Luis Carlos Saiz

• Pharmacy, PhD
• Researcher at Servicio Navarro de Salud

Some lifestyle habits and problematic behaviors have been associated to non-suicidal self-injury (NSSI) in adolescents in cross-sectional studies but their role as individual risk factors needs to be analyzed through proper longitudinal designs. The objective is to analyze and summarize the evidence on the association of lifestyle habits and proble...

Our analysis suggests that well-monitored warfarin might be equally good, or even better, for atrial fibrillation depending on the DOAC and outcome. Our analysis warrants granular investigations based on the COMBINE AF (A Collaboration between Multiple institutions to Better Investigate Non-vitamin K antagonist oral anticoagulant use in Atrial Fibr...

Las variables subrogadas requieren de una adecuada validación para acreditar su utilidad. No obstante, las autoridades sanitarias admiten variables con un nivel de exigencia progresivamente menor. Las aprobaciones aceleradas precisan de estudios confirmatorios que, con frecuencia, no se completan. La carga viral del VIH o la hipertensión arterial s...

INTRODUCTION When investigating drug efficacy, surrogate variables are becoming increasingly important. They are simpler and quicker to obtain than clinical variables, but only indirectly related to the effect of interest. The aim of this bulletin is to describe and reflect on the implications of adopting surrogate endpoints and accelerated approva...

https://pap.es/articulo/14258/conflicto-de-intereses-mas-vale-prevenir-que-declarar

Background: Chronic kidney disease (CKD) is an independent risk factor for cardiovascular disease, development of end-stage renal disease, and all-cause mortality. It affects around 10% of the population worldwide. The prevalence of hypertension in people with CKD ranges from 22% in stage 1 to 80% in stage 4. Elevated arterial blood pressure is on...

Objective To determine the efficacy and safety of CAR-T therapy in the treatment of patients with hematologic malignancies, in comparison with other current therapies. Design A living systematic review Methods We will include randomized trials evaluating the effect of CAR-T therapy versus other active treatments, hematopoietic stem cell transplanta...

PLEASE CONSIDER THE FOLLOWING KEY LIMITATION WHEN INTERPRETING THIS WORK: Considering the expected timings for developing immunity after vaccination, the immediate VE that we observed during the first week can be hardly attributed to the intervention, thus requiring careful interpretation. Similar findings were also observed in other studies analy...

LINKED CONTENT This article is linked to Leache et al papers. To view these articles, visit https://doi.org/10.1111/apt.17344 and https://doi.org/10.1111/apt.17531

During the last two years, vaccines against the SARS-CoV-2 virus have been extensively used in Spain and the rest of Europe undera conditional marketing authorization granted by the European Medicines Agency. The lack of previous clinical experience with these therapeutic tools, especially regarding those based on a novel mRNA technology, makes the...

Background: Chimeric antigen receptor T-cell (CAR-T) cell therapies have been claimed to be curative in responsive patients. Nonetheless, response rates can vary according to different characteristics, and these therapies are associated with important adverse events such as cytokine release syndrome, neurologic adverse events, and B-cell aplasia....

Objectives: N-Acetylcysteine (NAC) may confer protection against post-contrast acute kidney injury (PC-AKI), although evidence is sparse and conflicting. The objective was to analyse the evidence on the efficacy and safety of NAC vs no administration of NAC in preventing PC-AKI in patients with pre-existing kidney impairment undergoing a non-inter...

Purpose: Concomitant use of diuretics, renin-angiotensin-aldosterone system (RAAS) inhibitors, and non-steroidal anti-inflammatory drugs (NSAIDs) or metamizole, known as "triple whammy" (TW), has been associated with an increased risk of acute kidney injury (AKI). Nevertheless, there is still uncertainty on its impact in hospitalisation and mortal...

Background A randomized clinical trial assessing plasma rich in growth factors (PRGF) versus hyaluronic acid for knee osteoarthritis was published in 2012 (sponsor trial ID BTI-01-EC/07/ART). Evidence of misreporting was discovered following access to unpublished materials. In accordance with the principles of the Restoring Invisible and Abandoned...

