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  1. Article ; Online: Fifty years of pharmacovigilance - Medicines safety and public health.

    Laporte, Joan-Ramon

    Pharmacoepidemiology and drug safety

    2016  Volume 25, Issue 6, Page(s) 725–732

    Language English
    Publishing date 2016-06
    Publishing country England
    Document type Journal Article
    ZDB-ID 1099748-9
    ISSN 1099-1557 ; 1053-8569
    ISSN (online) 1099-1557
    ISSN 1053-8569
    DOI 10.1002/pds.3967
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  2. Article: La pharmaco-épidémiologie: ombres et lumières.

    Laporte, Joan-ramon / Diogene, Eduardo

    Bulletin de l'Academie nationale de medecine

    2015  Volume 199, Issue 2-3, Page(s) 281–288

    Abstract: Adverse drug reactions are a major cause of illness and death. They cause 5-10% of general practice consultations and 5 to 10% of hospital admissions and would be the third or fourth cause of death (after heart attack, stroke and cancer). It is a failure ...

    Title translation Pharmacoepidemiology: lights and shadows.
    Abstract Adverse drug reactions are a major cause of illness and death. They cause 5-10% of general practice consultations and 5 to 10% of hospital admissions and would be the third or fourth cause of death (after heart attack, stroke and cancer). It is a failure of contemporary medicine. The purpose of pharmacoepidemiology is the study of drug use in populations and its impact on public health. The author describes the four stages of the recent history of pharmacovigilance. The first, spontaneous reporting, has identified many adverse drug reactions but cannot provide with incidence or risk estimates. Observational epidemiological research has shaped second generation pharmacovigilance, providing incidence and relative and absolute risks which are essential for public health decision taking. The meta-analysis of clinical trials would be third-generation pharmacovigilance: it has contributed to the understanding of relatively common adverse drug reactions with great impact on public health. Research on big data will surely be the basis of the fourth generation of pharmacovigilance.
    MeSH term(s) Drug-Related Side Effects and Adverse Reactions/prevention & control ; Humans ; Pharmacoepidemiology ; Pharmacovigilance
    Language French
    Publishing date 2015-02
    Publishing country Netherlands
    Document type English Abstract ; Journal Article
    ZDB-ID 213227-8
    ISSN 0001-4079
    ISSN 0001-4079
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  3. Article ; Online: Vaccines against Covid-19, venous thromboembolism, and thrombocytopenia. A population-based retrospective cohort study

    Laporte, Joan-Ramon / Coma, Ermengol / Fina, Francesc / Garcia-Eroles, Luis / Vidal, Xavier / Medina, Manuel

    medRxiv

    Abstract: Background Covid-19 vaccines may increase the risk of venous thromboembolism (VTE), thrombocytopenia (TCP), and VTE associated with TCP. We aimed at estimating this risk by age and sex, after the first dose of both adenovirus vector-based and mRNA-based ... ...

    Abstract Background Covid-19 vaccines may increase the risk of venous thromboembolism (VTE), thrombocytopenia (TCP), and VTE associated with TCP. We aimed at estimating this risk by age and sex, after the first dose of both adenovirus vector-based and mRNA-based Covid-19 vaccines, and after the second dose of m-RNA vaccines. Methods In this population-based retrospective cohort study, we examined three groups: 1 662 719 people 10 years of age and over vaccinated with the first dose of a Covid-19 vaccine, 622 778 with the second dose, and 190 616 diagnosed of Covid-19 in the same period (between1 January 2021 and 18 April 2021). The rates of various clinical presentations of VTE and TCP were compared with those in the reference population (7 013 040 people served by the health care system in 2919). The two primary outcomes were the observed 21 day rate of a composite variable of cerebral venous sinus thrombosis, mesenteric thrombosis, portal vein thrombosis, or any venous thromboembolism (VTE) associated with thrombocytopenia (TCP), and the rate of any VTE associated with TCP (VTE+TCP). Analyses were standardised by age and sex. Findings The 21 day rate per 100 000 of the primary composite variable was 2.15 in the reference population, 5.65 following the first vaccine dose (standardised difference, 2.53 (95 percent confidence interval, 1.04-4.00), and 7.23 following the second dose (standardised difference, 4.07 (95 percent confidence interval, 1.43-6.70). The event rates of VTE+TCP and of all the secondary variables showed the same patterns. Excess event rates were higher in men than in women, and they were not especially increased in any particular age group. All Covid-19 vaccines were associated with increased rates of the outcome variables. Excess event rates were many-fold higher in the Covid-19 cohort. Interpretation We observed small increases of rates of venous thromboembolism in usual and unusual anatomical sites and of thrombocytopenia in recipients of both adenovirus vector and mRNA vaccines against Covid-19. Excess rates were higher in men than in women and they were not particularly elevated in any specific age group.
    Keywords covid19
    Language English
    Publishing date 2021-07-27
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2021.07.23.21261036
    Database COVID19

