in 17 (81%) of the 21 patients. Tolerance of bezafibrate was satisfactory. Only 2 patients suffered mild abdominal pain, which disappeared within a few days. One patient presented slight, transitory neutropenia at the end of the 3 months of treatment.

Adult↗
PubMed1992

Comparison of the efficacy and tolerance of a garlic preparation vs. bezafibrate.

The efficacy and tolerance of a garlic preparation (Sapec, Kwai) was investigated in a randomized double-blind study vs. bezafibrate. This multi-centre study was conducted in 5 general medical practices and involved 98 patients with primary hyperlipoproteinaemia. The daily doses of the active substances were 900 mg of garlic powder (standardized as to 1.3% alliin) and 600 mg of bezafibrate, respectively. The pre-phase with placebo lasted 6 weeks, the treatment period covered 12 weeks. All patients were advised to observe a low-fat "step-1 diet" for the duration of the study. The 98 case report forms allowed the statistical evaluation of total cholesterol, HDL cholesterol and triglyceride levels for 94 patients, and of LDL cholesterol values for 92 patients. In the course of the treatment both study medications caused a statistically highly significant reduction in total cholesterol, in LDL cholesterol and triglycerides, and an increase in HDL cholesterol. However, there was no significant difference in the efficacies of both medication groups. Side effects were mentioned by 5 patients each in both treatment groups, none of which led to the withdrawal of the patients. Concerning the garlic preparation, there was no correlation between the perception of garlic odour and the influence on the cholesterol level.

Aged↗
PubMed1992

[Different effects of fibrates on the lipoprotein profile. Comparison of the effectiveness of gemfibrozil and bezafibrate in various types of hyperlipoproteinemia].

AIMS: To compare the efficacy and tolerability of Gemfibrozil and Bezafibrate in patients with hyperlipoproteinemia, types IIa, IIb and IV. METHOD: In an open, randomized parallel study, the tolerability and efficacy of Gemfibrozil (G) and Bezafibrate (B) were investigated over a period of 12 weeks in 178 hyperlipidemic (HLP) patients first submitted to an 8-week "wash-out" (diet only) phase. In HLP type IIa patients, LDL cholesterol was lowered (G: -13%, B: -10%). In HLP type IIb, a decrease in triglyceride (TG) levels (G: -41%, B: -31%), an increase in HDL-cholesterol (G: +19%, B: +5%), and a decrease in the total cholesterol/HDL cholesterol ratio (G: -32%, B: -9%) predominated. Patients with type IV HLP responded to both fibrates with an appreciable reduction in TG levels (G: -45%, B: -42%). The effects of the preparations differed significantly with respect to the elevation of HDL cholesterol and a decrease in the total cholesterol/HDL cholesterol ratio in HLP type IIb patients. The respective lipid baseline concentration appeared to be of importance for the sense and extent of the changes induced.

Adult↗
PubMed2006

[Bezafibrate alone is an effective first-line therapy for primary sclerosing cholangitis: a case report].

The patient was a 58-year-old female. Though she had been in good health, increased hepatobiliary enzymes were detected in a health examination. She visited our hospital for close examination. The serum IgG4 level was normal, but ERCP and MRCP showed band-like stricture and beaded appearance of the bile ducts. A diagnosis of primary sclerosing cholangitis (PSC) was made. Since hyperlipidemia was also observed, oral administration of bezafibrate (400mg/day) alone was performed as the initial treatment, and transaminase, ALP, and GGT rapidly decreased. These results suggested that the initial administration of bezafibrate alone is effective against PSC.

Administration, Oral↗
PubMed1991

[Comparison of the efficacy of pantethine, acipimox, and bezafibrate on plasma lipids and index of cardiovascular risk in diabetics with dyslipidemia].

Atherosclerotic manifestations are more common and precocious in diabetics than in the general population. Due to the increased cardiovascular risk, a primary or secondary (to diabetes mellitus) lipoprotein disorder in diabetics has to be carefully considered. 27 diabetics (15 NIDDM and 12 IDDM) with dyslipidemia (14 type IV, 8 type IIa and 5 type IIb) were divided in 3 groups and treated with 3 different hypolipemic drugs (Group A: pantethine 600 mg/day; Group B: acipimox 500 mg/day; Group C: bezafibrate 600 mg/day) to test their efficacy and acceptancy. Body weight, Hb A1-c, serum lipoproteins have been measured before and during the 6 months treatment. A significant variation of lipidemic pattern was observed in Group C: a decrease of cholesterol (-20%), triglycerides (-40%), LDL (-24.4%) and apo B (-26.8%) with an increase of HDL (+23.6%). Pantethine and acipimox were more effective on triglycerides (-37.7% and -23.3% respectively). Cardiovascular risk (CT tot/CT HDL) was significantly reduced with acipimox and normalized with bezafibrate.

