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Biomedical subjects

Jean-François Bergmann

Publications and source records attributed to Jean-François Bergmann.

At least 19 recordsLinked to original sources
PubMed2007

Elderly medical patients treated with prophylactic dosages of enoxaparin: influence of renal function on anti-Xa activity level.

BACKGROUND: The safety and optimal use of prophylactic treatment with low-molecular-weight heparins in elderly patients with impaired renal function remain undefined. METHODS: The primary aim of this study was to analyse, in 'real life', the influence of renal function, as assessed by creatinine clearance (CL(CR)), on the level of anti-Xa activity in medical hospitalised elderly patients receiving prophylactic dosages of enoxaparin. Consecutive hospitalised acutely ill medical patients aged >or=75 years receiving daily dosages of enoxaparin 4000 IU for up to 10 days were prospectively enrolled in two centres. Peak anti-Xa activity was measured at the beginning and during the course of therapy. RESULTS: One hundred and twenty-five patients (31 men, 94 women), mean age 87.5 +/- 6.3 years, mean bodyweight 56.4 +/- 11.9 kg and mean CL(CR) 39.8 +/- 16.1 mL/min, were enrolled in the study. The mean maximum anti-Xa activity (day 1 to day 10) [anti-Xa(max1-10)] was 0.64 +/- 0.23 IU/mL (range 0.24-1.50 IU/mL). Weak negative correlations were found between CL(CR) and anti-Xa(max) and between bodyweight and anti-Xa(max). Mean anti-Xa(max) was slightly but significantly higher in patients with CL(CR) of 20-30 mL/min compared with patients with CL(CR) of 31-40, 41-50 or 51-80 mL/min (0.72 versus 0.61, 0.61 and 0.60 IU/mL, respectively), and in patients weighing <50 kg compared with patients weighing 50-60 kg or >60 kg (0.74 vs 0.64 and 0.52 IU/mL, respectively). Serious bleeding occurred in five patients, but anti-Xa(max) values in these patients were not different to those in patients without bleeding (p = 0.77). Individual anti-Xa(max) at the beginning or during the course of treatment was measured in the subgroup of 58 patients in whom anti-Xa activity was measured at least once during the study. The mean anti-Xa(max) value was slightly but significantly higher during the course of the therapy than at the beginning of the study (0.63 +/- 0.26 IU/mL vs 0.56 +/- 0.23 IU/mL, p = 0.012). CONCLUSION: Only CL(CR) <30 mL/min and bodyweight <50 kg were associated with significantly higher anti-Xa(max) values. The clinical relevance of these increases remains questionable. No conclusions about the safety of enoxaparin in elderly medical patients can be drawn from these findings.

Acute Disease↗
PubMed2006

Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg.

PURPOSE: To prospectively compare the efficacy and safety of 4 vs 2 mg intravitreal triamcinolone acetonide (TA) injection for diabetic macular edema. DESIGN: Interventional case series. METHODS PATIENTS: Thirty-two patients with diabetic macular edema unresponsive to laser photocoagulation. INTERVENTION: Patients were randomly assigned to receive 4 or 2 mg intravitreal TA in one eye (16 patients in each group). MAIN OUTCOME MEASURES: The main outcome was central macular thickness (CMT) measured by optical coherence tomography (OCT) at four, 12, and 24 weeks. Secondary outcomes were gain in Early Treatment Diabetic Retinopathy Study (ETDRS) scores, intraocular pressure (IOP), cataract progression, and duration of effect. RESULTS: Before injection, mean (+/- SD) CMT was 564.5 +/- 119 microm and 522.9 +/- 148.5 microm in the 4- and 2-mg groups, respectively. At four, 12, and 24 weeks after injection, it was 275.0 +/- 79.8, 271.4 +/- 128.7, and 448.7 +/- 146.4 microm, respectively, in the 4-mg group, and 267.3 +/- 82.4, 289.8 +/- 111.4, and 394.7 +/- 178.9 microm, respectively, in the 2-mg group. At no time was the difference in CMT between both groups statistically significant (P> 0.3). The between-group differences in the gain in the ETDRS score and in IOP were not statistically significant either. Diabetic macular edema recurred after a median period of 20 weeks vs 16 weeks in the 4- and 2-mg groups, respectively (P = 0.11). CONCLUSIONS: In the short term, intravitreal injection of 4 or 2 mg TA does not have different effects on CMT, visual acuity, or IOP.

