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1. Perception of teratogenic and foetotoxic risk by health professionals: a survey in Midi-Pyrenees area.

Author

Damase-Michel C, Pichereau J, Pathak A, Lacroix I, and Montastruc JL

Subjects
Teratogens, Health Knowledge, Attitudes, Practice, France, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, RS1-441
Abstract

Counselling or prescribing drugs during pregnancy requires health professionals to assess risk/benefit ratio for women and their baby. A misperception of the risk may lead to inappropriate decisions for pregnancy outcomes. The aim of the present study was to assess teratogenic and/or foetotoxic risk perception of common medications by general practitioners (GPs) and community pharmacists (CPs) from the Midi-Pyrenees area.Methods: 103 GPs and 104 CPs were interviewed. For 21 given drugs, a visual-analogue scale was used to evaluate the risk to give birth to a malformed infant if the mother had taken the drug during first trimester of pregnancy. For 9 drugs, health professionals had to say if they thought there was a potential foetotoxic and/or neonatal risk when drugs were administered during late pregnancy.Results: 97% and 91% of GPs and CPs respectively thought that isotretinoin and thalidomide are teratogenic and more than 80% thought that amoxicillin and acetaminophen are safe in early pregnancy. However, 19% of the GPs and 33% of CPs answered there were no teratogenic risk for valproate. Around 11% of both GPs and CPs said that warfarin was safe during pregnancy. For 22% of GPs and for 13% and 27% of CPs respectively, ibuprofen and enalapril were safe on late pregnancy. For each drug, mean value of perceived teratogenic risk by health professionals was higher than values that can be found in scientific references. Concerning isotretinoin, thalidomide and metoclopramide, perceived teratogenic risk was higher for CPs.Conclusion: These data show that the potential teratogenic and foetotoxic risk of several commonly used drugs is unknown by health professionals. Conversely, GPs and CPs who think that a risk exists, overestimate it. This misperception can lead to inappropriate decisions for pregnancy outcomes.

Published
2008

5. Differences in HIV cure clinical trial preferences of French people living with HIV and physicians in the ANRS‐APSEC study: a discrete choice experiment

Author

Protiere, Christel, Arnold, Michael, Fiorentino, Marion, Fressard, Lisa, Lelièvre, Jean D., Mimi, Mohamed, Raffi, François, Mora, Marion, Meyer, Laurence, Sagaon?Teyssier, Luis, Zucman, David, Préau, Marie, Lambotte, Olivier, Spire, Bruno, Suzan?Monti, Marie, Bergmann, J.F., Blacher, J., Blanc, A.P., Delobel, P., Girard, P.M., Goujard, C., Katlama, C., De Lacroix, I., Lafeuillade, A., Lelièvre, J.D., Lepeu, G., Michelet, C., Molina, J.M., Morlat, P., Peyramond, D., Piroth, L., Poizot?Martin, I., Raffi, F., Ragnaud, J.M., Senneville, E., Weiss, L., Yazdanpanh, Y., and Zucman, D.

Subjects
Clinical trials -- Management, AIDS (Disease) -- Research, AIDS research, HIV infection -- Care and treatment, Company business management, Health
Abstract

: Introduction: Despite the advent of HIV cure‐related clinical trials (HCRCT) for people living with HIV (PLWH), the risks and uncertainty involved raise ethical issues. Although research has provided insights into the levers and barriers to PLWH and physicians' participation in these trials, no information exists about stakeholders' preferences for HCRCT attributes, about the different ways PLWH and physicians value future HCRCT, or about how personal characteristics affect these preferences. The results from the present study will inform researchers' decisions about the most suitable HCRCT strategies to implement, and help them ensure ethical recruitment and well‐designed informed consent. Methods: Between October 2016 and March 2017, a discrete choice experiment was conducted among 195 virally controlled PLWH and 160 physicians from 24 French HIV centres. Profiles within each group, based on individual characteristics, were obtained using hierarchical clustering. Trade‐offs between five HCRCT attributes (trial duration, consultation frequency, moderate (digestive disorders, flu‐type syndrome, fatigue) and severe (allergy, infections, risk of cancer) side effects (SE), outcomes) and utilities associated with four HCRCT candidates (latency reactivation, immunotherapy, gene therapy and a combination of latency reactivation and immunotherapy), were estimated using a mixed logit model. Results: Apart from severe SE – the most decisive attribute in both groups – PLWH and physicians made different trade‐offs between HCRCT attributes, the latter being more concerned about outcomes, the former about the burden of participation (consultation frequency and moderate SE). These different trades‐offs resulted in differences in preferences regarding the four candidate HCRCT. PLWH significantly preferred immunotherapy, whereas physicians preferred immunotherapy and combined therapy. Despite the heterogeneity of characteristics within the PLWH and physician profiles, results show some homogeneity in trade‐offs and utilities regarding HCRCT. Conclusions: Severe SE, not outcomes, was the most decisive attribute determining future HCRCT participation. Particular attention should be paid to providing clear information, in particular on severe SE, to potential participants. Immunotherapy would appear to be the best HCRCT candidate for both PLWH and physicians. However, if the risk of cancer could be avoided, gene therapy would become the preferred strategy for the latter and the second choice for the former., Introduction HIV cure research, a desired but risky and “uncomfortable” innovation, raises several ethical questions. More specifically, to test the effectiveness of new HIV cure‐related clinical trials (HCRCT), clinicians must [...]