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  4. Article ; Online: Crisis y política de medicamentos.

    Laporte, Joan-Ramon / Bosch, Montserrat

    Atencion primaria

    2012  Volume 44, Issue 6, Page(s) 306–308

    Title translation The crisis and medicines policy.
    MeSH term(s) Cost Control ; Drug Prescriptions/economics ; Drug Prescriptions/standards ; Drug Utilization/economics ; Drug Utilization/standards ; Humans ; Spain
    Language Spanish
    Publishing date 2012-05-10
    Publishing country Spain
    Document type Editorial
    ZDB-ID 1200787-0
    ISSN 1578-1275 ; 0212-6567
    ISSN (online) 1578-1275
    ISSN 0212-6567
    DOI 10.1016/j.aprim.2012.03.006
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  5. Article ; Online: Merck Sharpe and Dohme versus Laporte.

    Laporte, Joan-Ramon

    Lancet (London, England)

    2004  Volume 364, Issue 9432, Page(s) 416

    MeSH term(s) Arthritis, Rheumatoid/drug therapy ; Cyclooxygenase Inhibitors/adverse effects ; Drug Industry/legislation & jurisprudence ; Humans ; Lactones/adverse effects ; Publishing/legislation & jurisprudence ; Publishing/standards ; Randomized Controlled Trials as Topic/standards ; Scientific Misconduct/legislation & jurisprudence ; Spain ; Sulfones
    Chemical Substances Cyclooxygenase Inhibitors ; Lactones ; Sulfones ; rofecoxib (0QTW8Z7MCR)
    Language English
    Publishing date 2004-07
    Publishing country England
    Document type Comment ; Letter
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(04)16761-5
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  6. Article ; Online: Prevalence of use of antipsychotic drugs in the elderly in Catalonia.

    Asensio, Carmen / Escoda, Núria / Sabaté, Mònica / Carbonell, Pere / López, Pilar / Laporte, Joan-Ramon

    European journal of clinical pharmacology

    2018  Volume 74, Issue 9, Page(s) 1185–1186

    MeSH term(s) Aged ; Aged, 80 and over ; Antipsychotic Agents/therapeutic use ; Databases, Factual ; Drug Utilization/statistics & numerical data ; Female ; Humans ; Male ; Prevalence ; Spain
    Chemical Substances Antipsychotic Agents
    Language English
    Publishing date 2018-05-23
    Publishing country Germany
    Document type Letter
    ZDB-ID 121960-1
    ISSN 1432-1041 ; 0031-6970
    ISSN (online) 1432-1041
    ISSN 0031-6970
    DOI 10.1007/s00228-018-2469-6
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  7. Article ; Online: Nightmares induced by montelukast in children and adults.

    Cereza, Gloria / Garcia Doladé, Núria / Laporte, Joan-Ramon

    The European respiratory journal

    2012  Volume 40, Issue 6, Page(s) 1574–1575

    MeSH term(s) Acetates/adverse effects ; Adolescent ; Adult ; Anti-Asthmatic Agents/adverse effects ; Child ; Dreams ; Female ; Humans ; Male ; Quinolines/adverse effects ; Risk ; Sleep Initiation and Maintenance Disorders/chemically induced ; Spain
    Chemical Substances Acetates ; Anti-Asthmatic Agents ; Quinolines ; montelukast (MHM278SD3E)
    Language English
    Publishing date 2012-12
    Publishing country England
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/09031936.00092812
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  8. Article ; Online: Gabapentin and Pregabalin and Risk of Atrial Fibrillation in the Elderly: A Population-Based Cohort Study in an Electronic Prescription Database.

