Search

Objective: Turkey's health reforms started in 2003 with providing changes in regulatory, financing, and healthcare services. Access to health care and pharmaceuticals increased rapidly, and this resulted with an increase in public pharmaceutical expenditures. Our study aims to quantify and to evaluate the impact of a specific process within the Turkish system called "Medicines Brought From Abroad" (MBFA).Methods: We reviewed the general reimbursement legislations of Social Security Institution (SSI), the guideline on MBFA, the SSI reimbursement list, the list of MBFA published by the Ministry of Health to describe the current supply mechanism of medicines and, in particular, the role of MBFA.Results: Total costs of the of MBFA medicines over the period 2011-17 went up to more than $520 million, which takes 7.5 percent of total public pharmaceutical expenditure for 2017. Our results showed that MBFA provides access to many orphan drugs and in total, forty-two orphan drugs listed in MBFA accounted for 83 percent of all MBFA budget in the year 2017. Nine of the top ten MBFA medicines were orphan drugs and total costs were $408 million. The highest budget impact was for eculizumab for "paroxysmal nocturnal hemoglobinuria" (PNH), covering 31 percent of total MBFA costs and 2.3 percent of overall drug costs in 2017.Conclusions: Turkey faced significant challenges for creating an access pathway for innovative medicines while continuing the sustainability of the public pharmaceutical budget like many other countries. Therefore, it may be argued that Turkey needs to create an independent health technology assessment organization to provide sustainable access to medicines in the future. [ABSTRACT FROM AUTHOR]

Copyright of Tijdschrift Voor Kindergeneeskunde is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background Drug-induced photosensitivity is difficult to predict and remains a challenge for both the dermatological clinical practice and pharmacovigilance. Purpose To assess the association between spectroscopic and molecular characteristics and the occurrence of photosensitivity reactions. Methods For 143 well-known photosensitisers (e.g. tetracyclines, diuretics), we retrieved information on spectroscopic and molecular parameters, including: absorption maximum λmax, molar absorption coefficient ε, area under the absorption curve (AUC), molecular weight and configuration, hetero and aromatic halogen atoms, lipophilicity (log P) and acid/base status (pKa). In the WHO-ADR database, all reports with suspected adverse drug reactions of the study drugs were selected. We identified all reports on photosensitivity reactions and defined them as cases. All other reports were selected as non-cases. A case-non-case approach was performed to assess the spectroscopic and molecular exposure variables as a factor for photosensitivity reactions. Logistic regression was used to calculate odds ratios (OR) with 95% confidence intervals (CI). Results A λmax between 290 and 320 nm (OR 3.74, 95% CI 3.45-4.06), and an ε > 20 000 M−1 cm−1 (OR 5.49, 95% CI 5.10-5.92) were highly associated with the reporting of photosensitivity reactions. Risk of the photosensitivity reactions was significantly increased among intermediate or high AUCs compared to low AUC. Low molecular weight and aromatic halogen atoms were associated with photosensitivity reactions (OR 2.37, 95% CI 2.07-2.71 resp. OR 3.37, 95% CI 3.15-3.61) as were log p < 1 and pKa < 7. Conclusion The reporting of photosensitivity reactions to established phototoxic drug classes is strongly influenced by spectroscopic and physicochemical characteristics of individual drugs. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Aims Drug-induced QTc-prolongation, resulting from inhibition of HERG potassium channels may lead to serious ventricular arrhythmias and sudden death. We studied the quantitative anti-HERG activity of pro-arrhythmic drugs as a risk factor for this outcome in day-to-day practice. [ABSTRACT FROM PUBLISHER]

