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J L Montastruc

Publications and source records attributed to J L Montastruc.

At least 19 recordsLinked to original sources
PubMed2007

Detection and incidence of drug-induced agranulocytosis in hospital: a prospective analysis from laboratory signals.

AIMS: Our objectives were to assess the detection and incidence of drug-induced agranulocytosis in two university hospitals using hematology laboratory data. METHODS: A prospective study was undertaken at Toulouse University Hospital (France) and Navarra University Hospital (Spain) for 1 year (from 1 May 2004 to 30 April 2005). Using a computerized process and hematology laboratory data, all neutrophil counts with a value less than 500/mm(3) were registered, allowing identification of inpatients suffering from agranulocytosis during the period of the study. Medical records of all selected patients were then consulted. Cytostatic drugs were excluded from this study. RESULTS: During the period of the study, 225,659 neutrophil counts were performed in both hospitals, of which 2,835 (1.26%) had a neutrophil count less than 500/mm(3), corresponding to 739 patients. Seventeen patients were excluded because of lack of data, and 20 cases of infants younger than 3 months were excluded. Among the remaining patients (n = 702), 23 cases of drug-induced agranulocytosis (excluding cytostatic drugs) were suspected. All cases were classified as "serious" since they led to death in 2 cases, hospitalization or prolongation of hospitalization in 19 cases and threatening of vital prognosis in 2 cases. Withdrawal of suspected drugs was done in all cases with regression of neutropenia in 21 cases. According to hospitalization data, the annual incidence of drug-induced agranulocytosis was 1.62 (1.0-2.6) per 10,000 inpatients in Toulouse University hospital (based on 534 cases) and 3.24 (0.9-8.3) per 10,000 inpatients in Navarra University Hospital (based on 168 cases). The involved drugs were mainly antibacterial (30.4%), immunosuppressive (17.4%), antithyroid (13.0%), antiplatelet (8.7%) and nonsteroidal anti-inflammatory (8.7%) ones. Only seven cases from Toulouse University Hospital were spontaneously reported by physicians during the same period. Thus, the underreporting coefficient (U) was 2.71 (63.2%) in France. CONCLUSION: Our survey allowed us to identify the suspected drug-induced agranulocytosis through a prospective study in a large sample of inpatients using only laboratory data analysis. We also note an important underreporting rate of this serious adverse drug reaction (ADR) to the official French pharmacovigilance system. Laboratory data analysis could be used for identifying serious ADRs.

Adult↗
PubMed2006

Adverse drug reactions in patients older than 70 years during the heat wave occurred in France in summer 2003: A study from the French PharmacoVigilance Database.

OBJECTIVE: To evaluate adverse drug reactions (ADRs) in patients older than 70 years reported during the 2003 summer heat wave in France to the French Network of Pharmacovigilance Centres and to discuss the interest of such a pharmacovigilance database in the surveillance of such sanitary alerts. METHODS: All 'serious' ADRs occurred in patients older than 70 years between 1st July and 31st August 2003, reported to the French network of Pharmacovigilance Centres and recorded in the French PharmacoVigilance Database, were analysed with respect to age, gender, type of ADR, drug(s) involved as well as imputability of heat wave. RESULTS: The total number of 'serious' ADRs registered in the French PharmacoVigilance Database in patients older than 70 years was similar in 2003 (a year with heat wave) and in 2002 (a year without heat wave). Sixty-eight ADRs [27 'possible' (I1), 27 'plausible' (I2) and 14 'likely' (I3)] related to heat occurred in 2003, with a maximal peak between the 28th July and the 17th August. The most frequently ADRs were metabolic (dehydratation, hydroelectrolytic disturbances) and neuropsychiatric (confusion, falls, coma). Drugs more frequently involved were diuretics, angiotensin converting enzyme inhibitors, antidepressants (mainly serotonin reuptake inhibitors), proton pump inhibitors, digoxin, benzodiazepines, oral hypoglycemics and sartans. CONCLUSION: This study underlines the role of heat wave in the occurrence of 'serious' ADRs in elderly. However, the French PharmacoVigilance Database was not enough sensitive to be used as an efficient surveillance system during such an acute episode, like a heat wave (at least while underreporting remains so important).

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Valvular heart disease in a patient taking benfluorex.

The authors describe a case of valvular heart disease in a 48-year-old woman receiving benfluorex (150 mg t.i.d. for 8 years) and leading to surgical mitral valve replacement. Examination showed severe dyspnea with severe mitral regurgitation associated with tricuspid regurgitation. No other common disease known to affect mitral valves nor intake of other drugs (ergot derivatives or appetite suppressant drugs) was found. The paper discusses the imputability of benfluorex, a drug used as an adjuvant in hypercholesterolemia, structurally related to amphetamines.