Objective The FOURIER trial showed a benefit of the PCSK9 inhibitor evolocumab over placebo with respect to cardiovascular outcomes in patients with cardiovascular disease. However, we observed some inconsistencies between the information in the Clinical Study Report (CSR) and that in the 2017 primary trial results publication. We aimed to restore...

Introduction Albumin is used in multiple situations in patients with cirrhosis, but the evidence of its benefit is not always clear. The aim was to synthesise the evidence on the efficacy and safety of albumin compared to other treatments or no active intervention in cirrhotic patients. Materials and Methods We conducted a systematic review includ...

Background: This is the third update of the review first published in 2017. Hypertension is a prominent preventable cause of premature morbidity and mortality. People with hypertension and established cardiovascular disease are at particularly high risk, so reducing blood pressure to below standard targets may be beneficial. This strategy could re...

Background: Thiopurines' toxicity often leads to dose reduction or discontinuation. This systematic review aims to synthesize the evidence on the effect of genotype-based dosing of thiopurines on treatment efficacy and safety in inflammatory bowel disease (objective #1), and the association between genotype status and the efficacy and safety profi...

Is chimaeric antigen receptor T-cell therapy really superior to standard of care as second-line therapy for large B-cell lymphoma? We have read with great interest the systematic review with the meta-analysis by Shargian et al., where chimaeric anti-gen receptor T-cell (CAR-T) therapies have been compared to standard of care (SoC) as second-line tr...

Background: “Triple whammy” (TW) refers to the simultaneous use of diuretics, renin-angiotensin-aldosterone system inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs). To date, the risk of developing acute kidney injury (AKI) associated to this combination has not been deeply investigated. The objectives are to analyze the incidence of AKI...

Objectives: To investigate concerns surrounding the benefits of antiresorptive drugs in older adults, a systematic review was carried out to evaluate the efficacy of these treatments in the prevention of osteoporotic hip fractures in older adults. Design: a systematic review and meta-analysis of randomized clinical trials. Setting and participa...

Objective: To compare the effects of intensive vs standard blood pressure (BP) targets on the mortality of hypertensive patients with chronic renal disease. Design and method: A bibliographic search of all relevant databases was carried out without restriction by language, year of publication or publication status.We considered randomized contro...

Background: “Triple whammy” (TW) refers to the simultaneous use of diuretics, renin-angiotensin-aldosterone system inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs). To date, the risk of developing acute kidney injury (AKI) associated to this combination has not been deeply investigated. The objectives are to analyze the incidence of AKI...

Resumen Las caídas en el medio hospitalario son un importante problema de salud por su alta prevalencia y sus consecuencias físicas, funcionales, psicológicas o económicas. Desde los años noventa se han desarrollado diferentes escalas de valoración del riesgo de caídas para detectar a los pacientes de alto riesgo, y que se aplican también en el med...

Background: Although intermittent androgen deprivation therapy was introduced many years ago to improve patients' quality of life with the same carcinologic efficiency as continuous hormonal therapy, recent data suggest that those patients could be overtreated. This study aims to estimate the prevalence of prostate cancer patients receiving intermi...

Objective: To determine the efficacy and safety of CAR-T therapy in the treatment of patients with hematologic malignancies, in comparison with other current therapies. Design: A living systematic review. Methods: We will include randomized trials evaluating the effect of CAR-T therapy versus other active treatments, hematopoietic stem cell transpl...

INTRODUCCIÓN El suicidio es un problema de salud pública en población infantil y adolescente, siendo una de las principales causas de mortalidad en este rango de edad. A partir de los años 1990, con la introducción de nuevas clases de antidepresivos, comenzó a extenderse la preocupación sobre el riesgo de tendencias suicidas asociado al consumo de...

Background: Although intermittent androgen deprivation therapy was introduced many years ago to improve patients’ quality of life with the same carcinologic efficiency as continuous hormonal therapy, recent data suggest that intermittency could be underutilised. This study aims to estimate the prevalence of prostate cancer patients receiving interm...

