Efficacy and safety of pixantrone for the treatment of multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas.

BACKGROUND AND OBJECTIVE: Few treatment options exist for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) who fail first- and second-line therapies. Pixantrone is a novel aza-anthracenedione agent with reduced potential for cardiotoxicity but maintained anti-tumour activity relative to anthracyclines. The current retrospective, observational, real-life study was undertaken in 79 patients who received pixantrone monotherapy for multiply R/R aggressive B-cell NHL in Spain and Italy. RESULTS: Before pixantrone, patients had received a median of 3 prior therapies and 84.6% of them were refractory to the last regimen. Median progression-free survival (mPFS) was 2.8 months (95% confidence interval [CI] 2.1-3.6) and median overall survival (mOS) was 4.0 months (95%CI 5.6-7.9), with an objective response rate (ORR) of 29% (complete remission [CR]: 13.2%, partial remission [PR]: 15.2%). Patients receiving ≥2 cycles of pixantrone showed mPFS and mOS of 3.1 and 6.0 months, respectively, and an ORR of 36.8% (CR: 17.5%, PR: 19.3%). Overall, 63.3% of patients reported ≥1 adverse event (AE), most commonly haematological AEs. One patient developed grade 2 sinus tachycardia. CONCLUSION: Pixantrone was effective and well tolerated in a real-world population of multiply R/R patients with aggressive B-cell NHL, many of whom had very poor prognostic factors.

Evaluation of the quality of care of elderly patients with chronic and breakthrough pain treated with opioids: SAND study.

OBJECTIVE: The objective of this study was to evaluate the quality of care of elderly patients with treatment for chronic pain (CP) and breakthrough pain (BTP). METHODS: A cross-sectional observational study was conducted in 20 pain units, selecting patients aged 70 years or older with baseline controlled CP in treatment with opioids and a diagnosis of BTP. Patients were classified as first episode of BTP or patient in follow-up. The patients completed the SF-12 quality of life questionnaire, Brief Pain Inventory, Lattinen Index, and Edmonton Symptoms Assessment Scale. The patient's satisfaction with the treatment was evaluated through a visual analogue scale (VAS). RESULTS: A total of 199 patients were included with 67.7% women (132). There were 28.5% (55) attending the first visit for BTP and 71.5% (138) were on follow-up visits. On the physical component of the SF-12, 95% had a score below the mean for the Spanish general population and 44% had a score below the mean on the mental component. Worse scores were observed for women in the bodily pain dimension (p = .032) and in the overall physical component (p = .045). There were 62.9% (112) patients satisfied with the treatment for BTP. In the multivariate analysis, SF-12 physical component scores (p = .017) and patient's satisfaction with BTP treatment was better in follow-up visits (p = .031). CONCLUSIONS: All clinical parameters compared between first visit for the treatment of BTP and follow-up visits were improved, so the quality of care was also considered improved. Elderly women and non-oncologic patients were observed to be the population with worse symptom control.

Attention Deficit Hyperactivity Disorder (ADHD) in the adult patients: view of the clinician.

INTRODUCTION: ADHD is a clinical entity that persists during adolescence and even into adulthood in many cases. Assuming that most adults with ADHD will not have been diagnosed in childhood, the GEDA-A group (Adult ADHD study group) considered that it was important to assess how much knowledge the clinicians had about ADHD in order to provide for the identification of the disorder in the adult. METHODOLOGY: A cross-sectional survey to be fill out by specialists involved in the diagnosis and treatment of ADHD was designed. This survey included questions on awareness of the disease in the different stages of life (childhood, adolescence and adulthood). RESULTS: 484 clinicians, with a mean age of 45 years (95% CI 44-46) and 17 years of professional experience (95% CI 16-18) filled out the survey. 384 were psychiatrists (79.5%), 67 neurologists (13.9%) and 19 addictive behavior specialists (3.9%). When their opinions were compared about the diagnosis and treatment of ADHD in childhood, adolescence and adulthood, significant differences of opinion were found regarding the three stages in all the dimensions analyzed (p<0.0001). Assessment in adulthood systematically showed a lower degree of awareness compared to ADHD in childhood and adolescence. CONCLUSIONS: In the clinician's opinion, ADHD in adulthood is a clinical entity that is less defined and whose diagnosis is not as clear, compared to ADHD in the other stages in life. The GEDA-A group suggests that it is necessary to have more comprehensive training that makes the diagnosis and treatment of ADHD in adults easier.

