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1.
Eur J Clin Pharmacol ; 76(3): 305-318, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31865412

RESUMO

PURPOSE: In recent decades, the life expectancy of HIV-infected patients has increased considerably, to the extent that the disease can now be considered chronic. In this context of progressive aging, HIV-infected persons have a greater prevalence of comorbid conditions. Consequently, they usually take more non-antiretroviral drugs, and their drug therapy are more complex. This supposes a greater risk of drug interactions, of hospitalization, falls, and death. In the last years, deprescribing has gained attention as a means to rationalize medication use. METHODS: Review of the different therapeutic approach that includes optimization of polypharmacy and control and reduction of potentially inappropriate prescription. RESULTS: There are several protocols for systematizing the deprescribing process. The most widely used tool is the Medication Regimen Complexity Index, an index validated in HIV-infected persons. Anticholinergic medications are the agents that have been most associated with major adverse effects so, various scales have been employed to measure it. Other tools should be employed to detect and prevent the use of potentially inappropriate drugs. Prioritization of candidates should be based, among others, on drugs that should always be avoided and drugs with no justified indication. CONCLUSIONS: The deprescribing process shared by professionals and patients definitively would improve management of treatment in this population. Because polypharmacy in HIV-infected patients show that a considerable percentage of patients could be candidates for deprescribing, we must understand the importance of deprescribing and that HIV-infected persons should be a priority group. This process would be highly feasible and effective in HIV-infected persons.

2.
J Investig Med ; 2019 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-31852749

RESUMO

Previous studies have shown the potential of microRNAs (miRNA) in the pathological process of stroke and functional recovery. Bone marrow mononuclear cell (BM-MNC) transplantation improves recovery in experimental models of ischemic stroke that might be related with miRNA modifications. However, its effect on circulating miRNA has not been described in patients with stroke. We aimed to evaluate the circulating levels of miRNAs after autologous BM-MNC transplantation in patients with stroke. We investigate the pattern of miRNA-133b and miRNA-34a expression in patients with ischemic stroke included in a multicenter randomized controlled phase IIb trial (http://www.clinicaltrials.gov; unique identifier: NCT02178657). Patients were randomized to 2 different doses of autologous intra-arterial BM-MNC injection (2×106/kg or 5×106/kg) or control group within the first 7 days after stroke onset. We evaluate plasma concentration of miRNA-113b and miRNA-34a at inclusion and 4, 7, and 90 days after treatment. Thirteen cases (8 with 2×106/kg BM-MNC dose and 5 with 5×106/kg dose) and 11 controls (BM-MNC non-treated) were consecutively included. Mean age was 64.1±12.3 with a mean National Institutes of Health Stroke Scale score at inclusion of 14.5. Basal levels of miRNA were similar in both groups. miR-34a-5p and miR-133b showed different expression patterns. There was a significant dose-dependent increase of miRNA-34a levels 4 days after BM-MNC injection (fold change 3.7, p<0.001), whereas miRNA-133b showed a significant increase in the low-dose BM-MNC group at 90 days. Intra-arterial BM-MNC transplantation in patients with ischemic stroke seems to modulate early circulating miRNA-34a levels, which have been related to precursor cell migration in stroke and smaller infarct volumes.

3.
Medicine (Baltimore) ; 98(42): e17528, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31626113

RESUMO

BACKGROUND: Extra virgin olive oil (EVOO) has shown beneficial effects on the lipid profile and inflammatory parameters in general population. Our goal is to analyze these changes together with those of intestinal microbiota in human immunodeficiency virus (HIV)-infected patients over 50 years of age. METHODS: Experimental single arm open study. HIV patients over the age of 50 with undetectable viral load were selected. EVOO was distributed among the patients so that each one consumed 50 g daily for 12 weeks. Lipid profile, C-reactive protein (CRP), and intestinal microbiota composition were analyzed at the beginning and at the end of the intervention. RESULTS: Total cholesterol decreased significantly (5 mg/dL), and a nonsignificant decrease in low-density lipoprotein cholesterol (12 mg/dL), triglycerides (21 mg/dL), and CRP (1.25 mg/dL) was observed. There was a significant increase in alpha diversity after the intervention in men and a decrease in proinflammatory genera such as Dethiosulfovibrionaceae was observed. Differences were also observed in the microbiota of men and women and according to the type of antiretroviral treatment. CONCLUSION: Sustained consumption of 50 g of EVOO in elderly HIV-infected patients might be associated with an improvement in lipid profile and alfa diversity of intestinal microbiota.


