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Biomedical subjects

Alfonso Muriel

Publications and source records attributed to Alfonso Muriel.

At least 19 recordsLinked to original sources

Technology choice, glycemic control and patient-reported outcome measures in adults with type 1 diabetes: A randomized crossover trial comparing a smart insulin pen with an automated insulin delivery system (EBIACE-1).

AIMS: To compare glycemic outcomes and patient-reported outcome measures (PROMs) between smart insulin pens (SIP) and an automated insulin delivery (AID) system in adults with type 1 diabetes (T1D), and to identify individuals able to maintain near-optimal glycemic control using SIP. METHODS: EBIACE-1 was a randomized, open-label, crossover trial including 31 adults with T1D. Participants received SIP (InPen&#x2122;) and AID (MiniMed&#x2122; 780G) for 6&#xa0;months each. Co-primary outcomes were time in range (TIR 70-180 mg/dL) and HbA1c. Treatment effects were assessed using longitudinal models in intention-to-treat (ITT) and per-protocol (PP) analyses. Predictors of near-optimal glycemic control with SIP were evaluated using multivariable logistic regression. RESULTS: AID improved glycemic control versus SIP, with higher TIR (81&#xa0;% vs 66&#xa0;%; +15&#xa0;%, 95&#xa0;% CI 10-19; P&#xa0;<&#xa0;0.001) and lower HbA1c (6.9&#xa0;% [52&#xa0;mmol/mol] vs 7.3&#xa0;% [56&#xa0;mmol/mol]; -0.4&#xa0;%, 95&#xa0;% CI&#xa0;-&#xa0;0.6 to&#xa0;-&#xa0;0.3; P&#xa0;<&#xa0;0.001). Near-optimal glycemic control with SIP was achieved by 12 of 26 participants (46&#xa0;%). In exploratory analyses, higher baseline diabetes-related life interference was associated with a lower probability of achieving this outcome. CONCLUSIONS: AID provides superior glycemic control, although nearly half of participants achieved near-optimal control with SIP, supporting a personalized approach to technology selection.

Adult↗

Meta-DiSc: a software for meta-analysis of test accuracy data.

BACKGROUND: Systematic reviews and meta-analyses of test accuracy studies are increasingly being recognised as central in guiding clinical practice. However, there is currently no dedicated and comprehensive software for meta-analysis of diagnostic data. In this article, we present Meta-DiSc, a Windows-based, user-friendly, freely available (for academic use) software that we have developed, piloted, and validated to perform diagnostic meta-analysis. RESULTS: Meta-DiSc a) allows exploration of heterogeneity, with a variety of statistics including chi-square, I-squared and Spearman correlation tests, b) implements meta-regression techniques to explore the relationships between study characteristics and accuracy estimates, c) performs statistical pooling of sensitivities, specificities, likelihood ratios and diagnostic odds ratios using fixed and random effects models, both overall and in subgroups and d) produces high quality figures, including forest plots and summary receiver operating characteristic curves that can be exported for use in manuscripts for publication. All computational algorithms have been validated through comparison with different statistical tools and published meta-analyses. Meta-DiSc has a Graphical User Interface with roll-down menus, dialog boxes, and online help facilities. CONCLUSION: Meta-DiSc is a comprehensive and dedicated test accuracy meta-analysis software. It has already been used and cited in several meta-analyses published in high-ranking journals. The software is publicly available at http://www.hrc.es/investigacion/metadisc_en.htm.

Clinical Laboratory Techniques↗

Risk factors for candidemia in pediatric patients with congenital heart disease.

