Conclusion and relevance Because of the telematic consulting programme, we have innovated, with technological tools, continuity of pharmaceutical care, which does not require a visit to the hospital, facilitating delivery of the medication to the patient. Also, patient satisfaction was high.
BackgroundDarunavir/cobicistat (DRV/COB) is the first fixed combination inhibitor of protease. Both are metabolised by the cytochrome CYP3A4, the reason why they are susceptible to present a multitude of drug interactions (DI).PurposeTo describe the DI of DRV/COB in HIV patients to avoid and to optimise therapy.Material and methodsRetrospective observational study performed in a county hospital. We reviewed the digital clinical history to collect the following data: patients treated with DRV/COB from 1 January 2016 to 1 November 2016, demographics, duration of treatment, concomitant medications, drugs involved, and DI. We review HIV-drug interactions using the database of the University of Liverpool to classify DI according to the mechanism of action (MA) and their potential severity. The pharmaceutical intervention (PI) was to notify to the prescribing physician, by report attached in the patient’s medical record, the contraindicated interactions (CI).ResultsThirty-five patients, 51% males (n=18). Race: 54% non-Caucasian (n=19). Median age 37 years (IQR 64–20). Median days of treatment 195 (IQR 465–22), total of concomitant medications 199, median 5 (IQR 1–19), DI 31% (n=62) median 1 (IQR 0–8), 40 drugs involved in DI. Type of DI according to their MA: CYP3A inhibition 62% (n=25), inhibition CYP2D6 10% (n=4), inhibition CYP3A and CYP2D6 7% (n=3) and inducer CYP3A 5% MA 15% (n=6). DI type according to its potential severity: high (CI) 15% (n=6) (midazolam, budesonide, phenobarbital, ivabradine, simvastatin and domperidone); and potential: 89% (n=35). PI: accepted 3 (50%): one change from simvastatin to rosuvastatin, one change from phenobarbital to levetiracetam and a change from midazolam to lormetazepam.ConclusionA high rate of DI is observed in patients receiving treatment with DRV/COB. The most relevant interactions are observed at the level of the CYP3A family. Acceptance of PI was low in the case of CI detected, probably because the prescribing physician was unaware of it. To have a higher success rate we could have made a phone call to him to put him on notice. The pharmacist is important in optimising drug therapy.References and/or AcknowledgementsThanks to all my colleagues in the Hospital de Poniente for their selfless helpNo conflict of interest
expression of PD-L1, performance status (ECOG-PS), treatment duration, toxicity (CTCAE V.5.0) and outcome were collected from the local electronic medical records. OS, defined as the time from the start of therapy to death or last followup, was compared in subgroups of patients using the log rank test (with R software); p<0.05 was considered statistically significant. Results This investigation provided preliminary results for 98 patients (of whom 64% were male). Median age was 73 years (range 44-89). ECOG-PS was 0 or 1 in 91% of cases and 29.6% of patients had a PD-L1 >90%. Median duration of treatment was seven cycles. At a median follow-up of 14.6 months, the percentage of patients still alive was 51% and median OS was 13.3 months (95% CI 10.5 to 31.4). The analysis revealed that OS was not influenced by sex or PD-L1, but significantly associated with ECOG-PS (p<0.001). Immunorelated adverse events occurred in 75.5% of patients (29.6% cutaneous, 24.5% gastrointestinal and 19.4% endocrinological). Patients with toxicity showed a significantly higher median OS (29.6 months, 95% CI 12.2 to NA) compared with those without significant toxicity (6.5 months, 95% CI 1.3 to 13.1, p=0.002). Conclusion and relevance These real life findings in the setting of advanced NSCLC patients with PD-L1 TPS !50% demonstrated the effectiveness of pembrolizumab. A median OS of 13.3 months was similar to that estimated in the real world Pembreizh study (15.3 months). The detection rate of AE of 75.5% was comparable with 73.4% in the KEYNOTE -024 study. However, pembrolizumab as mono-immunotherapy represents the standard of care as firstline treatment but results from trials evaluating combinations with chemotherapy (KEYNOTE189) could further change the therapeutic approaches.
BackgroundDetermination of the plasma concentration of free phenytoin (CpFL) could improve seizure control and prevent adverse effects.PurposeTo evaluate the safety profile of patients treated with phenytoin using CpFL.Material and methodsProspective study (2013–2014) in a hospital. Collected data: demographics, doses, CpFL, creatinine clearance (Clcr), serum albumin (g/dL), degree of intoxication, days of hospitalisation and concomitant medication. Phenytoin therapeutic range, CPFL: 1–2.5 μg/mL. Moderate intoxication, CpFL 2.5–3.0 μg/mL and severe, CpFL >3.0 μg/mL. To determine renal clearance, we used CKD-EPI. Moderate renal impairment was defined as Clcr 20–50 mL/min. Polymedicated patients: >5 drugs. Statistical analysis: Spearman correlation and the χ2 test.ResultsPatients93 (cases 192; phenytoin levels/patient 1–6). Men 51.6%. Age 58 years (range 27–84). Daily dose 299 mg/day. CpFL 1.1 μg/mL. Clcr 51.7 mL/min. Serum albumin 3.6 g/dL. Levels in the therapeutic range: 49.5% (95/192), 32.8% (63/192) were suboptimals and 17.7% were toxic (34/192) (CpFL 3.8 μg/mL; range 2.6–5.7 μg/mL). Intoxication, moderate was 64.7% and severe 35.3%. Average age (Intoxicated patients) 71 years. Clcr 38.9 mL/min. Serum albumin 3.4 g/dL. Three patients were hospitalised. Polymedicated patients: 71% vs. 50% for the rest. Patients with drugs that bind over 70% to plasma proteins: 48%. Patients >70 years had a higher risk of intoxication (p = 0.033). We observed an inverse correlation between CpFL and Clcr (Spearman rho: -0.562; p = 0.04) and with albumin (Spearman rho: -0.623; p < 0.01). In relation to moderate intoxication, the plasma concentration of phenytoin had a value 23% higher than CpFL.ConclusionElderly patients, polymedicated patients and those with moderate renal insufficiency and hypoalbuminaemia presented a higher risk of phenytoin toxicity. It would be advisable to be careful with these patients because in our study efficacy/toxicity is correlated better with CpFL.No conflict of interest.
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