Background Patients with advanced pancreatic cancer (PC) have a high risk of dying in the short or medium-term. This overview aimed to assess the evidence regarding systemic oncological treatments (SOT) versus supportive care for advanced PC. Methods We searched for systematic reviews (SRs) in MEDLINE, Embase, The Cochrane Library, Epistemonikos,...

(1) Background: Attention deficit hyperactivity disorder (ADHD) constitutes one of the leading mental health and behavioral disorders in childhood and adolescence. The main objective of this study was to analyze the time trend in the incidence of ADHD diagnoses in Navarre (Spain) from 2003 to 2019 in children and adolescents from 5 to 19 years old....

Background: Lower respiratory tract infections (LRTIs) are one of the leading causes of infectious disease mortality worldwide. The aims of the study were to determine the incidence of hospitalizations due to LRTIs, and to analyze the clinical outcomes of the hospitalized patients. Methods: An observational study of hospitalizations due to LRTIs...

INTRODUCCIÓN El suicidio es un problema de salud pública en población infantil y adolescente, siendo una de las principales causas de mortalidad en este rango de edad. A partir de los años 1990, con la introducción de nuevas clases de antidepresivos, comenzó a extenderse la preocupación sobre el riesgo de tendencias suicidas asociado al consumo de...

INTRODUCTION Suicide is a public health problem in the infant and adolescent population and is one of the leading causes of death in that age range. Since the introduction of new classes of antidepressants in the early 1990s, concerns about the risk of suicidality associated with the use of these drugs in children and adolescents began to appear. S...

IDEAS CLAVE - Hasta la fecha, el uso de corticoides (en especial dexametasona) es la única terapia que ha mostrado reducir la mortalidad en pacientes graves de Covid-19. - Remdesivir (RDV) ha recibido una autorización condicional de comercialización en Europa para tratar la Covid-19 en adultos y adolescentes que presenten neumonía y necesidad de ap...

KEY MESSAGES • At present, corticosteroids (particularly dexamethasone) are the only useful drug therapy in terms of mortality reduction in severe Covid-19 patients. • Remdesivir (RDV) has been granted in Europe with a conditional marketing authorisation for the treatment of Covid-19 in adults and adolescents with pneumonia requiring supplemental o...

Background: High blood pressure constitutes one of the leading causes of mortality and morbidity all over the world. At the same time, heavy drinking increases the risk for developing cardiovascular diseases, including cardiomyopathy, hypertension, atrial arrhythmias, or stroke. Several studies have already assessed specifically the relationship b...

Background: This is the second update of the review first published in 2017. Hypertension is a prominent preventable cause of premature morbidity and mortality. People with hypertension and established cardiovascular disease are at particularly high risk, so reducing blood pressure to below standard targets may be beneficial. This strategy could r...

La pandemia por COVID-19 ha generado una crisis a todos los niveles, desde el sanitario hasta el económico, laboral y social. Los sistemas sanitarios han mostrado una enorme capacidad de adaptación a las necesidades, que han requerido de rápidas actuaciones. Realizar un análisis de la situación es esencial para redimensionar las necesidades y hacer...

KEY POINTS • At the moment there is no effective treatment for COVID-19 adequately validated. • Chloroquine and hydroxychloroquine have been effective in vitro against COVID-19 but the available data do not confirm their usefulness from a clinical perspective • Nowadays, we have information from four clinical trials (one not published yet) and seve...

IDEAS CLAVE • Actualmente no existe un tratamiento efectivo bien validado para el COVID-19. • La cloroquina e hidroxicloroquina han mostrado eficacia in vitro frente al COVID-19 pero hasta el momento los datos disponibles no confirman su utilidad en la clínica. • Actualmente disponemos de información procedente de cuatro ensayos clínicos (uno aún n...

OBJECTIVE To evaluate the results of clinical trials in which direct oral anticoagulants are used for indications different from non-valvular atrial fibrillation and hip or knee replacement surgery. CONCLUSIONS Rivaroxaban had a higher incidence of thromboembolic events than warfarin in patients with antiphospholipid syndrome. The trial was termina...