Bezafibrate↗
PubMed1991

Comparative pharmacokinetics of two oral bezafibrate preparations.

The pharmacokinetics of two oral solid preparations of bezafibrate, available in the Spanish market, was studied. Both preparations were tablets, an immediate-release formulation (A) and the other a slow-formulation (C). We selected a crossover design, and twelve healthy male volunteers participated in the study. Using a sensitive HPLC method, plasma concentrations of bezafibrate were monitored over a period of 12 h. after administration of treatment A and 24 h. for treatment C. In treatment A, two tablets were administered at an interval of six hours. The maximum plasma concentration (Cmax), time to Cmax(tmax) and area under curve (AUC infinity o), in the two doses of treatment A, were compared by analysis of variance and found to be significantly different between the two doses. The relative bioavailability based on (C: 1st-Dose-A) ratio of AUC infinity o was within the range 100 +/- 20%.

Adult↗
PubMed1989

A cross-over controlled study on beclobrate versus bezafibrate in the treatment of type IIb hyperlipoproteinaemia.

The effects of the new fibric acid derivative beclobrate (100 mg) on some plasma lipidic and apoproteic parameters in 20 patients with type IIb hyperlipoproteinaemia were matched in a randomized cross-over study to a sustained release formulation of bezafibrate (400 mg). Inclusion criteria were: total cholesterol (TC) plasma levels greater than 260 mg/dl and triglyceride (TG) levels greater than 200 mg/dl, after a 2-month period of isocaloric diet. The drugs were administered once a day for 8 weeks, and then crossed-over after 8 weeks of wash-out for another 8 week period of treatment. Both drugs were significantly effective in reducing TC and TG, and in increasing HDL-C plasma levels, but only beclobrate significantly decreased Apo B and LDL-C whereas bezafibrate seemed to be more active in increasing HDL-C levels. The electrophoretic pattern of LP in patients treated with beclobrate revealed a decrease of VLDL, a normalization of the LDL fraction and an increase of HDL. The tolerability was generally good.

Adult↗
PubMed1988

Effect of bezafibrate on serum lipids in normo- and spontaneously hyperlipidemic rats.

Rats, due to their availability and ease of handling, are a frequently used animal model for studying the effects of drugs on lipid metabolism. Hypolipidemic effects showed great variations in different studies. We investigated the effect of bezafibrate on serum concentrations of cholesterol and triglycerides in different strains of rats from several breeders. Under these conditions Lewis rats seemed to be the most suitable strain to investigate drug effects on cholesterol in serum. A hypercholesterolemic male Lewis rat found in a screening program was mated with normolipidemic female Lewis rats. The hyperlipidemia was found in some of the male and female offspring. Cholesterol and triglycerides were dramatically elevated in older animals. Bezafibrate (75 mg/kg/d) produced a marked reduction of lipids in serum in normo- and hyperlipidemic male rats but only in hyperlipidemic female rats, which is in agreement with former findings. These spontaneously hyperlipidemic rats could be a useful tool for investigation of drug effects on disturbed lipid metabolism and its pathophysiology. Therefore, we tried to establish a hyperlipidemic strain of rats.

Animals↗
PubMed1987

Normal and slow-release formulations of bezafibrate: a comparative pharmacokinetic study in man.

In this study the pharmacokinetics of a new slow-release formulation of bezafibrate (a hypolipaemic drug) were evaluated in a group of six healthy volunteers. In the first part of the study the bioavailability of this formulation was compared to the normal preparation of bezafibrate. In the second part of the experiment the possible accumulation was studied. The subjects were administered the slow-release preparation at 08h00 for seven consecutive days. The resulting data indicate that the slow-release formulation shows a lower dispersion of Tmax values. There was an increase of the plasma half-life from 1.9 to 5.5 h, but a possibility of accumulation could be excluded.

Adult↗
PubMed1984

[Comparison of the antilipemic effect of bezafibrate with that of piperazine-sultosilate (A 585). A crossed double-blind study].

In 20 patients suffering from primary hyperlipoproteinaemia the action of sultosilic acid piperazine salt (A-585) was compared with bezafribrate. In a double-blind cross-over study parameters of the lipoprotein metabolism, as well as of fibrinolysis and of platelet function were examined. Both drugs significantly diminished total cholesterol, triglycerides, beta- and pre-beta cholesterol whilst alpha-cholesterol increased. Moreover, both drugs caused a significant shortening of the euglobulin lysis time and a diminution of platelet adhesiveness. In patients under oral anticoagulants the thrombotest levels were not influenced by A-585, but were depressed by bezafibrate. A slightly elevated gamma-GT normalized during bezafibrate therapy but was not influenced by A-585.

