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Biomedical subjects

Joan-Ramon Laporte

Publications and source records attributed to Joan-Ramon Laporte.

At least 19 recordsLinked to original sources
PubMed2006

Relative incidence of agranulocytosis and aplastic anemia.

Agranulocytosis and aplastic anemia are both rare, life-threatening blood dyscrasias. Agranulocytosis is mainly caused by medicines, whereas the etiology of aplastic anemia is largely unexplained. In two epidemiologic studies using the same methods, we observed a striking inverse relationship between the incidence of the two diseases in different regions, including five countries in Europe, and Israel and Thailand. The annual incidence of agranulocytosis ranged from 1.1 to 4.9 cases per million, and that of aplastic anemia, from 0.7 to 4.1 per million; the inverse correlation was consistent among the regions (R2 = 0.74). There is no clear explanation for this previously unreported pattern, but it seems unlikely to be due to methodology.

Agranulocytosis↗
PubMed2005

Cyanamide-induced aplastic anemia.

OBJECTIVE: To report a case of aplastic anemia in a patient treated with cyanamide, an alcohol-aversive drug. A 67-year-old man was admitted to hospital because of fever and pancytopenia. He had taken cyanamide for 6 months as an alcohol deterrent. No other risk factors for aplastic anemia were identified by interviewing the patient using a structured validated questionnaire. The results of bone-marrow biopsy showed severe aplastic anemia. Cyanamide was discontinued and the patient was treated according to a prespecified treatment protocol. One year after hospital admission, the patient was completely recovered with no need of immunosuppressive therapy. An objective causality assessment revealed that an adverse drug reaction was probable. DISCUSSION: As the efficacy of cyanamide has been questioned, due to the failure of various trials to show any benefit over placebo, its overall benefit/risk ratio should be reconsidered. The complete and rapid hematological recovery after discontinuation of the drug, and the absence of other factors that could explain the condition support the association of the present case of aplastic anemia with cyanamide. The mechanism remains unknown. Aplastic anemia is a rare but potentially serious adverse drug effect of cyanamide treatment. CONCLUSIONS: Given the poor evidence on the efficacy of cyanamide and the associated risk of aplastic anemia, its use in reducing alcohol consumption should be reconsidered.

Aged↗
PubMed2005

Population-based drug-induced agranulocytosis.

BACKGROUND: Since the publication of a major international case-control study on the risk of agranulocytosis associated with the use of medicines in the 1980s, many new drugs have been introduced in therapeutics. METHODS: Seventeen units of hematology contribute to the case-control surveillance of agranulocytosis and aplastic anemia in Barcelona, Spain. After a follow-up of 78.73 million person-years, 177 community cases of agranulocytosis were compared with 586 sex-, age, and hospital-matched control subjects with regard to previous use of medicines. RESULTS: The annual incidence of community-acquired agranulocytosis was 3.46:1 million, and it increased with age. The fatality rate was 7.0%, and the mortality rate was 0.24:1 million. The drug most strongly associated with a risk of agranulocytosis was ticlopidine hydrochloride with an odds ratio (OR) of 103.23 (95% confidence interval [CI], 12.73-837.44), followed by calcium dobesilate (OR, 77.84 [95% CI, 4.50-1346.20]), antithyroid drugs (OR, 52.75 [95% CI, 5.82-478.03]), dipyrone (metamizole sodium and metamizole magnesium) (OR, 25.76 [95% CI, 8.39-179.12]), and spironolactone (OR, 19.97 [95% CI, 2.27-175.89]). Other drugs associated with a significant risk were pyrithyldione, cinepazide, aprindine hydrochloride, carbamazepine, sulfonamides, phenytoin and phenytoin sodium, beta-lactam antibiotics, erythromycin stearate and erythromycin ethylsuccinate, and diclofenac sodium. Individual attributable incidences for all these drugs, which collectively accounted for 68.6% of cases, were less than 1:1 million per year. CONCLUSIONS: Agranulocytosis is rare but serious. A few drugs account for two thirds of the cases. Our results also provide reassurance regarding the risk associated with a number of newly marketed drugs.

Adolescent↗
PubMed2005

Treatment of type 2 diabetes in primary health care: a drug utilization study.

