BackgroundGabapentin and pregabalin are two GABA analogues, example of an evergreening strategy. Both have been associated with a markedly off-label use.PurposeTo describe the extent and nature of the off-label use of gabapentin and pregabalin.Material and methodsProspective observational study performed in a tertiary hospital. We included patients being treated with gabapentin or pregabalin at any time between June and August 2014. The variables collected were: sex, age, drug, therapeutic indication, dose and cost per patient-month (according to retail prices). These data were used to describe the rate and nature of the overall use and off-label use by drug. Data were collected through review of medical records and by electronic pharmacy refill records. Statistical analysis was performed using SPSS Statistics 20.0.ResultsSixty-five patients (54% male, mean age 60 ± 14 years) were included. Eighteen (28%) were being treated with gabapentin and 47 (28%) with pregabalin. The overall off-label use was 43% (28 patients), with no differences between the drugs (44% gabapentin and 43% pregabalin). The off-label use was related to the therapeutic indication (25 patients) or the dose (3 patients). The off-label indications for gabapentin were: central neuropathic pain (6), subacute or chronic low back pain (3), generalised anxiety disorder (3) and refractory visceral pain (1). The off-label indications for pregabalin were: subacute or chronic low back pain (6 patients), fibromyalgia (5), and essential tremor (1). The average cost per patient-month was €25 ± 11 for gabapentin and €156 ± 65 for pregabalin.ConclusionGabapentin and pregabalin are often prescribed for off-label use. Despite having failed to demonstrate clinically relevant differences over gabapentin, pregabalin holds a high prescription rate with consequent extra costs for the hospital, representing an area in which rational drug use could be promoted.ReferenceRadley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166:1021–6No conflict of interest.
BackgroundNon-adherence in patients with multiple chronic conditions (PMCC) is associated with poor disease control, reduced quality of life and increased risk of morbidity and mortalityPurposeTo assess the available scientific evidence regarding the efficacy of interventions aimed to improve medicines adherence that are applicable to PMCC.Material and methodsOverview of systematic reviews (SRs). The following databases were consulted (September 2013): PubMed, EMBASE, the Cochrane Library, CRD and WoS to identify SRs of clinical trials focused on PMCC, or otherwise, patients with chronic diseases common in the PMCC, or polypharmacy. SRs that compared the efficacy of any intervention aiming to improve compliance with medicines with clinical practice or other interventions were included. For every SR and type of intervention (behavioural, educational and combined) the percentage of clinical trials in which adherence improved was estimated. Rates were combined between SRs by means and ranges. Meta-analysis could not be conducted because of the heterogeneity of the data. This analysis was also applied to the components from those interventions described in ≥1 SR.Results566 articles were retrieved of which 9 SRs were included. None was specifically focused on PMCC but considered patients with chronic diseases common in PMCC, patients with more than one chronic disease and polypharmacy.Seven, three and six SRs reported behavioural, educational and combined interventions, respectively. The mean efficacy rates were 49% [0–100], 51% [0–100%] and 53% [44–75]. The components from those interventions which reported higher efficacy were: counselling about the patients’ target disease, the importance of treatment and compliance with treatment (5 SR, 79% [47–100]), reminders (4 SR, 70% [50–100]), simplified dosing (3 SR, 90% [75–100]) and special pill packaging (2 SR, 83% [66–100]).ConclusionThere is a large heterogeneity in the efficacy of interventions aimed to improve medicines adherence that are applicable to PMCC. Nevertheless, they seem to have a modest impact on adherence. Some components of the interventions appear to have greater efficacy.References and/or AcknowledgementsArch Intern Med 2007;167:540–50No conflict of interest.