OBJECTIVE: To identify the main risk factors for the acquisition of candidemia in children with congenital heart disease (CHD) in order to improve the clinical management of these patients. DESIGN: A case-control study. SETTING: A large tertiary-care referral center in Spain with a pediatric intensive care unit (PICU) to which more than 500 children with CHD are admitted annually. PATIENTS: All patients had CHD and were admitted to the PICU during 1995-2000. Case patients were defined as patients with candidemia, and control patients were defined as patients without candidemia. RESULTS: Twenty-eight case patients and 47 control subjects were included in the study. Case patients were younger (mean age [+/-SD], 12.5+/-32.0 vs 38.0+/-48.0 months; P<.01) and had a longer median PICU stay (19 vs 4 days; P<.01), and a greater percentage of case patients previously had Candida species isolated from specimens other than blood (eg, bronchial aspirates, urine, or skin specimens) (39% vs 4%; P<.01). Severity of clinical condition, as measured by the Therapeutic Intervention Scoring System (TISS) 1 week after PICU admission (odds ratio, 1.15; 95% confidence interval, 1.05-1.26; P<.01), and receipt of antibiotic treatment for more than 5 days (odds ratio, 13.42; 95% confidence interval, 1.31-137.13; P=.03) were independently associated with the development of candidemia. CONCLUSIONS: Patients with CHD who have a high TISS score 1 week after PICU admission and patients who have received prolonged antibiotic therapy should be considered at high risk for candidemia. Our results suggest that shorter courses of antibiotic therapy, routine surveillance culture for Candida species, and initiation of preemptive or empirical antifungal treatment could help in the clinical management of these patients.

Anti-Bacterial Agents↗

Non-specific low back pain in primary care in the Spanish National Health Service: a prospective study on clinical outcomes and determinants of management.

BACKGROUND: The Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP) is a prevalent disorder, generating large health and social costs. The objectives of this study were to describe its management in primary care, to assess patient characteristics that influence physicians' decisions, and to describe clinical outcome at 2 months. METHODS: A cross-sectional sample of 648 patients with non-specific low back pain was recruited by 75 physicians (out of 361-20.8%) working in 40 primary care centers in 10 of the 17 administrative regions in Spain, covering 693,026 out of the 40,499,792 inhabitants. Patients were assessed on the day they were recruited, and prospectively followed-up 14 and 60 days later. The principal patient characteristics that were analyzed were: sex, duration of the episode, history of LBP, working status, severity of LBP, leg pain and disability, and results of straight leg raising test. Descriptors of management were: performance of the straight leg raising test, ordering of diagnostic procedures, prescription of drug treatment, referral to physical therapy, rehabilitation or surgery, and granting of sick leave. Regression analysis was used to analyze the relationship between patients' baseline characteristics and physicians' management decisions. Only workers were included in the models on sick leave. RESULTS: Mean age (SD) of included patients was 46.5 (15.5) years, 367 (56.6%) were workers, and 338 (52.5%) were females. Median (25th-75th interquartile range) duration of pain when entering the study was 4 (2-10) days and only 28 patients (4.3%) had chronic low back pain. Diagnostic studies included plain radiographs in 43.1% of patients and CT or MRI scans in 18.8%. Drug medication was prescribed to 91.7% of patients, 19.1% were sent to physical therapy or rehabilitation, and 9.6% were referred to surgery. The main determinants of the clinical management were duration of the episode and, to a lesser extent, the intensity of the pain (especially leg pain), a positive straight leg raising test, and degree of disability. The main determinant of sick leave was the degree of disability, followed by the characteristics of the labor contract and the intensity of leg pain (but not low back pain). After at least 2 months of treatment, 37% of patients were still in pain and approximately 10% of patients had not improved or had worsened. CONCLUSION: Although the use of X-Rays is high, determinants of physicians' management of LBP in primary care made clinical sense and were consistent with patterns suggested by evidence-based recommendations. However, after 2 months of treatment more than one third of patients continued to have back pain and about 10% had worsened.

Adult↗

Lumbar bone mineral density in renal transplant patients on neoral and tacrolimus: a four-year prospective study.

BACKGROUND: This prospective study was designed to investigate the long-term evolution of bone mineral density (BMD) in kidney transplant recipients. METHODS: In 86 patients with functioning grafts, 65 on tacrolimus-based immunosuppression and 21 on cyclosporine-based immunosuppression, laboratory parameters and BMD measurements in lumbar spine (L2-L4) and femoral neck (FN) were performed by DEXA in the first month after transplantation (baseline) and yearly thereafter up to the fourth year. RESULTS: BMD did not change at 12 months in lumbar spine nor in the FN. Detailed analysis identified three patterns of BMD in lumbar spine at 12 months: BMD remained stable in 27 patients (31.4%), decreased >2% in 31 (36.0%) and increased >2% in 28 (32.6%). Patients with no change or gain presented a parallel increase of BMD in FN (P<0.001 in both groups). On multivariate analysis, the variables associated with no change or lumbar BMD loss were total prednisone dose in grams at 12 months (OR 1.402; 95% CI 1.038-1.893; P=0.028), calcitriol levels at 12 months (OR 0.936; 95% CI 0.892-0.982; P=0.007) and lumbar BMD at baseline (OR 1.006; 95% CI 1.002-1.010; P=0.002). Late treatment with calcium supplements and calcitriol did not improve osteopenia. CONCLUSIONS: One third of patients had bone loss mainly during the first year of follow-up. Bone loss was associated to higher baseline BMD, high steroid dose, and lower calcitriol levels at 1 year. Late administration of calcitriol and calcium supplements did not improve posttransplant osteopenia. More than 50% of patients were osteopenic 4 years after transplantation.