Adult↗
PubMed1980

Effect of bezafibrate on the high-density lipoprotein subfractions HDL2 and HDL3 in primary hyperlipoproteinemia type IV.

The effect of a six-month treatment with bezafibrate on HDL2 and HDL3, measured as cholesterol and apolipoprotein A-I, was studied in 10 hypertriglyceridemic patients. The significant increase of total HDL-cholesterol and HDL-apolipoprotien A-I was due to an increase of HDL2-cholesterol and HDL2-apolipoprotein A-I. The lowered ratio of cholesterol to apolipoprotein A-I in HDL, HDL2, and HDL3 remained unaltered. It is concluded that bezafibrate raises the possibly antiatherogenic HDL2, whereas the disturbed cholesterol/apolipoprotein A-I ratio is not changed.

Adult↗
PubMed1980

Clinical experience with bezafibrate.

We report on 41 patients with primary hyperlipoproteinemia (type IIa, IIb and IV) treated with 450 to 600 mg of bezafibrate for 12 months. Placebo periods of 8 weeks surrounded the treatment period. In types IIa and IIb total cholesterol decreased by up to 18,7%, triglycerides to 34,6%. In type IV serum triglycerides decreased up to 48,2 and cholesterol by 12,2%. In a second investigation we differentiated the cholesterol- and triglyceride-values of 16 patients regularly controlled. We found a significant decrease during the treatment period. Bezafibrate is a potent lipid-lowering agent of the new generation.

Bezafibrate↗
PubMed1995

Effects of bezafibrate and of 2 HMG-CoA reductase inhibitors on lipoprotein (a) level in hypercholesterolemic patients.

Lp(a) level is relatively stable in each individual and is mainly under genetic control. Attempts made to lower Lp(a) with pharmacological means gave conflicting results. In order to further evaluate the effect of hypocholesterolemic drugs on Lp(a) level, 66 patients with primary hypercholesterolemia were selected. The vast majority of the patients had Lp(a) concentration at the low end of the range of distribution, 7 had undetectable Lp(a) levels and only 2 had Lp(a) higher than 30 mg/dl. No relationship was found between Lp(a) level and serum and lipoprotein lipids. In 12 patients serum cholesterol was well controlled by diet alone and the patients continued the diet for up to 8 months. The other patients were randomly subdivided into 3 groups of therapy. The first group received slow release bezafibrate 400 mg once a day, the second one pravastatin 20 mg once a day and the third one simvastatin 10-40 mg once a day. Drug therapy lasted for 8 months. At the end of the period, 22 of 29 patients treated with the 2 HMG-CoA reductase inhibitors had Lp(a) higher than baseline. The difference was statistically significant in both groups of patients. No significant change in Lp(a) was observed in diet and in bezafibrate group. Serum and LDL cholesterol significantly decreased in all the 3 drug groups. The increase in Lp(a) after the 2 HMG-CoA reductase was small enough to have negligible effects on cardiovascular risk, but raises the problem of the role of LDL receptor in the catabolism of Lp(a).

Adult↗
PubMed1993

Radioautographic study on the intracellular localization of a hypolipidemic agent, bezafibrate, a peroxisome proliferator, in cultured rat hepatocytes.

In order to demonstrate the intracellular localization of the peroxisome proliferator in the hepatocytes, we have examined the localization of silver grains due to 14C-labelled bezafibrate in cultured rat hepatocytes by means of light and electron microscopic radioautography. As it results from the difference between chemical fixation and freeze-substitution by light microscopic radioautography, more numerous silver grains, about twice, were observed in freeze-substitution specimens in comparison with chemical fixation. On light microscopic radioautograms of the epoxy resin sections during each experimental condition, about 90% of all the silver grains were localized over the cytoplasm. Then, statistical significance was evaluated on grain density in the cytoplasm. On electron microscopic radioautograms of whole mount cultured cells, silver grains were localized not on the peroxisome but on the cytoplasmic matrix specially over the endoplasmic reticulum. From these results, it is concluded that bezafibrate was localized over endoplasmic reticulum. This fact suggests that the receptor of the peroxisome proliferator should be associated with the endoplasmic reticulum or that the receptor exists on the endoplasmic reticulum. Thus, it is demonstrated that the peroxisome proliferator acts on the endoplasmic reticulum of hepatocytes to proliferate peroxisomes.

Animals↗
PubMed1993

[Reductions in lipid fraction plasma levels induced by simvastatin and bezafibrate. Brazilian multicenter study].

