Background Conversion from intravenous (IV) to oral treatment has many advantages, such as avoiding the adverse events attributed to IV treatment and using less costly drugs. It is also more comfortable, requires fewer human resources and it potentially shortens the length of hospital stay. However it is very important not to have any contraindication for oral treatment. The drugs involved must have excellent bioavailability following oral administration. Purpose To evaluate the results of a pharmaceutical intervention on switching sequentially from IV to oral antibiotics. Materials and methods Prospective and comparative study, carried out over 3 months (between March and May 2012); consisted of a phase of observation and another phase of intervention. We collected demographic data, diagnosis, antibiotic dosage and treatment duration, signs and symptoms related to the infection improving and oral tolerance to medicines and nutrition. We selected all the patients on IV treatment with levofloxacin, ciprofloxacin, metronidazole and clindamycin. Over the intervention phase and after 48–72 h of the intravenous treatment, we consulted the physician for approval to switch to the oral drug. Statistical analysis was performed using SPSS 19.0 Results 140 patients were involved. 44 in the observation phase and 96 in the intervention phase. Mean age was 72.8 (95% CI 66.0–79.6) and 71.8 years old (95% CI 68.5–75.7) respectively. Main diagnoses were divided into these infections: respiratory, gastrointestinal, urinary tract and other. During observation phase these were as follows: respiratory 24 (54.5%), gastrointestinal 10 (22.7%), urinary tract 2 (4.5%) and other 8 (18.1%). During intervention phase the numbers were: 45 (46.8%), 21 (21.8%), 6 (6.25%) and 24 (25%) respectively. In the observation phase, IV treatment duration was 6.5 days (interquartile range, 3–11) and it reduced to 4 days (interquartile range, 3–9) in the intervention phase (p = 0.068). A tendency was seen in the number of days of IV administration to decrease. Conclusions Pharmaceutical intervention reduces length of IV treatment. Therefore, a pharmacist-managed intravenous to oral step down system may be a good tool to reduce costs and potential adverse events attributed to IV treatment. This could be an example of the importance of pharmaceutical care in hospitalised patients. No conflict of interest.
Background Telaprevir is one of the new drugs for chronic hepatitis C genotype 1. As it is a new drug is necessary to be aware of the emergence of new adverse reactions that may not be included in the SPC. Purpose To investigate possible severe adverse reactions not mentioned in telaprevir’s SPC. Materials and methods Descriptive and retrospective clinical case. Data were obtained by review of the patient medical history, Savac and Selene software and laboratory data. Results Fifty-seven-year-old male with HCV genotype 1a/1c. It was decided to start his first treatment for hepatitis C with ribavirin (RBV) 400 mg/12 h, Peg-interferon (P-INF) alfa 2a 180 mcg/week and telaprevir 750 mg/8 h. In week 8 of treatment he was admitted with symptomatology compatible with pancreatitis. Amylase 1888 IU/L appeared in laboratory data. Absolute diet, analgesic and antiemetic measures were established. The patient was discharged a week after admission with an amylase of 173 IU/L. The next day he was admitted with an amylase of 3406 IU/L and the same symptoms. Telaprevir was suspended (week 9 of treatment) in case it could be the cause, and he continued with P-INF and RBV. The patient was discharged 5 days later with an amylase of 365 IU/L. The Karch-Lasagna modified algorithm established as “possible” the relationship between pancreatitis and telaprevir. Conclusions A MEDLINE search was performed on 17.01.13 with the words “telaprevir” “pancreatitis” “abdominal pain” or “amylase” and we did not find any results that evidenced pancreatitis caused by telaprevir. A temporal association existed between drug use and pancreatitis symptoms as well as between telaprevir suspension and the patient’s improvement. Therefore, we concluded that telaprevir could have caused acute pancreatitis in this patient. No conflict of interest.