Published
2020
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7. Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial

Author

Pepin S., Nicolas J. -F., Szymanski H., Leroux-Roels I., Schaum T., Bonten M., Icardi G., Shrestha A., Tabar C., Van Damme P., Donazzolo Y., Launay O., Schurholz T., Sturm K., Toursarkissian N., Schenkenberger I., Vitale F., Brzostek J., Pajek B., Miszczak-Kowalska E., Khoury R., Grosbois M. -A., Gauby C., Lacroix I., Souzy F., Pandey A., Yandle S., Lupinsky N., Goulet F., Milcamps L., De Sousa J., Lardon M., Lyko V., Blattmann A., Janosczyk H., Samson S., De Bruijn I., Pepin S., Nicolas J.-F., Szymanski H., Leroux-Roels I., Schaum T., Bonten M., Icardi G., Shrestha A., Tabar C., Van Damme P., Donazzolo Y., Launay O., Schurholz T., Sturm K., Toursarkissian N., Schenkenberger I., Vitale F., Brzostek J., Pajek B., Miszczak-Kowalska E., Khoury R., Grosbois M.-A., Gauby C., Lacroix I., Souzy F., Pandey A., Yandle S., Lupinsky N., Goulet F., Milcamps L., De Sousa J., Lardon M., Lyko V., Blattmann A., Janosczyk H., Samson S., and De Bruijn I.

Subjects
safety, Adult, IMPACT, Influenza vaccine, Immunology, immunogenicity, Antibodies, Viral, Quadrivalent Influenza Vaccine, older adult, Immunogenicity, Vaccine, Double-Blind Method, Influenza, Human, Medicine and Health Sciences, Immunology and Allergy, Medicine, Humans, Vaccines, Combined, older adults, Pharmacology, business.industry, Immunogenicity, ADULTS, Hemagglutination Inhibition Tests, EFFICACY, Virology, influenza vaccination, High-dose influenza vaccine, Vaccines, Inactivated, Influenza Vaccines, Phase III trial, business
Abstract

A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60–64y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180d after vaccination. The primary immunogenicity objective was superiority of IIV4-HD versus IIV4-SD, for all four influenza strains 28d post vaccination in participants aged 60–64 and ≥65y. IIV4-HD induced a superior immune response versus IIV4-SD in terms of GMTs in participants aged 60–64 y and those aged ≥65y for all four influenza strains. IIV4-HD induced higher GMTs in those aged 60–64 y than those aged ≥65 y. Seroconversion rates were higher for IIV4-HD versus IIV4-SD in each age-group for all influenza strains. Both vaccines were well tolerated in participants ≥60y of age, with no safety concerns identified. More solicited reactions were reported with IIV4-HD than with IIV4-SD. IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged ≥60 y. IIV4-HD is assumed to offer improved protection against influenza compared with IIV4-SD in adults aged ≥60 y, as was previously assessed for adults aged ≥65y.