Assuntos
Microbioma Gastrointestinal/efeitos dos fármacos , Infecções por HIV/sangue , Infecções por HIV/microbiologia , Lipídeos/sangue , Azeite de Oliva/administração & dosagem , Idoso , Antirretrovirais/uso terapêutico , Proteína C-Reativa/análise , Colesterol/sangue , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Dieta/métodos , Feminino , HIV , Humanos , Masculino , Pessoa de Meia-Idade , Triglicerídeos/sangue
4.
Infect Dis (Lond) ; 51(9): 691-693, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31272264

RESUMO

Introduction: Generic drugs are helpful to enhance the efficiency of the sanitary system. A generic coformulation of abacavir (ABC) and lamivudine (3TC) is available since 2016 in Spain. A report of our experience with its use is exposed. Methods: Patients between February 2017 and June 2017 who were taking Triumeq® were switched to the generic ABC + 3TC plus DTG. Efficacy, safety, reasons for discontinuation and costs savings were evaluated at 48 weeks. Results: Switch was made in 93 patients, with a median age of 47 years and a mean time of 12.33 years with HIV infection. Six patients (6.5%) discontinued the new ART, being toxicity of the central nervous system the most frequent reason. The effective saving derived from the change after 1 year of treatment was 151.127 €. Conclusions: The change from Triumeq® to a generic regimen of ABC + 3TC and another pill of DTG seems to be safe and efficient at 48 weeks.

5.
Oncotarget ; 10(44): 4598-4608, 2019 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-31360307

RESUMO

Objectives: There are controversies regarding the long-term oncological safety of preservation of pelvic innervation during radical hysterectomy (RH). This study aimed to analyze the feasibility and safety of nerve-sparing radical hysterectomy (NSRH) for cervical cancer compared with non-NSRH following 17 years of experience in a tertiary cancer referral center. Materials and Methods: Between May 1999 and June 2016, all patients who underwent RH for cervical cancer were followed-up prospectively. Comparison analyses regarding surgical outcomes, complications, overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) were performed between patients treated with NSRH and non-NSRH. Results: A total of 188 patients were included (113 non-NSRH and 75 NSRH). The median follow-up was 112 months. Estimated blood loss and hospital stay were all significantly lower in the NSRH group. Overall intraoperative complication rate (p = 0.02) and need for transfusion (p = 0.016) were lower in the NSRH group. There were no differences in the median operation time, OS, DFS, CSS, or recurrence rates between the NSRH and non-NSRH group. Conclusions: Our study provides a wide perspective on the developments of nerve-sparing procedures for the management of women with early-stage cervical cancer. Our results suggest that NSRH is a feasible and safe procedure, with reduced morbidity outcomes.

6.
BMC Infect Dis ; 19(1): 291, 2019 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-30922322

RESUMO

BACKGROUND: Streptococcus tigurinus was recently described as a new streptococcal species within the viridans group streptococci (VGS). The objectives of the present work were to analyse the clinical and microbiological characteristics of S. tigurinus isolated from patients with bacteraemias, to determine the prevalence of S. tigurinus among VGS endocarditis in Spain, and to compare the clinical characteristics and outcomes of endocarditis caused by S. tigurinus and other VGS. METHODS: Retrospective nationwide study, performed between 2008 and 2016 in 9 Spanish hospitals from 7 different provinces comprising 237 cases of infective endocarditis. Streptococcal isolates were identified by sequencing fragments of their 16S rRNA, sodA and groEL genes. Clinical data of patients with streptococcal endocarditis were prospectively collected according to a pre-established protocol. RESULTS: Patients with endocarditis represented 7/9 (77.8%) and 26/86 (30.2%) of the bacteraemias caused by S. tigurinus and other VGS, respectively (p < 0.001), in two of the hospital participants. Among patients with streptococcal endocarditis, 12 different Streptococcus species were recognized being S. oralis, S. tigurinus and S. mitis the three more common. No relevant statistical differences were observed in the clinical characteristics and outcomes of endocarditis caused by the different VGS species. CONCLUSIONS: In this multicenter study performed in Spain, S. tigurinus showed a higher predilection for the endocardial endothelium as compared to other VGS. However, clinical characteristics and outcomes of endocarditis caused by S. tigurinus did not significantly differ from endocarditis caused by other oral streptococci.


