Novel Genetic Variants Explaining Severe Adverse Drug Events after Clinical Implementation of Genotype-Guided Therapy with Fluoropyrimidines: An Observational Study.

Fluoropyrimidines (FPs) are commonly prescribed in many cancer streams. The EMA and FDA-approved drug labels for FPs recommend genotyping the *2A (rs3918290), *13 (rs55886062), *HapB3 (rs56038477), alleles, and rs67376798 before treatment starts. We implemented the genotyping in our daily clinical routine, but we still found patients showing severe adverse drug events (ADEs) to FPs.

Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate.

Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in the treatment of COVID-19. They have been used massively worldwide. One of the major inconveniences of these vaccines is related to pharmaceutical stability issues.

Gut Microbiota Composition Can Predict Colonization by Multidrug-Resistant Bacteria in SARS-CoV-2 Patients in Intensive Care Unit: A Pilot Study.

The SARS-CoV-2 infection has increased the number of patients entering Intensive Care Unit (ICU) facilities and antibiotic treatments. Concurrently, the multi-drug resistant bacteria (MDRB) colonization index has risen. Considering that most of these bacteria are derived from gut microbiota, the study of its composition is essential.

Pharmacogenetics of siponimod: A systematic review.

Multiple sclerosis is a chronic inflammatory neurological disease, and siponimod (Mayzent) is the first oral treatment option for adult patients with secondary progressive multiple sclerosis. We performed a systematic review of the pharmacogenetics of Siponimod, and we found that (430 C>T; rs1799853) and CYP2C9 * 3 (1075 A>C; rs1057910), both translated no-function alleles, have been related to a lower metabolism of siponimod by CYP2C9 enzyme. The FDA-approved drug label and EMA risk management plan for siponimod require testing patients for CYP2C9 genotype before treatment starts.

Historical exposure to persistent organic pollutants and cardiovascular disease: A 15-year longitudinal analysis focused on pharmaceutical consumption in primary care.

Background: Despite restrictions on their production and use, most of the population is still exposed to Persistent Organic Pollutants (POPs), including organochlorine pesticides (OCPs) and polychlorinated biphenyls (PCBs). These chemicals are thought to contribute to the aetiology of highly prevalent chronic conditions, such as cardiovascular diseases (CVDs), although current evidences are still controversial.

Objectives: To explore the potential contribution of historical POP exposure to 15-year pharmaceutical consumption in relation to CVD.

Dalbavancin is a novel antimicrobial against Gram-positive pathogens: clinical experience beyond labelled indications.

Very limited labelled indications have been approved for the newer antimicrobials. Data on the clinical uses, efficacy and safety of dalbavancin are scarce, thus here we sought to describe our clinical experience. 16-month observational prospective study was performed.

Evaluation of quality indicators for nutrition and metabolism in critically ill patients: role of the pharmacist.

Objective: To assess compliance in a Spanish intensive care unit (ICU) with 8 of the 13 quality indicators of the Spanish Society of Intensive Medicine and Coronary Units (Sociedad Española de Medicina Intensiva y Unidades Coronarias, SEMICyUC) related to nutrition and metabolism in critically ill patients.

Patients And Methods: The study included all patients over 18 years of age with an ICU stay of >48 hours between January and May 2019. The pharmacist was integrated into the daily activity of the multidisciplinary team of a 20-bed ICU to monitor and carry out the control of the quality indicators of the SEMICyUC.

Intact charge variant analysis of ziv-aflibercept by cationic exchange liquid chromatography as a proof of concept: Comparison between volatile and non-volatile salts in the mobile phase.

Ziv-aflibercept (ziv-AFL) is a complex fusion protein which is widely used in hospitals for the treatment of colorectal metastatic cancer. Charge variants are critical attributes for assessing post-transitional modifications (PMTs) that have to be controlled during the development and manufacture of these proteins and until their administration to patients. Cation exchange (CEX) chromatography is a charge-sensitive analytical method that is well suited for analysing charge variants in proteins.

Impact of single nucleotide polymorphisms on the efficacy and toxicity of EGFR tyrosine kinase inhibitors in advanced non-small cell lung cancer patients.

EGFR tyrosine kinase inhibitors (EGFR-TKIs) are the treatment of choice for advanced-stage (IIIB-IV) NSCLC patients with mutations in EGFR. However, EGFR-TKIs clinical outcomes vary from person to person and these inter-individual differences may be due to genetic factors such as single nucleotide polymorphisms (SNPs). SNPs in genes involved in EGFR-TKIs pharmacodynamics, metabolism and mechanism of action have been demonstrated to be associated with response, survival and toxicity in advanced NSCLC patients treated with EGFR-TKIs.

Cutaneous leishmaniasis associated with TNF-α blockers: a case report.

Leishmaniasis is a chronic protozoan disease that is found in diverse geographical areas of the world. spp. are endemic in the Mediterranean coasts of southern Europe.

Pharmacogenetics in the Treatment of Cardiovascular Diseases and Its Current Progress Regarding Implementation in the Clinical Routine.

There is a special interest in the implementation of pharmacogenetics in clinical practice, although there are some barriers that are preventing this integration. A large part of these pharmacogenetic tests are focused on drugs used in oncology and psychiatry fields and for antiviral drugs. However, the scientific evidence is also high for other drugs used in other medical areas, for example, in cardiology.

