For the primary outcome measure of symptom relief at 8 wk, there was no statistically significant difference between esomeprazole 40 mg once a day and placebo. However, at 4 wk, esomeprazole was significantly more effective than placebo for symptom relief. The difference in therapeutic gain between 4 and 8 wk was largely due to a higher placebo response rate at 8 wk.
BackgroundProgressive multifocal leukoencephalopathy(PML) is caused by JC virus (JCV) and has severe consequences for the central nervous system. PML is an opportunistic infection, affecting HIV positive patients. There is no curative treatment, and the current approach is focused on immune reconstitution and antiviral therapy.1 PurposeThis is a case report of two patients with PML associated with HIV infection treated with aldesleukin/interleukin-2 (IL-2).Material and methodsWe report two cases, both men, aged 48 years (patient A) and 57 years (patient B), HIV diagnosed in 1992 and 1993, who developed LMP opportunistic JCV infection. Antiretrovirals were the only therapy previously employed. Patient A developed progressive neurological impairment, slow psychic reactions and right upper limb strength loss. Symptoms in patient B were progressive cognitive impairment, memory loss, lack of coordination, dysarthria, strength loss and right facial paralysis. Both patients showed hypodensity of white matter in the semi-oval centre on cranial CT.ResultsIL-2 was administered intravenously to both patients at 0.5 MU/m²/day for 4 weeks. Patient-A: IL-2 treatment (from 8 February 2010 to 7 March 2010) was well tolerated, although a self-limited fever and eosinophilia were reported without clinical correlations. The patient showed improvements in image tests (disappearance of signal hyperintensity and cytotoxic oedema on CT and MRI) and clinical outcomes (improvement of neurological symptoms), although progressive spasticity and dysarthria were maintained. JCV load was undetectable in February 2011. Patient A was treated for 1 year with mefloquine 250 mg/24 hours with good tolerance and stabilisation of PML, but without resolution. The patient died in December 2012 following intraparenchymal cerebral haemorrhage. Patient-B: therapy with IL-2 and mirtazapine (from 8 September 2016 to 5 October 2016) was well tolerated, but the infusion was discontinued once by a fever episode. Cranial CT showed no significant changes. The patient´s neurological impairment, hemiparesis and dysarthria persisted, but a slight improvement was observed. JCV load declined from >100 million to 12 million copies/mL, HIV from 645 to 147 copies/mL and CD4 T lymphocytes increased.ConclusionIL-2 could be an effective and well tolerated therapy in LMP, without severe adverse events. Patient A showed improvements in neurological and image tests, and undetectable viral load, whereas the response in patient B was only partial, with a decline in JCV and HIV, but maintaining neurological deterioration.References and/or acknowledgements1. Pavlovic D, et al. Ther Adv Neurol Disord2015;8:255–73.No conflict of interest
Nivolumab is approved and reimbursed by Italian Drug Agency (AIFA) in several tumors, including non-small cell lung cancer, head & neck cancer and renal cell cancer. In May 2018, the original schedule (3 mg/kg every 2 weeks) -used in pivotal clinical trials demonstrating treatment efficacy -was replaced by a flat dose (240 mg every 2 weeks). Aim of this study was to identify the most cost-effective dosing strategy of nivolumab in a real-world setting. The primary endpoint of this analysis was the difference of nivolumab costs between the real scenario based on data from our hospital, and the hypothetical expenditure according to different simulated strategies of nivolumab dosing. The secondary endpoint was to report the economic savings associated with "drug day" and dose rounding
Hospital pharmacy services had to implement a telepharmacy programme in record time, to bring drugs closer to patients. Aim and objectives To measure the impact of a telepharmacy programme in terms of direct and indirect costs and benefits for patients. Material and methods A retrospective observational study was conducted in a tertiary level hospital between March and September 2020. The following variables were collected: number of remote dispensings, number of patients enrolled in the telepharmacy programme, population characteristics, drugs and storage conditions, average distance, and direct and indirect costs. Results 13 216 remote dispensings were made relating to 4090 active patients within the telepharmacy programme. This represented 51.21% of the total number of our outpatients (7986). 50.81% (2078) of the patients were women and median age was 57 (±23) years. 44.59% (5894) of the total drugs sent were thermolabile drugs. The mean distance of the shipments was 41.7 (0.2-208) km. Establishing the ratio 0.226C ¼ /km, and 1 visit every 2 months to the hospital pharmacy service, direct costs would mean an average of 113.04C ¼ per year for patients. Establishing the 1 km/2 min relationship, the annual indirect costs represent 10.5 working hours: 7.7 hours as the average travel time and 2.8 hours as the average waiting time for face-to-face dispensings. Conclusion and relevance Telepharmacy has become one more tool for dispensing treatments to outpatients with savings for the patient in terms of travel and waiting times. The time of confinement due to the pandemic has accelerated the inclusion of patients in this programme, reaching more than 50% in 6 months.
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