Adult↗
PubMed2006

Skin lightening and its complications among African people living in Paris.

BACKGROUND: Complications caused by skin lightening practices have not been systematically studied in Europe. OBJECTIVE: Our aim was to assess the complications of skin lightening among people of African descent living in Paris. METHODS: This was a descriptive study. All patients presenting with complications from skin lightening procedures underwent a complete clinical examination and were questioned about their practice. RESULTS: Forty-six patients from various African countries (39 women, 7 men) presented with skin changes suggestive of side effects from skin lightening practices. The complications seemed mainly related to the use of clobetasol and hydroquinone. LIMITATIONS: The selection bias does not allow assessment of uncomplicated skin lightening. CONCLUSION: Complications arising from skin lightening practices represent a significant health problem for people of African descent living in Paris.

Adrenal Insufficiency↗
PubMed2006

Effects of aspirin and clopidogrel on plasma brain natriuretic peptide in patients with heart failure receiving ACE inhibitors.

BACKGROUND: By inhibiting prostaglandins, aspirin may be deleterious in heart failure (HF) and/or may counteract angiotensin-converting enzyme (ACE) inhibitor efficacy. Conversely, clopidogrel has no effect on prostaglandin metabolism. AIM: To investigate the effect of aspirin and clopidogrel on brain natriuretic peptide (BNP) levels in HF patients treated with ACE inhibitors. METHODS: 36 patients with stable HF (65+/-13 years, 24 males/12 females, NYHA class II to IV, ejection fraction <40%, 13 with coronary disease, all treated with ACE inhibitors) were enrolled in this prospective, double-blind study and randomised to aspirin 325 mg/day or clopidogrel 75 mg/day for 14 days. BNP was determined at day 0 and day 14. RESULTS: 19 patients were randomised to aspirin and 17 to clopidogrel. Baseline characteristics were similar in both groups. BNP levels increased in the aspirin group from day 0 to day 14 (107+/-103 to 144+/-149 pg/ml, p=0.04) whereas clopidogrel had no effect (104+/-107 and 97+/-99 pg/ml respectively, p=0.61). CONCLUSION: This study demonstrates an adverse effect of aspirin 325 mg/day on BNP plasma levels in HF patients treated with ACE inhibitors. In contrast clopidogrel 75 mg/day had no effect.

Aged↗
PubMed2006

Comparative evaluation of adherence to antiretroviral therapy in sub-Saharan African native HIV-infected patients in France and Africa.

Patients with human immunodeficiency virus (HIV) infection who were native to sub-Saharan Africa but lived in France were less adherent to antiretroviral therapy during a visit back to Africa, compared with their level of adherence in France. This was mainly related to self-perceived insufficient support from family members and/or fear of the consequences of disclosure of their HIV infection status to their family.

Adult↗
PubMed2006

Antiarrhythmic drugs for maintaining sinus rhythm after cardioversion of atrial fibrillation: a systematic review of randomized controlled trials.

BACKGROUND: A variety of antiarrhythmic drugs have been used to prevent recurrence of atrial fibrillation after conversion to sinus rhythm. We performed a systematic review to determine the effect of long-term treatment with those drugs on death, embolisms, adverse effects, and atrial fibrillation recurrence. METHODS: We searched MEDLINE, EMBASE, the Cochrane Library (all up to May 2005), and the reference lists of retrieved articles. We included randomized controlled trials that compared any antiarrhythmic against control (placebo or no treatment) or another antiarrhythmic, for more than 6 months. Postoperative atrial fibrillation was excluded. Two evaluators independently reviewed the retrieved studies and extracted all data. Disagreements were resolved by discussion. All results were calculated at 1 year of follow-up. RESULTS: Forty-four trials were included, with a total of 11 322 patients. Several class IA (disopyramide phosphate, quinidine sulfate), class IC (flecainide acetate, propafenone hydrochloride), and class III (amiodarone, dofetilide, sotalol hydrochloride) drugs significantly reduced recurrence of atrial fibrillation (number needed to treat, 2-9), but all increased withdrawals due to adverse effects (number needed to harm [NNH], 9-27) and all but amiodarone and propafenone increased proarrhythmia (NNH, 17-119). Class IA drugs, pooled, were associated with increased mortality compared with controls (Peto odds ratio, 2.39; 95% confidence interval, 1.03-5.59; P = .04; NNH, 109). No other antiarrhythmic showed a significant effect on mortality compared with controls. We could not analyze other outcomes because data were lacking. CONCLUSION: Class IA, IC, and III drugs are effective in maintaining sinus rhythm but increase adverse effects, and class IA drugs may increase mortality.