Objetivo Evaluar los resultados de los ensayos clínicos con anticoagulantes orales de acción directa (ACODs) en otras indicaciones diferentes a fibrilación auricular no valvular y cirugía de remplazo de cadera o rodilla. Conclusiones El rivaroxabán presentó mayor incidencia de eventos tromboembólicos que la warfarina en pacientes con síndrome antif...

IDEAS CLAVE - Actualmente no existe un tratamiento efectivo adecuadamente validado para el COVID-19 - La invitación a interrumpir tratamientos con IECA o ARA-II a causa del temor a la infección por COVID-19, no presentan fundamento científico a fecha de hoy. - La literatura científica que avala utilizar IECA o ARA-II en pacientes hipertensos para...

IDEAS CLAVE - En la actualidad, todos los tratamientos frente al COVID-19 son experimentales y se desconoce su particular balance daño/beneficio. - La combinación de antivirales lopinavir-ritonavir (LPV/r) ha mostrado eficacia in vitro y en modelos animales frente a los virus SARS-CoV y MERS-CoV. - El estudio LOTUS China es el primer ensayo clínico...

KEY MESSAGES - At present, all treatments against COVID-19 are under assessment and their particular risk / benefit balance is unknown. - The antiviral combination lopinavir-ritonavir (LPV/r) has shown in vitro efficacy, as well as in animal models against SARS-CoV and MERS-CoV. - The LOTUS China study is the first clinical trial to explore the eff...

IDEAS CLAVE - Actualmente no existe un tratamiento efectivo bien validado para el COVID-19. - Tocilizumab (TCZ) está autorizado en España para pacientes con afectación grave del síndrome de liberación de citoquinas (SLC) inducido por células T-CAR. - No existen ensayos clínicos con resultados disponibles acerca del uso de TCZ en pacientes con COVID...

KEY MESSAGES - Currently there is no effective treatment well validated for COVID-19. - Tocilizumab (TCZ) is authorized in Spain for patients with severe cytokine release syndrome (CRS) induced by CAR-T cells. - There are no clinical trials with available results on the use of TCZ in patients with COVID-19. - The study by Xu et al. has major limita...

As attentive readers of your prestigious journal, we are deeply concerned by a potentially serious case of misreporting affecting Arthroscopy. Early in 2019, our publicly funded research team was commissioned to assess the evidence on platelet-rich plasma and analogues in traumatology. We retrieved, among the appraised publications, the high-impact...

Background: This is the first update of a review originally published in 2017. Starting with one drug and starting with a combination of two drugs are strategies suggested in clinical guidelines as initial treatment of hypertension. The recommendations are not based on evidence about clinically relevant outcomes. Some antihypertensive combinations...

Purpose: To examine the association between use of methylphenidate and the risk for valvular heart disease (VHD) in the Spanish primary care database BIFAP. Methods: Case-control study nested in a cohort of patients aged 5 to 25 years between 2002 and 2014, based in a general practice research database. Cases were people with a validated diagnos...

The COVID-19 pandemic has generated a crisis at all levels, from health sector to the economic, working and social fields. Health systems have shown an enormous capacity to adapt to the needs, which have required rapid actions. To carry out an analysis of the situation is essential to resize needs and make a more efficient use of available resource...

We have read the article entitled Sacubitril–valsartan in heart failure and multimorbidity patients by Raquel Rodil et al.(1) First, it drew our attention that table 1 reads that 13 individuals were dead at baseline out of 65 included patients. No drop outs were reported and results of all 65 patients were shown (table 2), which also challenges th...

En los últimos años se ha observado un incremento considerable de las determinaciones y de la suplementación de vitamina D. Sin embargo, existe gran incertidumbre acerca de su beneficio clínico en situaciones diferentes a osteomalacia y raquitismo. Objetivo: Evaluar el papel de la monitorización y suplementación de la vitamina D en diferentes grup...

