Nuñez-Cordoba, J.M. (Jorge M.)

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    The Mediterranean diet and incidence of hypertension: the Seguimiento Universidad de Navarra (SUN) Study
    (Oxford University Press, 2009) Martinez-Gonzalez, M.A. (Miguel Ángel); Valencia-Serrano, F. (Félix); Toledo, E. (Estefanía); Alonso, A. (Alvaro); Nuñez-Cordoba, J.M. (Jorge M.)
    The Mediterranean diet is receiving increasing attention in cardiovascular epidemiology. The association of adherence to the Mediterranean diet with the incidence of hypertension was evaluated among 9,408 men and women enrolled in a dynamic Spanish prospective cohort study during 1999–2005. Dietary intake was assessed at baseline with a validated semiquantitative food frequency questionnaire, and a 9-point Mediterranean diet score was constructed. During a median follow-up period of 4.2 years (range, 1.9–7.9), 501 incident cases of hypertension were identified. After adjustment for major hypertension risk factors and nutritional covariates, adherence to the Mediterranean diet was not associated with hypertension (the hazard ratio was 1.10 (95% confidence interval (CI): 0.81, 1.41) for moderate adherence and 1.12 (95% CI: 0.79, 1.60) for high adherence). However, it was associated with reduced changes in mean levels of systolic blood pressure (moderate adherence, 2.4 mm Hg (95% CI: 4.0, 0.8); high adherence, 3.1 mm Hg (95% CI: 5.4, 0.8)) and diastolic blood pressure (moderate adherence, 1.3 mm Hg (95% CI: 2.5, 0.1); high adherence, 1.9 mm Hg (95% CI: 3.6, 0.1)) after 6 years of follow-up. These results suggest that adhering to a Mediterranean-type diet could contribute to the prevention of age-related changes in blood pressure.
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    Cardiometabolic characterization in metabolic dysfunction-associated fatty liver disease
    (2022) Perdomo-Zelaya, C.M. (Carolina M.); Bastarrika, G. (Gorka); Ampuero, J. (Javier); Frühbeck, G. (Gema); Ezponda, A. (Ana); Mendoza-Ferradas, F.J. (Francisco Javier); Escalada, J. (Javier); Nuñez-Cordoba, J.M. (Jorge M.)
    BackgroundTo better understand the patient's heterogeneity in fatty liver disease (FLD), metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed by international experts as a new nomenclature for nonalcoholic fatty liver disease (NAFLD). We aimed to evaluate the cardiovascular risk, assessed through coronary artery calcium (CAC) and epicardial adipose tissue (EAT), of patients without FLD and patients with FLD and its different subtypes. MethodsCross sectional study of 370 patients. Patients with FLD were divided into 4 groups: FLD without metabolic dysfunction (non-MD FLD), MAFLD and the presence of overweight/obesity (MAFLD-OW), MAFLD and the presence of two metabolic abnormalities (MAFLD-MD) and MAFLD and the presence of T2D (MAFLD-T2D). MAFLD-OW included two subgroups: metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The patients without FLD were divided into 2 groups: patients without FLD and without MD (non-FLD nor MD; reference group) and patients without FLD but with MD (non-FLD with MD). EAT and CAC (measured through the Agatston Score) were determined by computed tomography. ResultsCompared with the reference group (non-FLD nor MD), regarding EAT, patients with MAFLD-T2D and MAFLD-MUHO had the highest risk for CVD (OR 15.87, 95% CI 4.26-59.12 and OR 17.60, 95% CI 6.71-46.20, respectively), patients with MAFLD-MHO were also at risk for CVD (OR 3.62, 95% CI 1.83-7.16), and patients with non-MD FLD did not have a significantly increased risk (OR 1.77; 95% CI 0.67-4.73). Regarding CAC, patients with MAFLD-T2D had an increased risk for CVD (OR 6.56, 95% CI 2.18-19.76). Patients with MAFLD-MUHO, MAFLD-MHO and non-MD FLD did not have a significantly increased risk compared with the reference group (OR 2.54, 95% CI 0.90-7.13; OR 1.84, 95% CI 0.67-5.00 and OR 2.11, 95% CI 0.46-9.74, respectively). ConclusionMAFLD-T2D and MAFLD-OW phenotypes had a significant risk for CVD. MAFLD new criteria reinforced the importance of identifying metabolic phenotypes in populations as it may help to identify patients with higher CVD risk and offer a personalized therapeutic management in a primary prevention setting.
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    Pattern of relapse in patients with stage IB1 cervical cancer after radical hysterectomy as primary treatment. Minimally invasive surgery vs. open approach. Systematic review and meta-analysis.
