The effectiveness of romiplostim was variable with few adult patients achieving a durable response. Our paediatric patients responded better with most achieving a durable response. The treatment was safe for both groups of patients. Studies should be conducted to identify patients more likely to benefit from this treatment.
Background Ivabradine is authorised for the treatment of coronary artery disease and chronic heart failure with systolic dysfunction in adult patients, but there is little information on its efficacy and safety in children. Purpose To assess the use, efficacy and safety of ivabradine in paediatric patients. Materials and methods Observational study of the children treated with ivabradine in a university tertiary hospital. Patients’ clinical records were reviewed and the following data were collected: date of birth, sex, weight, diagnosis and concomitant conditions, treatment duration and ivabradine dosing. Heart rate was used to assess effectiveness. Treatment was considered effective if the heart rate decreased below 130 bpm. Safety was assessed by the occurrence of any adverse events described in the summary of product characteristics. Results Four children were treated with ivabradine in our institution, all of them for the indication of inappropriate sinus tachycardia as an off-label use. The median age at the start of treatment was 5.6 years (1.1–15.5). Three patients had undergone a heart transplant before treatment and the fourth started ivabradine before he had received a heart transplant. Median starting dose was 0.08 mg/kg/12 h (0.05–0.14). Median heart rate before treatment was 155 bpm (140–160). Ivabradine was effective for three patients, with a median of 110 bpm (110–128) after treatment, though one of them was considered a partial responder because the dose had to be doubled to maintain the desired heart rate. Treatment was ineffective for the remaining patient (median heart rate 147 bpm) and was discontinued. Overall, ivabradine was well tolerated. However, the dose had to be reduced to a half in one patient due to QT prolongation but was normalised after dose adjustment. Conclusions Ivabradine seemed to be an effective and safe treatment for inappropriate sinus tachycardia in most of our paediatric patients. Nonetheless, more studies are required to confirm these results. No conflict of interest.
Background Oral antineoplastic agents (OAA) interact with cytochrome P450. Therefore, one of the most important objectives of pharmaceutical care in cancer patients, who are usually polymedicated, is to review and identify drug interactions. Purpose To describe drug interactions detected in a Pharmaceutical Care Programme applied to patients who are starting treatment with OAA. Materials and methods An observational study was performed in patients who started treatment with OAA during the study period (January 2012 – August 2013). At the time of starting treatment, a clinical interview was conducted by the pharmacist, in order to detect drug interactions. Subsequently, prescriptions and reports from all patients were reviewed and interactions analysed using Lexicomp. Variables recorded were: gender, age, ECOG performance status, type and dose of OAA, other chronic treatment and interactions and their severity classified according to the FDA. Results 121 patients were included (62.0% male). The mean (SD) age was 67.9 (14.3) years old and 9.9% had an ECOG ≥2. The main OAA dispensed were: abiraterone (19.0%), lenalidomide (18.2%), sunitinib (11.6%), gefitinib (10.7%), imatinib (9.1%) and sorafenib (9.1%). The mean number of chronic co-medications used was 5.0 (2.1). Seventy two interactions were identified in 49 different patients, 27.8% had category D or X. Interactions were more prevalent with abiraterone (41.7%), gefitinib (16.7%) and imatinib (13.9%). Principal groups of drugs interacting with OAA were proton pump inhibitors (25.0%), antihypertensives (24.8%), statins (15.3%) and antidepressants (8.3%). Principal drugs interacting were amlodipine (11.1%), rabeprazole (8.3%), acenocoumarol (8.3%), atorvastatin (6.9%), simvastatin (6.9%) and tramadol (5.6%). The pharmacist was involved by informing the patient and the physician and monitoring the interaction in the follow-up. Conclusions Abiraterone is the OAA with most identified interactions. It is essential to review all the chronic drugs before starting a new OAA; be careful especially with proton pump inhibitors and antihypertensives. No conflict of interest.
ObjectivesTo evaluate the use, effectiveness and safety of tyrosine kinase inhibitors (TKIs) for chronic myelogenous leukaemia (CML) in clinical practice.MethodsA retrospective longitudinal study of patients with CML who received TKIs for at least 6 months was performed. Endpoints to evaluate effectiveness were haematological, cytogenetic and molecular responses. Safety was assessed according to the occurrence of adverse events.ResultsSixty-two patients were included. All received imatinib as the initial TKI; 8% switched to nilotinib due to lack of major molecular response (MMR) to imatinib and 3% switched to dasatinib because of progression to blast crisis or lack of MMR. At the end of the study all patients had achieved at least a complete cytogenetic response. With regard to safety, in 11 patients the dose of imatinib was decreased and four patients switched to a second-generation TKI due to imatinib toxicity.ConclusionsConsidering the good responses of most patients and its better known safety profile, imatinib should remain a good option for first-line treatment of CML.
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