Anti-Arrhythmia Agents↗
PubMed2006

Comparative effect of aspirin and clopidogrel on arterial function in CHF.

BACKGROUND: By inhibiting prostaglandins, aspirin may be deleterious in congestive heart failure (CHF) and/or partially counteract the efficacy of angiotensin-converting enzyme inhibitors (ACEI). Conversely, clopidogrel has no effect on prostaglandin metabolism. The aim of this study was to prospectively investigate the effect of aspirin and clopidogrel on arterial functional properties in CHF patients treated with ACEI. METHODS: Forty-five patients with stable NYHA class II-IV CHF (64.0+/-15.5 years), ejection fraction <40%, were included in this prospective double-blind study and randomized to receive aspirin 325 mg/day or clopidogrel 75 mg/day for 14 days. Reflected wave assessed by radial applanation tonometry and pulse wave velocity (PWV) were measured at day 0 and day 14. RESULTS: Aspirin resulted in an increase in the augmentation index of the reflected wave (Delta=+3.5+/-5.2%, p=0.005) and the height above the shoulder of the reflected wave (Delta=+1.7+/-3.1 mm Hg, p=0.023), without statistically variation in PWV. Conversely, clopidogrel had no effect on the same parameters (p=0.512, p=0.677 and 0.801, respectively). Overall, variations in the augmentation index of reflected wave significantly differed when compared aspirin with clopidogrel (p=0.0261). CONCLUSION: This study demonstrates the existence of a negative effect of aspirin 325 mg/day when compared to clopidogrel 75 mg/day on arterial functional properties in CHF patients treated with ACEI.

Aged↗
PubMed2006

[Use and misuse of intravenous drug administration in a department of internal medicine].

AIM: Numerous intravenously-administered medications are also available in equally effective oral forms. To assess the number of avoidable intravenous infusions, we retrospectively analyzed consecutive infusions prescribed in a department of internal medicine. METHODS: Between November and December 2004, we analyzed all patients who received at least one intravenous drug during hospitalization. Intravenous administration was considered unavoidable when prescribed for no more than 2 days in a patient unstable at admission, when oral administration or feeding was impossible, or when the drug was not available in oral form. RESULTS: During the study period 133 patients were admitted to the department. In all, 65 infusions were prescribed, 30% of which lasted more than 2 days for no medical reason. Four intravenous antibiotics were prescribed in patients when their antibiotic susceptibility tests indicated that another oral antibiotic could easily be given. Infusions for 16 other patients continued longer than 48 hours, although the oral route was not contraindicated in these patients and the medication was available in oral form. CONCLUSION: Systematic analysis of the daily prescriptions may be helpful in preventing or shortening use of intravenous medications and thereby decreasing iatrogenic infections and injuries, length of hospitalization, and costs.

Adult↗
PubMed2006

[Use and monitoring of vitamin K antagonists in everyday medical practice. French results of the international ISAM study of patients with nonvalvular atrial fibrillation].

