PubMed Health⌕ Search

Biomedical subjects

Joan-Ramon Laporte

Publications and source records attributed to Joan-Ramon Laporte.

28 records · Page 2Linked to original sources
PubMed2002

[First spontaneous reports of adverse reactions to the new selective COX-2 non-steroidal anti-inflammatory drugs].

BACKGROUND: [corrected] The new selective cyclooxygenase 2 non-steroidal anti-inflammatory drugs (NSAIDs) have been associated with a lower incidence of adverse gastrointestinal effects. MATERIAL AND METHOD: The first Yellow Cards received at the Catalan Centre of Pharmacovigilance reporting adverse effects of rofecoxib and celecoxib were reviewed and compared to those attributed to non-selective NSAIDs. RESULTS: Most frequent adverse effects of rofecoxib were gastrointestinal and cardiovascular; those of celecoxib were mostly cutaneous and gastrointestinal; and those of non-selective NSAIDs were gastrointestinal and neuropsychiatric. CONCLUSIONS: Rofecoxib and celecoxib are not devoid of gastrointestinal toxicity; they may also induce cardiovascular adverse effects.

Adult↗
PubMed2002

Dose-response relationships between individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data.

AIMS: To define by amalgamation of data obtained in contemporaneous case-control studies, the risks associated with individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) according to doses used. METHODS: Meta-analysis of individual patient data from three retrospective case-control studies using similar data collection protocols was carried out in hospitals in Catalonia, England, Scotland and Sweden. 2472 cases of upper gastrointestinal bleeding and 5877 controls were studied. Main outcome measures were risks associated with individual NANSAIDs according to dose used and the period of time for which they were given. RESULTS: Ibuprofen showed the lowest odds ratio (OR = 1.7; 95% confidence interval 1.1, 2.5), followed by diclofenac (4.9; 3.3, 7.1), indomethacin (6.0; 3.6, 10.0), naproxen (9.1; 6.0-13.7), piroxicam (13.1; 7.9-21.8) and ketoprofen (34.9; 12.7, 96.5). Striking dose-response relationships were seen with four to eight-fold increases in risk within conventionally used dose ranges for all except ketoprofen, where numbers were too few to allow dose analysis. Across the class, risk was highest during the first week of use (11.7; 6.5, 21.0), decreased thereafter with continuing use (5.6; 4.6, 7.0), and fell to 3.2 (2.1, 5.1) 1 week after discontinuing use. Concurrent use of more than one NANSAID substantially increased risk. CONCLUSIONS: The risk of upper gastrointestinal bleeding with NANSAIDs varies twenty-fold depending on the drug, and by three to seven-fold depending on the dose chosen. Risk is maximal during the first week and decreases thereafter. Paracetamol (acetaminophen) is not associated with upper gastrointestinal bleeding at any dose and should be the first-line analgesic wherever possible.

Aged↗
PubMed2002

Case-population studies in pharmacoepidemiology.

The case-population approach aims at providing a risk estimate by comparing the incidence of the disease of interest among those exposed to the drug under study with the incidence among the non-exposed. For that purpose, the cases with the disease of interest have to be ascertained independently of the exposure status. Their rate and pattern of exposure have to be ascertained by interview with a structured questionnaire. Information on the patterns and the prevalence of drug consumption is needed in order to estimate the rate of exposure, and drug consumption statistics can be used to this end. In this paper, we review the main characteristics of studies using this approach or a similar one, and studies where series of cases exposed to the drug of interest were compared with drug consumption statistics. We looked at selected basic methodological requirements. Most of the studies reviewed suffer from incomplete case ascertainment, inaccurate definition of the disease of interest, incomplete information on exposures and other risk factors, and/or limited control of potential confounding, among other limitations. All the reviewed studies had several limitations regarding the estimation of the population at risk. The methods used in case-population studies should be clearly described, particularly with respect to the identification of the cases (numerator) and the estimation of the consumption prevalence (denominator). Case-population studies can give approximate risk estimates, but the method should be validated by comparing its results with those of case-control studies.

Case-Control Studies↗
PubMed2002

Therapeutic ineffectiveness: heads or tails?

Reporting of therapeutic ineffectiveness through adverse drug reaction spontaneous reporting systems has been proposed by some authors. In the WHO Adverse Reactions Terminology (WHO-ART) and Medical Dictionary for Regulatory Activities (MedDRA) terminology, the term therapeutic ineffectiveness includes drug interactions, resistance, tolerance and tachyphylaxis, as well as pharmaceutical defects such as substandard, adulterated, and counterfeit drugs. Under certain circumstances, reporting therapeutic ineffectiveness may contribute to identifying pharmaceutical defects. However, the best approach to avoid their occurrence would be implementing good manufacturing practices and strengthening quality control activities. This would prevent the misuse of spontaneous reporting of adverse drug reactions (e.g. when reporting of therapeutic ineffectiveness is 'suggested' by interested parties, especially when a generic product has been substituted for a branded original product).

Adverse Drug Reaction Reporting Systems↗
PubMed2002

Regulatory decisions in a globalised world: the domino effect of phenylpropanolamine withdrawal in Latin America.

Rapid drug regulatory decisions regarding phenylpropanolamine (PPA)-containing common cold remedies and diet pills were taken in some Latin American countries following a US Food and Drug Administration (FDA) decision in the US. This situation is described as one that illustrates the important changes that regulatory decisions are experiencing as a consequence of globalisation. The evidence for the efficacy of PPA as a nasal decongestant and as an appetite-suppressant is very limited, at least by modern standards. Its potential to increase blood pressure and induce haemorrhagic stroke was described soon after its marketing. Although this poor benefit/risk ratio had been known for more than 20 years, regulatory action was taken in Latin America only after the US FDA withdrew the drug in the US on the basis of the results of a case-control study which added limited new evidence to the already known risk of stroke, but which, on the other hand, had attracted much attention from the media.

Appetite Depressants↗
PubMedDate not supplied

Health needs, drug registration and control in less developed countries--the Peruvian case.

A number of factors influence how medicines are used in each community, but drug registration is the initial and usually necessary step. In the course of an external advisory consultation, the list of approved medicines in Peru in 1998 was examined. Of 1672 newly approved forms, 119 were of 49 new chemical entities. Sildenafil, meloxicam, nimesulide, candesartan, irebesartan, naratriptan, trovafloxacin and grepafloxacin were among them. Several aspects about the new global drug situation and 'real' health needs versus 'induced' health needs are discussed from this example.

Developing Countries↗
PubMedDate not supplied

The Cuban experience in focusing pharmaceuticals policy to health population needs: initial results of the National Pharmacoepidemiology Network (1996-2001).

In 1996, a National Pharmacoepidemiology Network was set up in Cuba in order to disseminate problem-oriented information and develop continuing education activities on drug therapy, to perform research on drug utilisation and to promote interventions to improve drug use. It is coordinated by the Centre for the Development of Pharmacoepidemiology, which is also in charge of regulatory and administrative duties and collaborates with the National Pharmaceutical Industry. By 2001, a number of educational and information initiatives had been undertaken, particularly in primary health care, which resulted in improvement of indicators of drug use. Cuba keeps good health standards in spite of a short health budget.

Atenolol↗