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  1. Article ; Online: Clinical pharmacology facing the real-world setting: Pharmacovigilance, pharmacoepidemiology and the economic evaluation of drugs.

    Agustí, Antonia / Cereza, Gloria / de Abajo, Francisco J / Maciá, Miguel A / Sacristán, José A

    Pharmacological research

    2023  Volume 197, Page(s) 106967

    Abstract: Traditionally, clinical pharmacology has focused its activities on drug-organism interaction, from an individual or collective perspective. Drug efficacy assessment by performing randomized clinical trials and analysis of drug use in clinical practice by ...

    Abstract Traditionally, clinical pharmacology has focused its activities on drug-organism interaction, from an individual or collective perspective. Drug efficacy assessment by performing randomized clinical trials and analysis of drug use in clinical practice by carrying out drug utilization studies have also been other areas of interest. From now on, Clinical pharmacology should move from the analysis of the drug-individual interaction to the analysis of the drug-individual-society interaction. It should also analyze the clinical and economic consequences of the use of drugs in the conditions of normal clinical practice, beyond clinical trials. The current exponential technological development that facilitates the analysis of real-life data offers us a golden opportunity to move to all these other areas of interest. This review describes the role that clinical pharmacology has played at the beginning and during the evolution of pharmacovigilance, pharmacoepidemiology and economic drug evaluations in Spain. In addition, the challenges that clinical pharmacology is going to face in the following years in these three areas are going to be outlined too.
    MeSH term(s) Cost-Benefit Analysis ; Pharmacoepidemiology ; Pharmacology, Clinical ; Pharmacovigilance ; Drug Utilization
    Language English
    Publishing date 2023-10-20
    Publishing country Netherlands
    Document type Review ; Journal Article
    ZDB-ID 1003347-6
    ISSN 1096-1186 ; 0031-6989 ; 1043-6618
    ISSN (online) 1096-1186
    ISSN 0031-6989 ; 1043-6618
    DOI 10.1016/j.phrs.2023.106967
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Olmesartan for the prevention or delay of diabetic nephropathy: some considerations.

    Catalá-López, Ferrán / Martín-Serrano, Gloria / Maciá, Miguel A / Montero, Dolores

    Revista espanola de cardiologia (English ed.)

    2012  Volume 65, Issue 7, Page(s) 678–9; author reply 679–80

    MeSH term(s) Albuminuria/drug therapy ; Angiotensin II Type 1 Receptor Blockers/adverse effects ; Angiotensin II Type 1 Receptor Blockers/therapeutic use ; Diabetes Mellitus, Type 2/mortality ; Diabetic Cardiomyopathies/drug therapy ; Female ; Humans ; Imidazoles/adverse effects ; Imidazoles/therapeutic use ; Male ; Tetrazoles/adverse effects ; Tetrazoles/therapeutic use
    Chemical Substances Angiotensin II Type 1 Receptor Blockers ; Imidazoles ; Tetrazoles
    Language Spanish
    Publishing date 2012-07
    Publishing country Spain
    Document type Comment ; Letter
    ISSN 1885-5857
    ISSN (online) 1885-5857
    DOI 10.1016/j.recesp.2012.03.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Risk of meningioma among users of high doses of cyproterone acetate as compared with the general population: evidence from a population-based cohort study.

    Gil, Miguel / Oliva, Belén / Timoner, Julia / Maciá, Miguel A / Bryant, Verónica / de Abajo, Francisco J

    British journal of clinical pharmacology

    2011  Volume 72, Issue 6, Page(s) 965–968

    Abstract: Aim: Information from the spontaneous reporting system raised the hypothesis of an increased risk of meningioma in patients treated with high doses of cyproterone acetate (CPA). The objective of this study was to test the hypothesis of an increased risk ...

    Abstract Aim: Information from the spontaneous reporting system raised the hypothesis of an increased risk of meningioma in patients treated with high doses of cyproterone acetate (CPA). The objective of this study was to test the hypothesis of an increased risk of meningioma among users of high dose CPA as compared with non-users in a medical records computerized database.
    Methods: A retrospective cohort study was performed in a Spanish primary care database (BIFAP). Meningioma incidence rates were compared in patients exposed to high dose CPA (users) with those non-exposed and with those exposed to low dose CPA. Poisson regression analysis was used to estimate the incidence rate ratios after adjusting for age and gender.
    Results: Among 2474 users of high dose cyproterone (6663 person-years) four meningioma cases were identified, resulting in an incidence rate (IR) of 60.0 (95% CI 16.4, 153.7) per 100,000 person-years, which was significantly higher than that observed among the non-users (IR 6.6; 95% CI 6.0, 7.3) and among women users of low dose cyproterone (IR 0.0, 95% CI upper limit 5.5). After adjusting for age and gender, patients exposed to high dose CPA showed an increased risk of meningioma of 11.4 (95% CI 4.3, 30.8) as compared with non-users.
    Conclusions: The results of this study support the hypothesis that the exposure to high dose CPA increases the risk of meningioma.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Cohort Studies ; Cyproterone Acetate/administration & dosage ; Cyproterone Acetate/adverse effects ; Databases, Factual/statistics & numerical data ; Dose-Response Relationship, Drug ; Female ; Follow-Up Studies ; Humans ; Incidence ; Male ; Medical Records Systems, Computerized/statistics & numerical data ; Meningioma/chemically induced ; Meningioma/epidemiology ; Middle Aged ; Poisson Distribution ; Primary Health Care ; Regression Analysis ; Retrospective Studies ; Risk ; Sex Factors ; Spain ; Time Factors ; Young Adult
    Chemical Substances Antineoplastic Agents ; Cyproterone Acetate (4KM2BN5JHF)
    Language English
    Publishing date 2011-05-31
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/j.1365-2125.2011.04031.x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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