Souverein PC, Van Staa TP, Egberts ACG, De la Rosette JJMCH, Cooper C, Leufkens HGM. (Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands; Southampton University Hospital, Southampton, UK; and Academic Medical Centre, Amsterdam, The Netherlands). Use of α-blockers and the risk of hip/femur fractures. J Intern Med 2003; 254: 548–554. To study the association between use of α-blockers and risk of hip/femur fractures. Population-based case–control study. General Practice Research Database. Cases were defined as men, aged 40 years and older with a first diagnosis for hip/femur fracture. Controls were matched 1 : 1 on gender, year of birth and general practitioner-practice. In all, 4571 cases and an equal number of controls were identified. Current use of α-blockers (prazosin, doxazosin, indoramin, terazosin, alfuzosin and tamsulosin) was compared with non-use of α-blockers. Current use of α-blockers on the index date was associated with an increased risk of hip/femur fracture [adjusted odds ratio (OR) 1.9, 95% confidence interval (CI): 1.1–3.0] in the overall analysis. The effect was particularly strong for first prescriptions within a treatment episode (adjusted OR 5.1, 95% CI: 1.0–31.7) and during the first month of treatment (adjusted OR 4.1, 95% CI: 0.7–23.9). Stratification according to indication of use showed that current use of α-blockers was not associated with hip/femur fracture in men with a diagnosis of benign prostatic hyperplasia (adjusted OR 1.0, 95% CI: 0.4–2.5), but was associated in men who used α-blockers for cardiovascular disease (adjusted OR 2.8, 95% CI: 1.4–5.4). Current use of α-blockers was associated with an increased risk of hip/femur fracture and with the start of a new treatment episode. The effect seemed to be confined to patients who used α-blockers for cardiovascular disease. Caution with respect to first-dose effects related to the initiation of a new episode of α-blocker treatment is advised. [ABSTRACT FROM AUTHOR]

Objective: To develop a comprehensive and easily applicable prognostic model predicting mortality risk in patients with moderate to severe heart failure. Design: Prospective follow up study. Setting: Seven general hospitals in the Netherlands. Patients: 152 outpatients with heart failure or patients admitted to hospital because of heart failure, who were included in a randomised trial to assess the impact of a pharmacist led intervention to improve drug compliance. Duration of follow up was at least 18 months. Main outcome measures: Multivariable logistic regression modelling was used to evaluate information from history, physical examination (for example, blood pressure), drug use, and quality of life questionnaires that independently contributed to the prediction of death. The area under receiver operating characteristic curves (AUC) was used to estimate the predictive ability of the prognostic models. Results: During the 18 months of follow up, 51 patients (34%) died. Independent predictors of mortality were diabetes mellitus, a history of renal dysfunction (or higher creatinine), New York Heart Association (NYHA) functional class III or IV, lower weight or body mass index, lower blood pressure, ankle oedema, and higher scores on a disease specific quality of life questionnaire. The use of β blockers was predictive of a better prognosis. These factors were used to derive various prediction formulas. A model based on medical history, weight, presence of oedema, and lower blood pressure had an AUC of 0.77. Addition of use of β blockers to this model improved the AUC to 0.80. Addition of NYHA class increased the AUC to 0.84. Data on quality of life did not improve the AUC further (AUC 0.85). Conclusions: A prognostic model produced on the basis of easily obtainable information from medical history and physical examination can adequately stratify heart failure patients according to their short term risk of death. [ABSTRACT FROM AUTHOR]

Sildenafil utilization was prospectively evaluated among 1.53 men with a history of erectile dysfunction (ED)-prescription drug use prior to starting sildenafil and 164 men who were new starters of ED-prescription drugs. Further, some determinants of sildenafil discontinuation were identified. During a median follow-up period of 18 months 45% of all patients discontinued sildenafil treatment, regardless of earlier treatment history. However, patients with a history of drug treatment for ED were nearly eight times as likely to switch or re-start another EDprescription drug after discontinuing sildenafil compared to previously untreated users. Age > 60 y, diabetes medication, nitrate use, and use of incontinence pads (a proxy for disease/surgery in the pelvic region) were associated with an increased likelihood of discontinuing sildenafil. Although the introduction of sildenafil reduced the barrier to seek medical help for erectile problems, sildenafil treatment failure in previously untreated patients results in a high dropout rate from further ED drug treatment of any kind. [ABSTRACT FROM AUTHOR]

Discusses the use of spontaneous reports of adverse events to estimate the risk for developing cardiac arrhythmias due to the systemic use of nonsedating antihistamine drugs in the Netherlands. Risk estimate before and after the regulatory action to recall the over-the-counter status of some of these drugs; Indication that nonsedating antihistamines might have an increased risk for inducing arrhythmias.