PURPOSE: To compare the effects of simvastatin and bezafibrate on the lipid profile to attain the objectives proposed by National Cholesterol Education Program (NCEP). METHODS: One hundred twenty six hypercholesterolemic patients (69 females and 57 men, 56.0 +/- 10.0 years old), after selection and placebo period (4 weeks) were maintained on lipid-lowering diet and were randomly assigned in a double-blind fashion to receive for 12 weeks, bezafibrate (B, 200mg t.i.d. - BG(n = 66)) or simvastatin (S, 10-40mg q.p.m. - SG(n = 60)). During the study, 28 patients (SG0) received S 10mg; in 14 patients (SG1) dosage was titrated to 20mg and in 18 cases (SG2) to 40mg. Clinical examination, lipid profile and safety determinations, and adverse effects were assessed in different periods of the study. RESULTS: Mean profile analysis showed different behaviour of BG, SG0, SG1 and SG2 through time for TC, TG, LDL-C and VLDL-C. Mean reductions of TC and LDL-C were more marked in SG (30.3 and 40.9%) than in BG (18.8 and 24.8%). BG showed greater increase of TG (33.7%) and HDL-C (25.9%) than did SG (16.3 and 7.7% respectively). Reduction greater than 30% (optimal responses) and between 20 and 29% (good responses) were more frequent in SG and LDL-C. BG showed greater frequency of good and optimal responses for TG reduction and HDL-C increase. NCEP goals were achieved in 75.4% of SG and 46.9% of BG (p = 0.001). No clinical or laboratorial adverse experiences were reported in any treatment groups. CONCLUSION: Simvastatin was more effective in the reduction of plasma levels of atherogenic lipid fractions (TC and LDL-C) and this treatment allowed earlier achievement of the goals proposed by NCEP in a greater number of patients.

Bezafibrate↗
PubMed1993

[Comparison of the pharmacokinetics of a quick-release bezafibrate formulation with a sustained-release formulation. 1. Single-dose administration].

Comparison of the Pharmacokinetic Profiles of a Quick and a Sustained Release Bezafibrate Formulation/1st Communication: Single-dose application The hypolipaemic agent bezafibrate (CAS 41859-67-0) is available as immediate and sustained release formulation. The pharmacokinetic profile of an immediate release 300 mg dragee (A) was compared in a two-way cross-over design to that of a 400 mg sustained release dragee (B). Neglecting the dose difference, the AUEC of A (28.8 micrograms/ml.h) was equal to that of B (27.6 micrograms/ml.h), whereas the bioavailability of A appeared to be higher than that of B when AUEC was corrected for dose (AUEC ratio = 137%). Regarding Cmax and tmax, both formulations exhibited the expected differences.

Adult↗
PubMed1996

Efficacy and tolerance of 400 MG bezafibrate in diabetic and hyperlipidaemic patients.

The authors report the results of an open clinical study using 400 mg Bezafibrate once a day. Among 25 diabetic patients (type II.) underwent a 4 weeks period with nutritional advice. Average changes from inclusion levels were -24% for total cholesterol, -56% for triglicerides, +11.9% for HDL-cholesterol, -19% for plama fibrinogen. In conclusion, bezafibrate at a daily dose of 400 mg had significant lipid-modifying properties but also exhibited a beneficial effect on other related risk factors such as fibrinogen reduction.

Adolescent↗
PubMed1998

Baseline characteristics of patients participating in the Bezafibrate Infarction Prevention (BIP) Study.

Low high density lipoprotein (HDL) cholesterol, elevated triglycerides, or a combination of both, carries an increased risk of coronary heart disease (CHD). The benefit of therapy that increases serum HDL cholesterol concentrations and lowers triglyceride concentrations on the reduced incidence of myocardial infarctions and mortality has not been unequivocally demonstrated in healthy persons or patients with CHD. The Bezafibrate Infarction Prevention (BIP) study randomized men and women, with CHD and with total serum cholesterol 180 - 250 mg. dl-1, low density lipoprotein (LDL) cholesterol < or = 180 mg. dl-1 (< or = 160 mg. dl-1 below age 50 years), HDL cholesterol < or = 45mg. dl-1 and triglycerides < or = 300 mg. dl-1, to bezafibrate retard (400 mg once daily) or placebo. In addition to its effect on the lipids, this drug significantly lower plasma fibrinogen. The demographic, clinical and biochemical characteristics and existing cardiovascular therapy at baseline of 3122 patients randomized onto the study are presented here. A comparison is made with other on-going or recently published secondary prevention studies of lipid modification in CHD patients.

Adult↗