Adult↗

Candidemia in pediatric patients with congenital heart disease.

Candidemia is an important problem in pediatrics. In our hospital, highest candidemia rates were documented among children with congenital heart disease (CHD). A series was conducted to describe the clinical and mortality features of candidemia in these patients. Fifty-two cases (1988-2000) included very young infants (median age, 2 months) who received long-term antibiotic treatment (median, 20.5 days). Candida parapsilosis predominated (54%). Endovascular infections occurred in 11.5%. In-hospital mortality was 39% and related mortality 14%. Maintenance of catheter (odds ratio [OR], 6.0; 95% confidence interval [CI], 1.0-37.2; P = .05) and severity of patients as measured with the Pediatric Risk Score of Mortality I (OR, 1.1, 95% CI, 1.0-1.3; P = .05) were independently associated with mortality. In summary, candidemia in children with CHD is diagnosed to very young infants with prolonged antibiotic therapy. Mortality is high but, in most cases, is not related to candidemia. Optimal management may include exclusion of endocarditis, early antifungal treatment, and catheter removal.

Adolescent↗

Psychometric characteristics of the Spanish version of the FAB questionnaire.

STUDY DESIGN: Validation of a translated, culturally adapted questionnaire. OBJECTIVES: To translate and culturally adapt the Spanish version of the Fear Avoidance Beliefs Questionnaire (FABQ), and to validate its use in Spanish-speaking patients with low back pain (LBP). SUMMARY OF BACKGROUND DATA: The FABQ is a reliable evaluation instrument for fear avoidance beliefs, which includes two subscales (FAB-Work and FAB-Phys). No validated Spanish version was available. METHODS: Translation/retranslation of the English version of the FABQ was done blindly and independently by a multidisciplinary team. The study was done in 12 primary care centers and 9 hospital outpatient clinics from seven regions in Spain, with 209 acute, subacute, and chronic patients who visited their physician for LBP: 53 in the pilot phase and 156 in the validation phase. Subjects were given the FABQ, two VAS for LBP and referred pain, and the Roland-Morris and SF-12 Questionnaires on their first visit and 14 days later. In the pilot phase, on day 1 test-retest reliability was estimated by giving a second FABQ in which the name and order of the items had been changed. RESULTS: Time necessary to complete the FABQ was [median, P25, P75] 10 minutes (5,15). FABQ values were not normally distributed. Comprehensibility: No request for aid in interpretation was made during the validation phase and no item was left unanswered by >or= 10% of patients. Reliability: Scores [median, P25, P75] of the two FABQ were: 72.00 (47.25, 82.00) and 72.00 (49.50, 83.75), with an intraclass correlation coefficient of 0.9668 (95% confidence interval, 0.9421,0.9823). Mean of kappa values for all items was 0.743. Internal Consistency: Cronbach's alpha was 0.9337. VALIDITY: Values of FAB and FAB-Work were >37% higher for patients on sick leave. For FAB-Phys differences were below 8%. FABQ, FAB-Work and FAB-Phys strongly correlated with disability on days 1 and 15. CONCLUSIONS: The Spanish version of the FABQ has good comprehensibility, internal consistency, and reliability. It cannot be analyzed parametrically, but only nonparametrically. The total FABQ is at least as valid as its subscales and simpler to score, making it more suitable for routine clinical use.

Avoidance Learning↗

Effect of candesartan on coronary flow reserve in patients with systemic hypertension.