    (Elsevier, 2022) Chacón, E. (Enrique); Minguez, J.A. (José Ángel); Alcazar, J.L. (Juan Luis); Boria, F. (Félix); Chiva, L. (Luis); Rodriguez-Velandia, Y.P. (Yessica P.); Vara-García, J. (Julio); Manzour, N. (Nabil); Nuñez-Cordoba, J.M. (Jorge M.)
    Background. After the LACC trial, the SUCCOR study, and other studies, we know that patients who have un- dergone minimally invasive surgery for cervical cancer have worse outcomes, but today, we do not know if the surgical approach can be a reason to change the pattern of relapses on these patients. We evaluated the relapse pattern in patients with stage IB1 cervical cancer (FIGO, 2009) who underwent radical hysterectomy with differ- ent surgical approaches. Methods. A systematic review of literature was performed in PubMed, Cochrane Library, Clinicaltrials.gov, and Web of science. Inclusion criteria were prospective or retrospective comparative studies of different surgical approaches that described patterns or locations of relapse in patients with stage IB1 cervical cancer. Heterogeneity was assessed by calculating I2. Results. The research resulted in 782 eligible citations from January 2010 to October 2020. After filtering, nine articles that met all inclusion criteria were analyzed, comprising data from 1663 patients who underwent radical hysterectomy for IB1 cervical cancer, and the incidence of relapse was 10.6%. When we compared the pattern of relapse (local, distant, and both) of each group (open surgery and minimally invasive surgery), we did not see statistically significant differences, (OR 0.963; 95% CI, 0.602–1.541; p = 0.898), (OR 0.788; 95% CI, 0.467–1.330; p = 0.542), and (OR 0.683; 95% CI, 0.331–1.407; p = 0.630), respectively. Conclusion. There are no differences in patterns of relapse across surgical approaches in patients with stage IB1 cervical cancer undergoing radical hysterectomy as primary treatment.
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    Daylight photodynamic therapy for prevention of new actinic keratosis and keratinocyte carcinomas in organ transplants. A cryotherapy-controlled randomized clinical trial
    (European Academy of Dermatology and Venereology, 2020) Bernad-Alonso, I. (Isabel); Aguado, L. (Leyre); Redondo-Bellón, P. (Pedro); Nuñez-Cordoba, J.M. (Jorge M.)
    Background Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR. Objectives To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR. Methods A randomized, intra-subject controlled, evaluator-blind, split-face and/or scalp trial, from April 2016 to Octo- ber 2018. Participants were OTR older than 18 years, 1-year posttransplant, with at least 5 AK on each hemi-face/ hemi-scalp. One side received six field treatments with DPDT: two sessions 15 days apart at baseline, two at 3 months and two at 9 months after baseline. Control side received lesion-directed treatment with cryotherapy (double freeze– thaw) at baseline, 3 and 9 months. Total number of lesions (AK and KC) at 21 months, number of new AK and KC at 3, 9, 15 and 21 months and treatment preferences were analysed. Results Of 24 men included, 23 were analysed at 3 months; and 21, at 9, 15 and 21 months. Mean (SD) age was 69.8 years (9.2). The total number of lesions at 21 months was 4.7 (4.3) for DPDT and 5.8 (5.0) for control side; P = 0.09. DPDT showed significantly lower means [SD] of new lesions compared to control side at 3 months (4.2 [3.4] vs. 6.8 [4.8]; P < 0.001), 9 months (3.0 [3.3] vs. 4.3 [3.4]; P = 0.04) and 15 months (3.0 [4.6] vs. 4.8 [5.0]; P = 0.02), and non-signifi- cant at 21 months (3.7 [3.5] vs. 5.0 [4.5]; P = 0.06). Most participants preferred DPDT. Conclusion DPDT showed potential effectiveness in preventing new AK and KC in OTR by consecutive treatments of field cancerization. The preference for DPDT could facilitate adherence to the long-term treatment necessary in these patients.