Trends in endpoint selection and result interpretation in advanced non-small cell lung cancer clinical trials published between 2000 and 2012: A retrospective cohort study.

Background: The objective of this review was to investigate trends in clinical trial design, specifically, the primary outcomes used, interpretation of results, and the magnitude of the benefits described in phase III controlled clinical trials in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Methods: Seventy-six trials published between 2000 and 2012 were selected from a total of 122 identified in a structured search.

Results: Overall survival (OS) was evaluated as the primary study endpoint in 50 (65.

Extravasation accidents with liposomal/liposomal pegylated anthracyclines treated with dexrazoxane: an overview and outcomes.

The extravasation of chemotherapeutic agents is a challenge for oncologic care teams. The management of nonliposomal (conventional) anthracyclines is well established in clinical practice guidelines, including general measures and specific antidotes, such as dexrazoxane. However, there is little scientific evidence on the management of liposomal and pegylated liposomal anthracyclines.

Pomalidomide in the treatment of multiple myeloma: design, development and place in therapy.

Multiple myeloma is a very heterogeneous disease with variable survival. Despite recent progress and the widespread use of new agents, patients with relapsed and refractory disease have a poor outcome. Immunomodulatory drugs play a key role in both the front-line and the relapsed/refractory setting.

Antidiabetic medications use trends in an Andalusian region from 2001 to 2014.

Purpose: There is a widening range of antidiabetic medications available; however changes in consumption patterns remain poorly documented. The aim of this study is to analyze the evolution of consumption of antidiabetic medications during the period 2001-2014 in an Andalusian region.

Methods: All antidiabetic medicines on the market were selected for analysis.

The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent.

This article contains data related to the research article entitled "Results of genotype-guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent" (J. Sánchez-Ramos, C.L.

Effects of a primary care intervention to improve the quality of zolpidem prescriptions in elderly patients.

Purpose: The objective of this study was to measure the impact of an intervention on the prescription habits of general practitioners (GPs) in order to improve the quality of zolpidem prescriptions in patients aged 75 or older.

Methods: A prospective multicentric non-randomized trial was performed in the Metropolitan Granada Primary Healthcare Area (Andalusian Public Healthcare Service, Spain), which serves a total population of approximately 675,000 inhabitants. All health centers volunteering to participate in the trial were included.

Results of genotype-guided antiplatelet therapy in patients who undergone percutaneous coronary intervention with stent.

Background: Clopidogrel has provided beneficial effects in acute coronary syndrome and percutaneous coronary intervention. Different polymorphisms have been associated with differences in clopidogrel response. The aim of this study was to check if CYP2C19/ABCB1-genotype-guided strategy reduces the rates of cardiovascular events and bleeding.

Genetic polymorphisms influence on the response to clopidogrel in peripheral artery disease patients following percutaneous transluminal angioplasty.

Aim: To study the association of ABCB1 and CYP2C19 polymorphisms and the clopidogrel response in Spanish peripheral artery disease patients following percutaneous transluminal angioplasty (PTA) and to perform a meta-analysis.

Materials & Methods: 72 patients were recruited and 122 patients included in the meta-analysis. We evaluated the effect of ABCB1 3435 C>T, CYP2C19*2 and CYP2C19*3 and primary end point (restenosis/occlusion of the treated lesions) during 12 months after PTA.

Trends in phase III randomized controlled clinical trials on the treatment of advanced non-small-cell lung cancer.

The objective of this review was to analyze trends in outcomes and in the quality of phase III randomized controlled trials on advanced NSCLC published between 2000 and 2012, selecting 76 trials from a total of 122 retrieved in a structured search. Over the study period, the number of randomized patients per trial increased by 14 per year (P = 0.178).

A New Pharmacogenetic Algorithm to Predict the Most Appropriate Dosage of Acenocoumarol for Stable Anticoagulation in a Mixed Spanish Population.

There is a strong association between genetic polymorphisms and the acenocoumarol dosage requirements. Genotyping the polymorphisms involved in the pharmacokinetics and pharmacodynamics of acenocoumarol before starting anticoagulant therapy would result in a better quality of life and a more efficient use of healthcare resources. The objective of this study is to develop a new algorithm that includes clinical and genetic variables to predict the most appropriate acenocoumarol dosage for stable anticoagulation in a wide range of patients.

Medication reconciliation at admission to surgical departments.

Rationale, Aims And Objectives: We aim to determine the prevalence of reconciliation errors (REs) at admission to surgery departments, report their potential clinical impact and analyse possible risk factors.

Methods: Prospective observational study was conducted for 8 months in a regional public hospital in Spain. The study included patients consecutively hospitalized in the Department of Orthopedic Surgery and Traumatology or Department of Angiology and Vascular Surgery from May through December 2010.

Influence of the HER2 Ile655Val polymorphism on trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients: a meta-analysis.

Background: The HER2 655 A>G genetic variant has recently been associated with trastuzumab-induced cardiotoxicity in HER2 breast cancer patients. Considering previous results, the aim of our study was to validate the role of this polymorphism as a predictor of the cardiac toxicity of trastuzumab in breast cancer patients.

Methods: Our study population was composed of 78 HER2 breast cancer patients receiving trastuzumab.