Objetivo: El perfil de seguridad de canagliflozina ha ido evolucionando desde su comercialización en España. La finalización de ensayos clínicos y los programas de farmacovigilancia han generado nuevas evidencias de seguridad. El objetivo de nuestro estudio fue describir las sospechas de reacciones adversas (RAM) con canagliflozina, sola o en combi...

Background: This is the first update of the review published in 2017. Hypertension is a prominent preventable cause of premature morbidity and mortality. People with hypertension and established cardiovascular disease are at particularly high risk, so reducing blood pressure to below standard targets may be beneficial. This strategy could reduce c...

Objetivo: Examinar críticamente la evidencia científica de las distintas estrategias de deshabituación tabáquica, con atención especial a los resultados de seguridad obtenidos en el reciente ensayo EAGLES. Métodos: Se llevó a cabo una búsqueda bibliográfica actualizada a Noviembre 2017 sobre terapia sustitutiva de nicotina, bupropión y vareniclina...

Objective: To carry out an in-depth analysis of the evolution and current management of ADHD, paying attention to the neurobiological model narrative, statistical data, information on drug efficacy and safety, trends in adult population and non-pharmacological alternatives. Methods: A bibliographical search was carried out (December 2017) on ADHD...

Background: Hypertension is a prominent preventable cause of premature morbidity and mortality. People with hypertension and established cardiovascular disease are at particularly high risk, so reducing blood pressure below standard targets may be beneficial. This strategy could reduce cardiovascular mortality and morbidity but could also increase...

Oral anti-diabetic drugs (OADs) have been associated with community-acquired pneumonia (CAP). We aimed to validate the recording of CAP in the Spanish Database for Pharmacoepidemiological Research in Primary Care (BIFAP) for the future evaluation of OAD–CAP association. The incidence rate (IR/1000 person-years) of CAP in type 2 diabetes mellitus (T...

A Cochrane systematic review on immediate-release methylphenidate for adults with attention deficit hyperactivity disorder (ADHD) was withdrawn from the Cochrane Library on 26 May 2016 after substantial criticism of its methods and flawed conclusions. Retraction of scientific papers on this basis is unusual but can be necessary. We provide a summar...

Background: In January 2014, the EMA's Pharmacovigilance Risk Assessment Committee recommended that strontium ranelate no longer be used for osteoporosis. However, EMA's Committee for Medicinal Products for Human Use decided to restrict its use rather than ban it. Starting from this fact, evidence of drugs for fracture prevention over the last 30 y...

Aim: To evaluate the association between use of different oral antidiabetic agents (OAD) and the risk of community-acquired pneumonia (CAP) in patients with type-2 diabetes (T2DM). Methods: Case-control study nested in a cohort of patients with T2DM and use of OAD between 2002-2013, based in a Spanish general practice research database. Cases we...

Objective: To critically appraise the EMPA-REG OUTCOME trial and identify the appropriate place of the antidiabetic drug empagliflozin in therapeutics. Methods: A review was performed of the data provided in the main journal publication, supplementary appendix and different versions of the protocol, all published in The New England Journal of Med...

Background: Starting with one drug and starting with a combination of two drugs are strategies suggested in clinical guidelines as initial treatment of hypertension. The recommendations are not based on evidence about clinically relevant outcomes. Some antihypertensive combinations have been shown to be harmful. The actual harm-to-benefit balance o...

Background: Elevated levels of total cholesterol and low-density lipoprotein play an important role in the development of atheromas and, therefore, in cardiovascular diseases. Cholesterol biosynthesis follows a circadian rhythm and is principally produced at night (between 12:00 am and 6:00 am). The adjustment of hypolipaemic therapy to biologic r...

La talidomida fue un fármaco comercializado entre los a˜nos1957 y 1963 para el tratamiento de las náuseas durante los 3 prime-ros meses del embarazo. Su uso se asoció con importantes efectosteratogénicos, especialmente focomelia, y fue retirado del mercado.Espa˜na fue uno de los últimos países en suspender su comerciali-zación. Hasta ese momento no...