Published
2021

10. Arch Womens Ment Health

Author

BENARD-LARIBIERE, Anne, PAMBRUN, Elodie, SUTTER-DALLAY, Anne-Laure, GAUTIER, S., HURAULT-DELARUE, C., DAMASE-MICHEL, C., LACROIX, I., and PARIENTE, Antoine

Subjects
PharmacoEpi-Drugs
Published
2020

13. HIV Infection and Long‐Term Residual Cardiovascular Risk After Acute Coronary Syndrome

Author

Boccara, Franck, primary, Mary‐Krause, Murielle, additional, Potard, Valérie, additional, Teiger, Emmanuel, additional, Lang, Sylvie, additional, Hammoudi, Nadjib, additional, Chauvet, Marion, additional, Ederhy, Stéphane, additional, Dufour‐Soulat, Laurie, additional, Ancedy, Yann, additional, Nhan, Pascal, additional, Adavane, Saroumadi, additional, Steg, Ph. Gabriel, additional, Funck‐Brentano, Christian, additional, Costagliola, Dominique, additional, Cohen, Ariel, additional, Weber, S., additional, Wahbi, K., additional, Beaufils, P., additional, Henri, P., additional, Sideris, G., additional, Thomas, D., additional, Montalescot, G., additional, Beygui, F., additional, Meuleman, C., additional, Janower, S., additional, Raoux, F., additional, Dufaitre, G., additional, Benyounes, N., additional, Michel, P. L., additional, Petillon, B., additional, Hammoudi, N., additional, Gueret, P., additional, Dubois‐Rande, J. L., additional, Teiger, E., additional, Lim, P., additional, Slama, M., additional, Colin, P., additional, Saudubray, C., additional, Dubourg, O., additional, Milleron, O., additional, Gallet, B., additional, Duclos, F., additional, Godard, S., additional, Fuchs, L., additional, Dormagen, V., additional, Lewy, P., additional, Cattan, S., additional, Nallet, O., additional, Grollier, G., additional, Shayne, J., additional, Wolf, J. E., additional, Cottin, Y., additional, Machecourt, J., additional, Bouvaist, H., additional, Finet, G., additional, De Breyne, B., additional, Trochu, J. N., additional, Baudouy, M., additional, Ferrari, E., additional, Benhamou, M., additional, Allal, J., additional, Coisne, D., additional, Le Breton, H., additional, Bedossa, M., additional, Puel, J., additional, Elbaz, M., additional, Larifla, L., additional, Matheron, S., additional, Landman, R., additional, Fremont, G., additional, Spiridon, G., additional, Blanche, P., additional, Morini, J. P., additional, Sicard, D., additional, Zeller, V., additional, Batisse, D., additional, Clevenbergh, P., additional, Cessot, G., additional, Dohin, E., additional, Valantin, M. A., additional, Khelifa, S., additional, Girard, P. M., additional, Lallemand, F., additional, Lefebvre, B., additional, Laporte, J. P., additional, Meynard, J. L., additional, Bideault, H., additional, Picard, O., additional, Meyohas, M. C., additional, Campa, P., additional, Tredup, J., additional, Fonquernie, L., additional, Raguin, G., additional, Molina, J. M., additional, Furco, A., additional, Gharakanian, S., additional, Vincensini, J. P., additional, Guiard‐Schmid, J. B., additional, Pialoux, G., additional, Cardon, B., additional, Lascaux, A. S., additional, Chaix, F., additional, Lesprit, P., additional, Fior, R., additional, Boue, F., additional, Dupont, C., additional, Bellier, C., additional, Blanc, A., additional, Lambert, T., additional, Touahri, T., additional, Force, G., additional, de Truchis, P., additional, Compagnucci‐Seguenot, M. A., additional, Cahitte, I., additional, Roudière, L., additional, Techer, M. E., additional, Thelpin, P., additional, Troisvallets, D., additional, Lepretre, A., additional, Echard, M., additional, Le Mercier, Y., additional, Houlbert, D., additional, Dargere, S., additional, Bazin, C., additional, Verdon, R., additional, De Goer, B., additional, Duong, M., additional, Chavanet, P., additional, Gozlan, E., additional, Leclercq, P., additional, Brunel‐Dal Mas, F., additional, Durant, J., additional, Heudier, P., additional, Brunet‐François, C., additional, Le Moal, G., additional, Chapplin, J. M., additional, Arvieux, C., additional, Chaumentin, G., additional, Guerin, B., additional, Bonnet, E., additional, Poinsignon, Y., additional, Boulard, F., additional, De Lacroix, I., additional, Goerger‐Sow, M. T., additional, Kirstetter, M., additional, Volstein, M., additional, Laylavoix, F., additional, Copin, X., additional, and Ceppi, C., additional

Published
2020
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14. Eur Arch Psychiatry Clin Neurosci

Author

HURAULT-DELARUE, C., LACROIX, I., BENARD-LARIBIERE, Anne, MONTASTRUC, J. L., PARIENTE, Antoine, and DAMASE-MICHEL, C.

