The MBDS is a useful and accessible instrument to determine the incidence of ADR in a hospital, resulting in the notification of severe events that might otherwise not be reported. Its use also improves identification of the main drugs responsible for ADR and of the patient populations at greatest risk, facilitating the implementation of alert systems and the development of prevention and detection strategies.
Myelosuppression secondary to chemotherapy remains a serious adverse effect of cancer therapy that causes high morbidity and mortality. Several current European and American guidelines recommend consideration of primary prophylaxis with colony-stimulating factors (CSFs) when the risk of febrile neutropenia is higher than 20 %. The main factors associated with a high risk of febrile neutropenia include the chemotherapy regimen, tumor type, and patient-related factors such as old age and/or comorbidities. The purpose of this paper is to summarize the most relevant clinical trials and updated recommendations of the main guidelines on the role of granulocyte colony-stimulating factors (G-CSFs) in febrile neutropenia, examining whether the combination of G-CSF with chemotherapy improves overall survival. Future directions for G-CSF use are also discussed.
registers compiled and updated on the AIFA (Italian Drugs Agency) web monitoring platform. Patient data such as age, sex, smoking, diabetes, hypertension and adherence were extracted and processed using Microsoft Access. In the same way, lipid ratios were calculated, and factors and percentage cardiovascular risk at 10 years were calculated using the Framingham Heart Study algorithm. Results Average age was 63 years and 68% were men. About 60% of 120 patients had arterial hypertension and 22% had diabetes mellitus. Concomitant therapy with statins (evolocumab-alirocumab) was present in 42% and 56% of patients, respectively, while intolerance was found in 52% and 47% of cases, respectively. Adherence to therapy was 100%. LDL and triglyceride concentrations decreased (LDL À60%) while HDL values remained constant over the study period. The percentage risk of a 10 year cardiovascular event was reduced from about 35% to 15% in 6 months and remained stable at 12 months. Conclusion and relevance The results confirmed a reduction in LDL cholesterol levels. These drugs represent treatment for patients subject to therapeutic failure. Alirocumab and evolocumab are innovative drugs with high costs. Their use should be limited to patient categories who have no real feedback with conventional drugs used in hypercholesterolaemia.
Background Chronic myeloid leukaemia (CML) is a myeloproliferative disorder associated with the Philadelphia chromosome resulting in the BCR-ABL fusion gene. This produces a continued proliferative signal resulting in the clinical manifestations of CML. Purpose To analyse the use of tyrosine kinase inhibitors (TKIs) in CML patients, and their safety profile. Materials and methods Descriptive observational study in a third level hospital. We included patients who were under treatment with TKIs at the time of the data collection (September 2013). Data was compiled through the electronic prescription program (APD Prisma). Variables included demographics (age, sex); clinical data (age at diagnosis, time since diagnosis, treatment) and adverse reactions (ADRs). Data were obtained from medical records. Results We analysed 54 patients who picked up TKIs in a pharmacy service at the time of data collection. Fifty percent (n = 27) were male, with a mean age of 58.0 (8.83). Mean time since diagnosis was 7.1 years (1.26). 67% of the patients (n = 37) received imatinib, 21.8% (n = 12) nilotinib, and 10.9% (n = 6) dasatinib. More than 66% of patients receiving second generation TKIs were on second-line treatment after imatinib, the remaining 33% were first-line. ADRs for imatinib included: 10 patients with oedema (8 relating to the eyelids), 8 musculoskeletal pain and cramps, 4 asthenia, 2 skin rash, 1 pleural effusion, and 4 other. ADRs for nilotinib: 2 patients with oedema, 2 irritability, and 5 other. ADRs for dasatinib: 1 fatigue and 1 muscle pain. ADRs were not reported in 34 patients. Conclusions Clinical practice in our hospital is consistent with the Summary of Product Characteristics. All the ADRs reported are included as very common (>1/10) in the above-mentioned summary. Only 11% of CML patients are initially treated with second generation TKIs. Although this approach has gradually increased in our hospital, there are not enough cases of CML patients treated with nilotinib and dasatinib to draw definitive conclusions. No conflict of interest.
BackgroundIn Spain, a therapeutic positioning report (TPR) for sacubitril valsartan indicates its use in adult patients for the treatment of symptomatic chronic heart failure and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤35%), elevated B-type natriuretic peptid (BNP) seric levels and patients previously treated well with standard of care therapy (ACE inhibitors/ARBs, beta-blockers, mineralcorticoid antagonists and diuretics).PurposeTo evaluate the suitability of sacubitril valsartan prescriptions to the recommendations in a health management area.Material and methodsRetrospective descriptive study including patients treated with sacubitril valsartan from September 2016 until July 2017.Variables considered were: sex, age, treatment with ACE inhibitors/ARBs, beta-blockers, mineralcorticoid antagonists and/or diuretics, dosage regimen, contraindications or intolerance to standard therapy, LVEF previous to sacubitril valsartan, dose escalation, dose reduction, discontinuation and cause of discontinuation.To evaluate the suitability of the prescriptions we analysed: intolerance/contraindications to standard therapy, therapy before change, dosage regimen, dose tritation and LEVF ≤35%. Audit data were sent to their prescriptors to review.For data compilation we used the Microstrategy® prescription database and medical records.ResultsFifty-three patients started treatment with sacubitril valsartan in the cited period. Median age was 66.6 years: 83% (n=44) were men.According to previous standard care received: seven patients (13.2%) had not received ACE inhibitors/ARBs and only six patients (11.3%) received optimal doses of these.As for beta-blockers, nine patients (16.98%) had not received them and only five patients (9.4%) had received the optimal dose. Regarding mineralcorticoid antagonist, 14 patients had not received them (26.4%) and three patients received the optimal dose. LVEF was >35% in 16 patients.Overall, none of our patients met all the predetermined conditions in the TPR. No intolerance or contraindication to standard therapy was notified.A correct dose tritation or appropiate periodic examination was made in only 16 patients (30%).During the considered period, one patient received a reduced dose for hypotension and 10 patients discontinued treatment: four lack of indication, one economic conditions, one death, two hypotension and one cardiac transplantation.ConclusionThe results show an inadequate use of sacubitril valsartan according to TPR indications in most cases. With this analysis we intend to improve sacubitril valsartan use in our reference area. Audits are an effective method to improve the rational use of medicines.No conflict of interest
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