Unethical behaviours causing different types of bias have been extensively reported in biomedical literature. At the same time, quality of systematic reviews can be affected by misconduct in primary publications. Objective: To describe several cases of serious duplicate publication detected as a result of a Cochrane review, raising potential synerg...

To describe several cases of serious duplicate publication detected as a result of a Cochrane Review, raising potential synergies between publishers and Cochrane.

Objetivo: Examinar en profundidad los hallazgos del ensayo EMPA-REG OUTCOME, describiendo los factores decisivos que pueden ayudar a establecer un adecuado lugar en la terapéutica del antidiabético empagliflozina. Métodos: Se analiza la información contenida en el artículo principal, apéndice suplementario y sucesivas versiones del protocolo, publ...

To determine if ’Lower’ blood pressure targets (≤135/85mmHg) are associated with reduction in mortality, morbidity and serious adverse events compared with ’Standard’ blood pressure targets (≤140-160/90-100mmHg) inhypertensive adult patients with established cardiovascular disease. In addition to the lack of benefit in total or cardiovascular morta...

The IMPROVE-IT trial does not provide sufficient evidence supporting the use of ezetimibe in combination with a statin for ACS Overtreatment risk with ezetimibe should be seriously considered and actively managed

Objective: to carry out a critical analysis of the evolution and management of Attention Deficit Hyperactive Disorder (ADHD), through a revision of its historical perspective, the aspects regarding drug efficacy and safety, alternative approaches to management and a focus from a social sciences perspective. Methods: a bibliographical research was c...

Atentos al déficit de atención (TDAH) Entre la naturaleza incierta y la prescripción hiperactiva " There is no greater power than the right to define the question " John McKnight, 1995 Luis CarLos saiz fErnándEz Coordinador de investigación en farmacoterapia sº Prestaciones farmacéuticas. sns-o NOV-DIC 2013 VOLUMEN 21, Nº 5 www.bit.navarra.es @BITN...

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This is the protocol for a review and there is no abstract. The objectives are as follows: To determine if there are differences in clinical outcomes between monotherapy and combination therapy when used as initial treatment for primary hypertension.

This is the protocol for a review and there is no abstract. The objectives are as follows:To determine if 'lower' blood pressure targets (? 135/85 mmHg) are associated with reduction in mortality and morbidity as compared with 'standard' blood pressure targets (? 140-160/ 90-100 mmHg) in the treatment of patients with hypertension and a history of...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of interventions to reduce alcohol intake for controlling hypertension in hypertensive people. © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Objective To determine the percentage of new Specialist Healthcare prescriptions received and modified by Primary Healthcare physicians.DesignDescriptive, cross-sectional and multi-centre study with the participation of Primary Healthcare physicians from one Madrid Health Area during 2 months. A method was established for registering the origin of...

To determine the percentage of new Specialist Healthcare prescriptions received and modified by Primary Healthcare physicians. Descriptive, cross-sectional and multi-centre study with the participation of Primary Healthcare physicians from one Madrid Health Area during 2 months. A method was established for registering the origin of the new prescri...

The American Journal of Gastroenterology is published by Nature Publishing Group (NPG) on behalf of the American College of Gastroenterology (ACG). Ranked the #1 clinical journal covering gastroenterology and hepatology*, The American Journal of Gastroenterology (AJG) provides practical and professional support for clinicians dealing with the gastr...

To evaluate the results of a plan for improving pharmacy indicators in a Primary Care (PC) Health Area. Quasi-experimental study with a control group. The differences between the pre-intervention (Jan-Dec 2007) and post-intervention (Jan-Dec 2008) periods were evaluated. Intervention group: Primary Care doctors from PC Area 7 of the Community of Ma...

The treatment of tuberculosis usually includes the antibiotic rifampicin, especially in patients with concomitant human immunodeficiency virus infection. Some of these patients are in withdrawal therapy for drug abuse. When opiate screening is carried out in patients receiving rifampicin, false positive results are detected with the kinetic interac...