Objective: During proton pump inhibitor (PPI) use, in clinical trials, headache is one of the most frequently reported adverse events (frequency 1.3 to 8.8%), while results of one observational study indicate that headache is the fifth most frequently reported adverse event (incidence densities 2.5 to 4.6 per 1000 patient-months of exposure). However, there are no observational studies performed regarding the occurrence and features of headache during use of PPIs in daily practice. For this reason this study was set up with the aim to assess the incidence and characteristics of headache and to investigate possible associated co-factors in PPI users in daily practice.Design: Data were used from a prospective, observational study in which 10 008 lansoprazole users were followed over time. The study was designed according to the Safety Assessment of Marketed Medicines guidelines. A nested case-control design was used to compare PPI users reporting headache or not.Results: The frequency of headache was 2.5% in users of lansoprazole and the incidence density was 7.2 per 1000 patient-months of PPI lansoprazole use. Two-thirds of patients with headache had tension headache and one-third had migraine. The analysis of co-factors revealed that women, patients with previous use of analgesics and patients reporting several adverse events, were at risk to develop headache during PPI use. Patients with headache also, significantly more often, reported diarrhoea, nausea and dizziness. A discontinuation of PPI therapy resulted in a cessation or reduction of the headache in 80.0% (20 of 25).Conclusions: As can be expected, headache was reported less frequently in this study compared with clinical trials with lansoprazole. The incidence density was comparable with other observational data of lansoprazole and omeprazole users. Besides several commonly accepted co-factors such as female gender and a history of analgesic use, we also found the reporting of other adverse events to be associated with the reporting of headache during lansoprazole use. The cessation of headache after a discontinuation of use of the PPI and the observed dose relationship suggested that headache was indeed an adverse effect of lansoprazole use. [ABSTRACT FROM AUTHOR]

Aims The aim of the present study was to investigate whether use of specific antibiotic drugs decreases the risk of coronary heart disease in diabetes mellitus type 2 patients.Methods and Results Data were obtained from the PHARMO Record Linkage System comprising pharmacy records and hospitalizations for all 450000 residents of eight Dutch cities. In a nested case-control study among diabetes mellitus type 2 patients, 244 cases with a first hospitalization for coronary heart disease and 686 controls without coronary heart disease matched on age, sex, calendar time, and registration date in PHARMO RLS were selected. Use of antibiotic drugs among cases and controls was determined over 3 years prior to the event. Use of fluorquinolones for more than 14 days compared to no use of fluorquinolones was associated with a lower risk of coronary heart diseases (ORadj=0·30 (95%CI: 0·12–0·75)). No association between tetracycline, macrolide and lincosamide treatment, or other antibiotic drugs (penicillins, cephalosporines, sulphonamides and trimethoprim), and the risk of coronary heart disease was found.Conclusion Our results suggest that treatment with fluorquinolones in doses commonly prescribed in routine clinical practice is associated with a reduction in the risk of coronary heart diseases among diabetes mellitus type 2 patients. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved. [ABSTRACT FROM PUBLISHER]

Background: Proton pump inhibitors (PPI) demonstrate high healing rates of 85 98% in clinical trials. Due to the limited knowledge regarding response and non response to lansoprazole in daily practice and for the reason that resistance to PPIs is scarce, we investigated factors possibly associated with non response. Methods: Data were used from a prospective, open label, observational follow up study in which 10,008 lansoprazole users were followed over time. The study was designed according to the SAMM guidelines. A matched nested case control design was used to compare non responding (cases) and responding (controls) lansoprazole users. Non response was defined as worsening or non improvement of symptoms at the first evaluation after at least 8 weeks of use, response as disappearance or improvement of symptoms within 8 weeks of use. Controls were matched for the evaluating physician. Results: A total of 186 non responders and 372 responders to PPI treatment were identified as cases and controls. Age of over 60 years, heavy smoking and previous use of PPIs were significantly more common in non responding patients compared with responding patients. There were no differences found between the reported diagnosis regarding response. Conclusion: In daily clinical practice, previous use of PPIs, heavy smoking and an age > 60 years were significantly associated with non response to treatment with lansoprazole. Previous use of PPIs in non responding patients might suggest resistance to PPIs. The knowledge that non response drives non response may encourage physicians to follow PPI users with previous PPI use more closely. [ABSTRACT FROM AUTHOR]