Trastorno por Déficit de Atención con Hiperactividad (TDAH) en el paciente adulto: visión del clínico / Attention Deficit Hyperactivity Disorder (adhd) in the adult patients: view of the clinician

Introducción. El TDAH es una entidad clínica que persiste en muchos casos, durante la adolescencia incluso en la edad adulta. Asumiendo que la mayor parte de los adultos con TDAH no habrán sido diagnosticados en la infancia, el grupo de trabajo GEDA-A (Grupo de Estudio para el Déficit de Atención en el Adulto) consideró importante valorar el grado de conocimiento del TDAH por el clínico, para facilitarla identificación del trastorno en el adulto. Metodología. Se diseñó una encuesta transversal, completada por especialistas implicados en el diagnóstico y tratamiento del TDAH. Se incluyeron preguntas sobre el conocimiento de la patología en las distintas etapas de la vida (infancia, adolescencia y edad adulta). Resultados. 484 clínicos, con edad media de 45 años (IC95% 44 a 46) y 17 años de ejercicio profesional (IC95%16 a 18) completaron la encuesta. 384 eran psiquiatras (79,5%), 67 neurólogos (13,9%) y 19 especialistas en conductas adictivas (3,9%). En la comparación de sus opiniones sobre el diagnóstico y el tratamiento del TDAH en la infancia, adolescencia y edad adulta, se observaron diferencias de opinión significativas respecto a las tres etapas, en todas las dimensiones analizadas (p<0,0001). La valoración en la edad adulta fue sistemáticamente de menor grado de conocimiento en comparación con el TDAH en la infancia y la adolescencia. Conclusiones. En opinión de los clínicos, el TDAH en la edad adulta es una entidad clínica menos definida y con un diagnóstico menos claro, en comparación con las otras etapas de la vida. El Grupo GEDA-A sugiere que es necesaria una formación más completa que facilite el diagnóstico y tratamiento del TDAH en el adulto (AU)

Introduction: ADHD is a clinical entity that persists during adolescence and even into adulthood in many cases. Assuming that most adults with ADHD will not have been diagnosed in childhood, the GEDA-A group (Adult ADHD study group) considered that it was important to assess how much knowledge the clinicians had about ADHD in order to provide for the identification of the disorder in the adult. Methodology: A cross-sectional survey to be fill out by specialists involved in the diagnosis and treatment of ADHD was designed. This survey included questions on awareness of the disease in the different stages of life (childhood, adolescence and adulthood). Results: 484 clinicians, with a mean age of 45 years (95% CI 44-46) and 17 years of professional experience (95% CI 16-18) filled out the survey. 384 were psychiatrists (79.5%), 67 neurologists (13.9%) and 19 addictive behavior specialists (3.9%). When their opinions were compared about the diagnosis and treatment of ADHD in childhood, adolescence and adulthood, significant differences of opinion were found regarding the three stages in all the dimensions analyzed (p<0.0001). Assessment in adulthood systematically showed a lower degree of awareness compared to ADHD in childhood and adolescence. Conclusions: In the clinician’s opinion, ADHD in adulthood is a clinical entity that is less defined and whose diagnosis is not as clear, compared to ADHD in the other stages in life. The GEDA-A group suggests that it is necessary to have more comprehensive training that makes the diagnosis and treatment of ADHD in adults easier (AU)

[Diagnostic delay and differences by sex and clinical subtype in a cohort of outpatients with bipolar disorder]. / Retraso diagnóstico y diferencias por sexo y subtipo clínico en una cohorte de pacientes ambulatorios con trastorno bipolar.

INTRODUCTION: We describe the clinical and sociodemographic features at baseline of a cohort of bipolar patients included in a prospective study. METHODS: A total of 296 consecutive outpatients with bipolar disorder were recruited. Diagnosis relied on clinical judgment according to DSM-IV-TR criteria and the semi-structured MINI Interview. Retrospective data on the course of the disease and cross-sectional data on social adaptation (Social Adaptation Adjustment Self-Assessment Scale (SASS) and affective symptoms were collected. Affective symptomatology (euthymia, subsyndromal symptoms and episodes) was studied according to clinical criteria and the Hamilton Depression and Young rating scales. Differences between type I and II bipolar patients and between men and women were analyzed. RESULTS: The mean age was 48.8 years (95% CI 47.2-50.4); 56.8% were women and 43.2% were men. A total of 65.2% had a diagnosis of type I bipolar disorder and 23.3% of type II; 49.8% of the sample were euthymic, 32.7% had subsyndromal symptoms and 17.5% had had an affective episode. Diagnostic delay was 9.3 years (95% CI 8.2-10.3). In patients with type II bipolar disorder, the mean age (54.4 years; 95% CI 50.9-57.9 vs. 47.7 years; 95% CI 45.8-49.7, p=0.007), age at onset of illness (35.7 years; 95% CI 31.8-39.7 vs. 29.8 years; 95% CI 28-31.6, p=0.008) and age at diagnosis (47.7 years; 95% CI 44-51.3 vs. 37.9; 95% CI 35.9-39.8, p<0.0001) were higher than in patients with type I bipolar disorder. Manic polarity in the initial episode and psychotic episodes were more frequent in men, while depressive episodes and hypothyroidism were more frequent in women. CONCLUSIONS: Our results confirm data published in our environment on sociodemographic and clinical variables but diagnostic delay in our study was longer. Compared with American samples, age at onset and at diagnosis were higher in our sample but comorbidity was much lower.