BACKGROUND: Patients with hypertension have structural and functional changes in conductance and resistance vessels. In the absence of coronary stenosis the coronary microvascular function can be analysed by studying the coronary reserve. The aim of this study was to evaluate, non-invasively, the effect of candesartan on coronary microvascular function in hypertensive patients. METHODS: Twenty-two hypertensive patients (> 40 years) without clinical coronary disease (age 63.86 +/- 10.3 years; women, 59.1%) were studied. In addition to blood pressure (BP), measurement of carotid intima-medial thickness (IMT), left ventricle mass index (LVMI) and the coronary flow reserve (CFR) were evaluated with echography at the beginning, and after 3 months of treatment with 16 mg/day of candesartan. Twelve hypertensive controls (64.50 +/- 10.8 years; women, 58.4%) completed the same study without any change in treatment. RESULTS: A 15% improvement in CFR (3.10 +/- 1.02 to 3.56 +/- 1.06; P = 0.001) was observed simultaneously with the BP reduction. There was no change in CFR in the control group (2.9 +/- 1.1 to 3.01 +/- 0.9; P = 0.23). The IMT was not modified significantly at the end of the follow-up (0.86 +/- 0.1 to 0.83 +/- 0.1 mm; P = 0.103). CONCLUSION: Candesartan improves the CFR in hypertensive patients. The improvement was not related to BP control or LVMI regression. Patients with a lower CFR show a better response to candesartan. This fact can be demonstrated non-invasively with echography after 3 months of therapy.

Aged↗

The influence of fear avoidance beliefs on disability and quality of life is sparse in Spanish low back pain patients.

STUDY DESIGN: Correlation between previously validated questionnaires. OBJECTIVES: To assess the influence of fear avoidance beliefs (FAB) on disability and quality of life in Spanish low back pain (LBP) patients. SUMMARY OF BACKGROUND DATA: FAB has shown to be a major determinant of disability in LBP patients in Northern European and Anglo-Saxon cultural environments. There are no data on its influence on Latin-Mediterranean patients. METHODS: The study was done in 12 primary care and 9 hospital services from seven different regions of Spain, with 209 patients who were in a potentially active working situation and visited the National Health Service for LBP. None was excluded and the sample was balanced for acute, subacute, and chronic patients. On their first visit and 14 days later, patients were given two independent Visual Analogue Scales (VAS) for LBP and leg pain, as well as the validated Spanish versions of the Fear Avoidance Beliefs (FABQ), Roland-Morris (RMQ), and SF-12 questionnaires. RESULTS: Correlations between LBP, leg pain, FABQ, disability, and quality of life were moderate on day 1 (r = 0.320-0.564) and stronger on day 15 (r = 0.457-0.637). All of them were statistically highly significant (P = 0.000). Regression models showed that LBP severity explains 33% of disability on day 1 and 20% on day 15, while FAB only explains 6% on day 1 and 2% on day 15. FAB does not explain mental quality of life. It explains only 5% of physical quality of life on day 1 and 4% on day 15. There was no interaction between FAB and chronicity, and FABQ values on day 1 did not predict disability or quality of life at day 15. CONCLUSIONS: As opposed to what has been shown in other cultural settings, FAB have virtually no clinical relevance in Spanish LBP patients who are treated in the National Health Service and who are in a potentially active working situation. The influence of FAB on disability is minimal and much less than that of pain severity, and their contribution to the patient's quality of life is irrelevant. Further studies should explore the potential value of FAB in other Latin-Mediterranean countries.

Adult↗

HCV clearance and treatment outcome in genotype 1 HCV-monoinfected, HIV-coinfected and liver transplanted patients on peg-IFN-alpha-2b/ribavirin.

