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  • 1
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    Allergy 51 (1996), S. 0 
    ISSN: 1398-9995
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Type of Medium: Electronic Resource
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  • 2
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 46 (1994), S. 95-99 
    ISSN: 1432-1041
    Keywords: Myocardial infarction ; Drug utilization ; secondary prevention ; β-adrenoceptor antagonists ; acetylsalicylic acid ; calcium channel blockers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract To examine whether the results of trials on the secondary prevention of myocardial infarction have led to a change of prescription practice, the discharge forms of a random sample of 737 patients admitted to a university hospital with a diagnosis of acute myocardial infarction (MI) with Q wave from 1982 to 1988 were examined. Information about cardiovascular and other risk factors, contraindications, and prescription of β-adrenoceptor antagonists (βAA), acetylsalicylic acid (ASA) and calcium channel blockers (CCB) was collected. The prescription of these drugs was analysed in relation to clinical variables and the date of patients' discharge from hospital. During the 7 years of follow-up, the prescription of βAA increased gradually from 20% to 30–35%; the prescription of CCB was above 30% during the same period and did not change significantly with time. The prescription of ASA increased from 0% to 30–35% in the last 3 years of follow-up. Contraindications to βAA were present in 23.2% of cases and contraindications to ASA in 14.4%. In a multivariate analysis, hypertension (odds ratio 2.29, 95% confidence interval 1.55–3.38) and the period 1986–1988 (OR 2.27, 95% CI 1.57–3.30) were associated with the prescription of βAA, although the prescription of βAA decreased significantly with advancing age. Other variables inversely associated with the prescription of βAA were contraindications (OR 0.41, 95% CI 0.24–0.66) and the presence of heart failure during admission (OR 0.08, 95% CI 0.03–0.20). The prescription of CCB was inversely associated with the prescription of βAA (OR 0.41, 95% CI 0.27–0.63); the preference for CCB over βAA was notable among patients with the following characteristics: age 〉 70 years (39.3% vs 9.3%) angina (51.6% vs 24.7%), heart failure during admission (25.5% vs 3.2%), and contraindications to the use of βAA (28.1% vs 11.1%). The only clinical variable which was significantly (and inversely) associated with the prescription of ASA was the presence of contraindications (OR 0.13, 95% CI 0.04–0.41). These results suggest that clinical trials on the secondary prevention of ischaemic heart disease have had some influence on cardiologists' prescription habits. However, they document a large underuse of efficacious drugs such as βAA and ASA, especially among the elderly and among those patients with more severe cardiovascular disease. The frequent prescription of CCB recorded in the present study, in spite of their unproven efficacy in this condition, suggests that these drugs are often preferred to βAA for the survivors of an acute MI, especially in certain groups of patients.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 47 (1994), S. 297-303 
    ISSN: 1432-1041
    Keywords: Non-steroidal anti-inflammatory drugs ; Adverse drug reactions
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Non-steroidal anti-inflammatory drugs (NSAIDs) are the third most commonly prescribed group of drugs in Spain. We present here the profile of adverse drug reactions (ADRs) attributed to them and reported to the Spanish System of Pharmacovigilance (SSPV) between 1983 and 1991, together with a preliminary analysis of topical, slow-release (SR) and enteric-coated (EC) preparations. Out of 18 348 reports of ADRs included in the SSPV database, 1609 (8.8%) implicated an NSAID. NSAIDs ranked second after antibiotics (15.1% of all reports) among the most commonly implicated drugs. Half of the patients were more than 55 years old, and 60% were women. Diclofenac (364 reports), piroxicam (282), indomethacin (197), naproxen (155), and ketoprofen (137) were the most commonly implicated NSAIDs in reports of ADRs. The most commonly reported ADRs were gastrointestinal (39%), cutaneous (20%), and those affecting the central and peripheral nervous system (9%). Seven reactions had a fatal outcome, and 138 were considered life threatening. Forty-nine reports included previously undescribed ADRs. There were 98 reports describing ADRs attributed to topical NSAIDs; 5 of these described 11 general reactions, such as duodenal ulcer, gastrointestinal bleeding, diarrhoea, dyspnoea, facial oedema, aggravation of bronchospasm, and angioedema. One hundred and sixty-eight reports referred to SR and EC preparations. The ratio of gastrointestinal to non-gastrointestinal reactions to SR-EC diclofenac was higher in the case of SR-EC diclofenac than in the case of plain diclofenac (P=0.037); similarly, the ratio of CNS to non-CNS reactions to SR-EC indomethacin was also higher than the corresponding ratio with plain indomethacin (P=0.002). Although differential selective reporting of these preparations cannot be excluded, these results raise doubts about the relative safety of SR and EC preparations of NSAIDs in practice.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1432-1041
