BackgroundThe increase in elderly patients with comorbilities who are treated with direct-acting oral anticoagulants (DOACs) makes necessary an individualised pharmacotherapy follow-up during hospitalisation.PurposeOur objective is to describe the causes of pharmaceutical interventions related to DOACs and to determite the acceptance of these interventions by physicians.Material and methodsDescriptive observational study of all patients with a DOAC prescription admitted in internal medicine from the Emergency Department (January to May 2017) and descriptive analysis of pharmaceutical interventions related to DOACs. These interventions were done through a message in the electronic prescription program. Data sources: electronic medical records and electronic prescription program. Collected data: demographic and clinical variables, laboratory data and concomitant treatments.ResultsA total of 78 patients with nonvalvular atrial fibrillation treated with DOACs were included in the study, who had had 107 episodes of hospitalisation. Mean age: 79 years (54–93), 55% male. The average of chronic concomitant medications prescribed before admission was 8.8 medications (2–16). Patients were treated with apixaban (49%), rivaroxaban (37%) and dabigatran(14%). Pharmaceutical interventions were done in 49 patients to adapt anticoagulant therapy to acute episodes: 31 recommendations of DOACs’ dose reduction (52% accepted) and 18 recommendations of DOAC suspension (100% accepted). The most common cause of DOACs’ dose reduction recommendation was renal failure, followed by advanced age, active bleeding or high risk of bleeding, drug interaction and, finally, low bodyweight. Among recommendations of DOACs’ suspension, acute renal failure was the main cause, followed by active bleeding or high risk of bleeding, drug interaction, duplication of anticoagulants and liver failure. In addition, a total of 17 concomitant treatments were stopped during the study period because of the potential interactions with DOACs: benzodiazepins (eight), antiplaquet drugs (five) and others (four).ConclusionActive surveillance is needed during the acute episodes in patients treated with DOACs. Impaired renal function, advanced age, active bleeding, pharmacodynamic and pharmacokinetic interactions, liver failure and low bodyweight are causes of overexposure to DOACs. Pharmaceutical interventions have a high rate of acceptance by physicians and can prevent adverse events.References and/or Acknowledgements2016 ESC Guidelines for the management of atrial fibrillation.No conflict of interest
BackgroundLung cancer is the most common cancer worldwide as well as the leading cause of cancer-related deaths. Non-small cell lung cancer (NSCLC) accounts for up to 85% of all lung cancers. Multiple advances in the staging, diagnostic procedures and therapeutic options, as well as molecular knowledge have been achieved during the past years, although the overall outlook has not greatly changed for the majority of patients with the overall 5 year survival. Patients diagnosed with stage 4 NSCLC have poor survival rates (median 9–12 months).PurposeTo analyse and describe the clinical case of a long-term survival lung cancer patient.Material and methodsObservational retrospective clinical case. Data were obtained by review of the electronic medical records.ResultsA 46-years-old female followed by the oncology service for an advanced NSCLC anaplastic lymphoma kinase (ALK) positive EGFR wild-type. She received as first-line treatment crizotinib (250 mg, twice daily) from May 2013 until July 2015, when it was stopped by the disease’s progression, which was determined by imaging test. Crizotinib was well tolerated, and delays or interruptions were not necessary. In August 2015, she was involved in a clinical trial beginning treatment with AP26113 (brigatinib) 90 mg/24 hours 7 days and continuation with 180 mg/24 hours until June 2017, when it was interrupted by clinical progression. During this period, the drug was discontinued due to pneumonitis grade 1 (1–28 October 2015). She started treatment with lorlatinib (one daily 100 mg) until August 2017. In this period she suffered nail loss grade 1–2, with haemiparesis worsening and dysarthria increasing. In August, alectinib was authorised as a new line of treatment (fourth line). Currently, she continues with this treatment, presenting only dysgeusia grade 1.ConclusionActivating gene rearrangements in ALK have been identified as driver mutations in approximately 2% to 7% of patients with NSCLC. Although crizotinib is an effective treatment, some patients have a relatively short duration of response, and other patients fail to achieve a response. It is important to develop therapies that potentially can provide significant improvement in terms of treatment in ALK positive patients. In the case of this patient, there is a clear benefit of this type of therapy.Reference and/or Acknowledgements1. Clin Transl Oncol2015;17:1020–1029.No conflict of interest