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    11C-methionine PET/CT in assessment of multiple myeloma patients: comparison to 18F-FDG PET/CT and prognostic value evaluation
    (2022) Guillén-Valderrama, E.F. (Edgar Fernando); Marcos-Jubilar, M. (María); Sancho-Rodriguez, L. (Lidia); Prieto-Azcárate, E. (Elena); Alfonso-Piérola, A. (Ana); Garcia-Velloso, M. J. (María José); Rodriguez-Otero, P. (Paula); Rosales, J.J. (Juan José); Nuñez-Cordoba, J.M. (Jorge M.); San-Miguel, J.F. (Jesús F.); Morales-Lozano, M. I. (Mª Isabel)
    Multiple myeloma (MM) is the second most common haematological malignancy and remains incurable despite therapeutic advances. 18F-FDG (FDG) PET/CT is a relevant tool MM for staging and it is the reference imaging technique for treatment evaluation. However, it has limitations, and investigation of other PET tracers is required. Preliminary results with L-methyl-[11C]- methionine (MET), suggest higher sensitivity than 18F-FDG. This study aimed to compare the diagnostic accuracy and prognostic value of 1FDG and MET in MM patients. We prospectively compared FDG and MET PET/CT for assessment of bone disease and extramedullary disease (EMD) in a series of 52 consecutive patients (8 smoldering MM, 18 newly diagnosed MM and 26 relapsed MM patients). Bone marrow (BM) uptake patterns and the detection of focal lesions (FLs) and EMD were compared. Furthermore, FDG PET parameters with known MM prognostic value were explored for both tracers, as well as total lesion MET uptake (TLMU). Median patient age was 61 years (range, 37-83 years), 54% were male, 13% of them were in stage ISS (International Staging System) III, and 31% had high-risk cytogenetics. FDG PET/CT did not detect active disease in 6 patients, while they were shown to be positive by MET PET/CT. Additionally, MET PET/CT identified a higher number of FLs than FDG in more than half of the patients (63%). For prognostication we focussed on the relapsed cohort, due to the low number of progressions in the two other cohorts. Upon using FDG PET/CT in relapsed patients, the presence of more than 3 FLs (HR 4.61, p = 0.056), more than 10 FLs (HR 5.65, p = 0.013), total metabolic tumor volume (TMTV) p50 (HR 4.91, p = 0.049) or TMTV p75 (HR 5.32, p = 0.016) were associated with adverse prognosis. In MET PET/CT analysis, TMTV p50 (HR 4.71, p = 0.056), TMTV p75 (HR 6.27, p = 0.007), TLMU p50 (HR 8.8, p = 0.04) and TLMU p75 (HR 6.3, p = 0.007) adversely affected PFS. This study confirmed the diagnostic and prognostic value of FDG in MM. In addition, it highlights that MET has higher sensitivity than FDG PET/CT for detection of myeloma lesions, including FLs. Moreover, we show, for the first time, the prognostic value of TMTV and TLMU MET PET/CT in the imaging evaluation of MM patients.
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    Assessment of indeterminate pulmonary nodules detected in lung cancer screening: Diagnostic accuracy of FDG PET/CT
    (Elsevier BV, 2016) Torre, W. (Wenceslao); Campo, A. (Arantza); Lozano, M.D. (María Dolores); Bastarrika, G. (Gorka); Sancho, L. (Lidia); Richter, J.A. (José Ángel); Sanchez-Salcedo, P. (Pablo); Torres, J.P. (Juan P.) de; Garcia-Velloso, M. J. (María José); Alcaide, A.B. (Ana Belén); Nuñez-Cordoba, J.M. (Jorge M.); Zulueta, J. (Javier)
    Background: A major drawback of lung cancer screening programs is the high frequency of false-positive findings on computed tomography (CT). We investigated the accuracy of selective 2-[fluorine-18]- fluoro-2-deoxy-d-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan in assessing radiologically indeterminate lung nodules detected in lung cancer screening. Methods: FDG PET/CT was performed to characterize 64 baseline lung nodules >10 mm and 36 incidence nodules detected on low-dose CT screening in asymptomatic current or former smokers (83 men, age range 40–83 years) at high risk for lung cancer. CT images were acquired without intravenous contrast. Nodules were analyzed by size, density, and metabolic activity and visual scored on a 5-point scale for FDG uptake. Nodules were classified as negative for malignancy when no FDG uptake was observed, or positive when focal uptake was observed in the visual analysis, and the maximum standardized uptake value (SUVmax) was measured. Final diagnosis was based on histopathological evaluation or at least 24 months of follow-up. Results: A total of 100 nodules were included. The prevalence of lung cancer was 1%. The sensitivity, specificity, NPV and PPV of visual analysis to detect malignancy were 84%, 95%, 91%, and 91%, respectively, with an accuracy of 91% (AUC 0.893). FDG PET/CT accurately detected 31 malignant tumors (diameters 9–42 mm, SUVmax range 0.6–14.2) and was falsely negative in 6 patients. With SUVmax thresholds for malignancy of 1.5, 2, and 2.5, specificity was 97% but sensitivity decreased to 65%, 49%, and 46% respectively, and accuracy decreased to 85%, 79%, and 78% respectively (AUC 0.872). Conclusions: The visual analysis of FDG PET/CT scan is highly accurate in characterizing indeterminate pulmonary nodules detected in lung cancer screening with low-dose CT. Semi-quantitative analysis does not improve the accuracy of FDG PET/CT over that obtained with a qualitative method for lung nodule characterization.