Assuntos
Endocardite Bacteriana/diagnóstico , Endocardite Bacteriana/epidemiologia , Infecções Estreptocócicas/diagnóstico , Infecções Estreptocócicas/epidemiologia , Estreptococos Viridans/isolamento & purificação , Adulto , Idoso , Idoso de 80 Anos ou mais , Bacteriemia/diagnóstico , Bacteriemia/epidemiologia , Bacteriemia/microbiologia , Endocardite Bacteriana/microbiologia , Monitoramento Epidemiológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Espanha/epidemiologia , Infecções Estreptocócicas/complicações , Infecções Estreptocócicas/microbiologia , Estreptococos Viridans/classificação , Estreptococos Viridans/fisiologia , Adulto Jovem
7.
JMIR Mhealth Uhealth ; 7(3): e9904, 2019 03 06.
Artigo em Inglês | MEDLINE | ID: mdl-30839281

RESUMO

BACKGROUND: New technologies can promote knowledge of HIV infection among patients suffering from this disease. Older patients with HIV infection represent an increasingly large group that could benefit from the use of specific apps. OBJECTIVE: The aim of the study was to observe the acceptability and use of a mobile app on HIV infection in patients at least 60 years old and offer them the possibility of anonymously establishing contact with their peers. METHODS: A series of clinical and psychosocial parameters were studied in 30 HIV-infected patients of over 60 years. The patients must be at least 60 years old, with a follow-up in the outpatient clinic for at least 1 year and without pathologies that limit his or her life expectancy to less than a year. They must know how to read and write. To be part of the group assigned to the app, they had to have their own smartphone and confirm that they were connected to the internet from that device. Overall, 15 of them were randomized to use an app and 15 were in the control group. All tests were repeated after 6 months. RESULTS: The median age of patients was 66.5 years. Among them, 29 patients had an undetectable viral load at baseline. The median number of comorbid diseases was 2. Overall, 11 of them lived with their partners and 19 lived alone. They spent an average of 5 hours a day sitting down, and 56% (17/30) of them referred high physical activity. They scored 4 out of 5 for general quality of life perception. Moreover, 80% (24/30) presented high adherence to their treatment, and the average number of concomitant medications was 5. In the 6-min walking test, they covered a distance of 400 meters, and 3 of them desaturated during the test. The 15 patients made frequent use of the app, with 2407 sessions and an average of 7 min and 56 seconds time of use with a total of 13,143 screen views. During the 6 months of the trial, 3 non-AIDS events took place. There were no significant modifications to body mass index, blood pressure measurements, lipid profile, or immuno-virology information data. There were no differences in the questionnaire scores for perception of quality of life, confessed physical activity, or antiretroviral treatment (ART) and non-ART treatment adherence. CONCLUSIONS: Significant differences between studied parameters were not objectified in these patients, possibly because this trial has significant limitations, such as a small sample size and only a brief follow-up period. However, patients did use the app frequently, making this a possible intervention to be proposed in future subsequent studies.


Assuntos
Geriatria/instrumentação , Infecções por HIV/terapia , Aplicativos Móveis/normas , Interface Usuário-Computador , Idoso , Exercício/psicologia , Feminino , Geriatria/métodos , Geriatria/estatística & dados numéricos , Infecções por HIV/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Aplicativos Móveis/estatística & dados numéricos , Projetos Piloto , Estatísticas não Paramétricas , Inquéritos e Questionários , Avaliação da Tecnologia Biomédica/métodos , Avaliação da Tecnologia Biomédica/estatística & dados numéricos
8.
BMC Infect Dis ; 19(1): 207, 2019 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-30819101