    Keywords: Key words Superficial phlebitis ; Topical heparin ; Randomized trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: To assess the clinical efficacy of a topical gel containing 1000 IU · g−1 of heparin, applied three times daily for a maximal period of 7 days to patients with acute superficial phlebitis secondary to indwelling intravenous catheter. Methods: A Double-blind, randomized, placebo-controlled study was conducted in one of the internal medicine wards of a tertiary General Hospital in Barcelona, Spain. Inpatients of both genders over 18 years of age that developed superficial phlebitis and gave informed consent were included in the study. The sample size estimation was 132 patients. Sixty-six patients were allocated to each group. There were five protocol deviations and 24 withdrawals in the intervention group, and one protocol deviation and 25 withdrawals in the control group. Consequently, 37 patients in the intervention group and 40 in the control group completed the trial. The main outcome measure was the disappearance of the symptoms and signs of superficial phlebitis. Clinical course, investigator's global impression and adverse events were also recorded. Results: According to the intention-to-treat analysis, after treatment for 7 days superficial phlebitis healed in 27 of the 61 patients (44.3%) who received topical heparin, and in 17 of the 65 patients (26.1%) receiving placebo, giving a relative risk [95% confidence interval (CI)] of 1.69 (1.03–2.78). This indicates that six patients (95% CI, 3–72) have to be treated in order to induce one additional healing. The clinical course and the overall clinical impression were similar in both groups. One patient treated with topical heparin developed mild urticaria. Conclusion: Topical heparin is safe and effective for the treatment of superficial phlebitis secondary to indwelling intravenous catheter.
    Type of Medium: Electronic Resource
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  • 5
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 55 (2000), S. 761-764 
    ISSN: 1432-1041
    Keywords: Key words Pyrithyldione ; Agranulocytosis ; Pharmacoepidemiology
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: Pyrithyldione, a sedative-hypnotic drug with a poor clinical pharmacological development, was associated with anecdotal cases of agranulocytosis in the 1940s in the USA, in the 1960s and 1970s in the ex-Democratic Republic of Germany and in the 1980s in Japan. We describe the estimation of the risk of agranulocytosis associated with its use in Spain, which led to its withdrawal from the market. Methods: In collaboration with the haematology units of all the hospitals in a defined area (3.3–3.9 × 106 inhabitants), all cases of agranulocytosis meeting strict diagnostic criteria were identified. Each case – defined as an episode of agranulocytosis – was reviewed by a haematologist without knowledge of previous drug exposures. Cases and age-, gender- and hospital-matched controls were interviewed with a structured questionnaire about previous drug exposures. In addition, in order to estimate the risk of pyrithyldione-associated agranulocytosis through a case-population approach, its consumption among the cases was compared with its consumption among the general population. Results: After a follow-up of 66.5 × 106 person-years, 330 cases of agranulocytosis (230 community cases) were assembled. Reliable information on previous exposures was obtained for 204 cases. They were compared with 1314 controls. Eleven patients (14 cases, 6.9%) and zero controls had been exposed to pyrithyldione. The adjusted OR was 200.11 (CI 95% 22.62–∞). All patients were female; none had a fatal outcome; three exhibited positive rechallenge; and all had concomitantly taken other drugs. Although pyrithyldione was a prescription-only medicine, only 8% had been dispensed with medical prescriptions. Assuming the worst case, i.e. that all the exposed cases could be attributed to pyrithyldione, the incidence was 35.6 cases per 100,000 patient-years (95% CI, 18.9–60.9), which gives a risk ratio estimate of 109.6 (57.5–191.5) if compared with the incidence of agranulocytosis among the non-exposed population [3.26 cases (CI 95% 2.83–3.71) per 106 inhabitants and per year]. Discussion: Pyrithyldione was viewed by pharmacists as a mild hypnotic, and apparently this had conferred to this drug an unjustified image of safety. The National Commission of Pharmacovigilance recommended to the Ministry of Health its withdrawal from the market when eight cases of agranulocytosis had been identified. However, it took more than 2 years to withdraw it, and six additional cases occurred in the study area. This illustrates the need for quick regulatory action when pharmacoepidemiological data suggest an unfavourable benefit/risk ratio.