Aim of study: The role of pharmacists in today's healthcare is changing rapidly. As they are close to the prescribing process, pharmacists are in the position to identify and adjust prescribing errors before dispensing. The objective of this study was to identify relevant determinants of interventions directly linked to prescription processing in community pharmacy. Methods: As part of a yearly continuing education programme, all community pharmacies in the region of 'Zeeland' (N=23) in the south west of The Netherlands kept detailed records of all interventions directly linked to prescription processing during one week in May 1998. For every patient involved in an intervention, a control patient was matched on pharmacy practice, date, gender and age. Results: A total of 39,357 prescriptions were evaluated by the 23 pharmacies during the one week intervention programme. Out of these, one out of 10 resulted into an intervention. Being a first prescription in a new treatment episode was found to be a significant determinant (OR 1.75, 95 CI% 1.18 2.33). Variables reflecting drug therapy complexity (> 3 prescribers, > 15 prescriptions in 3 months before, > 3 different medications) showed all ORs higher than 1.00, but not significant. When looking at the individual drug categories, anti infectives, respiratory drugs and cardiovascular medicines came out as important drug classes for intervention risk. We could not find any association between the number of signals per pharmacy and the number of interventions. Conclusion: The 'whistle blower' model of pharmacy based interventions is a valid one but needs a targeted and integral way of implemented thinking and use of information technology. In such an environment, interventions are a logical step of in process quality control in the drug usage system. [ABSTRACT FROM AUTHOR]

Introduction: Shortly after their introduction, fluoroquinolones were associated with reports of tendinitis and tendon rupture. During the past years, the number of reports has risen, possibly because of an increased use of fluoroquinolones. In this study, we describe the use of fluoroquinolones in the Dutch community and the possible public health effects of an association between fluoroquinolone use and tendon ruptures. Methods: In the PHARMO drug database we identified all prescriptions for fluoroquinolones in the period 1991 1996. The incidence of fluoroquinolone use was expressed as the number of fluoroquinolone episodes per 1000 inhabitants in one year, and extrapolated to the Dutch population after standardisation on age and gender. The annual incidence of non traumatic tendon ruptures in the period 1991 1996 was calculated with data from the nation wide hospital registry. The expected number of fluoroquinolone attributable tendon ruptures was calculated on the basis of the use of fluoroquinolones, the number of non traumatic tendon ruptures and an assumed relative risk of 1.5 10. Results: In 1996, approximately 251,000 patients experienced 318,000 episodes of fluoroquinolone use in the Netherlands. Females used more often fluoroquinolones than males, and the number of episodes increased exponentially with age. In the period 1991 through 1996, the absolute number of fluoroquinolone episodes increased by 160%, from 122,000 to 318,000. The absolute number of hospitalised tendon ruptures increased with 28%, from 768 in 1991 to 984 in 1996. Assuming a relative risk of 1.5 to 10.0, 1 to 15 tendon ruptures could be attributed to fluoroquinolone use in 1996. Only 7 % of the observed increase could be attributed to the increased use of fluoroquinolones. If the total increase of hospitalised non traumatic tendon ruptures would be attributable to the increase in fluoroquinolone use, this would mean that the risk of non traumatic tendon ruptures to fluoroquinolones would be more than 250 times the risk during non use. Conclusion: In the Netherlands, a large simultaneous increase in non traumatic tendon ruptures and fluoroquinolone use was observed in the period between 1991 to 1996. Assuming a relative risk of 1.5 to 10.0 for tendon ruptures during fluoroquinolone use, only 0.5 to 7% of the increase in non traumatic tendon ruptures could be attributed to the increased fluoroquinolone use. The increase in the incidence of non traumatic hospitalised tendon ruptures in the Netherlands is not likely to be explained solely by the increased use of fluoroquinolones. [ABSTRACT FROM AUTHOR]

