Background Clofarabine is a recently marketed drug used in paediatric patients with refractory acute lymphoblastic leukaemia (ALL) after at least two prior chemotherapy regimens. Its safety and effectiveness have not been evaluated in adults. Purpose To evaluate the effectiveness and safety of clofarabine in adult and paediatric patients in a tertiary hospital and compare the results between the two populations. Materials and methods Retrospective and descriptive study. Inclusion criteria: all patients treated with clofarabine in the hospital. Data collected from clinical history and pharmacy database: patient age, diagnosis, prior relapses and number of cycles of clofarabine received. Efficacy variables: disease remission (complete/partial) and the need for transplantation. Safety variables: all serious adverse reactions observed. Results 16 patients were included: 10 adults and 6 children. Mean age was 33.4 (18–63) and 8 (3.7–13.5) years old, respectively. Diagnoses were ALL (10 patients), acute myelogenous leukaemia (5) and lymphoblastic lymphoma (1). 2 (12.5%) patients received 2 cycles and the rest (87.5%) 1 cycle, all after the second relapse. A complete response was attained in 33.3% of adults and 50% of children. 10% of adults had a partial response and 40% of adults and 33.3% children didn’t respond. 56.25% of patients needed subsequent transplantation. The most significant adverse reactions in children were post-chemotherapy pancytopenia with infections (66.67%) and fulminant hepatic failure (16.67%). In adults pancytopenia (100%), bacteraemia, sepsis and severe infections (70%), hepatotoxicity (40%), central venous thrombosis (20%), severe gastrointestinal toxicity (20%), grade 4 mucositis (10%) and tumour lysis syndrome (10%) were observed. 13 patients died at the end point. 2 adults and 1 child died immediately after clofarabine treatment (due to post-chemotherapy hypovolaemic shock, tumour lysis syndrome and fulminant hepatic failure, respectively). Conclusions Clofarabine effectiveness is low and bears a high risk of severe adverse effects in adults (especially infectious diseases or liver toxicity). In paediatric patients, clofarabine is more effective and better tolerated. No conflict of interest.
Background Since pemetrexed was marketed for the treatment of non-squamous non-small cell lung cancer (NSCLC), several patients have been treated with the combination of platinum-pemetrexed instead of other cytotoxic regimens, which is much more expensive, although its efficacy is unknown. CPC098 table 1Anthropometric characteristics Sex Performance status (%) Chemotherapy Male (%) Female (%) Age (mean) 0-1 2-3 Total Pt-Paclitaxel 68.2 31.8 61 75 25 22 Pt-Pemetrexed 63.2 36.8 62 75 25 19 Pt-Vinorelbine 45.5 54.5 55 90 10 11 Other 57.1 42.9 66 43 57 7 Purpose To describe the treatment of patients diagnosed with non-squamous NSCLC over time and to explore the differences in efficacy. Materials and methods Observational study of all the patients treated in a university hospital for metastatic non-squamous NSCLC during the period 1 July 2008 to 30 June 2010. Clinical and anthropometric data were collected from medical history records, treatment data were collected from pharmacy records. Efficacy was measured as overall survival, measured as the difference between the date of diagnosis and date of death. Results 59 patients were treated during the study period for metastatic non-squamous NSCLC. The most frequent regimens were platinum-paclitaxel (22), platinum-pemetrexed (19) and platinum-vinorelbine (11). 7 patients received other different chemotherapy regimens. Anthropometric characteristics were similar between the two first groups (table 1). In the second six months of 2008 the most frequently-prescribed regimen was the combination of platinum-paclitaxel. During the first six months of 2009, the combination platinum-pemetrexed became the most frequently prescribed regimen, at the expense of the previous. During the second six months of 2009 and the first six months of 2010 these combinations were used approximately equally often. During these periods overall survival was similar, between 9.5 and 11.7 months, with a total of 10 censored data (Fig 1). Median overall survival times for each regimen were: platinum-paclitaxel 9 months, platinum-pemetrexed 10.1 months, platinum-vinorelbine 16.8 months, other regimens 9 months. Conclusions Most patients with non-squamous NSCLC were treated over these 2.5 years with two different regimens: platinum-paclitaxel and platinum-pemetrexed, with similar results in overall survival. Studies should be performed to demonstrate if the quality of life is worth the price difference.