INTRODUCTION: Bleeding complications of vitamin K antagonist (VKA) therapy are currently the most frequent iatrogenic event in France. OBJECTIVES: The aim of the ISAM study, an international longitudinal observational survey was to evaluate the use of VKA treatment and the quality of laboratory monitoring in everyday medical practice. METHODS: In France, a representative sample of general practitioners and cardiologists selected patients with nonvalvular atrial fibrillation who had been treated with VKA for at least 60 days during the past 12 months. Physicians and patients responded to standardized questionnaires collecting retrospective data for the previous year. RESULTS: Overall, 43 general practitioners and 20 cardiologists recruited 278 patients who completed questionnaires. INR was at least 2 for 264 patients during the study period. During the year preceding inclusion, INR had been within the target range (i.e., between 2.0 and 3.0) 59% of the time and above 3.0 27%. Physicians reported having giving approximately half their patients written recommendations about the VKA dosage regimen, but only 3% supplied a specific VKA information and monitoring booklet. Most patients (65%) reported receiving information on VKA therapy from their general practitioners, although 18% said they had not been informed about their treatment, 44% did not know their target INR, and 66% were unaware that bleeding events were a matter of concern. Finally, 45% of patients reported carrying a card indicating that they were taking VKA. CONCLUSION: Overall, these results show that better education of both physicians and patients could help to improve management, appropriate use and laboratory monitoring of VKA treatment.

Aged↗
PubMed2006

Effect of widely used combinations of antiretroviral therapy on liver CYP3A4 activity in HIV-infected patients.

AIMS: To evaluate the effects of combined antiretroviral drugs (HAART) on liver CYP3A4 activity using the [(14)C-N-methyl]-erythromycin breath test (ERMBT). METHODS: HIV-infected patients (31 women, 30 men) with mean (+/- SD) age of 38 +/- 9 years were enrolled and underwent complete clinical and laboratory evaluation. Patients were divided into five groups and were treated with two nucleoside analogues (NAs) and one of the following: nelfinavir alone (n = 13), any ritonavir-boosted protease inhibitor with (n = 8) or without (n = 13) nevirapine, nevirapine alone (n = 15), or a third NA (n = 12). Three or four ERMBTs were performed 7 days prior to (D-7) and at the beginning of treatment (D0), D14 (only for patients taking nevirapine) and on D28. RESULTS: Mean baseline liver CYP3A4 activity displayed high interindividual variability (47%) but low intraindividual variability (15%). Women had 30% higher ERMBT values than men [2.7 +/- 1.3 vs. 1.9 +/- 0.7; 95% confidence interval (CI) 20.5, 49.5; P = 0.003]. The ERMBT data correlated with body weight, alpha- and beta-globulins and alanin aminotransferases (0.10 < r(s) < 0.20; P < 0.01). Whereas nevirapine had no effect on liver CYP3A4 activity, nelfinavir-based and ritonavir-boosted drug regimens inhibited it by 69% (95% CI 64.7, 72.9; P = 0.005) and by 95% (95% CI 93.3, 96.7; P = 0.001), respectively. CONCLUSION: Evaluation of the effect of HAART on liver CYP3A4 activity may aid in preventing inappropriate treatment regimens in HIV-infected patients.

Adult↗
PubMed2006

Intravitreal triamcinolone acetonide for diffuse diabetic macular oedema: 6-month results of a prospective controlled trial.

PURPOSE: To evaluate prospectively the efficacy and safety of one intravitreal injection of 4 mg triamcinolone acetonide for refractory diffuse diabetic macular edema. METHODS: Seventeen patients with bilateral diabetic macular edema unresponsive to laser photocoagulation. In all patients, one eye was injected, and the other served as a control. The intervention consisted in intravitreal injection of 4 mg triamcinolone acetonide. The main outcome measure was central macular thickness (CMT) at 4, 12 and 24 weeks, measured by Optical Coherence Tomography. Secondary outcomes were Early Treatment Diabetic Rentinopathy Study (ETDRS) scores, intraocular pressure and cataract PROGRESSION. RESULTS: Before injection, mean +/- SD CMT was 566.4 +/- 182.4 mum in injected eyes. Four, 12, and 24 weeks after injection, it was 228.4 +/- 47.5 mum, 210.9 +/- 87.2 mum and 358.5 +/- 160.5 mum respectively. CMT was significantly lower in injected eyes vs. control eyes except 24 weeks after injection because of a recurrence of macular edema in 9/17 injected eyes. Mean +/- SD gain in ETDRS score was significantly better in injected eyes vs. control eyes 4, 12 and 24 weeks after TA injection. In 9 of the 17 injected eyes, intraocular pressure exceeded 24 mmHg and was controlled by topical medication. CONCLUSION: In the short-term, intravitreal injection of triamcinolone effectively reduces macular thickening due to diffuse diabetic macular edema and improves visual acuity in most cases. The long-term effect of this treatment and predictive factors of visual recovery remain to be elucidated.