Objective To identify a Dutch cohort of sildenafil users and describe their baseline characteristics. Patients and methods Each pharmacy in The Netherlands (n = 1571) was asked to identify prospectively the first 20 sildenafil prescriptions in their pharmacy over 1 year, and to complete and return a registration form. The collected data included patient characteristics, the details of the sildenafil prescription (date, prescriber, number of prescriptions, dosing), and the use of co-medication by the patient in the year preceding the sildenafil prescription. Results Data were collected from 4460 sildenafil prescriptions during the year under study, relating to 3477 individual patients. Most of the cohort had cardiovascular morbidity or diabetes. Sildenafil seems to have been used by a new, previously untreated population of patients with erectile dysfunction. In addition, 69 men were identified who could have been using nitrates and sildenafil concomitantly. Conclusion A cohort of patients using sildenafil was identified and characterized; they appeared to be representative of sildenafil users in The Netherlands. This cohort will be followed prospectively to evaluate the medical status (particularly cardiovascular) of the patients with time. [ABSTRACT FROM AUTHOR]

Objective: To investigate differences in attitudes, knowledge and actual use of economic evaluations in different groups of decision-makers, and to compare the results from the Netherlands with the overall European results of the European Network on Methodology and Application of Economic Evaluation Techniques (EUROMET) project.Design and Setting: Members of the EUROMET group conducted interviews and surveys with politicians, regulators, hospital pharmacists and physicians in The Netherlands. Three approaches of investigation could be adopted: (i) a postal questionnaire survey, (ii) semi-structured interviews, and (iii) a focus-group approach.Main Outcome Measures and Results: In the Netherlands, decision-makers generally have a positive attitude towards economic evaluations. Nevertheless, their actual use and knowledge of economic evaluations are still limited. Hospital pharmacists and regulators are more objective than physicians and politicians, who also base their judgements on other societal values. Hospital pharmacists and regulators have a greater knowledge of economic evaluations, and they use them more often than the other groups. Most decision-makers do not want to base their decisions strictly on a cost-effectiveness ranking alone. Our findings were similar to the findings in other European countries.Conclusions: Decision-makers prefer to make their own broad comparisons of advantages and disadvantages, and do not base their decisions solely on a single summary measure. [ABSTRACT FROM AUTHOR]

Adverse drug events in hospitalized patients lead to increased morbidity, mortality and costs. Early detection of adverse drug events could aid in the prevention of these adverse outcomes. A cost effective system for the early detection of adverse drug events should focus on high risk patients. A study was set up with the primary aim to identify characteristics that are associated with the development of adverse drug events (ADEs) in hospitalized patients.ADE reports were gathered from physicians and nurses (spontaneous reports) and from patients after intensive ward interviews by hospital pharmacists. All patients admitted to the internal medicine wards of two Dutch hospitals, during a two month period, were included.The following characteristics were analyzed for their potential relationship to the occurence of ADEs: age (categorized), gender, number of drugs prescribed during hospital stay, types of drugs used and changes in drug use on admission.Age was found to be inversely associated with the development of ADEs (OR 0.36, CI 0.21 0.61 for age category > 80 years; OR 0.56; CI 0.31 1.02 for age category 75 80 years and OR 0.69; CI 0.42 1.11 for age category 60 74 years). Furthermore, statistically significant associations were found for the number of drugs prescribed per hospitalized patient (for the class of 4 6 drugs per patient OR 2.61, CI 1.32 5.18), for newly prescribed drugs (OR 6.65, CI 2.63 16.81) and for the cessation of drugs on hospital admission (OR 1.50, CI 1.02 2.20). The use of gastrointestinal drugs (OR 2.13, CI 1.32 3.45), central nervous system drugs (OR 1.66, CI 1.07 2.57) and antibiotics (OR 2.44, CI 1.65 3.60) were associated with the development of ADEs, when compared to all other drugs taken by the patients.In this study, the most important risk factors are the number of drugs used per patient and the starting of a new drug during hospitalization. As most hospitalized patients start new drug therapies while in hospital, this seems an inappropriate focus. However, careful monitoring of patients using more than 7 drugs at a time may be possible in a cost effective system for the early detection of ADEs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Patients with inflammatory bowel disease (IBD) have an increased risk of Iow bone mass, the pathogenesis of which is multifactorial. There are limited data on fracture. We therefore conducted a primary care based case-control study to determine the risk and major risk factors of fracture in IBD patients. 231 778 patients with a fracture and 231 778 age and sex matched controls were recruited from the General Practice Research Database. The database has been previously demonstrated to be a representative sample of the general population of England and Wales. Adjusted odds ratios (OR) were estimated from conditional logistic regression. The mean age of cases and controis was 51 years and 52.5% were women. A history of IBD was found in 1134 fracture cases, compared with 896 of the controls (adjusted OR 1.21; 95% CI 1.10 to 1.32). The OR was 1.72 (1.132.61) for vertebral fracture and 1.59 (1.14 to 2.23) for hip fracture. The risk of fracture was greater in patients with a history of Crohn's disease (OR 1.32 (1.13-1.53)) than in patients with ulcerative colitis (OR 1.13 (1.02-1.27)). The risk of fracture in patients with a history of IBD was significantly related to disease severity as assessed by the number of symptoms (OR in IBD patients without symptoms, 1.02 (090-1.17) 1 symptom, 1.66 (1.41-1.96); and ≥2 symptoms, 1.74 (1.43-12.12)). Similarly, severity assessed by medication demonstrated increasing fracture risks compared with untreated patients: aminosalicylates use 1.32 (1.14-1.54), oral corticosteroids 1.46 (1.18-1.82), and steroid sparing agents 1.86 (1.15-3.02). IBD patients with a history of bowel surgery did not have an increased risk of fracture (OR 1.03 (0.84-1.28)). Use of oral corticosteroids increased with severity of disease; after adjustment for oral corticosteroid use the risk of hip fracture remained elevated (OR 1.46 (1.04-2.04)). In conclusion, IBD patients have a higher risk of fractures, which is due to a combination of disease activity... [ABSTRACT FROM AUTHOR]