BACKGROUND/AIMS: Differences in HCV-RNA clearance during therapy might explain the lower efficacy of peg-IFN/RBV in HIV/HCV-coinfection. There are limited data on HCV-RNA clearance and treatment outcomes in liver transplanted (LT) patients. METHODS: To assess the rates of SVR and baseline predictors of failure after 48 weeks of weight-adjusted peg-IFN-alpha-2b/RBV in 120 patients with HCV genotype 1: 61 HCV-monoinfected, 40 HIV-coinfected and 19 LT-patients. Viral clearance was evaluated in patients completing 24 weeks of therapy (n=112, 93%). RESULTS: SVR was significantly lower in HIV-coinfection than in HCV-monoinfection or LT (18 vs. 39 vs. 42%, P<0.02). By multivariate analysis, HIV-coinfection (OR 3.048, 95% CI 1.133-8.196; P=0.027), baseline HCV-RNA over 800,000 IU/ml (OR 2.800; 95% CI 1.121-6.993, P=0.027) and higher AST values (OR 1.009; 95% CI 1.001-1.018; P=0.028) were significantly associated to failure. Despite similar baseline HCV load (5.67 vs. 5.75 vs. 5.90 log10 IU/ml), HIV-coinfection showed significantly lower HCV-RNA decreases than HCV-monoinfection at weeks 4 (P=0.015), 12 (P=0.015) and 24 (P=0.0003), and than LT at weeks 12 (P=0.003) and 24 (P=0.023). 36/60 subjects (60%) reaching EVR by week 12 obtained SVR vs. 3/60 (5%) who did not. CONCLUSIONS: HIV-coinfection was independently associated to treatment failure, and led to a significantly slower HCV-RNA clearance.

Adult↗

Scoliosis after median sternotomy in children with congenital heart disease.

STUDY DESIGN: A retrospective review of spinal deformity in patients with congenital heart disease surgically treated through a median sternotomy before the age of 8 years. Assessment was done on chest roentgenograms at skeletal maturity. OBJECTIVES: To determine if patients surgically treated through a median sternotomy present a higher prevalence of spinal deformity. SUMMARY OF BACKGROUND DATA: Congenital heart disease is associated with a higher prevalence of scoliosis. The etiology of scoliosis in this group of patients is unknown. Thoracotomy causes scoliosis, but median sternotomy has not been identified as a causal agent in these patients. METHODS: Chest roentgenograms were done after skeletal maturity in 128 patients to assess for the presence of a spinal deformity in the sagittal or coronal plane as a result of a median sternotomy for treatment of congenital heart disease before the age of 8 years in patients without any prior radiographic evidence of spinal or costal deformity before surgery. RESULTS: Forty-four (34.3%) of these patients had scoliosis greater than 10 degrees , 16 of them (12.5%) had curves greater than 20 degrees , and 33 (25.8%) had thoracic kyphosis lesser than 20 degrees . Patients operated before the age of 18 months had a significantly increased risk of developing scoliosis than those operated at a later age (odds ratio = 3.5; confidence interval = 1.3-9.6; P = 0.016). The presence of scoliosis was not related to the type of congenital heart disease. CONCLUSIONS: There is a high prevalence of scoliosis in patients with congenital heart disease surgically treated through a median sternotomy. The prevalence of scoliosis increases in patients operated at an earlier age.

Adolescent↗

Safe use of pegylated interferon/ribavirin in hepatitis C virus cirrhotic patients with hypersplenism after partial splenic embolization.

BACKGROUND AND AIMS: Partial splenic embolization (PSE) is a non-surgical alternative for the treatment of hypersplenism. Thrombocytopenia precludes the use of pegylated interferon (peg-IFN) and ribavirin in cirrhotic patients with hepatitis C virus (HCV). We aimed to evaluate the role of PSE as a procedure allowing combined HCV therapy in this setting. METHODS: A retrospective analysis of the safety and rate of sustained virological response (SVR) after a full-dose course of peg-IFN plus ribavirin in eight HCV cirrhotic patients with severe hypersplenism undergoing PSE at a tertiary centre in Madrid, Spain, from May 2002 to August 2004. RESULTS: Six patients (75%) were in Child-Pugh class B (median score 7). PSE significantly improved the mean platelet (P = 0.012), leucocyte (P = 0.017) and haemoglobin (P = 0.035) levels, and prothrombin activity (P = 0.012). After a mean of 20 weeks after PSE all patients started weight-adjusted ribavirin plus peg-IFN-alpha2b (n = 6) or 180 microg/week of peg-IFN-alpha2a (n = 2). Six subjects (75%) completed therapy with no peg-IFN dose reductions; the dose of ribavirin was reduced in two patients reaching haemoglobin levels of less than 10 g/dl (one also received erythropoietin and granulocyte colony-stimulating factor because of neutrophil counts < 300 cells/microl). Three patients (38%) achieved SVR. Portal vein thrombosis was observed in 50% of patients, but did not preclude antiviral therapy. The pathogenic mechanism was multifactorial. It was successfully managed with anticoagulant therapy in two cases. CONCLUSIONS: PSE allowed the safe use of peg-IFN plus ribavirin in HCV cirrhotic patients with severe cytopenias who otherwise would never have been treated. The rate of SVR was 38%.