Adult↗
PubMed2006

Pharmacodynamics of a new ophthalmic mydriatic insert in healthy volunteers: potential alternative as drug delivery system prior to cataract surgery.

Cataract surgery requires a satisfactory degree of mydriasis throughout the entire operation. A phase I, open-labelled, randomised, cross-over trial was conducted in 18 healthy volunteers to compare mydriasis obtained with subsequent administration of phenylephrine 10% and tropicamide 0.5% eyedrops or a new insoluble-matrix retropalpebral ophthalmic insert containing 5.38 mg phenylephrine and 0.28 mg tropicamide. Phenylephrine serum concentrations were measured over 6 hr following each treatment administration. Secondary end-points included cardiovascular, general and local tolerance and quantification of bacterial colonisation of the conjunctiva and the cultured insert, respectively. When normalized to the pupil diameter after conventional treatment, the diameter achieved with the insert was 1.13 (95% confidence interval, 0.94-1.48, P=0.38). Moreover, standard eye drops provided faster effective mydriasis than the insert, starting 30 min. as compared to 90 min. upon treatment administration (P<0.01, repeated-measures ANOVA). Phenylephrine concentrations remained almost undetectable for both treatments and no change in heart rate or blood pressure were observed throughout the study. Only three superficial punctuate keratitis were diagnosed with the insert and two with the eye drops. No significant bacterial contamination of conjunctiva swab and cultured insert was observed. The new insoluble-matrix retropalpebral ophthalmic mydriatic insert produced similar but delayed effective and prolonged mydriasis as compared to the standard delivery system. In addition to its potential usefulness in patients undergoing cataract surgery, such new ophthalmic delivery system may be an advantage in children who need to undergo fundus photography due to the single administration and excellent tolerance as well.

Adolescent↗
PubMed2006

Interaction between paracetamol and warfarin in patients: a double-blind, placebo-controlled, randomized study.

BACKGROUND AND OBJECTIVES: Paracetamol (acetaminophen) has occasionally been reported to interact with warfarin. The primary end-point of this study was to investigate whether paracetamol initiation potentiates the anticoagulant effect of warfarin and the mechanism of the interaction. DESIGN AND METHODS: In a double-blind placebo-controlled, randomized, cross-over study, 20 patients on stable oral anticoagulant therapy with warfarin for at least 1 month were randomized to receive placebo or paracetamol 1g four times daily for 14 days. International Normalized Ratio (INR) and clotting factors activities were measured before the first administration and then on days 2, 4, 7, 9, 11,14. RESULTS: Mean INR rose rapidly after the start of paracetamol and was significantly increased within one week of paracetamol intake compared to placebo, p=0.0002. The INR values reached a mean maximum of 3.45+/-0.78 with paracetamol versus 2.66+/-0.73 with placebo (p=0.03), corresponding to a maximum increase from baseline of 1.20+/-0.62 with paracetamol versus 0.37+/-0.48 with placebo (p<0.001). Together with the rise in INR on paracetamol treatment there were significant reductions in the vitamin K-dependent clotting factors II, VII, IX and X. INTERPRETATION AND CONCLUSIONS: The most plausible hypothesis to explain the in vivo interaction is that paracetamol (or its metabolites) interfere with enzymes involved in vitamin K-dependent coagulation factor synthesis. Paracetamol at 4 g daily (a dose higher than that used in clinical practice) potentiates the anticoagulant response produced by warfarin. Clinicians should be aware of this clinically significant and underestimated interaction.

Acetaminophen↗
PubMed2005

Which treatment for patent foramen ovale in cryptogenic stroke?