Female↗
PubMed2006

[Myocardial infarction in a young female smoker taking oral contraception].

A 33 year old woman suffered a lateral myocardial infarction for the first time, and was treated by pre-hospital thrombolysis and secondary angioplasty on the diagonal artery. Fifteen days before the cardiac event she had undergone a left ovarian cyst excision and left salpingectomy for an ectopic pregnancy. She was a moderate smoker and had been taking a second-generation biphasic minidose oral contraceptive (ethinyl-estradiol 30-40mg and levonorgestrel 150-200 mg) for about ten years. Fifteen days before the myocardial infarction and due to the ectopic pregnancy she had changed to a combined monophasic minidose oral contraceptive pill containing ethinylestradiol (30 mg) and drospirenone (3 mg). The eventual outcome was favourable, with no complications. In this article we discuss the possible implications of the various factors (oral contraceptive, tobacco use, and surgical intervention) in this young woman with a myocardial infarction.

Adult↗
PubMed2005

[Consensus statement on severe dementia].

Under the auspices of the French Society of Gerontology and Geriatrics, a multidisciplinary group of experts, including geriatricians, neurologists, epidemiologists, psychiatrists, pharmacologists, and public health specialists developed consensus recommendations about care for patients with severe dementia. They defined 21 recommendations for general practitioners, long-term care physicians, and specialists, based on the knowledge currently available (2005). The aim of care at all stages is to mitigate the quality-of-life of patient, caregiver, and family insofar as possible, combining care and future planning until the end of life. Management, to take into account problems including nutritional status, behavior disorders, and ability (or inability) to perform activities of daily living, must be global, multidisciplinary, and coordinated and must optimize use of local medical and social resources. The group also stressed the importance of clinical research to improve knowledge of disease course and assess management strategies and recommended specific area for research.

Aged↗
PubMed2005

COX-2 inhibitors and arterial hypertension: an analysis of spontaneous case reports in the Pharmacovigilance database.

OBJECTIVE: To evaluate the main characteristics of case reports of arterial hypertension (AH) related to COX-2 inhibitor (coxib) use in real-life practice. METHODS: This study was based on spontaneous reports of adverse drug reactions (ADRs) submitted to the French Pharmacovigilance system. Associations between AH and the different groups of those using non-steroidal anti-inflammatory drugs (NSAIDs: rofecoxib, celecoxib and non-selective NSAIDs) were compared using calculation of the odds ratio (OR) with 95% confidence intervals (CIs). RESULTS: In France, between 1 April 2000 and 30 November 2003, 34 AH cases related to coxibs were reported. Case reports include predominantly patients older than 65 years, with a previous story of essential AH. Most AH (60%) occurred during the first 15 days of treatment. The AH was reported significantly more frequently for rofecoxib than celecoxib. The OR for development of AH with rofecoxib versus celecoxib was 3.3 (1.6-6.9). The AH was also reported more frequently with coxib (2.8%) than with non-selective NSAID (0.5%) use, OR = 5.9 (3.8-9.0). CONCLUSION: This study shows that coxibs are associated with a risk of AH in real-life practice. More spontaneous reports of AH to the French Pharmacovigilance system concern rofecoxib than celecoxib (and coxibs than non-selective NSAIDs). This ADR is of special epidemiological importance due to both the risks of AH and the large use of coxibs.

Adult↗
PubMed2005

"Medicamentation" of society, non-diseases and non-medications: a point of view from social pharmacology.

This review presents the definition and goals of "social pharmacology", a new branch of clinical pharmacology, investigating relationships between drugs and society through the example of "medicamentation", defined as the use of drugs for social problems previously not requiring drug utilisation (ageing, smoking cessation, vigilance troubles, sleep synchronisation, loss of libido, etc.). The involvement of the different "actors" from our society (patients, physicians, pharmaceutical industries, clinical pharmacologists, regulatory agencies, etc.) in this phenomenon is also discussed.

Aging↗
PubMed2005

Psychoactive drug consumption: performance-enhancing behaviour and pharmacodependence in workers.

