BackgroundNoPurposeTo evaluate the prescription pattern and efficacy of telaprevir (TLP) and boceprevir (BOC) in the clinical management of chronic hepatitis C (HCV) infection in a region.Material and methodsMulticentre observational cohort study of HCV patients treated with protease-inhibitor triple therapy from September 20012 to April 2014. The information extracted from electronic health records was: age, gender, comorbidity and previous experience of HCV treatment. The virological response (VR) was assessed in patients who reached 24 and 48 weeks treatment; quick virological response rate (QVR) and discontinued treatment rates were also assessed.Results124 patients were included (TLP = 82; BOC = 42), 65% were male (63.4% treated with TVR and 69% with BOC p = 0.533). There was no difference between the selection of treatment according to comorbidity, with the exception of HIV co-infected patients (total: 8.9%; TVR: 13.6% vs. BOC: 0%; p = 0.012) or with mental illness (21.2%; 27.3% vs. 10.5%; p = 0.044). The distribution of patients according to previous experience was: treatment-naïve patients (total: 41.1%; TLP: 36.6% vs. BOC: 50%; p = 0.151), null responders (18.5%; 14.6% vs. 26.2%; p = 0.117), partial responders (12.9%; 11% vs. BOC = 16.7%; p = 0.371), relapsers (26.6%; 36.6% vs. 7.1%; p = 0.0001). At week 24, 83 patients achieved VR: 62.7%; (TLP = 66.7% BOC = 55.2%; p = 0.346). QVR rates were 53.1%; (62.2% vs.50.7%; p = 0.023). According the previous treatment experience, VR were: relapsers 81.8%, treatment-naïve patients 63.8%, partial responders: 58.3% and null responders: 37.5% (p = 0.048). At week 48, 61 patients achieved VR or 57.4% (TLP: 62.2% vs. BOC: 50%; p = 0.348). Discontinuation rate was 13.6% (TLP: 20% vs. BOC: 3.8%, p = 0.062).ConclusionTLP was the preferred treatment in HIV co-infected patients, mentally ill patients or relapsers. The statistical trend shows higher efficacy and discontinued treatment rate with TLP, but the differences are statistically irrelevant. Both drugs showed worse results in clinical management than reported in clinical trials.References and/or acknowledgementsNo conflict of interest.
and 72.4% and 37.8% in those receiving galcanezumab. Their clinical trials showed an MMD reduction of !50% and !75% in 39.9% and 17.0% with erenumab and 62.3% and 38.8% with galcanezumab.Comparing both treatments with their clinical trials, erenumab gets better results in the real world, although both treatments get similar results as in clinical trials with a reduction of 75%. Confronted with both treatments, galcanezumab has better results in real life, reducing MMD in !50% (72.4% vs 58.3%). Conclusion and relevanceErenumab and galcanezumab seem to achieve better results in real patients, but galcanezumab appears better than erenumab, although both treatments are better than their clinical trials. Facing them, galcanezumab seems to achieve a better response, so further studies are required to check this observation out.These new treatments can improve a patient's quality of life, so their use should be reviewed and follow up should be collaborative between neurologists and pharmacists to see the real effect of this medication.
BackgroundThe pharmaceutical validation procedure itself reduces a large number of medicines errors. The Electronic Prescribing System (EPS) is a computerised physician order entry and clinical decision support system. Its advantages are the opportunity to standardise clinical practice and avoid the transcription of prescriptions.PurposeWe identified pharmaceutical interventions (PIs with the objective of improving the safety of medical care and for their influence in clinical practice.Material and methodsWe identified PIs for 6 months after the implementation of the EPS. PIs were classified into 2 groups: firstly wrong use of the tool and secondly to conduct pharmacotherapeutic monitoring (FTM). The pharmacist, via an internal messaging system, wrote recommendations to the prescriber before the dispensing and administration of medicines. Subsequently we quantified the PIs for the next 6 months in order to assess whether these interventions contributed to an improvement in prescribing.ResultsThe hospital ward has an average of 32 patients with 275 prescriptions per day. During the first part of the study there were 588 PIs of which 279 (47%) were due to wrong use of the EPS. In the second part there were 431 PIs (26.7% fewer than in the previous period), 39% (39.42% fewer than previously) were due to the use of the program. The main errors in the use of the program were prescribing ”if it is needed”, the shortening of the duration of treatment, choice of frequencies, prescription of insulin, etc. FTM errors (52.5% during the first part and 60.98% in the second) were related to inadequate following of the Hospital Formulary, recommendations for alternative medicines, avoiding duplication, choice of pharmaceutical form, dose in the elderly, wrong frequency, route or dose, etc.ConclusionPharmaceutical validation can substantially increase the safety of the drug treatment process. PIs contribute to improving physicians’ performance in the use of EPS and to reducing medicines errors.References and/or acknowledgementsNo conflict of interest.
A683suggest that PIM is a cost-effective treatment strategy compared to OTT for HIV-1 infected patients who have achieved sustained virological suppression.
Background Treatment with bortezomib is frequently associated with haematological toxicity. In addition infrequent gastrointestinal disorders such as ischaemic colitis, irritable bowel syndrome and paralytic ileus are described, among others. Purpose To describe a case of ischemic colitis associated with treatment with bortezomib and to evaluate causality. Materials and methods The authors report on a woman, 77 years old, diagnosed with multiple myeloma, chronic renal insufficiency and echinococcosis, being treated with enalapril 20 mg/day, bisoprolol 2.5 mg/day, isosorbide 50 mg/day, calcium carbonate 1.25 g/8 h, furosemide 40 mg/day, darbepoetin α 40 mcg/15 days, omeprazole 20 mg/day. In June 2011, she was given fresh treatment with bortezomib 2.2 mg/72 h and dexamethasone 40 mg/week. After the fourth dose, the patient went to the emergency services with abdominal pain and constipation that had been coming on for several days. It was decided to interrupt treatment and she was admitted to the digestion ward. Naranjo's algorithm and Karch–Lasagna's algorithm were used to determine the reason. Results An urgent colonoscopy showed abundant red stained faecal residue in the descending colon, diffuse mucous with black plaques and surface ulcers which demonstrated severe ischaemic colitis. An abdominal axial CT scan reflected a remarkable oedematous thickening of the colon wall (7 cm) with adjacent frayed fatty tissue related to the colitis diagnosis. After 12 days the patient progressed satisfactorily on conservative treatment having interrupted her standard treatment. When the bortezomib treatment restarted the patient resumed the same medical regimen but very soon she experienced abdominal distension, nausea and vomited bile. Chronic mesenteric ischaemia was diagnosed. After a further 15 days the patient was discharged from hospital and is now trying oral lenalidomide as second line treatment of the multiple myeloma. After applying the causality algorithms, the adverse reaction came out in both cases as definitively due to bortezomib (10 points). Conclusions Ischaemic colitis is described in the bortezomib technical data sheet as an uncommon adverse event (<0.01%) as reported in postmarketing studies. In the Sistema Español de Farmacovigilancia (FEDRA) Spanish Pharmacovigilance System for Medicines for Human Use 239 bortezomib adverse events are recorded, 44 related to gastrointestinal disorders. Close monitoring of patients showing constipation during their bortezomib treatment is recommended together with notification of possible adverse events not described or listed as uncommon in their severity.
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