Examines the effects of antihypertensive drug therapies on plasma lipid levels. Treatment of hypertensive; Cholesterol levels of antihypertensive; Prevalence of hypertension in women.

The main objective of this study was to evaluate the risk of renal toxicity in patients using aminosalicylates 5-ASA). The medico records of GPs in the UK (from the Genera Practice Research Database) were used to estimate the incidence rates of renal toxicity of adult patients with either a record of inflammatory bowel disease (IBD) or prescription for 5-ASA (eg mesalazine or sulfasalazine) and that of control patients. Each case of renal toxicity was subsequently matched by age, sex, practice, and calendar time to one patient without renal toxicity. 37 984 adult patients with a record of BD or 5-ASA prescription and a similar number of control patients were included n the patients without a history of arthropathy we found that IBD patients using 5-ASA had an increased risk of renal toxicity: the overall incidence was about 1 case per 1000 person-years of treatment (double compared to non-users). The case control analysis revealed the risk of renal disease was related to indicators of IBD severity. It was also increased in current and recent users (ie their last prescription in the 3 to 12 months before the index date of 5-ASA. Compared to non-users, the odds ratio (OR for renal events was 1.80 (95% CI 1.22 to 2.60) in current 5-ASA users. This excess risk markedly reduced in current users after adjustment for concomitant disease and drug use (adjusted OR 1.22 [0.69-2.16]). For recent users, the crude OR was 3.96 (2.20-7.13) and adjusted OR 2.80 (1.33-5.91). Users of mesalazine and sulfasalazine had comparable risks (crude ORs 1.66 [0.94-2.96] and 1.93 [1.18-3.14], and adjusted ORs 1.05 [0.472.31] and 1.34 [0.68-2.62], respectively). There was no relationship between 5-ASA dose and risk of renal disease. Numbers were too small to compare individual 5-ASA compounds. Users of 5-ASA hod an increased risk of renal disease which may be influenced by the underlying disease severity. There were no differences in risk of renal disease between mesalazine and sulfasalazine. [ABSTRACT FROM AUTHOR]

Evaluates whether adverse drug reactions (ADR) to selective serotonin reuptake inhibitors (SSRI) were associated with extrapyramidal syndrome in the Netherlands. Calculation of ADR reporting odds ratios; Other drugs associated with extrapyramidal syndrome; Risk of extrapyramidal syndrome on patients under SSRI and other antidepressant drugs.