PURPOSE: The aim of this study was to investigate factors associated to psychoactive medication use and dependence in working environment during a 1-year period. METHODS: We performed a 1-year-follow-up cohort study including workers from Toulouse metropolitan area. During their annual compulsory examination to assess their aptitude to work, subjects were asked to fill in an anonymous questionnaire at 1 year interval, in May 2000 and May-June 2001. RESULTS: Among a study sample of 1273 subjects (47.4% of men, mean age 39.2 +/- 9.2 years), the prevalence of psychoactive medication use at baseline was 9.1% (4.3% anxiolytic, 1.9% hypnotic, 1.7% antidepressant, 2.1% opiate analgesic and 0.5% antipsychotic drugs, according to ATC classification). Dependence on these drugs was found in 3.5% of workers. This consumption was associated with professional categories (higher in employees versus senior executive, Odds Ratio: 1.80; 95% Confidence Interval [1.04-3.11]), low job satisfaction and outside workplace (1.92; [1.30-2.84] and 3.40; [2.27-5.09] respectively), and patterns of medication use at workplace: for sleeping disorders related to job (18.27; [11.81-28.26]), for enhancing performance at work (28.13; [12.00-65.92]), for relieving unpleasant symptoms at work (22.98; [9.59-55.01]). The risk of psychoactive medication chronic use (psychoactive drug users in 2000 and 2001), and dependence at 1 year were both strongly associated with nicotine dependence (5.99 and 6.23, respectively) and performance-enhancing behaviour with drugs and/or alcohol (8.35 and 3.32 respectively), whereas current use (psychoactive drug users only in 2001) was strongly associated with performance-enhancing behaviour. CONCLUSIONS: Among workers using psychoactive drugs, one out of three are dependent on psychoactive medications. Performance-enhancing behaviour and coping strategies might be a determinant of psychoactive drug use and could lead to dependence in the workplace.

Adolescent↗
PubMed2005

Insulin downregulates M(2)-muscarinic receptors in adult rat atrial cardiomyocytes: a link between obesity and cardiovascular complications.

OBJECTIVE: To determine whether decreased cardiac parasympathetic activity observed in obesity is due to insulin-induced alterations in cardiac M(2)-muscarinic receptors and/or adenylyl cyclase activity. DESIGN AND METHODS: After incubation with increasing concentrations of insulin, adult rat atrial cardiomyocytes were assayed for M(2)-muscarinic receptor binding density and affinity, and for M(2)R mRNA expression using RT-PCR analysis. Forskolin-stimulated adenylyl cyclase activity and its inhibition by carbachol were also assayed, as was endothelial nitric oxide synthase mRNA expression. The effects of insulin on M(2)-muscarinic receptor density and mRNA expression levels were analyzed using the insulin signaling inhibitors rapamycin, wortmanin and PD 098059. RESULTS: Insulin induces a concentration- and time-dependent decrease in expression of the M(2)R mRNA, and in [(3)H]N-methylscopolamine binding by the receptor. These effects on the M(2)R mRNA levels and on [(3)H]N-methylscopolamine binding were prevented by PD 98059, but not by wortmanin or rapamycin. Basal and forskolin-induced cAMP production did not differ, but the inhibition of forskolin-simulated enzyme activity by carbachol was blunted by insulin. No change in the mRNA levels for endothelial nitric oxide synthase was observed. CONCLUSION: In rat atrial cardiomyocytes, insulin markedly alters both the M(2)-muscarinic receptor density, and its mRNA expression through transcriptional regulation and adenylyl cyclase activity. These data suggest that the obesity-associated decrease in cardiac parasympathetic tone may be related to hyperinsulinemia, which could directly contribute to cardiovascular morbidity in obese patients.

Adenylyl Cyclases↗
PubMed2004

Upper gastrointestinal adverse drug reactions and cyclo-oxygenase-2 inhibitors (celecoxib and rofecoxib): a case/non-case study from the French Pharmacovigilance Database.

OBJECTIVE: To evaluate the gastrointestinal safety of cyclo-oxygenase-2 inhibitors under their real conditions of use. DESIGN. Case/non-case study. SETTING: Adverse drug reactions (ADRs) in adults recorded in the French Pharmacovigilance Database between 25 May 2000 and 31 December 2002. MATERIALS: Cases were all reports of "serious" oeso-gastro-duodenal ADRs (oeso-gastro-duodenal ulcers, oesophagitis, gastritis, duodenitis). Five non-cases were randomly selected for one case from all other non oeso-gastro-duodenal reports in the database after matching them for age, gender and period of occurrence. ANALYSIS: Coxib exposure was compared among cases and non-cases, with adjustment for matching factors: French Regional Pharmacovigilance Centres that collected ADRs, reporter health professional's characteristics and exposures to non-selective non-steroidal anti-inflammatory, aspirin, anticoagulant, antiplatelet and gastroprotective drugs. RESULTS: Included in the study were 505 cases and 2,525 non-cases. A positive association was found between occurrence of oeso-gastro-duodenal ADRs and coxib (adjusted odds ratio 14.9 [95% CI 9.3-23.7]), diclofenac (9.2 [3.8-22.2]), ibuprofen (7.3 [3.2-16.6]) or oxicam (25.3 [11.9-53.6]) use. CONCLUSION: Despite the compulsory limits of the case/non-case methodology, the present study shows that coxibs did induce "serious" gastrointestinal ADRs in real clinical practice. These results underline the need for pharmacoepidemiological studies under real conditions of use in order to verify (or not) the conclusions of clinical trials.