Antiviral Agents↗

CD4 cell recovery during successful antiretroviral therapy in naive HIV-infected patients: the role of intravenous drug use.

We evaluated the impact of HIV risk practice on immune reconstitution in a prospective cohort of 288 patients (176 former injecting drug users) who maintained complete virus suppression for more than 24 months. Significant differences in CD4 cell counts at 6 and 24 months were detected. Multivariate analysis showed that drug use was an independent predictor of poor immunological recovery. Injection drug abuse impairs short and long-term CD4 cell recovery in HIV-positive patients initiating successful highly active antiretroviral therapy.

Adult↗

Correlation between pain, disability, and quality of life in patients with common low back pain.

STUDY DESIGN: Correlation among previously validated questionnaires. OBJECTIVES: To determine the correlation between pain, disability, and quality of life in patients with low back pain. SUMMARY OF BACKGROUND DATA: The Visual Analogue Scale (VAS), and the Roland-Morris (RMQ), Oswestry (OQ), and EuroQol (EQ) Questionnaires are validated instruments to assess pain, low back pain-related disability, and quality of life. METHODS: The study was done in the primary care setting, in Mallorca, with 195 patients who visited their physician for LBP. Individuals were given the VAS, RMQ, OQ, and EQ on their first visit and 14 days later. RESULTS: Median duration of pain when entering the study was 10 days (P25,P75: 3, 40). On day 1, simple correlation was r = 0.347 between VAS and RMQ, r = -0.422 between VAS and EQ, and r = -0.442 between RMQ and EQ. On day 15, simple correlation was r = 0.570 between VAS and RMQ, r = -0.672 between VAS and EQ, and r = -0.637 between RMQ and EQ. Multiple linear regression models showed that, on day 1, the VAS score explains 12% of the RMQ score and the VAS and RMQ scores explain 27% of the EQ score. On day 15, the VAS score explains 33% of the RMQ score, and the VAS and RMQ scores explain 58% of the EQ score. On day 1, a 10% increase in VAS worsens disability by 3.3% and quality of life by 2.65%. On day 15, a 10% increase in VAS worsens disability by 4.99% and quality of life by 3.80%. Prestudy duration of pain had no influence on any model. All these correlation coefficients and models are significant at the P < 0.001 level. The OQ had lower correlation values with the other three scales, and only two of them were significant. CONCLUSION: Clinically relevant improvements in pain may lead to almost unnoticeable changes in disability and quality of life. Therefore, these variables should be assessed separately when evaluating the effect of any form of treatment for low back pain. The influence of pain and disability on quality of life progresses while they last, and doubles in 14 days. In acute and subacute patients, this increase is not dependent on the previous duration of pain.

Disability Evaluation↗

High rate of didanosine-related mitochondrial toxicity in HIV/HCV-coinfected patients receiving ribavirin.

BACKGROUND: Nucleoside analogues may induce mitochondrial toxicity, particularly didanosine. Ribavirin increases didanosine exposure, which might be clinically relevant when coadministered in HIV/HCV-coinfected patients. OBJECTIVE: To evaluate, among 89 patients receiving highly active antiretroviral therapy (HAART) and therapy for chronic hepatitis C, clinically relevant mitochondrial toxicity in those treated with concomitant ribavirin and didanosine (n=35, 39%). METHODS: From January 2000 to July 2002 longitudinal analysis of the incidence and clinical course of didanosine-related hyperamylasaemia, pancreatitis, hyperlactataemia/lactic acidosis or neuropathy. Risk factors were evaluated using univariate and multivariate Cox's proportional hazards model. RESULTS: Among 35 patients who received concomitant didanosine (400 mg/day in 86%) and ribavirin (> or = 10 mg/kg/day in 91%), 20 (57%) developed one or more adverse events after a mean of 87 days. Most frequent laboratory abnormalities were hyperamylasaemia (18 patients, 51%) and hyperlactataemia (eight patients, 23%). Acute pancreatitis and symptomatic hyperlactataemia developed in 10 (28%) and six (17%) patients, respectively. Two patients (6%) with pancreatitis and severe lactic acidosis died; the other patients recovered uneventfully despite continuation of anti-HCV therapy in 83% after didanosine withdrawal in 40%. In the Cox's model higher baseline amylase levels (HR: 1.04, 95% CI: 1.02-1.06, P=0.001) and three nucleoside reverse transcriptase inhibitor-based HAART (HR: 5.3, 95% CI: 1.73-16.24, P=0.003) were significantly associated to toxicity. CONCLUSIONS: The coadministration of didanosine and ribavirin should be avoided in HIV/HCV-coinfected patients, due to a high rate of clinically significant toxicity, particularly in triple nucleoside-based HAART. Amylase levels should be strictly monitored, especially if elevated at baseline.