RESUMO

BACKGROUND: The objective was to analyze the effectiveness and safety of dual therapy with rilpivirine plus boosted-darunavir (RPV + bDRV) in real-life patients. METHODS: Observational, retrospective, multi-center study in HIV+ patients who had received RPV + bDRV for 24 weeks to optimize/simplify their previous antiretroviral treatment. We determined the percentage of patients without virologic failure (2 consecutive viral loads > 50 copies/mL) at 24 weeks of treatment. RESULTS: The study included 161 patients from 15 hospitals with median age of 49 years; 29.3% had previous AIDS stage and median CD4+ lymphocyte nadir of 170 cells/uL. They had been diagnosed with HIV for a median of 17 years and had received 14 years of ART, with five previous treatment combinations, and 36.6% had a history of virological failure. The reasons for the switch were simplification/optimization (49.7%), toxicity/intolerance (17.4%), or inadequate effectiveness of previous ART (10.6%). Baseline VL of 50-1000 copies/mL was recorded in 25.5% of the patients. In the"intention-to-treat" analysis at 24 weeks, 87.6% of 161 patients continued the study treatment without virologic failure criteria. In the "on treatment" analysis (excluding patients who discontinued treatment with dual therapy for any reason other than virologic failure) the efficacy was 94.6% (141/149 patients). CONCLUSIONS: Dual therapy with RPV + DRVb proved to be effective and safe in patients with advanced HIV infection, long exposure to ART, low CD4 nadir, previous virologic failure, and/or history of ineffective ART.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Darunavir/uso terapêutico , Infecções por HIV/tratamento farmacológico , Rilpivirina/uso terapêutico , Adulto , Linfócitos T CD4-Positivos/efeitos dos fármacos , Quimioterapia Combinada , Feminino , Infecções por HIV/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Carga Viral
9.
Enferm Infecc Microbiol Clin ; 37(3): 151-159, 2019 03.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29884455

RESUMO

BACKGROUND: The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC+RAL (PR). The effectiveness varies from 0.82 for TAF/FTC+DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC+RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR).


Assuntos
Síndrome de Imunodeficiência Adquirida/tratamento farmacológico , Síndrome de Imunodeficiência Adquirida/economia , Antirretrovirais/economia , Antirretrovirais/uso terapêutico , Análise Custo-Benefício , Fidelidade a Diretrizes/economia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Humanos , Modelos Econômicos , Espanha
10.
J Low Genit Tract Dis ; 23(1): 7-12, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30161052

RESUMO

OBJECTIVES: The data available on vaginal intraepithelial neoplasia (VAIN) and infection by HIV are scarce. We therefore aimed to review the clinical presentation, management, and survival outcomes of VAIN in this group of women. MATERIALS AND METHODS: This is an observational cohort study of women diagnosed with VAIN for a 23-year period. Clinical characteristics and outcomes were analyzed according to women's HIV infection status. Disease-free and progression-free survival were compared between groups. RESULTS: Twenty-two of 87 women were HIV positive (25.3%) compared with the HIV-negative group, HIV-positive women were younger (median age = 39 vs 57 years, p < .001) and more frequently smokers (p < .001). They also presented with multifocal and multicentric disease more often (p = .004 and p = .033, respectively) in relation to infection by human papillomavirus. All HIV-positive women were receiving antiretroviral treatment. The median time from the diagnosis of HIV to the development of VAIN was 14 years (range = 1-22 years). There were no significant differences in survival outcomes between groups. CONCLUSIONS: HIV-positive women are at an increased risk of developing VAIN and frequently present at a younger age with multifocal and multicentric disease. Vaginal intraepithelial neoplasia lesions can develop many years after the initial diagnosis of HIV infection reason why prolonged surveillance is essential to enable prompt diagnosis and treatment.


Assuntos
Carcinoma in Situ/diagnóstico , Carcinoma in Situ/terapia , Gerenciamento Clínico , Infecções por HIV/complicações , Neoplasias Vaginais/diagnóstico , Neoplasias Vaginais/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma in Situ/mortalidade , Carcinoma in Situ/patologia , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Análise de Sobrevida , Resultado do Tratamento , Neoplasias Vaginais/mortalidade , Neoplasias Vaginais/patologia
11.
BMC Pharmacol Toxicol ; 19(1): 63, 2018 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-30305176

RESUMO

BACKGROUND: Generic drugs may help to support antiretroviral treatment. We want to assess the efficacy and safety at 24 weeks of the change of coformulated (abacavir + lamivudine + dolutegravir) to (abacavir + lamivudine) coformulated as a generic pharmaceutical specialty + dolutegravir. METHODS: Between February and June 2017, switch from Triumeq® to a generic pharmaceutical specialty co-formulated tablet (abacavir + lamivudine) plus Tivicay® was made. Demographic, viroimmunological characteristics and the Charlson index were collected. Six months after switching, efficacy and safety were evaluated. RESULTS: Switch was made in 93 patients, with a mean age of 47 years, after six months there were five patients (5.4%) with viral loads between 50 and 400 copies, no patient had viral loads of greater amount. There were 2 interruptions due to toxicity (2.15%), in relation to symptoms of the central nervous system. There were no differences in the amount of years with HAART, nor in the previous months with the STR regimen based on abacavir + lamivudine + dolutegravir, nor in the Charlson index. The effective saving in 2017 derived from the change in these 93 patients was € 125.512. CONCLUSIONS: The change from a regimen of abacavir + lamivudine + dolutegravir seems to be safe and effective at 24 weeks.