Background Gefitinib is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-TK activating mutations. Purpose To evaluate the effectiveness and safety of gefitinib in patients with NSCLC from a general hospital and compare it to the results of published studies (IPASS, INTEREST and ISEL). Materials and methods A retrospective observational study was made of patients with NSCLC treated with gefitinib between January 2012 and September 2013. Study variables: age, sex, smoking, histology, stage, EGFR mutation, ECOG functional status, treatment line, tumour response rate based on the Response Evaluation Criteria in Solid Tumours (RECIST), progression-free survival (PFS) and toxicity. Data source: SELENE software application and clinical records. Results 6 patients (83.33% women) with a mean age of 70.17 years (range 58–73) were evaluated. 5 were non-smokers (83.33%), while 1 was an ex-occasional smoker (16.67%). All of the tumours were mutated EGFR adenocarcinomas: stage IV (66.67%) and stage IIIB (33.33%). The ECOG score was ≤2. 3 patients (50.00%) started gefitinib 250 mg/day as first line therapy, 2 as second line treatment (33.33%), and 1 as third line treatment (16.67%). All patients showed clinical improvement (lessened dyspnoea and cough), and the first radiological study, based on the RECIST criteria, showed 5 patients to have a partial response (83.33%), while 1 presented stable disease (16.67%). The median PFS was 10 months (range 4–18) (1 patient who abandoned after 4 months due to unknown reasons was excluded). 4 patients continued with the treatment at the end of the study (66.67%). The following side effects (AEs) were observed: grade (G)1–2 diarrhoea (26.67%), G1 asthenia (20.00%), G1–2 acne (20.00%), moderate ALAT elevation (13.33%), G1 mucositis (6.67%), G1 anorexia (6.67%) and G1 conjunctivitis (6.67%). All of these effects were manageable without the need for dose reduction, except ALAT elevation, which required treatment discontinuation for 7 days. Conclusions Gefitinib showed similar efficacy to published studies. AEs were those described, well tolerated and all reversible. Owing to the small sample size it would be necessary to obtain a larger sample to draw definitive conclusions. No conflict of interest.
Background Eribulin is a new drug against metastatic breast cancer, one of the most common cancers in women Purpose To study the effectiveness and safety of treatment with eribulin in metastatic breast cancer in patients who have been treated with at least two processing lines including anthracyclines and taxanes Materials and methods Retrospective descriptive study of patients who received eribulin from marketing until September 2013. Variables examined: sex, age, hormone receptor and lines of treatment prior to HER-2, progression-free survival (PFS) and adverse reactions (RA). Source of data: history and pharmaceutical validation program Farmis-Oncofarm. Results We included 26 female patients with a median age of 57 years, 22 (84.6%) hormone-sensitive and 20 (77%) HER-2 negative. Median prior lines of treatment were 5. Of the 26 patients, 23 had previously been treated with capecitabine, and drug median PFS was 140 days. The median number of eribulin cycles received was 6 and the median PFS was 137 days (range 31–663 days). Regarding safety, 18 (61.5%) patients experienced 36 RA Grade 1 or 2 and 6 grade 3 or 4 (G3/G4). The RA found were: asthenia 10 (1 G3/4), gastrointestinal disorders 10 (2 G3/G4), neuropathy 4 (1 G3/G4), anaemia 4 (1 G3/G4), skin disorders and/or alopecia 4 (1 G3/G4), neutropenia 3 and liver disorders 1 G3/4. Five patients had their dose reduced to 0.97 mg/m2. All patients received prophylactic G-CSF to reduce hematologic toxicity. Conclusions In the EUPHORIA study (presented in ASCO 2013). 104 patients were treated (64.4% hormone-sensitive). The median PFS was 97 days (3 months) With regard to the most frequent adverse reactions were similar to those in this study. The effectiveness results obtained in this study are consistent with those reported in the pivotal clinical trials (133 days, 3,8 months). The PFS of EUPHORIA study may be lower because the lower rate of hormone-sensitive patients. Moreover, the patients who have been treated with capecitabine and eribulin exhibit similar PFS. Given the effectiveness and safety of the drug, treatment should be evaluated with other cytostatic drugs with better cost-effectiveness profile-security such as capecitabine. No conflict of interest.
Background Pneumonia is one of the most common causes of mortality in geriatric patients. The appropriate antibiotic treatment of this pathology can decreases the mortality rate in the patient group. Purpose To study the features of the patients with community acquired pneumonia (CAP) and the use of antibiotics in their treatment. Materials and methods We selected 102 hospitalised patients who met the CAP criteria. Demographics, stay, comorbidities, smoking/drinking habits, microbiological tests performed and empirical antibiotic treatment were collected. Finally, we compared the treatment we found with clinical practice guidelines. Results Of the 102 patients selected (58.8% men and 41.2% woman) 75 (73.5%) of patients were over 65, and the median age was 70. The average stay was 8.6 days. The most frequent comorbidities in patients with CAP were diabetes in 31 patients (30.4%) and onco-haematology disease in 26 patients (25.5%) follow by respiratory disease in 22 patients (21.6%). The most common empirical treatments were fluoroquinolone monotherapy (36.27%) and fluoroquinolone associated with B-lactam (38.25%). Finally 14 (87.5%) of the 16 who died had at least one comorbidity, and 5 (31.25%) had at least three comorbidities. Conclusions Patients with CAP included in the study were treated in accordance with clinical guidelines. In patients with comorbidities there is a greater risk of dying. No conflict of interest.
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