    Ortiz de Landaluce, Leticia / Carbonell, Pere / Asensio, Carmen / Escoda, Núria / López, Pilar / Laporte, Joan-Ramon

    Drug safety

    2018  Volume 41, Issue 12, Page(s) 1325–1331

    Abstract: Introduction: Gabapentin and pregabalin are widely prescribed to elderly people, but data on their pharmacokinetics, safety, and efficacy in this population are scarce. Neurological adverse effects are common. Atrial fibrillation (AF) associated with ... ...

    Abstract Introduction: Gabapentin and pregabalin are widely prescribed to elderly people, but data on their pharmacokinetics, safety, and efficacy in this population are scarce. Neurological adverse effects are common. Atrial fibrillation (AF) associated with their use has been described in several case reports and case series, but the incidence is unknown.
    Objective: The aim of this study was to assess the association between exposure to gabapentin or pregabalin and AF in the elderly.
    Methods: Patients ≥ 65 years of age starting treatment with either gabapentin or pregabalin between January 1 and March 31, 2015, free of cardiovascular disease, and who did not receive the alternate study medications were studied. They were compared with patients who initiated treatment with an analgesic opiate or with alprazolam or diazepam. The two primary outcome variables were a first claim of an oral anticoagulant plus an antiarrhythmic drug (OAC + AA), or of an oral anticoagulant or an antiplatelet agent plus an antiarrhythmic drug (OAC/APA + AA), in the 3 months after treatment initiation.
    Results: Compared with opiate analgesics, both gabapentin and pregabalin were associated with an increased risk of initiating OAC/APA + AA. The incidence was 6 of 668 (9.0 per 1000 patients) with gabapentin, versus 12 of 3889 (3.1 per 1000) with opiates, relative risk (RR) 2.91 (95% confidence interval [CI] 1.10-7.73), and for pregabalin it was 6 of 698 (8.6 per 1000) RR 2.79 (95% CI 1.05-7.40). The comparison with alprazolam/diazepam gave similar results. The risks did not vary by age, sex, or co-treatment with NSAIDs, and they increased with dose.
    Conclusion: In elderly patients free of cardiovascular disease, an association between new exposure to gabapentin or pregabalin and initiating treatment for AF was found. These results should be confirmed in other studies.
    MeSH term(s) Age Factors ; Aged ; Analgesics/adverse effects ; Atrial Fibrillation/chemically induced ; Atrial Fibrillation/diagnosis ; Atrial Fibrillation/epidemiology ; Cohort Studies ; Databases, Factual/trends ; Electronic Prescribing ; Female ; Gabapentin/adverse effects ; Humans ; Male ; Population Surveillance/methods ; Pregabalin/adverse effects ; Retrospective Studies ; Risk Factors
    Chemical Substances Analgesics ; Pregabalin (55JG375S6M) ; Gabapentin (6CW7F3G59X)
    Language English
    Publishing date 2018-06-28
    Publishing country New Zealand
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-018-0695-6
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  9. Article ; Online: Separating the wheat from the chaff: essential information in therapeutics.

    Llop, Roser / Bosch, Montse / Figueras, Albert / Laporte, Joan-Ramon

    European journal of clinical pharmacology

    2011  Volume 68, Issue 4, Page(s) 335–337

    MeSH term(s) Drug Industry ; Humans ; Information Dissemination ; Marketing ; Practice Patterns, Physicians' ; Publication Bias
    Language English
    Publishing date 2011-10-21
    Publishing country Germany
    Document type Editorial
    ZDB-ID 121960-1
    ISSN 1432-1041 ; 0031-6970
    ISSN (online) 1432-1041
    ISSN 0031-6970
    DOI 10.1007/s00228-011-1135-z
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  10. Article ; Online: Failures of the therapeutic chain as a cause of drug ineffectiveness.

    Figueras, Albert / Laporte, Joan-Ramon

    BMJ (Clinical research ed.)

    2003  Volume 326, Issue 7395, Page(s) 895–896

    MeSH term(s) Drug Approval ; Drug Therapy/standards ; Humans ; Marketing of Health Services ; Pharmaceutical Preparations/economics ; Pharmaceutical Preparations/standards ; Treatment Failure ; United States ; United States Food and Drug Administration
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2003-04-26
    Publishing country England
    Document type Editorial
    ZDB-ID 1362901-3
    ISSN 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    ISSN (online) 1756-1833
    ISSN 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    DOI 10.1136/bmj.326.7395.895
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