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    Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II)
    (BMC, 2018) Cañizo, C. (C.) del; Granero-Moltó, F. (Froilán); Bondia, J.M. (J. M.); Aquerreta, D. (Dámaso); López-Elío, S. (Silvia); Villarón, E. (Eva); Mora, G. (Gonzalo); Andreu, E.J. (Enrique José); Blanco, J.F. (J. F.); Valentí-Nin, J.R. (Juan Ramón); Prosper-Cardoso, F. (Felipe); Nuñez-Cordoba, J.M. (Jorge M.); Lamo-Espinosa, J.M. (J. M.); Sanchez-Guijo, F.M. (Fermín M.); Valentí-Azcárate, A. (Andrés)
    Background: Mesenchymal stromal cells (MSCs) are a promising option to treat knee osteoarthritis (OA). Their safety and usefulness have been reported in several short-term clinical trials but less information is available on the longterm efects of MSC in patients with osteoarthritis. We have evaluated patients included in our previous randomized clinical trial (CMM-ART, NCT02123368) to determine their long-term clinical efect. Materials: A phase I/II multicenter randomized clinical trial with active control was conducted between 2012 and 2014. Thirty patients diagnosed with knee OA were randomly assigned to Control group, intraarticularly administered hyaluronic acid alone, or to two treatment groups, hyaluronic acid together with 10×106 or 100×106 cultured autol‑ ogous bone marrow-derived MSCs (BM-MSCs), and followed up for 12 months. After a follow up of 4 years adverse efects and clinical evolution, assessed using VAS and WOMAC scorings are reported. Results: No adverse efects were reported after BM-MSCs administration or during the follow-up. BM-MSCs-adminis‑ tered patients improved according to VAS, median value (IQR) for Control, Low-dose and High-dose groups changed from 5 (3, 7), 7 (5, 8) and 6 (4, 8) to 7 (6, 7), 2 (2, 5) and 3 (3, 4), respectively at the end of follow up (Low-dose vs Control group, p=0.01; High-dose vs Control group, p=0.004). Patients receiving BM-MSCs also improved clinically accord‑ ing to WOMAC. Control group showed an increase median value of 4 points (−11;10) while Low-dose and Highdose groups exhibited values of −18 (−28;−9) and −10 (−21;−3) points, respectively (Low-dose vs Control group p=0.043). No clinical diferences between the BM-MSCs receiving groups were found. Conclusions: Single intraarticular injection of in vitro expanded autologous BM-MSCs is a safe and feasible proce‑ dure that results in long-term clinical and functional improvement of knee OA.
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    Effect of sugammadex on processed EEG parameters in patients undergoing robot-assisted radical prostatectomy
    (2023) Panadero-Sánchez, A. (Alfredo); Valencia, M. (Miguel); Martinez-Simon, A. (Antonio); Cacho-Asenjo, E. (Elena); Manzanilla-Zapata, Ó. (Óscar); Honorato-Cía, C. (Cristina); Alegre-Esteban, M. (Manuel); Rubio-Baines, I. (I.); Nuñez-Cordoba, J.M. (Jorge M.)
    Background: Sugammadex has been associated with increases in the bispectral index (BIS). We evaluated the effects of sugammadex administration on quantitative electroencephalographic (EEG) and electromyographic (EMG) measures.Methods: We performed a prospective observational study of adult male patients undergoing robot-assisted radical prostatectomy. All patients received a sevoflurane-based general anaesthetic and a continuous infusion of rocuronium, which was reversed with 2 mg kg(-1) of sugammadex i.v. BIS, EEG, and EMG measures were captured with the BIS VistaTM monitor.Results: Twenty-five patients were included in this study. Compared with baseline, BIS increased at 4-6 min (13 coefficient: 3.63; 95% confidence interval [CI]: 2.22-5.04; P<0.001), spectral edge frequency 95 (SEF95) increased at 2-4 min (13 coefficient: 0.29; 95% CI: 0.05-0.52; P=0.016) and 4-6 min (13 coefficient: 0.71; 95% CI: 0.47-0.94; P<0.001), and EMG increased at 4-6 min (13 coefficient: 1.91; 95% CI: 1.00-2.81; P<0.001) after sugammadex administration. Compared with baseline, increased beta power was observed at 2-4 min (13 coefficient: 93; 95% CI: 1-185; P=0.046) and 4-6 min (13 co-efficient: 208; 95% CI: 116-300; P<0.001), and decreased delta power was observed at 4-6 min (13 coefficient: -526.72; 95% CI: -778 to -276; P<0.001) after sugammadex administration. Neither SEF95 nor frequency band data analysis adjusted for EMG showed substantial differences. None of the patients showed clinical signs of awakening.Conclusions: After neuromuscular block reversal with 2 mg kg(-1) sugammadex, BIS, SEF95, EMG, and beta power showed small but statistically significant increases over time, while delta power decreased.
