Tolerabilidad y efectividad del citrato de fentanilo oral transmucosa en el tratamiento a largo plazo del dolor irruptivo en pacientes oncológicos: estudio ECODIR

INTRODUCTION: Oral trans-mucosal fentanyl citrate (OTFC) is the one drug specifically developed for the management of breakthrough pain. This study assesses the long-term safety and efficacy of OTFC standard clinical conditions. Patients and methods. Six-month observational study performed on cancer patients with episodes of breakthrough pain. Safety was assessed by recording the advent of adverse events and efficacy by the evaluating the intensity of breakthrough pain. RESULTS: 174 cancer patients were recruited into the study. All adverse reactions reported were mild or moderate. OTFC was significantly faster (time to the commencement of pain relief: 12.7 +/- 11.4 vs 32.7 +/- 18.4 minutes; p < 0.001) and potent (post-treatment pain intensity: 3.4 +/- 1.5 vs 4.3 +/- 1.5; p < 0.001) than the previously-used drugs. CONCLUSIONS: This observational study confirms the good safety profile of OTFC as well as its effectiveness over long-term period treatment of breakthrough pain.     

Beta-blockade and exercise capacity in patients with mitral stenosis in sinus rhythm

BACKGROUND AND AIM OF THE STUDY: The study aim was to determine whether beta-blocker treatment (atenolol) improves cardiopulmonary exercise performance and ventilatory response in patients with mitral stenosis in sinus rhythm. METHODS: A prospective study comparing the results of cardiopulmonary exercise tests (CPETs) was performed before and after atenolol therapy in 17 patients in NYHA classes I and II with mitral stenosis in sinus rhythm. Transthoracic echocardiography was performed pre-study, and left ventricular diameters, ejection fraction and mitral valve area monitored. CPETs (Naughton protocol) were performed by two different investigators before and after one-week atenolol therapy (50 mg/day). The second investigator was blinded to the result of the baseline test. O2 consumption, CO2 production, ventilatory parameters and respiratory exchange ratios were measured on line. RESULTS: Maximal O2 uptake (VO2max) did not differ significantly before and after beta-blockade (median 16.8 and 15.0 ml/kg/min, respectively. Median heart rate at rest (72 versus 55 beats/min; p = 0.0003) and during peak exercise (153 versus 105 beats/min; p = 0.0003), and anaerobic threshold (10 versus 8.9 ml/kg/min; p = 0.02) were lower with beta-blockade compared with the baseline state. Minute ventilation at maximum exercise (41 versus 40 l/min) and ventilatory equivalent for CO2 (34 versus 35) were unchanged with atenolol therapy, indicating no improvement in ventilatory performance. When patients were grouped into those in whom VO2max was improved with atenolol therapy (n = 7) and those in whom it was impaired (n = 10), there were no inter-group differences with respect to age, left ventricular function, severity of mitral stenosis, NYHA class and grade of beta-blockade reached. Four patients felt symptomatically worse during atenolol treatment (lower NYHA functional class). CONCLUSION: Beta-blockade does not improve exercise tolerance in patients with mitral stenosis in sinus rhythm. In addition, ventilatory performance does not change with treatment.     

Association of ADHD symptoms and social competence with cognitive status in preschoolers

We aimed to investigate the association of attention-deficit hyperactivity disorder (ADHD) symptoms and social competence outcomes with cognitive status in preschool children. The study population was drawn from three birth cohorts belonging to the Spanish INMA (Infancia y Medio Ambiente) project: Menorca (n = 289), Ribera d’Ebre (n = 60), and Granada (n = 108). Children were assessed at the age of 4 years for cognitive functions (McCarthy Scales of Children’s Abilities, MSCA) by psychologists and for inattention and hyperactivity symptoms (ADHD Criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, ADHD-DSM-IV) and social competence (California Preschool Social Competence Scale) by their teachers. Multiple regression analyses were conducted to examine potential associations between behavioral outcomes (ADHD symptoms and social competence) and MSCA cognitive outcomes, adjusting for confounders. The presence of general ADHD symptoms (inattention, hyperactivity, or both) and poorer social competence both showed negative associations with cognitive outcomes. When we compared children according to ADHD subtypes, those with inattention symptoms alone and those with both inattention and hyperactivity symptoms showed significantly lower cognitive function scores in comparison to children with no ADHD symptoms. Behavioral dysfunctions in preschoolers may be associated with impairment of cognitive functions.     

1-year follow-up of patients treated with risperidone and topiramate for a manic episode

BACKGROUND: The safety and efficacy of the combination of risperidone and topiramate in the long-term treatment of mania were assessed in a 12-month, multicenter open study. METHOD: Subjects (N = 58) who met DSM-IV criteria for bipolar disorder and for a manic episode received both risperidone and topiramate for the treatment of their manic symptoms. Patients with mixed episodes were excluded. Risperidone could be discontinued at any point, but patients had to be on topiramate therapy for at least 12 months to be considered completers. Efficacy was assessed with the Young Mania Rating Scale (YMRS) and a modified version of the Clinical Global Impressions for Bipolar Disorder (CGI-BP-M). Safety was assessed with systematic collection of side effect data, weight, and the Hamilton Rating Scale for Depression (HAM-D) scores, to address the risk of switch into depression. RESULTS: 41 patients (70.7%) completed the study. There was a significant improvement on the YMRS (p <.001) and the CGI-BP-M subscales for manic symptoms (p <.005) and long-term outcome (p <.005) from week 2 onward. Relapse rates were significantly lower during the 12-month study period compared to the precedent year (p <.0001). There was no increase in depressive symptoms as measured by the HAM-D. 37 patients (63.8 %) experienced at least 1 adverse event, the most frequent of which was somnolence (N = 7, 12.1%). At endpoint, the patients' mean weight had decreased an average of 1.1 +/- 0.4 kg. CONCLUSION: Despite the limitations inherent to the open design, this naturalistic study suggests that the combination of risperidone and topiramate may be a valuable option for the short- and long-term treatment of mania.     

Evaluation of do not resuscitate orders (DNR) in a Swiss community hospital

OBJECTIVE: To evaluate the effect of an intervention on the understanding and use of DNR orders by physicians; to assess the impact of understanding the importance of involving competent patients in DNR decisions. DESIGN: Prospective clinical interventional study. SETTING: Internal medicine department (70 beds) of the hospital of La Chaux-de-Fonds, Switzerland. PARTICIPANTS: Nine junior physicians in postgraduate training. INTERVENTION: Information on the ethics of DNR and implementation of new DNR orders. Measurements and main results: Accurate understanding, interpretation, and use of DNR orders, especially with respect to the patients' involvement in the decision were measured. Junior doctors writing DNR orders had an extremely poor understanding of what DNR orders mean. The correct understanding of the definition of a DNR order increased from 31 to 93% (p<0.01) after the intervention and the patients' involvement went from 17% to 48% (p<0.01). Physicians estimated that 75% of their DNR patients were mentally competent at the time of the decision. CONCLUSION: An intervention aimed at explaining the ethical principles and the definition of DNR orders improves understanding of them, and their implementation, as well as patient participation. Specific efforts are needed to increase the involvement of mentally competent patients in the decision.