combination presented benefit in terms of OS and PFS in untreated metastatic squamous NSCLC (mSNSCLC), regardless of PD-L1 expression. No randomised clinical trials (RCTs) of Pb-CT versus Pb alone have been done. Aim and objectives To assess the comparative efficacy of Pb and Pb-CT in untreated mSNSCLC patients with PD-L1 !50% using an adjusted indirect treatment comparison (ITC). Material and methods A bibliographic search was conducted in the Pubmed database (2 October 2019). Inclusion criteria were phase III RCTs, Pb and Pb-CT treatments, similar mSNSCLC population (with PD-L1 !50%), follow-up period and end points(OS or PFS). Exclusion criteria were mSNSCLC population with EGFR or ALK mutations. An ITC was developed using Bucher's method. Delta value (D), maximum acceptable difference as a clinical criterion of no inferiority, was set at 0.70 (and its inverse, 1.43), used to calculate the sample size in the Pb-CT trial. The Shakespeare method was used to estimate the probability of the results out of the D margins. Results Two studies, one for each regimen, 1 2 were found in the literature search. Limitations found between Pb-CT and Pb trials included populations (all patients vs only patients with PD-L1 !50%, respectively, subgroup data used for ITC) and small size of the squamous subgroup. No OS data were available for the squamous subgroup in the Pb trial. PFS was taken as the primary end point for ITC. Results of RCTs and ITC are shown in table 1. No significant differences in PFS between Pb-CT and Pb were found. The 95% CI exceeded D on both sides (high level of uncertainty). The probability of a result out of D were 24.14% below and 16.54% above. Conclusion and relevance ITC did not show significant differences in PFS between Pb-CT and Pb. No evidence of clinically relevant benefit from one or other regimen was found. Considering the toxicity related to the addition of CT, Pb monotherapy would be preferable in untreated mSNSCLC with PD-L1 !50%.
BackgroundImmunosuppressive treatment for kidney transplantation is tailored to the clinical and immunological features of donors and recipients.PurposeTo describe the incidence of infection with cytomegalovirus (CMV) after immunosuppressant treatment with rabbit anti-thymocyte globulin (ATG) in kidney transplant patients, and the relationship with CMV serology and ATG dose.Material and methodsA retrospective descriptive study was carried out that included all kidney transplant patients who received ATG immunosuppressant induction treatment in 2012. The following variables were collected:Patient data: weight, sexTransplant data: type of donor: living donor or dead (brain death or asystole)Treatment data: dose and cumulative doseCMV: donor and recipient serology, CMV viral loadAll ATG protocols include ganciclovir or valganciclovir prophylaxis from the third day post-transplant for three months.Results36 patients (25 men) were included. Regarding the type of donor: 19 were from brain death, 12 from asystole and 5 were from living donors.12 of the 36 patients (33.33%) who received ATG developed CMV infection. 20 transplants were donor positive – recipient positive (D+/R+), and 4 of them were infected (20%). 10 patients were (D-/R+) and 3 of them were infected (30%). Only one patient was (D-/R-) and was not infected.The most important result was in the high risk group (D+/R-) because 4 patients were included and all of them developed primary infections. Another R+ patient was infected but we didn’t know the donor serology.No differences were found in the average dose received in infected patients (0.97 mg/kg/day) versus non-infected patients (1.01 mg/kg/day).The dose of ganciclovir and valganciclovir were switched from prophylaxis to treatment until viral load control was achieved in all of them.ConclusionThere was a high percentage of kidney transplant patients with ATG immunosuppression. Despite prophylaxis with ganciclovir or valganciclovir they had CMV infections, mainly in the D+/R- serology group, in which all of them developed CMV infection.No relationship were found with CMV infection and ATG dose received.References and/or AcknowledgementsNo conflict of interest.