Adolescent↗
PubMed2004

Detection and incidence of muscular adverse drug reactions: a prospective analysis from laboratory signals.

AIMS: The awareness of muscular adverse drug reactions (ADRs) increased since the withdrawal of cerivastatin, a HMG-CoA reductase inhibitor, from the market in August 2001. Our objectives were to assess the detection and incidence of muscular ADRs in a University Hospital using biochemical laboratory data and to evaluate the underreporting rate of drug-induced muscular disorders. METHODS: A prospective study was undertaken at Toulouse University Hospital, France, for 1 week per month from November 2001 to October 2002. Patients were selected by means of a computerized process using biochemical laboratory data based on serum creatine phosphokinase (CPK) values (over twofold normal). Medical records of all selected patients were then consulted. RESULTS: During the period of the study, 2017 CPK tests were performed, among which 171 values were over twofold normal corresponding to 129 patients. Because of lack of data, 26 patients were excluded. Among these patients ( n=103), 28 cases of muscular ADRs were suspected, 22 of which were detected in outpatient departments. Four patients were totally asymptomatic and five had an increase of CPK over fivefold normal. Nine cases were classified as "serious". Withdrawal of suspected drugs were done in 16 cases with regression of ADRs in 13 cases. According to hospitalization data, the incidence of muscular ADRs was estimated as 7.2 (2.6-15.7) per 10,000 inpatients and 9.3 (5.8-14.1) per 10,000 outpatients over 12 weeks. The involved drugs were mainly: statins (46.4%), fibrates (14.3%), antiretrovirals (14.3%), angiotensin-II receptor antagonists (10.7%), immunosuppressants (7.1%) or hydroxychloroquine (7.1). Only two cases, judged as "serious", were spontaneously reported by physicians during the same period. CONCLUSION: The results of this survey underline the importance to take into account drug hypothesis in muscular injuries diagnosis.

Adult↗
PubMed2004

Drug counselling in pregnancy: an opinion survey of French community pharmacists.

PURPOSE: The aim of the present study was to determine whether community pharmacists recommend appropriate medications and give valid information to pregnant women. METHODS: A total of 163 community pharmacists randomly selected in the Midi-Pyrénées area were interviewed by means of an open questionnaire. Ten scenarios were proposed concerning back pain, headache, coughs and sore-throats, fever, constipation, nausea, dyspepsia, 'venous insufficiency', allergic rhinitis and insomnia. RESULTS: Out of the total, 130 pharmacists accepted to answer. Out of them 94.5% reported advising homeopathy, especially for coughs and allergy. They often advised medication for pain, fever, nose and oropharynx disorders, 'venous insufficiency', dyspepsia or constipation. By contrast, they referred the women to the general practitioner for nausea and vomiting or back pain. Advice without drug dispensation was given for gastrointestinal disorders or 'venous insufficiency'. Phytotherapy only concerned 0.5-2% of the answers except for anxiety and sleep disturbances (59%), 'venous disorders'(17%) and sore-throat (9%). Pharmacists' answers were sometimes inappropriate involving (1) pharmacologically illogical advice, (2) drugs for which neither clinical nor experimental data are available and (3) drugs potentially harmful in pregnancy. CONCLUSIONS: The present study shows that French community pharmacists do not always give appropriate advice to pregnant women. As primary health care providers, pharmacists have to improve counselling regarding drug use in pregnancy.

Community Pharmacy Services↗
PubMed2004

Buprenorphine in pregnant opioid-dependent women: first results of a prospective study.