BackgroundIpilimumab is a cytotoxic T lymphocyte antigen 4 (CTLA-4) blocking monoclonal antibody indicated for the treatment of unresectable or metastatic melanoma. In phase III studies, ipilimumab has been shown to increase overall survival by 3.6 months, progression free survival (PFS) by 2.7 months with a response rate of 9.5% with the induction dosing regimen: intravenous administration 3 mg/kg every 3 weeks, for a total of 4 applications.PurposeTo describe the demographic characteristics, efficiency in terms of response, PFS and toxicity of Ipilimumab in a third level hospital.Material and methodsRetrospective review of 100% of medical charts of patients diagnosed with metastatic melanoma and treated with ipilimumab from January to September 2015.Results8 medical charts were reviewed. 75% of patients were women and the average age was 62 years (range 49–75 years). 100% of patients had an ECOG performance status 0–1. 100% of patients had received prior systemic therapy with fotemustine. 1 patient did not complete the four course of ipilimumab due to progression of disease after the third dose. Efficacy data: 1 partial responder (response rate 12.5%), 2 stable disease and 5 cases of disease progression. In the 5 patients with disease progression, median PFS was 2.9 months (range 68–96 days). All patients had toxicity to ipilimumab but in no case was it necessary to delay/discontinue the treatment. Registered adverse effects were grade I or II: diarrhoea (3 patients), headache (2 patients), impaired vision (2 patients), pruritus (1 patient), oedema (1 patient), pain costal (1 patient) and epigastritis (1 patient).ConclusionPFS and the response rate in patients receiving ipilimumab in our hospital were significantly higher than those obtained in the pivotal trial. Ipilimumab is a well tolerated drug. It is essential to measure the results and health of novel and expensive drugs to rationalise their use and optimise efficiency in the oncology area.References and/or AcknowledgementsUS Food and Drug Administration. Medication Guides. Yervoy. Silver Spring, MD. 2011. )European Medicines Agency. Yervoy EPAR Product Information. EMA/H/C/002213/2011. Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711-23. (Clinicaltrials.gov Identifier: NCT00094653)No conflict of interest.
BackgroundThe availability of biosimilar infliximab (IFX) has been postulated to offer cost savings compared with innovator IFX, which could lead to patients being switched between drugs.PurposeTo analyse demographic characteristics and pathologies of patients treated with IFX and to evaluate the cost effectiveness of switching from innovator to biosimilar drug.Material and methodsThis was an observational, retrospective, 6 month study. Sample: 100% adult patients treated with IFX, which was prepared in the pharmacy service. Data sources: electronic medical records (IANUS), pharmaceutical application (SIMON) and management application (SINFHOS). Analysed data: number of intravenous mixtures prepared, number of patients, age, sex, weight, diagnosis, treatment received, dosage and cost of treatment.Results616 intravenous mixtures were prepared during the 6 months for 189 patients included in the study (70.5% innovator IFX and 29.5% biosimilar IFX). 131 patients received innovator IFX. Average age: 47.3 years (12–83), average weight 71.7 kg (48–132 kg), 68 women (51.9%). Diagnoses: A. Crohn’s disease, 31; B. ulcerative colitis, 27; C: psoriatic arthritis, 25; D. rheumatoid arthritis, 23; E. ankylosing spondylitis, 18; F. psoriasis. 2; other, 5. 81 patients were treated with doses of 5 mg/kg and 50 patients with 3 mg/kg. 58 patients received biosimilar IFX. Average age: 42.5 years (8–72), average weight 65.8 kg (23–160 kg), 32 women (55.2%). Diagnoses: A. ulcerative colitis, 14; B. psoriatic arthritis, 11; C. Crohn’s disease, 11; D. rheumatoid arthritis, 7; E. ankylosing spondylitis, 6; F. psoriasis, 1; other, 8. 36 patients were treated with doses of 5 mg/kg and 22 patients with 3 mg/kg. In the 6 month study, innovative drug consumption cost €508 297.20 while consumption of biosimilar drug was €177 923.20 (total expenditure: €686 505.4). If all patients were treated with the biosimilar drug, the total expenditure would be €609 190.4, assuming an estimated annual saving of €144 024.ConclusionBiosimilar drugs are a good alternative compared with innovator drugs due to the saving which can be obtained with their use. A close follow-up of patients treated with biosimilar IFX would be very important to evaluate long term efficacy and safety of the treatment.References and/or acknowledgementsBrodszky V. Budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis. Eur J Health Econ2014.No conflict of interest
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