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Biomedical subjects

R Benghozi

Publications and source records attributed to R Benghozi.

9 recordsLinked to original sources
PubMed2001

Effects of fluvastatin on cardiac events in renal transplant patients: ALERT (Assessment of Lescol in Renal Transplantation) study design and baseline data.

BACKGROUND: Recent clinical trials of primary and secondary prevention of cardiovascular disease have demonstrated that lowering plasma cholesterol with 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors ('statins') reduces morbidity and mortality from coronary heart disease in diverse patient populations. STUDY AIMS: The aim of the present ALERT (Assessment of Lescol in Renal Transplantation) study is to determine whether renal transplant recipients would also benefit from statin therapy. ALERT is a multicentre, randomized, double-blind, placebo-controlled trial to assess the effect of fluvastatin in renal transplant recipients with mild-to-moderate hypercholesterolaemia. The primary objective is to investigate the effects of fluvastatin on major adverse cardiac events (MACE). In addition, the effects on cardiovascular and all-cause mortality, as well as renal function, will be addressed. STUDY POPULATION: The study population contains patients with functioning renal allografts of more than 6 months' duration, recruited from 75 centres in Northern Europe and Canada. Patients of both sexes, aged 30-75 years, with a total cholesterol level of 4.0-9.0 mmol/l (155-348 mg/dl) were included, except for those with a history of myocardial infarction, where the upper limit for inclusion was 7.0 mmol/l (270 mg/dl). STUDY DESIGN: A total of 2100 patients were recruited by the end of October 1997 and will be followed for up to 6 years. This report presents the design features of the study (recruitment, follow-up, sample size, data analysis and study organization), along with baseline results. ALERT is the first large-scale prospective, randomized, double-blind study to address the prevention of cardiovascular mortality in renal transplant patients receiving an HMGCoA reductase inhibitor.

Adult↗
PubMed1996

Comparison between a bid and a tid regimen: improved compliance with no improved antihypertensive effect. The EOL Research Group.

OBJECTIVES: To compare compliance with an antihypertensive treatment administered either twice daily or three times daily. The two formulations of the antihypertensive treatment used (nicardipine) "regular tablets" (t.d.) and "slow release tablets" (b.d.) are bioequivalent at the daily dosage used in the study. STUDY DESIGN: Open, controlled, parallel designed study with centralised, randomised allocation to the treatment groups: TID group: A nicardipine 20 mg tablet, three times daily for 3 months. BID group: A capsule of slow release (SR) nicardipine, 50 mg twice daily for 3 months. PATIENTS: 7274 hypertensive patients were investigated by 2.651 general practitioners. Compliance with the nicardipine was assessed by means of standardised interviews with the patients and by a questionnaire for the investigators. RESULTS: Compliance was slightly higher in the BID than in the TID group; 71.2% and 24.5% of patients in the first group declared their compliance was 100% and 80% compared to 82.3% and 15% in the second group. A statistically significant relationship was shown between compliance with nicardipine and the decrease in blood pressure after three months of therapy. However, no significant difference was noticed between the two groups of patients in the absolute decrease in blood pressure after the treatment period: 25.7/14.7 mm Hg in the TID group compared with 25.9/15.0 mm Hg in the BID group. CONCLUSIONS: A difference in compliance between the bioequivalent BID and TID formulations of the same active agent was shown in hypertensive patients. However, the difference was not large enough to lead to a difference either in the number of controlled patients or in the decrease in blood pressure. Reducing the number of daily doses does not automatically lead to greater efficacy of treatment.

Antihypertensive Agents↗
PubMed1995

Comparison of fluvastatin versus pravastatin treatment of primary hypercholesterolemia. French Fluvastatin Study Group.