Background and importance Chemotherapy induced nausea and vomiting (CINV) remains an important adverse effect as it affects the quality of life of patients, implies chemotherapy dose reductions and compromises adherence. Aim and objectives To evaluate the effectiveness of antiemetic therapy in the control of CINV, comparing groups of patients with adequate and inadequate patterns, according to clinical practice guidelines. Material and methods This was a longitudinal retrospective study for population characterisation and non-intervention. Patients receiving intravenous chemotherapeutic treatment from April to July 2018 were included. Independent variables: demographics (age and sex), and adequacy of the guidelines. Dependent variables: chemotherapy induced nausea (CIN), quantified by adding the scores obtained through a self-administered questionnaire based on the CTCAE scale, for the three phases (anticipated+acute +delayed); and chemotherapy induced vomiting (CIV), similarly quantified. Data are expressed as mean (SD) for continuous variables and absolute and relative frequency for categorical variables. Multivariable logistic regression models were used to study the association of adequacy and effectiveness. Statistical analyses were performed with the R software (V.3.4.3). A p value <0.05 was considered statistically significant. Results A total of 797 chemotherapy cycles were administered to 148 patients during the study period. Of these, 133 patients aged 62.26 (11.13) years, 70 (52.63%) women, were included. They were divided into three groups, according to the adequacy of the guidelines: sufficient (75), excessive (38) and insufficient (20). The excess deviations (OR=0.311 (0.038, 1.535), p=0.197) or insufficient adequacy (OR=0.388 (0.057, 1.878), p=0.278) were not predictors of nausea. In contrast, insufficient adequacy was a predictor of vomiting (OR=17.907 (2.078, 290.042), p=0.015), while the excess deviation was not (OR=1.799 (0.064, 37.415), p=0.688). Conclusion and relevance For all CINV anticipated, acute and delayed phases considered together, an insufficient antiemetic pattern was associated with worse control of vomiting, but not nausea. In future studies, separate assessment of the influence of the adequacy of the antiemetic pattern on each of the CINV phases deserves further investigation. REFERENCES AND/OR ACKNOWLEDGEMENTS No conflict of interest.
antiretroviral treatment or switched to dual therapy based on lamivudine and dolutegravir between June 2018 and September 2019 were included. Study variables were age, sex, date and reason for the change, duration of treatment, viral load (CV, copies/mL), CD4 and CD8 cells (cells/mL) before and after the change and on the date of the last available analysis, previous therapy, glomerular filtration rate (GFR) (mL/min), and levels of cholesterol (mg/dL), low density lipoprotein (LDL, mg/dL) and triglycerides (mg/dL). Results Nine patients (66.66% men) with a mean age of 49 years (30-58), 3 of whom were naive patients (33.33%) were analysed. Effectiveness was 100% of patients who achieved CV <50 copies at 4-6 weeks, maintaining the virological response for an average of 26 weeks. CD4 and CD8 counts increased significantly from 690 to 805 and 910 to 943, respectively. The lipid profile showed differences in LDL from 170 to 120. A significant decrease in GFR was observed from 102 to 87. The annual cost saw a decrease of 1690C ¼ /patient/ year. Conclusion and relevance Simplification to dual therapy was a safe and effective option that allowed optimisation of the resources against triple therapy.
BackgroundReport of a case of a patient allergic to albumin. In the absence of therapeutic alternatives we proposed an albumin desensitisation protocol.PurposeTo describe how the samples were prepared and the technique administered. To evaluate the effectiveness and safety of the desensitisation protocol for albumin in a patient who developed a hypersensitivity reaction to it.Material and methodsReview of the clinical history of a 72 year-old female diagnosed with liver cirrhosis HCV that had developed over 8 years, portal hypertension, ascites, oesophageal varices and splenomegaly. She was thought to have suffered an allergic reaction to intravenous albumin, based on symptoms after administration including neck rash, facial flushing and chest tightness, after we had eliminated allergy to any of the product excipients.Alternatives such as administering albumin with premedication (corticosteroids and antihistamines), diuretics and plasma expanders were evaluated without getting the desired result.After an unsuccessful literature review in which we could not find an albumin desensitisation protocol or a similar case, a protocol was suggested that involved the administration of increasing doses of albumin until a total cumulative dose achieved therapeutic levels.ResultsThree albumin preparations were devised: 0.6 grams of albumin diluted in 250 ml of physiological saline to give a concentration of 0.0024 g/ml, a second one with 6 grams in 250 ml for a concentration of 0.024 g/ml and a third preparation with 60 grams of undiluted albumin, which were administered at infusion rates of 5, 10, 20 and 40 ml/h every 15 min.After four sessions of paracentesis, with subsequent return of 60 grams of albumin infusion as per the desensitisation protocol, the patient did not have a further anaphylactic reaction. The regimen was well tolerated, achieving a final infusion rate of 50 ml/h.ConclusionThe protocol and formulation have proved to be effective and safe for desensitisation to albumin in the clinical case described.Multidisciplinary collaboration of the professionals involved has enabled treatment with post-paracentesis albumin to be considered a valid therapeutic strategy for patients in the same clinical situation.References and/or acknowledgementsNo conflict of interest.
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