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  • 1
    ISSN: 1432-1041
    Keywords: Key words Tamsulosin ; Benign prostatic hyperplasia
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: This study was performed to estimate whether the pharmacokinetics and safety of tamsulosin, an α1A-adrenoceptor antagonist for the treatment of symptomatic benign prostatic hyperplasia (BPH), are influenced by impaired renal function. Methods: In an open-label study design, the plasma concentration profile of 0.4 mg tamsulosin p.o. was studied in age-matched groups of male subjects with normal (n = 10), moderately impaired (n = 10), and severely impaired (n = 8) renal function after single-dose administration and in steady state, i.e. after 21 days of multiple-dose administration. Results: The AUC of total, but not of unbound, tamsulosin was correlated to creatinine clearance and α1-acid glycoprotein plasma levels, and was found to be significantly higher in both groups of subjects with impaired renal function than in controls after single- and multiple-dose administration. However, the pharmacokinetics of total and unbound tamsulosin were comparable for both trial periods. Conclusions: Impaired renal function increases total tamsulosin plasma concentration by approximately 100% after single-dose administration and in steady state. Since active unbound drug levels are not affected, no dose modification is required in symptomatic BPH patients with renal impairment.
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  • 2
    ISSN: 1432-1041
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1432-1041
    Keywords: Key words Adverse drug event reporting ; Hospitalized ; patients ; Source/relative value of reports
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: This study investigated the relative value of adverse drug events reported by doctors, nurses and patients. Methods: The study was conducted on a total of four wards: the paediatric and internal medicine wards (including geriatric patients) of two peripheral hospitals in the Netherlands. Adverse drug events were collected by spontaneous reporting (doctor and nurse reports) and by daily ward visits, during which the patients were interviewed by a hospital pharmacist (patient reports). Criteria for relative value of the reported adverse drug events were the number of potentially serious reactions, the number of reactions not mentioned in the patient information leaflet and the number of reactions reported to new drugs (5 years or less on the Dutch market). No formal causality assessment was applied. Results: Over a period of 2 months in 1996 (Hospital I) and 2 months in 1997 (Hospital II) a total of 620 patients were included in the study and adverse drug events were reported in 179 (29%) of these cases. Doctors reported a statistically significant larger number of serious (26% of all doctor reports; odds ratio (OR) 3.2; confidence interval (CI) 1.2–8.7) and unknown (39%; OR 2.5; CI 1.0–6.0) adverse drug events than patients themselves during the daily ward visit. Doctors also reported more serious and unknown adverse drug events than nurses. Adverse reactions to new drugs were reported during the daily ward visit only (8% of all daily ward visit reports). Conclusion: This study reconfirms that doctors are the main source for reports of serious and unknown adverse drug events in hospitalized patients. However, patients themselves seem to report more adverse reactions to new drugs (during the daily ward visit). By focusing on patients using new drugs, the daily ward visit might become cost-effective. This needs to be explored in future studies.
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  • 4
    ISSN: 1432-1041
    Keywords: Key words Osteoporosis ; Treatment ; Bisphosphonates
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: To investigate whether the alkylbisphosphonate etidronate is associated with an increased risk of gastrointestinal symptoms. Methods: We conducted an observational follow-up study on a possible relationship between etidronate use and the risk of gastrointestinal symptoms in a cohort of 2754 women over 50 years of age. The study was performed with data on drug prescriptions obtained from the PHARMO database in the Netherlands. Women were included when they used either cyclical etidronate (n=1050) or estrogen (n=1704) for at least 14 days. They were followed-up for incident use of antiulcer drugs while on exposure medication. Results: The mean ages were 72 years and 59 years in the etidronate and estrogen groups, respectively. In total, there were 95 women with incident prescriptions for gastrointestinal events after a median duration of follow-up of 2.7 months (range 0.1–19.4 months). The crude relative risk of a gastrointestinal event for etidronate compared with estrogen use was 1.2 [95% confidence interval (95% CI) 0.8–1.8]. Adjusted for baseline age, use of corticosteroids, salicylates and nonsteroidal anti-inflammatory drugs, the relative risk reversed to 0.6 (95% CI 0.4–1.2). Conclusion: The use of cyclical etidronate is not associated with an elevated risk of symptoms of peptic ulcer disease.
