Background Improving the haemoglobin levels preoperatively leads to a reduction in transfusions required. Intravenous iron III sucrose (IVI), with a good safety profile, represents a new therapeutic option for the treatment of anaemia. Purpose To determine whether IVI administration in postoperative colorectal cancer (CRC) decreases the number of transfusions required. Materials and methods Retrospective case-control study in patients undergoing CRC surgery in the years 2008, 2009 and 2010, matched by age (±3 years), sex, type of surgery, tumour stage and surgical approach. Variables recorded: sex, age, tumour location, tumour stage, type of surgery, surgical approach, haemoglobin prior to surgery (Hbs) and at discharge (Hbd), number of transfusions after surgery (Ts) and doses of IVI received. Statistical analysis: Pearson's χ2 test or Fisher's exact test and Student's t or Mann-Whitney test using SPSS 15.0. software. Results The number of patients was 342, of which 104 were paired into 2 groups of 52 patients (G1-IVI treated and G2-IVI untreated), 33 men and 19 women per group, with a mean age of 70.9±11.1 and 70.6±10.9 years, respectively. Tumour location in both groups: rectum (25/22), left colon (15/17), and right colon (12/13). Tumour stage in both groups: III in 36.5%, 0 in 26.9%, IV in 13.5%, I in 11.5% and II in 11.5%. Type of surgical procedure in both groups: anterior resection of rectum in 36.4%, left and right colectomy in 28.8% and 21.2%, respectively. Surgical approach: 92.3% by laparotomy and 7.7% by laparoscopy. Hbs was 12.3±1.6 g/dl (G1) and 12.8±1.9 µg/dl (G2)(p=0.133), and Hbd was 10±1.1 g/dl (G1) and 10.6±1.2 µg/dl (G2)(p=0.012). Ts was 3±1.6 (G1) and 3.3±3 (G2)(p=0.682). 28.8% and 30.8% in groups 1 and 2, respectively, were transfused (p=0.830). The mean dose of IVI was 592±445 mg. Conclusions Administration of IVI does not appear to decrease transfusion requirements, possibly because bone marrow physiologically requires a period longer than the hospital stay to increase haemoglobin levels. Additional studies are needed to show more clearly the value of IVI.
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 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 In renal failure, alteration in the pharmacokinetics increases the frequency of overdoses. Purpose To evaluate pharmaceutical care using a computer programme for drug dose adjustment in renal failure. Materials and Methods The study period lasted from September 2011 to January 2012 (inclusive), in a 420-bed hospital. Every day creatinine values over 130 mmol/l were filtered. Treatment was reviewed and we obtained creatinine clearance values (Crockcoft & Gault) of selected patients. After consulting the drug dose adjustment on the sheet and in Micromedex, a report was sent with the pharmaceutical recommendation. ResultsThere were 68 interventions for the 2147 patients studied: Internal Medicine (34) Cardiology (1), Short Stay Unit (5), Orthopaedics (7), Urology (5), Haematology (7) Surgery (5), Neurology (1), Intensive Care Unit (ICU) (2) Oncology (1). 55.9% of notifications were for changes in the dose of enoxaparin (38), 11.8% of amoxicillin-clavulanic acid (8), piperacillin-tazobactam 14.7% (10), 8.8% levofloxacin (6), 2.9% meropenem (2), 2.9% ciprofloxacin (2), 1.5% imipenem (1) and 1.5% aztreonam (1). The proportion of suggested changes accepted was 58.8% (40). 5.9% (4) discontinued treatment, 5.9% (4) were discharged and 29.4% (20) not changed. Of the latter, five were for changes in the pattern of enoxaparin in trauma patients, another 5 from Internal Medicine and 2 more from Haematology and ICU. The rest of them were changes in the pattern of antibiotics (imipenem 1, 2 levofloxacin, 1 meropenem, 1 ciprofloxacin, piperacillin-tazobactam 3) that were given out in the different services. Conclusions A high percentage of doctors followed the recommendations. Part of the unaccepted tally corresponds to trauma patients whose prophylactic regimen of enoxaparin (40 mg/24 h) was not modified due to the service criteria. Some of the antibiotic prescriptions were not changed because of the severity of the patient’s illness (1 levofloxacin and 1 Internal Medicine Meropenem Imipenem Oncology and 1). The rest were rejected without explanation. 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.
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