Assuntos
Fármacos Anti-HIV/administração & dosagem , Didesoxinucleosídeos/administração & dosagem , Medicamentos Genéricos/administração & dosagem , Infecções por HIV/tratamento farmacológico , Compostos Heterocíclicos com 3 Anéis/administração & dosagem , Lamivudina/administração & dosagem , Terapia Antirretroviral de Alta Atividade , Combinação de Medicamentos , Substituição de Medicamentos , Feminino , Infecções por HIV/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Carga Viral/efeitos dos fármacos
13.
PLoS One ; 13(1): e0190544, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29309418

RESUMO

BACKGROUND: CRF19_cpx is a complex circulating recombination form (CRF) of HIV-1. We describe the characteristics of an outbreak of the CRF19_cpx variant among treatment-naïve patients in southern Spain. METHODS: The study was undertaken at the Virgen de la Victoria Hospital, a reference centre for the analysis of HIV-1 genotype in Malaga (Spain). Subtyping was performed through REGA v3.0 and the relationship of our CRF19_cpx sequences, among themselves and regarding other reference sequences from the same variant, was defined by phylogenetic analysis. We used PhyML program to perform a reconstruction of the phylogeny by Maximum Likelihood method as well as further confirmation of the transmission clusters by Bayesian inference. Additionally, we collected demographic, clinical and immunovirological data. RESULTS: Between 2011 and 2016, we detected 57 treatment-naïve patients with the CRF19_cpx variant. Of these, 55 conformed a very well-defined transmission cluster, phylogenetically close to CRF19_cpx sequences from the United Kingdom. The origin of this subtype in Malaga was dated between 2007 and 2010. Over 50% of the patients presented the non-nucleoside reverse transcriptase inhibitor G190A resistance mutation. This variant was mostly represented by young adult Spanish men who had sex with men. Almost half of them were recent seroconverters, though a similar percentage was diagnosed at a late state of HIV infection. Five cases of AIDS and one non-AIDS defined death occurred during follow-up. The majority of patients treated with first-line combination antiretroviral therapy (ART) responded. CONCLUSIONS: We report the largest HIV-1 CRF19_cpx cohort of treatment-naïve patients outside Cuba, almost all emerging as an outbreak in the South of Spain. Half the cases had the G190A resistance mutation. Unlike previous studies, the variant from Malaga seems less pathogenic, with few AIDS events and an excellent response to ART.


Assuntos
Surtos de Doenças , Infecções por HIV/epidemiologia , HIV-1/genética , Adulto , Teorema de Bayes , Contagem de Linfócito CD4 , Estudos de Coortes , Feminino , Genótipo , Infecções por HIV/virologia , HIV-1/classificação , Humanos , Masculino , Filogenia , Espanha/epidemiologia , Carga Viral , Adulto Jovem
14.
Enferm Infecc Microbiol Clin ; 36(5): 268-276, 2018 05.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28532596

RESUMO

INTRODUCTION: GESIDA and the Spanish National AIDS Plan panel of experts have recommended preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral therapy (ART) as initial therapy in HIV-infected patients for 2017. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, resistance studies and HLA B*5701 screening. The setting was Spain and the costs correspond to those of 2017. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranged from 6882 euro for TFV/FTC/RPV (AR) to 10,904 euros for TFV/FTC+RAL (PR). The efficacy varied from 0.82 for TFV/FTC+DRV/p (AR) to 0.92 for TAF/FTC/EVG/COBI (PR). The efficiency, in terms of cost-efficacy, ranged from 7923 to 12,765 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TFV/FTC+RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TFV/FTC/RPV (AR) and TAF/FTC/EVG/COBI (PR).