Published
2019

19. Patterns of antidepressant use during pregnancy: a nationwide population-based cohort study

Author

BENARD-LARIBIERE, Anne, Pambrun, Elodie, Sutter-Dallay, Anne-Laure, Gautier, S., HURAULT-DELARUE, C., Damase-Michel, C., LACROIX, I., Begaud, Bernard, Pariente, Antoine, Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
PharmacoEpi-Drugs, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Abstract

AIMS: We explored the patterns of antidepressant use during pregnancy. METHODS: A cohort of women who started a pregnancy in 2014 was identified using data from the French reimbursement healthcare system (covering approximately 99% of the population). Antidepressant usage (initiated before or during pregnancy) was assessed. Explored changes in antidepressant treatment were: associations, switches, discontinuation and resumption of antidepressants during pregnancy. RESULTS: The cohort included 766 508 pregnancies (755 519 women). Antidepressant use during pregnancy was 25.7 per 1000 [95% CI: 25.3-26.0]. New use concerned 3.9 per 1000 [95% CI: 3.7-4.0]; the most initiated class during pregnancy was selective serotonin reuptake inhibitors (SSRIs), while the most prescribed individual drug in second and third trimesters was amitriptyline, a tricyclic. Most changes were observed before pregnancy and during the first trimester: 63% of ongoing treatments in the year before pregnancy were discontinued before conception; 68% of treatments maintained after conception were discontinued during the first trimester; switches or antidepressant associations mostly occurred during the periconceptional period or during the first trimester. Regardless of initial antidepressant, switches to sertraline were the most frequent. Associations mainly consisted of a prescription of tri-/tetracyclic or mirtazapine/mianserin in addition to an SSRI. Discontinuation during pregnancy led to treatment resumption in 22% of pregnancies. CONCLUSIONS: These results suggest that pregnancy was planned or the treatment especially adapted in accordance with existing recommendations in a large proportion of women under antidepressants or in whom such treatments have been initiated after starting a pregnancy.

Published
2018
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29. Book Reviews

Author

Paccaud Laurent, Horvath Kenneth, Lacroix Isabelle, Stamm Christoph, Suter Christian, Sabot Cléolia, and Gandar Hélène

Subjects
Sociology (General), HM401-1281
Published
2020
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30. [Follow-up of 'medications and pregnancy' at the Midi-Pyrenees Pharmacovigilance Center']

Author

Lemoine T, Lacroix I, Maryse Lapeyre-Mestre, Jl, Montastruc, and Damase-Michel C

Subjects
Adult, Adolescent, Drug-Related Side Effects and Adverse Reactions, Illicit Drugs, Smoking, Infant, Newborn, Pregnancy Outcome, Abnormalities, Drug-Induced, Infant, Newborn, Diseases, Drug Therapy, Pregnancy, Prenatal Exposure Delayed Effects, Adverse Drug Reaction Reporting Systems, Humans, Female, France, Follow-Up Studies
Abstract

The follow-up of 283 gestations recorded by the Midi-Pyrénées Pharmacovigilance Centre concerned 544 medications, 17 solvents and 12 illicit drugs. Pregnancy outcomes were live births for 74.2 per cent of the women and voluntary (14.8 per cent), spontaneous (8.5 per cent) or therapeutic (1.8 per cent) abortions. Among the newborns, 11 had a malformation and 18 a neonatal disease. We observed an increased risk of neonatal disease for women exposed to illicit drugs during the third trimester of their pregnancy (OR = 14.28 [1.19-747.40] p = 0.0155) and for smokers (OR = 19.11 [2.11-445.00] p = 0.0011). Moreover, an increase of teratogenic risk was associated with a first trimester exposure to neurologic drugs (OR = 14.28 [2.08-100.00] p = 0.006). Women included in the present survey were more often exposed to potentially harmful drugs than the general population. However, the rates of obstetric and/or neonatal complications appear similar to those reported in France as a whole.

Published
2001

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

Author

Lacroix, I., Lapeyre-Mestre, M., Bagheri, H., Pathak, A., and Montastruc, J. L.

Subjects
*NONSTEROIDAL anti-inflammatory agents, *DRUG side effects, *PRIMARY care, *PHARMACOEPIDEMIOLOGY, *LIVER diseases, *LIVER cancer
Abstract

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. [ABSTRACT FROM AUTHOR]

Published
2004
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