    Type of Medium: Electronic Resource
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  • 6
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 26 (1984), S. 583-586 
    ISSN: 1432-1041
    Keywords: rifampicin ; tuberculous meningitis ; retrospective analysis ; mortality rate ; isoniazid ; neurological side-effects
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary To shed some light on the potential value of rifampicin in the treatment of tuberculous meningitis (TBM) in adults, a retrospective analysis has been made of 143 medical records from 4 hospitals for the period 1967–80. Treatment of TBM with rifampicin and other antituberculous drugs in combination (Group B) was compared to other regimes which did not include rifampicin (Group A). There were 64 patients in Group B and 79 in Group A. The two groups of patients did not differ significantly in their prognostic characteristics. The total mortality was 14.7%: it was higher among patients not treated with rifampicin (24%; Group A) than amongst those given rifampicin (3.1%; Group B; x 2=10.74; p〈0.005). The difference was also statistically significant (x 2=6.88; p〈0.01) if patients who died during the first 48 h after the institution of treatment were excluded. No significant difference in mortality rate was found when patients treated with rifampicin plus isoniazid (INH) 8–10 mg/kg (1 death out of 41 patients) were compared to patients treated with INH 15 mg/kg (2 deaths out of 20 patients). Neurological sequelae recorded during a 6 month follow-up period were more severe among patients not treated with rifampicin.
    Type of Medium: Electronic Resource
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  • 7
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 24 (1983), S. 591-593 
    ISSN: 1432-1041
    Keywords: amiodarone ; pulmonary fibrosis ; hypersensitivity mechanism ; adverse drug effect
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Of 25 cases of idiopathic pulmonary fibrosis, confirmed by open chest lung biopsy between January 1979 and July 1981, 5 patients had been taking amiodarone in doses less than 600 mg daily for 1 to 6 years. No lung disease had been observed in any patient before the administration of amiodarone, and other drugs, factors and diseases thought to play a role in the causation of pulmonary fibrosis were ruled out. Two patients died of respiratory insufficiency, and only 1 does not now suffer from serious sequelae. Review of a further 5 cases reported in the literature and the present data suggest a causal link between administration of amiodarone and pulmonary fibrosis, and tend to indicate a hypersensitivity mechanism.
    Type of Medium: Electronic Resource
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  • 8
    ISSN: 1432-1041
    Keywords: Key words Anticoagulants ; Atrial fibrillation ; Ace nocoumarol ; Aspirin; drug utilization,
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objectives: The aim of the present study was to evaluate the impact of the results of clinical trials on the prophylactic treatment of non-rheumatic atrial fibrillation with oral anticoagulants. Methods: Retrospectively, we studied a random sample of 375 patients discharged from our hospital with a diagnosis of non-rheumatic atrial fibrillation between 1991 and 1993. Information about diagnoses, other clinical variables and treatments prescribed at discharge was obtained from the hospital medical records. Results: During the whole study period, 14% of patients were prescribed an oral anticoagulant agent and 17% were prescribed acetylsalicylic acid. A non-significant increase in the proportion of patients prescribed oral anticoagulant drugs, from 9% to 17%, was observed. Multivariate analysis showed that a history of stroke (OR = 5.96) and younger age were significantly associated with the prescription of oral anticoagulants. ASA prescription was strongly associated with a history of concomitant vascular disease (OR = 5.8), but not with other risk factors for stroke. Sixty-five percent of patients had one or more risk factors for stroke, did not present any contraindications to anticoagulant agents, but nevertheless were not prescribed one of these drugs. Conclusions: Anticoagulant agents and acetylsalicylic acid were largely underprescribed to patients with non-rheumatic atrial fibrillation, and oral anticoagulants were not prescribed according to the individual patients' risk of stroke.