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  • 5
    ISSN: 1432-1041
    Keywords: Key words Asthma therapy ; Corticosteroids; hospitalisation ; case-control study ; compliance ; attitude ; behaviour
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Background: The relationship between therapy and adverse outcome in asthma is debated especially for naturally occurring situations. This is due in part to insufficient information regarding actual use of medications. Objective: This study was conducted to clarify the relationship between actual intake of anti-asthma drugs and asthma hospitalisation, considered as an outcome. Methods: A case-control study was performed. Patients hospitalised for an asthma exacerbation were matched to community controls identified in surrounding general practices. Patients were questioned to identify prior use of anti-asthma medications, level of use of inhaled corticosteroids and attitude towards therapy. Results: Twenty-three cases and 31 matched controls were interviewed. Cases tended to have more severe asthma than controls, as judged by more frequent use of oral corticosteroids. Cases tended to make more frequent use of oral xanthines and inhaled anticholinergics, but the proportion of patients using inhaled β2-adrenoceptor agonists and inhaled corticosteroids was similar in both groups. Use of lower doses of inhaled corticosteroids was associated with an increased risk of hospitalisation, while higher dosage was associated with␣decreased risk. Cases and controls differed as to their answers to a questionnaire concerning attitudes: cases expressed less interest in optimal usage of inhaled␣corticosteroids than controls; they also expressed more confidence in inhaled β2-agonists. When both risks were combined, overconfidence in β2-agonists and suboptimal use of inhaled steroids, the relationship with hospitalisation was significant (OR 5.5, 95% CI 1.1; 26.1). Conclusion: The results suggest that patients' attitudes to inhaled corticosteroids and actual consumption of these medications are directly related to adverse outcome in asthma.
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  • 6
    ISSN: 1432-1041
    Keywords: Drug–drug interaction Pharmacovigilance Spontaneous reporting system
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract. Objective: Drug–drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug–drug interactions. We developed a method that may enable signalling of these possible interactions, which are often not explicitly reported, utilising reports of adverse drug reactions in data sets of SRS. As an example, the influence of concomitant use of diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) on symptoms indicating a decreased efficacy of diuretics was examined using reports received by the Netherlands Pharmacovigilance Foundation Lareb. Methods: Reports received between 1 January 1990 and 1 January 1999 of patients older than 50 years were included in the study. Cases were defined as reports with symptoms indicating a decreased efficacy of diuretics, non-cases as all other reports. Exposure categories were the use of NSAIDs or diuretics versus the use of neither of these drugs. The influence of the combined use of both drugs was examined using logistic regression analysis. Results: The odds ratio of the statistical interaction term of the combined use of both drugs was increased [adjusted odds ratio 2.0, 95% confidence interval (CI) 1.1–3.7], which may indicate an enhanced effect of concomitant drug use. Conclusion: The findings illustrate that spontaneous reporting systems have a potential for signal detection and the analysis of possible drug–drug interactions. The method described may enable a more active approach in the detection of drug–drug interactions after marketing.
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  • 7
    ISSN: 1573-739X
    Keywords: Benzodiazepines ; Anxiolytics ; Hypnotics ; Pharmacoepidemiology ; Drug utilization ; Longitudinal study ; Usage patterns
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Only a few longitudinal studies have addressed benzodiazepine use over time. We therefore conducted a 10‐year follow‐up study (1983‐1992) on usage patterns of benzodiazepines in a Dutch community of 13500 people. Use decreased during the time of the study. Twelve (1983) to ten (1992) percent of the inhabitants was a recipient at least once a year of a benzodiazepine prescription. The use by gender showed more women using more prescriptions as men. Women were not prescribed more DDDs per prescription as men. Individual benzodiazepines showed differences in use by gender. Use increased with age among both women and men. Most of the users were 55 years or older. One out of three patients was either an incidental user (1‐30 days use in one calendar year), a regular (31‐180 days), or a long term user (more than 180 days). The use of long half‐life hypnotics decreased, the use of the short half‐life ones showed an increase. Behind a stable overall trend we found strong fluctuations in use of individual benzodiazepines.