Following a 6-week placebo period, 134 patients with low density lipoprotein cholesterol (LDL-C) > or = 160 mg/dL and plasma triglyceride < or = 400 mg/dL, despite following a standard lipid-lowering diet, were randomized to double-blind, double-placebo treatment with fluvastatin (22 women, 46 men; age 21-71 years) or pravastatin (25 women, 41 men; age 19-76 years). Fluvastatin at 40 mg and pravastatin at 20 mg were given for the first 4 weeks, both once daily with the evening meal. For the following 12 weeks, fluvastatin at 40 mg twice daily and pravastatin at 40 mg once daily were given with the evening meal. Both drugs were equally effective in lowering LDL-C after 4 weeks of treatment (-24.0% with fluvastatin, -24.1% with pravastatin) but, after 16 weeks, LDL-C reduction was -30.4% with fluvastatin and -26.6% with pravastatin. This further lowering of LDL-C between week 4 and week 16 was significant (p < 0.001) for fluvastatin but not pravastatin. Adverse events were reported by 23 fluvastatin patients and 22 pravastatin patients: 3 patients in each group withdrew from the study because of these. No notable abnormalities in levels of alanine or aspartate aminotransferase values (defined as > 3 times the upper limit of normal on 2 consecutive occasions) or of creatine phosphokinase (defined as > 10 times the upper limit of normal on any occasion) were observed in either treatment group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1995

[Relation between plasma renin level and antihypertensive response to nicardipine].

The antihypertensive efficacy of calcium antagonists could depend on the concentration of circulating renin. To investigate this hypothesis, 102 hypertensive men or women were included in this study. After an initial 2 week placebo period, the patients were administered slow-release nicardipine, 50 mg twice a day for twelve weeks. The blood pressures were measured with a mercury sphygmomanometer at inclusion (S2) and after 12 weeks of treatment (S14), in addition to home automeasure during the week before inclusion and the two weeks preceding the final visit. The plasma renin activity (RA) was measured at S2 and S14. Its value at inclusion was used to differentiate patients with low renin (< or = 11 ng/l) from those with normal (> 11 < or = 17 ng/l) or high renin activity (> 17 ng/l). The blood pressure measured by sphygmomanometer or automeasure was significantly lower at the end of the active treatment period (SBP: -8 mmHg; DBP: -9.5 mmHg; and SBP: -5.8 mmHg; DBP: -5.7 mmHg respectively); the reduction in blood pressure was significantly higher in the group with low RA than in the group with high RA. The reductions in SBP measured in the morning and evening and in DBP measured in the morning were significantly greater in the group with low RA than in the group with high RA. The reduction of SBP measured in the morning at midday, and in the evening was correlated to the basal value of RA. Mild side effects were observed in 20 patients leading to the interruption of treatment in 11 cases because of headache. The best antihypertensive response is observed in patients with low plasma RA. This could explain the good response to calcium antagonists usually observed in elderly hypertensives.

Blood Pressure↗
PubMed1992

[Methodological problems of prevention/regression trials of atherosclerosis].

Animal models of atherosclerosis have improved our understanding of the pathogenic mechanisms involved in the formation of the atherosclerotic plaque. However, extrapolation of these data to the clinical situation is difficult. In addition, evaluation of the prevention or regression of atherosclerosis raises methodological problems. Although improved techniques provide a better evaluation of the extension of the plaques and their functional consequences, a number of points remain undecided: when to intervene, in which patients and how to extrapolate the results. A standardisation of the methods of evaluation of the atherosclerotic plaque is essential as is the fact that the benefit observed should be a reduction in cardiovascular complications and not simply the progression or regression of an angiographic lesion.

Animals↗
PubMedDate not supplied

[Example of a phase IV trial involving several physicians and aiming at answering a scientific question: EOL].

The aim of this trial was to test the hypothesis that a reduced number of doses improves compliance in current medical practice. Compliance with twice a day dosage was compared with compliance with three doses a day. Two bioequivalent presentations of nicardipine were used, the regular presentation (t.i.d.) and the slow-release (b.i.d.). The trial was controlled, randomized, open, in two parallel groups: (1)'t.i.d.' group: one tablet of regular nicardipine, 20 mg, three times a day, three months; (2) 'b.i.d.' group: one capsule of slow-release nicardipine, twice a day, three months. 2651 general practitioners randomized 7274 hypertensive patients. The primary criterion was documented in 93.7 per cent of the cases at the end of the trial. The remaining 6.3 per cent comprised treatment withdrawal (2.8 per cent) and patients lost to follow-up (3.5 per cent). The primary criterion study was compliance, assessed by a self-questionnaire filled in by the patient and a standardised interview by the physician. Compliance was slightly better in the b.i.d. group than in the t.i.d. group (p < 0.001). Remaining pill count was also used but it was a failure. A random sample of investigators made on-site visits. Discordant data were infrequent and were limited to dates of visits. Difficulties with on-site visits were mostly due to a rather frequent lack of source records.

Antihypertensive Agents↗