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    Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and Open-Label Placebo-Controlled Clinical Trial
    (2019) Sabaté-Brescó, M. (Marina); Labrador-Horrillo, M. (Moises); Gastaminza, G. (Gabriel); Quiñones, D. (Dolores); Diaz-Donado, C. (Carmen); Baeza, M.L. (María Luisa); Echechipía, S. (Susana); Azofra, J. (Julián); Gaig, P. (Pere); Zubeldía, J.M. (José Manuel); Garcia, B.E. (Blanca Esther); Sala-Cunill, A. (Anna); Ferrer-Cardona, M. (Marta); Nuñez-Cordoba, J.M. (Jorge M.); Beristain, A. (Ana)
    Background: Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature. Objective: To explore the safety and efficacy of omalizumab in controlling UCOL. Methods: We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded followed by 8 months open-label) placebo-controlled clinical trial in 22 patients suffering from UCOL who were unresponsive to a double dose of antihistamines. We performed an exercise challenge test during each visit as our main outcome variable. Results: The overall rate of exercise challenge test negative at week 48 was 31.3%, with an average increase in exercise challenge test negative rate of 2.9% points (95% CI, 1.5-4.2) per visit. Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study). However, from the fourth dose, a progressive improvement was observed. When comparing before and after treatment, statistically significant improvements in all secondary outcome measures were noted after 4 doses (UCOL score: P = .0015; visual analog scale score: P = .0108; days with symptoms: P = .0125) and after 8 doses (UCOL score: P = .0005; chronic urticaria quality of life questionnaire: P = .0105; visual analog scale score: P = .0008; and days with symptoms: P = .0144). In the follow-up visit after the cessation of treatment, the symptoms reappeared, with positive exercise challenge test result and significant increases in all variables. Only 4 of 22 patients remained asymptomatic after 3 months of no treatment. No adverse effects were reported. Conclusions: This randomized mixed double-blind and open-label placebo-controlled trial showed evidence of the safety and potential efficacy of omalizumab in patients with UCOL.
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    Adherence to Mediterranean diet and risk of developing diabetes: prospective cohort study
    (BMJ Publishing Group Ltd, 2008) Martinez-Gonzalez, M.A. (Miguel Ángel); Fuente-Arrillaga, C. (Carmen) de la; Bes-Rastrollo, M. (Maira); Benito-Corchon, S. (Silvia); Beunza, J.J. (Juan José); Tortosa, A. (A.); Vazquez-Ruiz, Z. (Zenaida); Basterra-Gortari, F.J. (Francisco Javier); Nuñez-Cordoba, J.M. (Jorge M.)
    Objective To assess the relation between adherence to a Mediterranean diet and the incidence of diabetes among initially healthy participants. Design Prospective cohort study with estimates of relative risk adjusted for sex, age, years of university education, total energy intake, body mass index, physical activity, sedentary habits, smoking, family history of diabetes, and personal history of hypertension. Setting Spanish university department. Participants 13 380 Spanish university graduates without diabetes at baseline followed up for a median of 4.4 years. Main outcome measures Dietary habits assessed at baseline with a validated 136 item food frequency questionnaire and scored on a nine point index. New cases of diabetes confirmed through medical reports and an additional detailed questionnaire posted to those who self reported a new diagnosis of diabetes by a doctor during follow-up. Confirmed cases of type 2 diabetes. Results Participants who adhered closely to a Mediterranean diet had a lower risk of diabetes. The incidence rate ratios adjusted for sex and age were 0.41 (95% confidence interval 0.19 to 0.87) for those with moderate adherence (score 3-6) and 0.17 (0.04 to 0.75) for those with the highest adherence (score 7-9) compared with those with low adherence (score <3). In the fully adjusted analyses the results were similar. A two point increase in the score was associated with a 35% relative reduction in the risk of diabetes (incidence rate ratio 0.65, 0.44 to 0.95), with a significant inverse linear trend (P=0.04) in the multivariate analysis. Conclusion Adherence to a Mediterranean diet is associated with a reduced risk of diabetes.