Background The principles of deprescribing (the process of tapering, withdrawing, discontinuing or stopping medicines) arise from appropriateness methods (Beers and STOPP criteria). They include reviewing all current medicines and identifying medicines to be withdrawn, substituted or reduced. Considering the high pill burden for patients with several comorbidities, such patients might benefit from a systematic approach to deprescribing. Purpose To identify the available evidence about deprescribing strategies in the elderly and/or patients with several chronic conditions and, if applicable, assess its efficacy. Materials and methods Systematic review of studies published from 1967–2013 in MEDLINE and EMBASE. Eligible studies had to report the success rate [SR] of deprescribing strategies. Success was defined as not having to modify further the withdrawn, substituted or reduced drug during the study follow-up. The search strategy included terms for deprescribing (drug withdrawal, appropriateness), study population (polypathological [PP], chronic disease, elderly) and study design (clinical trial [CT], observational study[OS]). Results Seventy-two articles were examined. Twenty of them (14 CTs, 6 OSs) fulfilled all inclusion criteria. None focused on PP patients. Several of them focused on benzodiazepines 5(30%), diuretics 2(10%) and antihypertensive drugs 2(10%). Strategies based on a full pharmacotherapy review conducted by pharmacists or physicians (5 studies) showed a 70% SR. They were based on clinical practice or explicit methods (Beers or STOPP-criteria). In contrast, the SR for single drug class strategies (15 studies) was 30%. Furthermore, the SR was higher in CTs (80%) than Oss (20%). Health outcomes were collected in all the studies but did not show a statistically significant improvement across all the intervention groups. Conclusions Currently there is no evidence of the benefit of deprescribing on PP. Interventions in patients with chronic conditions and the elderly seems more effective if a full pharmacotherapy review done by pharmacists or physicians in the context of a CT. There is no current evidence of efficacy from systematic interventions based on software programs or similar tools. No conflict of interest.
BackgroundDrugs with anticholinergic and sedative effects carry significant risks in older people. An increased incidence of falls, impaired physical function and cognitive decline has been attributed to the use of these drugs.PurposeTo estimate the Risk of Anticholinergic Effects (RAE) in patients with several conditions based on their pharmacotherapy.Material and methodsCross-sectional study of RAE in a cohort of patients included in the IMPACT project (October 2010–April 2012).Anticholinergic exposure was calculated using the Anticholinergic Risk Scale (ARS) and Anticholinergic Cognitive Burden (ACB). These are reliable lists of drugs with a measure for the anticholinergic load. Higher scores are associated with increased RAE.The age, sex and pharmacotherapy were collected for each patient. The RAE measured was defined as patients treated with at least one anticholinergic drug according to the ARS and ACB scales.ResultsEighty patients were analysed. The mean age was 78.2 ± 8.2 years, 55.0% were men and the mean number of medicines was 12.9 ± 3.5.The ACB identified 68 patients (85% of individuals) as exposed to a medicine with anticholinergic potency: 47 patients (58.7%) with ACB level of 1, 13 (16.2%) with level 2 and 8 (10.0%) with level ≥3.The ARS identified 15 patients (18.7%): 11/15 patients with ARS level of 1 and 4/15 with level 2.The most common medicines was furosemide (77.5%) with ACB level of 1, digoxin (6.25%) with ACB level of 1, metoclopramide (5%) with ARS level of 1, risperidone (5%) with a level of 1 on both scales, atenolol (3.75%) with ACB level of 1 and paroxetine (3.75%) with ACB level of 3 ACB and ARS level of 1.ConclusionA high proportion of polymedicated patients are at risk of anticholinergic adverse events due to treatment. Detection of patients with RAE can be an important strategy for optimising drug treatment in these patients.ReferenceKersten H, Wyller TB. Anticholinergic Drug Burden in Older People’s Brain – How well is it Measured? Basic Clin Pharmacol Toxicol 2014;114(2):151–221. doi: 10.1111/bcpt.12140No conflict of interest.
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