BACKGROUND: Metabolic control in type 2 diabetes depends on patient adherence to therapy. Quantitative consumption data do not supply information regarding the appropriate use of medicine. Drug utilization studies are useful to identify treatment adherence problems and, thus, design interventions to improve drug use. OBJECTIVE: To describe the treatment and outcome in terms of degree of metabolic control in these patients, assess the agreement between the doses of antidiabetic drugs reported by the patient and those written in the medical record, and describe the drug utilization characteristics in relation to the standards of care. METHODS: This drug utilization study was conducted in primary care centers in Barcelona, Spain. Consecutive patients with type 2 diabetes attending a follow-up visit were interviewed regarding lifestyle, diet, glycosylated hemoglobin level, and treatment. Concordance between the information obtained through medical records and patient interviews was analyzed. RESULTS: Metabolic control was deficient in 73 (40%), acceptable in 50 (28%), and good in 58 (32%) of the 181 patients with available information. For 38 (19%) patients, there was disagreement between the dose of the antidiabetic drug reported by the patient and that written in the medical record. For 83 (41%) patients, the treatment in the medical history was in agreement with published standards. CONCLUSIONS: Identification of disagreement between standards of care and clinical practice in type 2 diabetes management is the basis to improve drug utilization and achieve better metabolic control in these patients.

Aged↗
PubMed2005

Case-control study of regular analgesic and nonsteroidal anti-inflammatory use and end-stage renal disease.

BACKGROUND: Studies on the association between the long-term use of aspirin and other analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs) and end-stage renal disease (ESRD) have given conflicting results. In order to examine this association, a case-control study with incident cases of ESRD was carried out. METHODS: The cases were all patients entering the local dialysis program because of ESRD in the study area between June 1, 1995 and November 30, 1997. They were classified according to the underlying disease, which had presumably led them to ESRD. Controls were patients admitted to the same hospitals from where the cases arose, also matched by age and sex. Odds ratios were calculated using a conditional logistic model, including potential confounding factors, both for the whole study population and for the various underlying diseases. RESULTS: Five hundred and eighty-three cases and 1190 controls were included in the analysis. Long-term use of any analgesic was associated with an overall odds ratio of 1.22 (95% CI, 0.89-1.66). For specific groups of drugs, the risks were 1.56 (1.05-2.30) for aspirin, 1.03 (0.60-1.76) for pyrazolones, 0.80 (0.39-1.63) for paracetamol, and 0.94 (0.57-1.56) for nonaspirin NSAIDs. The risk of ESRD associated with aspirin was related to the cumulated dose and duration of use, and it was particularly high among the subset of patients with vascular nephropathy as underlying disease [2.35 (1.17-4.72)]. CONCLUSION: Our data indicate that long-term use of nonaspirin analgesic drugs and NSAIDs is not associated with an increased risk of ESRD. However, the chronic use of aspirin may increase the risk of ESRD.

Adult↗
PubMed2004

Agranulocytosis associated with dipyrone (metamizol).

OBJECTIVES: Reported estimates of the risk of agranulocytosis associated with metamizol have varied by several orders of magnitude. We assessed this association in a large database for the surveillance of blood dyscrasias. METHODS: Since 1980, all laboratory units of haematology in a defined area (3.3-4.1x10(6) inhabitants) contribute to the ascertainment of all cases of agranulocytosis meeting strict diagnostic criteria. These cases of patients with agranulocytosis and sex-, age-, hospital- and date-matched controls were interviewed using a structured questionnaire about previous drug exposures, and relative risks were calculated for several categories of exposure to metamizol. RESULTS: After a total follow-up of 78.73x10(6) person-years, 273 community cases of agranulocytosis had been found--of which 96 were excluded for various reasons and 177 were included in the case-control analysis--and were compared with 586 matched controls. Thirty cases of agranulocytosis (16.9%) and nine controls (1.5%) had been exposed to metamizol during the week before the index day. The adjusted relative risk was 25.8 [95% confidence interval (CI), 8.4-79.1], and the attributable incidence was 0.56 (0.4-0.8) cases per million inhabitants and per year. The risk disappeared after more than 10 days since the last dose of metamizol, and it increased with duration of use. Those with agranulocytosis exposed to metamizol had taken the drug for longer periods than the exposed controls. Compared with the cases recently reported from Sweden, the duration of use of metamizol by our exposed cases was substantially shorter, and the use of concomitant medications potentially causing agranulocytosis was lower. DISCUSSION: In our milieu, agranulocytosis attributable to metamizol is rare. Geographical disparities in its risk estimate can be partly explained by differences in its patterns of use, in terms of dose, duration and concomitant medications.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

[News about therapeutic use of Cannabis and endocannabinoid system].