The management of a patient with a cryptogenic stroke and a patent foramen ovale (PFO) depends on the existence of identifiable causes of stroke, on the PFO characteristics, on the characteristics of the patient, on the contraindications to antithrombotic therapy, and on the preference of the patient. There is no consensus on the management of a patient with a cryptogenic stroke and a PFO, but the algorithm presented in this article seems reasonable to these authors.

Journal Article↗
PubMed2005

Efficacy and safety of three ophthalmic inserts for topical anaesthesia of the cornea. An exploratory comparative dose-ranging, double-blind, randomized trial in healthy volunteers.

BACKGROUND: Cataract surgery requires prolonged anaesthesia, concomitant with permanent hydration and lubrication of the cornea, in order to provide a clear view of the operation area. AIMS: The primary objective of the study was to assess several formulae of a soluble ophthalmic insert: TOPICSERT [bupivacaine (Bupi) + hyaluronic acid (HA) or sodium hyaluronate] in terms of complete and long-lasting anaesthesia of the cornea. The hydration properties of HA were not assessed in this study. METHODS: In a prospective double-blind, cross-over, randomized study, with latin-square allocation of treatments, 16 healthy volunteers received a single dose of each formula (A, 1 mg Bupi and 0.1 mg HA; B, 0.5 mg Bupi and 0.1 mg HA; C, 1 mg Bupi and 0 mg HA, and D acting as a placebo) via the ocular route with 1 week of wash-out between each period. Corneal anaesthesia was measured using a Cochet-Bonnet esthesiometer. RESULTS: There was a statistically significant difference between treatments with regard to the main criterion (complete anaesthesia lasting at least 20 min) when general association statistics were used (Mantel-Haenzel test, P < 0.0001): 68.75% (n = 11) of subjects receiving treatment A, 37.5% (n = 6) receiving treatment B, and 87.5% (n = 14) on treatment C reached complete and satisfactory anaesthesia, while this was not achieved in any of the subjects receiving placebo. Ninety-five percent confidence intervals of the difference between treatments were as follows: treatment A vs. B (-0.03, 0.66), treatment A vs. C (-0.47, 0.10), treatment B vs. C (-0.84, - 0.16). Only the difference between B and C was statistically significant (adjusted probability by the method of Bonferroni, P < 0.001). When complete anaesthesia was reached, mean (+/-SD) duration of anaesthesia was as follows: 20.7 (+/-6.5), 15.3 (+/-11.4) and 24.7 (+/-7.6) min for treatments A, B, C, respectively. CONCLUSIONS: Bupivacaine 1 mg seems to be the efficient and safe dose. The value of hyaluronic acid as a corneal hydration agent and used in association with bupivacaine will be the subject of further studies.

Adjuvants, Immunologic↗
PubMed2005

Circadian fluctuations of macular edema in patients with morning vision blurring: correlation with arterial pressure and effect of light deprivation.

PURPOSE: This study explored the causes of vision fluctuations in patients with chronic macular edema. METHODS: Fifteen patients (16 eyes) with vision blurring at awakening due to post-central retinal vein occlusion (CRVO) macular edema underwent three examination sessions over 24 hours (at 7 PM, immediately after awakening at 7 AM, and at 7 PM), which comprised assessment of Early Treatment Diabetic Retinopathy Study score and measurement of macular thickness (MT) by optical coherence tomography. Ocular perfusion pressure was calculated from ambulatory arterial pressure measurement. In addition, after the 7 AM measurements, the patients were randomly selected for monocular light deprivation during the day to evaluate the role of retinal illumination in these fluctuations. RESULTS: Circadian fluctuation of MT was documented in all patients. At 7 AM, mean visual acuity (VA) was worse (mean +/- SD of the difference: 6.5 +/- 7.2 points; P < 0.002) and mean MT was higher (57.4 +/- 34 microm; P < 0.001) than at 7 PM. Fluctuations of MT were correlated to fluctuation of arterial pressure (P = 0.05), but were not influenced by monocular light deprivation. CONCLUSIONS: In most patients complaining of visual fluctuations due to macular edema secondary to CRVO, MT and VA were found to undergo a circadian cycle. These short-term anatomic and functional variations were associated with arterial pressure variations (that is, macular thickening was inversely correlated to the arterial pressure drop during the night), but were not due to light deprivation.

Adult↗