Adult↗

[Noninvasive assessment of the effect of atorvastatin on coronary microvasculature and endothelial function in patients with dyslipidemia].

INTRODUCTION AND OBJECTIVES: The effect of statins has been monitored mainly in peripheral arteries. It is now possible to study coronary microcirculation by analyzing coronary reserve with transthoracic echocardiography. The aim of this study was to use this noninvasive technique to evaluate the effect of atorvastatin on peripheral endothelial function and on the coronary microvasculature in patients with dyslipidemia. PATIENTS AND METHOD: We included 21 patients with dyslipidemia but no clinical antecedents of atherosclerosis. Mean (SD) age was 64.9 (11) years, and women made up 61.9% of the group. All patients were treated with 20 mg atorvastatin during 3 months. Lipid profile, carotid intima-media thickness, endothelium-dependent vasodilation and coronary flow reserve were determined at baseline and at the end of treatment. All studies were performed with echocardiographic techniques. RESULTS: Together with improvements in the lipid profile, we found a 43% increase in endothelium-dependent vasodilation (4.3 [4.4] to 6.2 [3.8]; P=.07) and a 25% increase in coronary flow reserve (2.5 [0.6] vs 3.1 [0.8]; P=.002). The increase in endothelium-dependent vasodilatation correlated with age (r=-0.60; P=.004), intima-media thickness (r=-0.47; P=.029), low-density lipoprotein level before treatment (r=-0.43; P=.05), and baseline endothelium-dependent vasodilatation (r=-0.63; P=.002). The increase in coronary flow reserve correlated with low-density lipoprotein level after treatment (r=-0.51; P=.04). CONCLUSIONS: Short-term treatment with atorvastatin improved the lipid profile, coronary microvascular function and endothelium-dependent vasodilation in the peripheral circulation. The noninvasive assessment of coronary reserve is feasible with transthoracic echocardiography.

Aged↗

Effect of firmness of mattress on chronic non-specific low-back pain: randomised, double-blind, controlled, multicentre trial.

BACKGROUND: A firm mattress is commonly believed to be beneficial for low-back pain, although evidence supporting this recommendation is lacking. We assessed the effect of different firmnesses of mattresses on the clinical course of patients with chronic non-specific low-back pain. METHODS: In a randomised, double-blind, controlled, multicentre trial, we assessed 313 adults who had chronic non-specific low-back pain, but no referred pain, who complained of backache while lying in bed and on rising. Mattress firmness is rated on a scale developed by the European Committee for Standardisation. The H(s) scale starts at 1.0 (firmest) and stops at 10.0 (softest). We randomly assigned participants firm mattresses (H(s)=2.3) or medium-firm mattresses (H(s)=5.6). We did clinical assessments at baseline and at 90 days. Primary endpoints were improvements in pain while lying in bed, pain on rising, and disability. FINDINGS: At 90 days, patients with medium-firm mattresses had better outcomes for pain in bed (odds ratio 2.36 [95% CI 1.13-4.93]), pain on rising (1.93 [0.97-3.86]), and disability (2.10 [1.24-3.56]) than did patients with firm mattresses. Throughout the study period, patients with medium-firm mattresses also had less daytime low-back pain (p=0.059), pain while lying in bed (p=0.064), and pain on rising (p=0.008) than did patients with firm mattresses. INTERPRETATION: A mattress of medium firmness improves pain and disability among patients with chronic non-specific low-back pain.

Adult↗