Assuntos
Antirretrovirais/economia , Antirretrovirais/uso terapêutico , Análise Custo-Benefício , Infecções por HIV/tratamento farmacológico , Adulto , Humanos , Guias de Prática Clínica como Assunto , Espanha
16.
Int J Cardiol ; 241: 295-301, 2017 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-28487153

RESUMO

BACKGROUND: Infective endocarditis (IE) is a severe complication associated with high mortality. OBJECTIVES: To examine the clinical characteristics of IE in hemodialysis (HD) patients and to determine prognostic factors related to HD. METHODS: From January 2008 to April 2015, 2488 consecutive patients with definite IE were included. Clinical characteristics of IE patients on HD were compared with those of IE patients who were not on HD. RESULTS: A total of 126 patients (63% male, median age: 66years; IQR: 54-74years) with IE (5.1%) were on HD. Fifty-two patients died during hospitalization (41%) and 17 additional patients (14%) died during the first year. The rate of patients who underwent surgery during hospitalization was lower in HD patients (38 patients, 30%) than in non-HD patients (1177 patients, 50%; p<0.001). Age >70years (OR: 4.1, 95% CI: 1.7-10), heart failure (OR: 3.3, 95% CI: 1.4-7-6), central nervous system (CNS) vascular events (OR: 6.7, 95% CI: 2.1-22) and septic shock (OR: 4.1, 95% CI: 1.4-12.1) were independently associated with fatal outcome in HD patients. Of the 38 patients who underwent surgery, 15 (39.5%) died during hospitalization. CONCLUSIONS: HD patients with IE present a high mortality. Advanced age and complications, such as heart failure, CNS stroke or septic shock, are associated with mortality.


Assuntos
Endocardite/mortalidade , Endocardite/terapia , Sistema de Registros , Diálise Renal/efeitos adversos , Diálise Renal/mortalidade , Idoso , Endocardite/diagnóstico por imagem , Endocardite Bacteriana , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Espanha/epidemiologia
17.
Enferm Infecc Microbiol Clin ; 35(2): 88-99, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27459919

RESUMO

INTRODUCTION: GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens. METHODS: Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2016. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable, and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,894 Euros for TDF/FTC+RAL (PR). The efficacy varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/efficacy, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR), and RAL+DRV/r (OR), respectively. CONCLUSION: Despite the overall most efficient regimen being 3TC+LPV/r (OR), among the PR and AR, the most efficient regimen was ABC/3TC/DTG (PR). Among the AR regimes, the most efficient was TDF/FTC/RPV.


Assuntos
Fármacos Anti-HIV/economia , Fármacos Anti-HIV/uso terapêutico , Análise Custo-Benefício , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Humanos , Guias de Prática Clínica como Assunto , Espanha
18.
Stroke ; 47(11): 2870-2873, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27758944

RESUMO

BACKGROUND AND PURPOSE: The STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin) was conducted to demonstrate the efficacy and safety of simvastatin treatment in acute stroke. METHODS: STARS07 was a multicentre, phase IV, prospective, randomized, double-blind, placebo-controlled trial. Patients with Acute ischemic stroke recruited within 12 hours from symptom onset were randomized to oral simvastatin 40 mg or placebo, once daily for 90 days. Primary outcome was proportion of independent patients (modified Rankin Scale score of ≤2) at 90 days. Safety end points were hemorrhagic transformation, hemorrhagic events, death, infections, and serious adverse events. RESULTS: From April 2009 to March 2014, 104 patients were included. Fifty-five patients received intravenous tissue-type plasminogen activator. No differences were found between treatment arms regarding the primary outcome (adjusted odds ratio, 0.99 [0.35-2.78]; P=0.98). Concerning safety, no significant differences were found in the rate of hemorrhagic transformation of any type, nor symptomatic hemorrhagic transformation. There were no differences in other predefined safety outcomes. In post hoc analyses, for patients receiving tissue-type plasminogen activator, a favorable effect for simvastatin treatment was noted with higher proportion of patients experiencing major neurological recovery (adjusted odds ratio, 4.14 [1.18-14.4]; P=0.02). CONCLUSIONS: Simvastatin plus tissue-type plasminogen activator combination seems safe in acute stroke, with low rates of bleeding complications. Because of the low recruitment, the STARS trial was underpowered to detect differences in simvastatin efficacy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01073007.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Fibrinolíticos/farmacologia , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacologia , Sinvastatina/farmacologia , Acidente Vascular Cerebral/tratamento farmacológico , Ativador de Plasminogênio Tecidual/farmacologia , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Fibrinolíticos/administração & dosagem , Fibrinolíticos/efeitos adversos , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Masculino , Pessoa de Meia-Idade , Sinvastatina/administração & dosagem , Sinvastatina/efeitos adversos , Ativador de Plasminogênio Tecidual/administração & dosagem , Ativador de Plasminogênio Tecidual/efeitos adversos
19.
Ann Surg Oncol ; 23(9): 2966-74, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27098143