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  • 8
    ISSN: 1573-739X
    Keywords: Asthma ; Long acting β2‐agonists ; Pharmacoepidemiology
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Long acting β2‐agonists (LBA) have become an important therapeutic strategy in the treatment of asthma. There is, however, debate whether LBA increase the risk of asthma exacerbations (AE). We studied whether the risk of AE was increased in patients starting LBA therapy and whether the risk was associated with severity. Patients, aged 5‐49 years, who were firstly prescribed LBA between 1992 and 1995, and who had at least two consecutive prescriptions of LBA, were selected from the PHARMO‐RLS database. The exposure period was the interval between the first and last dispensing of the first exposure episode. The year before the onset was the control period. Single short courses of oral glucocorticosteroids or antibiotics were used as proxy indicators for AE. Severity indicators, assessed in the 6 months before initiation of LBA, were used to classify patients' severity. A total of 788 patients met the inclusion criteria (men: 45.1%, median age: 35). The incidence rate of AE increased significantly (p〈0.001) with severity from 1.7 to 2.4 and 1.1 to 2.7 AE per person year in index and control period, respectively. The risk was merely elevated among patients who start LBA therapy without being treated with other anti‐asthma drugs before (RR 1.4, 95% CI 1.0‐2.2). First starters of LBA showed no overall change in incidence of AE when compared with the year before starting treatment. A total of 6.9% of patients used LBA as step‐one therapy. These patients suffer, in contrast to the whole population, a 40% increased risk of having AE. Although this could be due to confounding, we recommend being reluctant to prescribe LBA to patients who have not been treated before with other anti‐asthma drugs.
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  • 9
    ISSN: 1573-739X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
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  • 10
    ISSN: 1573-739X
    Keywords: Anti-inflammatory agents ; Data collection ; Drug utilization ; Epidemiologic methods ; Netherlands ; Pharmacies, community
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Non-steroidal anti-inflammatory drugs represent an important drug class in ambulatory care. A utilization study among half a million persons showed that 8.6% could be identified as having used one or more non-steroidal anti-inflammatory drugs (excluding salicylates) in 1987. Data were drawn from a representative sample of pharmacy records which comprise full medication histories of individual patients. Overall utilization of non-steroidal antiinflammatory drugs was 10.8 defined daily doses/(1000 persons · day). Approximately three quarters of the patients are ‘incidental’ users and receive non-steroidal anti-inflammatory drugs for a relatively short time (30 days or less). Patients who were identified as ‘regular’ (31–210 days of therapy) and ‘heavy’ (〉210 days of therapy) users, accounted for 21.2% respectively 4.8% of all users. ‘Heavy’ users are responsible for 17.3% of all non-steroidal anti-inflammatory drug prescriptions. Especially the elderly and females are prone to be ‘heavy’ users. Five drugs account for 90.4% of all prescriptions (diclofenac, ibuprofen, naproxen, piroxicam, indometacin). A total of 71.1% of the patients with more than one prescription for non-steroidal anti-inflammatory drugs switched in therapy. There are two classes of concomitant drug use especially relevant with respect to detecting non-steroidal anti-inflammatory drugs-associated risks: H2 blockers and antacids (belonging to anatomical therapeutic and chemical anatomic class A) and diuretics (belonging to anatomical therapeutical chemcial anatomic class C). More than half of the ‘heavy’ users showed concomitant use of drugs in these classes.
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