Growing basic research in recent years led to the discovery of the endocannabinoid system with a central role in neurobiology. New evidence suggests a therapeutic potential of cannabinoids in cancer chemotherapy-induced nausea and vomiting as well as in pain, spasticity and other symptoms in multiple sclerosis and movement disorders. Results of large randomized clinical trials of oral and sublingual Cannabis extracts will be known soon and there will be definitive answers to whether Cannabis has any therapeutic potential. Although the immediate future may lie in plant-based medicines, new targets for cannabinoid therapy focuses on the development of endocannabinoid degradation inhibitors which may offer site selectivity not afforded by cannabinoid receptor agonists.

Cannabinoid Receptor Modulators↗
PubMed2004

Upper gastrointestinal bleeding associated with the use of NSAIDs: newer versus older agents.

AIM: The relative gastrointestinal toxicity of NSAIDs in normal clinical practice is unknown. The aim of this study was to estimate the risk of upper gastrointestinal bleeding associated with NSAIDs and analgesics, with special emphasis on those agents that have been introduced in recent years. DESIGN: Multicentre case-control study. PATIENTS: All incident community cases of upper gastrointestinal bleeding from a gastric or duodenal lesion in patients aged >18 years of age (4309 cases). After secondary exclusions, 2813 cases and 7193 matched controls were included in the analysis. SETTING: Eighteen hospitals in Spain and Italy with a total study experience of 10,734,897 person-years. MAIN OUTCOME MEASURE: Odds ratios of upper gastrointestinal bleeding for each drug, with adjustment for potential confounders. For each individual drug the reference category was defined as those not exposed to the drug. RESULTS: The incidence of upper gastrointestinal bleeding was 401.4 per million inhabitants aged >18 years. Thirty-eight percent of cases were attributable to NSAIDs. Individual risks for each NSAID were dose dependent. Ketorolac was associated with the highest risk estimate (24.7; 95% CI 8.0, 77.0). For newer NSAIDs, the risks were as follows: aceclofenac 1.4 (95% CI 0.6, 3.3), celecoxib 0.3 (95% CI 0.03, 4.1), dexketoprofen 4.9 (95% CI 1.7, 13.9), meloxicam 5.7 (95% CI 2.2, 15.0), nimesulide 3.2 (95% CI 1.9, 5.6) and rofecoxib 7.2 (95% CI 2.3, 23.0). The risk was significantly increased in patients with a history of peptic ulcer and/or upper gastrointestinal bleeding, and in those taking antiplatelet drugs. CONCLUSIONS: NSAID-induced upper gastrointestinal bleeding is a common cause of hospital admission. Apart from the patient's history of peptic ulcer, its risk depends on the particular drug and its dose, and on concomitant treatments. Our results do not confirm that greater selectivity for COX-2 confers less risk of upper gastrointestinal bleeding.

Adult↗
PubMed2003

[Generic drug prescription at discharge from a hospital emergency service].

BACKGROUND AND OBJECTIVE: Drug prescription at hospital discharge often implies continuation of the treatment in primary health care. The aim of this study was to assess prescription of generics at discharge from a hospital emergency service. MATERIAL AND METHOD: Longitudinal and retrospective study, on a random sample of medical reports in a hospital emergency service during one year (August 2000 to July 2001). Information on the medical specialty, prescribed generic drugs and marked availability of the corresponding generic drugs pharmaceutical specialties was collected. Factors associated with generic prescription were analyzed by means of logistic regression analysis. RESULTS: A sample of 1,245 medical reports was selected in which 2,315 drugs were prescribed. Although generic drugs were available for 33.3% (CI 95%, 31.4-35.2) of prescriptions, 9.5% (95% CI, 8.3-10.7) of prescribed drugs were generics. The average price of trademark prescribed medicines, for which there was a generic equivalent, was 7.09 Euros (95% CI, 6.54-7.63 Euros), and that of the corresponding generic versions was 5.08 Euros (95% CI, 4.68-5.48 Euros). Variables associated with generic drug prescription included the particular study period (OR=1.35; 95% CI, 0.99-1.84), the medical specialty of the prescriber (OR=1.40; 95% CI, 1.05-1.86), availability of generic drugs (OR=1.76; 95% CI, 1.30-2.39) and low price of prescribed drugs (OR=2.67; 95% CI, 1.80-3.98). CONCLUSION: In spite of the availability of generic drugs, prescription of generic drugs at discharge of this hospital emergency service was low. Prescription and use of generic drugs should be promoted in hospitals.