RESUMO

BACKGROUND: There is an ongoing debate on which approach, transperitoneal or extraperitoneal, is superior for the performance of laparoscopic aortic lymphadenectomy (LPA-LND) for the surgical staging of gynecologic cancer. A prospective randomized trial (STELLA trial) was designed to compare the perioperative outcomes and node retrieval of extraperitoneal versus transperitoneal aortic lymphadenectomy by laparoscopy or robot-assisted laparoscopy. METHODS: Patients with endometrial or ovarian carcinoma requiring aortic lymphadenectomy for surgical staging were randomized to an extraperitoneal or transperitoneal approach by laparoscopy or robot-assisted laparoscopy between June 2012 and July 2014. RESULTS: A total of 60 patients were entered into the study, 48 with endometrial cancer (80 %) and 12 with ovarian cancer (20 %). Thirty-one patients (51.6 %) were randomly assigned to the extraperitoneal group and 29 to the transperitoneal group (48.3 %). The means LPA-LND operating time was 90 min in both group (p = 0.343). The mean (range) blood loss was 105 (10-400) mL for extraperitoneal versus 100 (5-1000) mL for transperitoneal group (p = 0.541). There were no differences in the number of collected lymph nodes between the two groups [median (range) for extraperitoneal 12 (4-41) vs. 13 (4-29) for transperitoneal (p = 0.719)]. CONCLUSIONS: The extraperitoneal and transperitoneal approaches for laparoscopic and robotic aortic lymphadenectomy provide similar perioperative outcomes and nodal yields. TRIAL REGISTRATION: The STELLA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT01810874.


Assuntos
Neoplasias do Endométrio/patologia , Laparoscopia/métodos , Excisão de Linfonodo , Neoplasias Ovarianas/patologia , Procedimentos Cirúrgicos Robóticos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Prospectivos
20.
Int J Stroke ; 10(7): 1149-52, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26044701

RESUMO

RATIONALE: No neuroprotective or neurorestorative therapies have been approved for ischemic stroke. Bone marrow mononuclear cell intra-arterial transplantation improves recovery in experimental models of ischemic stroke. AIMS: This trial aims to test safety and efficacy of intra-arterial injection of autologous bone marrow mononuclear cell in ischemic stroke patients. DESIGN: Multicenter, prospective, phase II, randomized, controlled (non-treated group as control), assessor-blinded clinical trial. Seventy-six stroke patients will be enrolled. Patients fulfilling clinical and radiological criteria (e.g. age between 18 and 80 years, middle cerebral artery ischemic stroke with a National Institutes of Health Stroke Scale score of 6-20 within one- to seven-days from stroke onset and no lacunar stroke) will be randomized to intervention or control group (1 : 1). Bone marrow harvest and intra-arterial injection of autologous bone marrow mononuclear cell will be done in the intervention group with two different doses (2 × 10(6) /kg or 5 × 10(6) /kg in 1 : 1 proportion). Patients will be stratified at randomization by National Institutes of Health Stroke Scale score. Patients will be followed up for two-years. STUDY OUTCOMES: The primary outcome is the proportion of patients with modified Rankin Scale scores of 0-2 at 180 days. Secondary outcomes include National Institutes of Health Stroke Scale and Barthel scores at six-months, infarct volume, mortality, and seizures. DISCUSSION: This is the first trial to explore efficacy of different doses of intra-arterial bone marrow mononuclear cell in moderate-to-severe acute ischemic stroke patients. The trial is registered as NCT02178657.


Assuntos
Transplante de Medula Óssea/métodos , Isquemia Encefálica/terapia , Acidente Vascular Cerebral/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/complicações , Feminino , Humanos , Injeções Intra-Arteriais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Método Simples-Cego , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Adulto Jovem
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