AIM: To report results on the prospective follow-up of 34 pregnant women exposed to buprenorphine maintenance for opiate dependence. DESIGN AND SETTING: Prospective multicentre study: all pregnant women receiving buprenorphine as maintenance therapy were included as early as possible during their pregnancy. PARTICIPANTS: The pregnant women were recruited from opiate maintenance therapy centres, general practitioner-networks involved in addiction, maternity hospitals and centres for drug information during pregnancy. MEASUREMENTS: Women: drugs and medications consumed, medical and obstetrical events; offspring: withdrawal syndrome, malformation, neonatal disease. FINDINGS: The buprenorphine-exposed pregnancies resulted in 31 live births, one stillbirth, one spontaneous abortion and one voluntary termination. A neonatal withdrawal syndrome was observed in 13 cases (41.9%) and eight of these babies required opiate treatment. Two neonates had a malformation: a premature ductus arteriosus stricture and a tragus appendix. CONCLUSION: Taken together with other prospective studies, no alarming results were observed concerning pregnancy outcomes. However, further data from the comparative prospective study are required to determine whether buprenorphine can be considered as a good alternative to methadone treatment in pregnant women.

Adult↗
PubMed2004

Nonsteroidal anti-inflammatory drug-induced liver injury: a case-control study in primary care.

Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been withdrawn from the market because of hepatic adverse drug reactions (ADRs). Moreover, some cases of liver diseases have been reported in patients taking NSAIDs (arylcarboxylic NSAIDs, piroxicam, sulindac, nimesulide, etc.). Pharmacoepidemiological studies have shown a risk of hepatic ADRs with NSAIDs used in association with other hepatotoxic drugs. In contrast, other studies performed in hospitalized patients did not found any association. The aim of this study was to assess the hepatic risk associated with the use of NSAID in the setting of primary care. The study design was a case-control study where cases and controls were all recruited among patients seen in the context of medical community care. Eighty-eight cases and 178 controls were included between January 1998 and December 2000. Cases used more drugs than controls in the 15 days before index day (2.9 +/- 2.2 vs. 1.8 +/- 1.8 different consumed drugs; P < 10(-4)). After adjustment, we found a significant association between liver injury and NSAID exposure in women [odds ratio (OR) = 6.49 (1.67-25.16)] but not in men [OR = 1.06 (0.36-3.12)]. A total of 22 cases were exposed to NSAIDs. Of them, seven patients were exposed to salicylates, five to diclofenac, four to ibuprofen, four to ketoprofen, two to niflumic acid, one to flurbiprofen and one to meloxicam (two patients were simultaneously exposed to two different NSAIDs: salicylate + niflumic acid and salicylate + diclofenac). These patients suffered from hepatocellular (53.3%), cholestatic (20%) or mixed (26.7%) injury. In 18 cases, liver enzymes returned to normal values after discontinuation of drug. No case had a fatal outcome. This study shows the existence of a significant association between liver disturbances and NSAID use in women.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2003

Efficacy and tolerability of entacapone in patients with Parkinson's disease treated with levodopa plus a dopamine agonist and experiencing wearing-off motor fluctuations. A randomized, double-blind, multicentre study.

The efficacy and tolerability of entacapone was investigated in a randomized, double-blind, placebo-controlled, 3-month study of 162 patients with Parkinson's disease (PD) treated with levodopa and a dopamine agonist and experiencing wearing-off motor fluctuations. Patients were randomized in a 3 : 2 ratio to entacapone 200 mg or placebo, administered with each dose of levodopa. Efficacy was judged on the improvement of "on" and "off" time while awake (Patient Diary and UPDRS part IV Item 39), Investigators' Global Assessment, the SF-36 Health Survey, and changes in levodopa dosages. Patients were monitored for adverse events, laboratory safety and vital signs throughout the study. Improvements in "on" time as assessed using patient diary data showed a trend in favour of entacapone, however these did not reach statistical significance. "Off" time while awake (UPDRS part IV Item 39) showed an improvement of at least one category in 36% of entacapone-treated patients, compared with 22% in the control group (p = 0.0038). The proportion of patients showing an improvement at the Investigators' Global Assessment was significantly higher (p = 0.0006) in the entacapone-treated group of patients. Also, the proportion of patients with a reduction in their daily levodopa dose was significantly higher (p = 0.02) in the entacapone group (28%) compared with placebo (13%). As expected, the most frequent adverse events were dopamine-mediated (dyskinesia: entacapone 31% versus placebo 13%), and harmless urinary discoloration. The modest increase in dyskinesias could be readily managed by levodopa down-adjustment, and, at study end there was no significant difference for the UPDRS "overall dyskinesia score" between entacapone and placebo. In conclusion, although the primary efficacy variable did not reach statistical significance, the present results demonstrate that entacapone provides additional antiparkinsonian benefits to levodopa therapy and is well tolerated in levodopa-treated PD patients experiencing wearing-off motor fluctuations despite adjunct dopamine agonist therapy.

Aged↗