Costs and Cost Analysis↗
PubMed2003

Adverse effects of ACE inhibitors in patients with chronic heart failure and/or ventricular dysfunction : meta-analysis of randomised clinical trials.

BACKGROUND: The evidence-based benefit/risk evaluation of therapeutic interventions in randomised clinical trials should include both the assessment of the benefits and of the adverse outcomes. There is ample evidence that ACE inhibitors improve the symptoms and prognosis of chronic heart failure (CHF) and ventricular dysfunction. However, there is little systematic information on the tolerability and adverse effects associated with their use in these conditions. OBJECTIVE: To estimate the adverse events related to ACE inhibitor use in the treatment of CHF and ventricular dysfunction. DESIGN AND METHODS: Description of adverse events in reports of randomised clinical trials of ACE inhibitors in CHF or ventricular dysfunction was examined, and a meta-analysis was performed. Trials were included if they were placebo- or standard treatment-controlled, and if the treatment duration was at least 8 weeks. Relative risks and their 95% CIs were estimated with a random effects model. RESULTS: Only 22 (43%) of 51 original reports contained information on the number of withdrawals and their causes. Missing information from the remaining 29 trials was obtained from the authors. The weighted mean duration of treatment was 100.2 weeks. After excluding administrative reasons, heart failure, myocardial infarction and hypertension, the withdrawal rates attributed to adverse events were 13.8% and 9.4% for the ACE inhibitor and control groups, respectively (RR = 1.54 [95% CI 1.30-1.83]; weighted difference = 3.1 per 100 treated patients [95% CI 1.8-4.4]). Cough, hypotension, renal dysfunction, dizziness, hyperkalaemia, and impotence were all significantly more prevalent among patients treated with ACE inhibitors than among those in the control groups. CONCLUSIONS: Among patients with CHF or ventricular dysfunction enrolled in randomised clinical trials, treatment with an ACE inhibitor for an average of 2 years leads to an additional 3% of treatment withdrawals. In a significant proportion of the reports on these randomised clinical trials, information on adverse events leading to treatment withdrawal was inadequate. Proper evidence-based evaluation of the benefit/risk of therapeutic interventions needs a more systematic approach to reporting of adverse events experiences recorded in clinical trials.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed2003

Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads.

BACKGROUND: The effectiveness of voluntary reporting systems in pharmacovigilance highly depends on the number of assembled reports. AIM: The aim of this study was to measure the effect of the periodical distribution of a bulletin on drug safety issues and of including yellow cards in prescription pads on the rate of adverse drug reaction (ADR) reporting. STUDY DESIGN AND METHODS: The Catalan Centre of Pharmacovigilance began its activities at the end of 1982. Since 1985, an ADR bulletin (ADRB) has been mailed approximately quarterly to all physicians in its catchment area, with one yellow card enclosed. Additionally, from 1991-1994, a yellow card was included in the prescription pads of the Catalan Health Service. Time series methodology, with adjustment of the monthly number of reports to an Auto-Regressive Integrated Moving Average (ARIMA) model, was used to evaluate the effect of these two measures. RESULTS: From January 1983-October 1995, 6240 spontaneous ADR reports were received, and 41 issues of the ADRB were sent out. Initially, the mean monthly spontaneous ADR reporting rate was 34.4 (SD = 14.1; n = 106 months). After the inclusion of yellow cards in prescription pads, the mean monthly spontaneous ADR reporting rate increased to 53.9 (SD = 14.4; n = 48 months). According to an ARIMA model, when a bulletin was send out (MONTH1), a mean increase of 9.4 reports was produced in that month, plus 12.3 additional reports in the following month (MONTH2), and 6.3 in the second month after sending the ADRB (MONTH3). A yellow card in the prescription pads elicits a monthly mean increase of 19.8 in the number of reports. CONCLUSIONS: The present study suggests that ADRBs elicit a temporal increase of the ADR reporting rate. Including a yellow card in prescription pads was followed by an even greater increase in the reporting rate, possibly because it guarantees that yellow cards are available at the workplace.

Adverse Drug Reaction Reporting Systems↗