    Type of Medium: Electronic Resource
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  • 9
    ISSN: 1432-1041
    Keywords: Key words Surveillance of rare disease ; European net work
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: Euronet, a case-population surveillance scheme, aims to estimate the risk of certain rare conditions which are commonly iatrogenic, by comparing drug use amongst non-selective cases with overall drug use in the general population. Methods: The method is based on three provisos: (1) all incident cases (irrespective of suspected aetiology) should be ascertained and studied; (2) a full drug history should be obtained from cases by direct interview; and (3) drug-use data for the products of interest should be available for this population from which cases are chosen. The feasibility of this problem-oriented approach for the identification of new signals of adverse drug reactions and for risk estimation will be tested in relation to agranulocytosis, Stevens-Johnson syndrome and toxic epidermal necrolysis in four defined areas in Europe, totalling 19 × 106 inhabitants, with these latest two outcomes being studied in only three regions. The design, methods and main limitations of this case–population surveillance approach are described.
    Type of Medium: Electronic Resource
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  • 10
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 54 (1998), S. 203-208 
    ISSN: 1432-1041
    Keywords: Key words Myocardial infarction ; Drug utilization
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: The efficacy of β-adrenergic blocking agents and acetylsalicylic acid in the secondary prevention of myocardial infarction has been well recognized since the beginning of the 1980s. In a previous paper, however, we reported a lower than expected use of these drugs during the period 1982–1988. In 1989 the results of this survey were presented and discussed with the prescribing physicians. In the present paper we describe the prescription patterns for the same indication and in the same centre over the following 6 years (1989–1994). We also describe the use of angiotensin-converting enzyme (ACE) inhibitors, for which efficacy in certain subgroups has been recently shown. Methods: Random samples of patients discharged from our hospital between 1989 and 1994 with a diagnosis of acute myocardial infarction with Q-wave were studied. Information about diagnoses, other clinical variables and treatments prescribed at discharge was obtained from the hospital discharge forms. The results were compared with those obtained in the previous study. Results: We studied 514 patients (80% men) with a median age of 59 years (range 31–89). The proportions of patients prescribed β-adrenergic blocking agents and acetylsalicylic acid increased from 34% and 28%, respectively, in 1986–1988, to 62% and 75% in 1989–1991. In 1994 they had reached a steady state (63% and 71%). In addition, a continued decrease in the use of calcium channel blockers was noted, from 36% in 1986–1988 to 17% in 1994. The increase in the prescription of β-adrenergic blocking agents was especially remarkable in the subgroups for which a larger underuse was recorded in the previous study, such as the elderly. The proportion of patients prescribed an ACE inhibitor increased from 14% in 1989–1991 to 23% in 1994. In a multivariate analysis the prescription of ACE inhibitors was associated with female gender, hypertension during admission, heart failure during admission, and previous myocardial infarction. A substantial increase in the prescription of β-adrenergic blocking agents and acetylsalicylic acid and a decrease in the prescription of calcium channel blockers was recorded between 1982 and 1994. The prescription rate of β-adrenergic blocking agents has increased substantially in certain subgroups where underuse had been previously recorded. Most of the changes occurred in 1989–1991, and reached a steady state in 1994. In 1994 an increase in the prescription of ACE inhibitors was also recorded.
    Type of Medium: Electronic Resource
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