BackgroundThe use of nephrotoxic drugs can further worsening renal function in chronic kidney disease (CKD) patients. It is therefore imperative to explore prescribing practices that can negatively affect CKD patients.AimTo analyze the use of nephrotoxic drugs in CKD patients in a general population of Southern Italy during the years 2006–2011.MethodsThe general practice “Arianna” database contains data from 158,510 persons, registered with 123 general practitioners (GPs) of Caserta. CKD patients were identified searching: CKD-related ICD-9 CM codes among causes of hospitalization; CKD-relevant procedures undergone in hospital (e.g. dialysis); drug prescriptions issued for a CKD-related indication. A list of nephrotoxic drugs was compiled and validated by pharmacologists and nephrologists. The summary of product characteristics was used to classify drugs as ‘contraindicated’ or ‘to be used with caution’ in renal diseases. Frequency of nephrotoxic drug use, overall, by drug class and single compounds, by GPs within one year prior or after first CKD diagnosis and within one year after dialysis entry was calculated.ResultsOverall, 1,989 CKD patients and 112 dialysed patients were identified. Among CKD patients, 49.8% and 45.2% received at least one prescription for a contraindicated nephrotoxic drug within one year prior or after first CKD diagnosis, respectively. In detail, 1,119 CKD patients (56.3%) had at least one nonsteroidal anti-inflammatory drugs (NSAIDs) prescription between CKD diagnosis and end of follow-up. A large proportion of CKD patients (35.6%) were treated with NSAIDs for periods exceeding 90 days. Contraindicated nephrotoxic drugs were used commonly in CKD, with nimesulide (16.6%) and diclofenac (11.0%) being most frequently used.ConclusionsContraindicated nephrotoxic drugs were highly prescribed in CKD patients from a general population of Southern Italy. CKD diagnosis did not seem to reduce significantly the prescription of nephrotoxic drugs, which may increase the risk of preventable renal function deterioration.

PurposeTo explore the prescription patterns of erythropoiesis-stimulating agents (ESAs) in four large Italian geographic areas, where different health policy interventions to promote biosimilar use in routine care are undertaken.MethodsA retrospective drug utilization study was conducted during the years 2009–2013. The data sources were the administrative databases of the Tuscany region and of the Caserta, Palermo, and Treviso Local Health Units (LHUs). The characteristics, prevalence, and switching patterns of different ESAs (biosimilars and reference products), stratified by indication for use, were calculated over time and across centers.ResultsOverall, 49,491 patients were treated with ESAs during the years 2009–2013 in the four centers. Of these, 41,286 patients (83.4 %) were naive users. The prevalence of ESA use increased from 2.9 to 3.4 per 1000 inhabitants in the years 2009–2011 but decreased thereafter (3.0 per 1000 in 2013). Moreover, the proportion of biosimilar users increased overall from 1.8 % in 2010 to 33.6 % in 2013, with larger increase in Treviso (from 0.0 to 45.0 %) and Tuscany (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). Switching between different ESAs during the first year of therapy was frequent (17.0 %), much more toward reference products than toward biosimilars.ConclusionOverall, the prevalence of ESA use decreased slightly, while use of biosimilar ESAs, especially in naive patients, increased significantly but to different extents in these four large Italian geographic areas. Switching between different ESAs during the first year of treatment was very frequent, which may affect pharmacovigilance monitoring. New strategies are necessary to further improve market penetration of low-cost medicines, such as biosimilars, and also to harmonize effective health policy interventions that aim to reduce pharmaceutical expenses and optimize patient benefit across all regions.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-015-0132-7) contains supplementary material, which is available to authorized users.

BackgroundNon-steroidal anti-inflammatory agents (NSAIDs) are known to be associated with renal damage. No clear evidence exists regarding differential risk of chronic kidney disease (CKD), specifically, across various NSAIDs.AimThe aim of this population-based case-control study was to evaluate the association between use of individual NSAIDs and risk of CKD in a general population of Southern Italy.MethodsA nested case-control study was carried out using the general practice Arianna database, identifying incident CKD patients as cases and matched controls from 2006 to 2011. The date of first CKD diagnosis was defined as the index date (ID). Conditional logistic regressions were performed to estimate the risk of CKD associated with NSAIDs by class and individual drugs as compared to non-use during different time windows (within one year, six or three months prior to ID), with the latter being defined as current users. Among current users, the effect of cumulative exposure to these drugs was evaluated.ResultsOverall, 1,989 CKD cases and 7,906 matched controls were identified. A statistically significant increase in the risk of CKD was found for current users of oxicams (adjusted OR: 1.68; 95% CI: 1.15-2.44) and concerning individual compounds, for ketorolac (adj. OR: 2.54; 95% CI: 1.45-4.44), meloxicam (adj. OR: 1.98; 95% CI: 1.01-3.87) and piroxicam (adj. OR: 1.95; 95% CI: 1.19-3.21).ConclusionsThe risk of CKD varies across individual NSAIDs. Increased risk has been found for ketorolac, which may precipitate subclinical CKD through acute renal damage, and long-term exposure to oxicams, especially meloxicam and piroxicam.

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• In the last years there has been a growing trend in anti-epileptic drug (AED) use, particularly in elderly patients, but few data concerning indication of use are available in general practice.• Various AEDs, including newer agents, have been approved for indications other than epilepsy and are increasingly also used for unlicensed indications.• No data about the impact of re-imbursement restrictions on the choice of anti-epileptic drugs in general practice are available. WHAT THIS STUDY ADDS• In general practice, a rapid increase of AED prescriptions in the elderly was observed, principally due to the use of newer AEDs for indications other than epilepsy.• Re-imbursement restrictions influenced newer AED use, particularly pregabalin and gabapentin prescriptions.• Phenobarbital, accounting for more than 50% of total AED volume, was the most prescribed medication during the entire study period. This finding should be considered in light of the potential risks associated with phenobarbital use in the geriatric population. AIMSThe aims of the study were to assess the trend of older and newer anti-epileptic drugs (AEDs) in the elderly population and to analyze the effects of a health-policy intervention with regard to AED use in general practice in a setting in Southern Italy. METHODSData were extracted from the 'Caserta-1' Local-Health-Unit Arianna database in the years 2004-07. Patients aged over 65 years, receiving at least one AED prescription and registered in the lists of 88 general practitioners, were selected. The use of older and newer AEDs was calculated as 1 year prevalence and incidence of use and defined daily dose (DDD) per 1000 inhabitants day -1. Sub-analyses by gender, age and indication of use were performed. RESULTSMost of AED users were treated because of neuropathic pain (64.8%). However, the main indication of use for older AEDs (57.8%) was epilepsy, whereas newer AEDs (79.5%) were used for neuropathic pain. Prevalence and incidence of newer AED use increased until 2006, followed by a reduction in 2007. Newer AEDs, particularly gabapentin and pregabalin, were used in the treatment of more patients than older AEDs. However phenobarbital, accounting for more than 50% of total AED volume, was the most prescribed medication during the entire study period. CONCLUSIONSAn increasing use of AEDs has been observed during 2004-07, mostly due to the prescription of newer compounds for neuropathic pain. The fall in the use of newer AEDs during 2007 coincides with revised re-imbursement criteria for gabapentin and pregabalin. The large use of phenobarbital in the elderly should be considered in the light of a risk of adverse drug reactions.