Time spent with symptoms in a cohort of bipolar disorder outpatients in Spain: a prospective, 18-month follow-up study.

OBJECTIVE: Most research on the symptomatic burden in bipolar disorder has included patients enrolled exclusively from tertiary centers, and only a few studies have analyzed factors related to it. We investigated the proportion of time and the proportion of visits with symptoms in a cohort of bipolar outpatients followed-up for 18 months, as well as the associated variables. METHODS: 296 DSM-IV-TR bipolar outpatients were included in a naturalistic longitudinal follow-up study, with quarterly assessment. Euthymia was defined by a Hamilton Depression Rating Scale score <7 and Young Mania Rating Scale score <5. Depressive episode, by a HDRS score of >17, hypomanic episode by a YMRS score of 10-20, and manic episode by a YMRS score >20. Sub-syndromal symptoms required scores of 7-17 in HDRS and 5-10 in YMRS. Based on a detailed recall of affective symptoms in the time between interviews, time in episode was also determined. RESULTS: Patients were symptomatic for one third of the follow-up, and also one third of the visits. They spent three times more days depressed than manic or hypomanic. More prior affective episodes were related both to more time symptomatic and more visits with symptoms. LIMITATIONS: Some of the data were collected retrospectively. Treatment was naturalistic. CONCLUSIONS: In a bipolar outpatient cohort from Spain, time with symptoms was shorter than previously found in tertiary care settings. In accordance with other longitudinal studies, those patients spent much more time depressed than manic.

Gender differences in evidence-based pharmacological therapy for patients with stable coronary heart disease.

BACKGROUND: Women have a higher morbidity and mortality than men after an acute coronary event. We analyzed the prescription rates of evidence-based pharmacological therapies for patients with stable coronary heart disease and whether there were any differences with respect to gender. DESIGN: This cross-sectional study evaluated 8817 patients, 26.3% women, receiving attention from 1799 family doctors in primary care centers (PCC) throughout Spain, and who had had a coronary event requiring hospitalization in the previous 6 months to 10 years. RESULTS: Mean age was 65.4 years and a mean time-lapse since hospitalization of 37.4 months. In the overall population, prescription medications were: antiplatelet drugs in 80.5% of patients, 79% statins, 66% blockers of the angiotensin-renin system (BARS) and 47% beta-blockers. Males received less cardiovascular disease medications than females (4.3+/-1.5 versus 4.6+/-1.6, respectively; p<0.001), but when adjusted for risk factors the significance was lost (p=0.231). Following adjustment for risk factors and for co-morbidities, the use of diuretics was significantly higher in women while beta-blockers and statins were higher in men. The triple combination of antithrombotics, beta-blockers and statins was used in 41.4% (43.8% males versus 34.6% females; p<0.001) while 24.3% used this triple combination plus a BARS; without significant difference between the genders. CONCLUSIONS: An important percentage of patients with stable coronary disease, particularly women, attended-to in primary care do not receive medications that have been shown to decrease the morbido-mortality of cardiovascular disease.

Usefulness of the Spanish version of the mood disorder questionnaire for screening bipolar disorder in routine clinical practice in outpatients with major depression.

BACKGROUND: According to some studies, almost 40% of depressive patients - half of them previously undetected - are diagnosed of bipolar II disorder when systematically assessed for hypomania. Thus, instruments for bipolar disorder screening are needed. The Mood Disorder Questionnaire (MDQ) is a self-reported questionnaire validated in Spanish in stable patients with a previously known diagnosis. The purpose of this study is to evaluate in the daily clinical practice the usefulness of the Spanish version of the MDQ in depressive patients. METHODS: Patients (n = 87) meeting DSM-IV-TR criteria for a major depressive episode, not previously known as bipolar were included. The affective module of the Structured Clinical Interview (SCID) was used as gold standard. RESULTS: MDQ screened 24.1% of depressive patients as bipolar, vs. 12.6% according to SCID. For a cut-off point score of 7 positive answers, sensitivity was 72.7% (95% CI = 63.3 - 82.1) and specificity 82.9% (95% CI = 74.9-90.9). Likelihood ratio of positive and negative tests were 4,252 y 0,329 respectively. LIMITATIONS: The small sample size reduced the power of the study to 62%. CONCLUSION: Sensitivity and specificity of the MDQ were high for screening bipolar disorder in patients with major depression, and similar to the figures obtained in stable patients. This study confirms that MDQ is a useful instrument in the daily clinical assessment of depressive patients.

Achievement of therapeutic goals and utilization of evidence-based cardiovascular therapies in coronary heart disease patients with chronic kidney disease.

To evaluate whether the presence of chronic kidney disease (CKD) influenced the rate of prescription of evidence-based cardiovascular preventive therapies and attainment of therapeutic goals in patients with stable coronary heart disease, 7,884 patients (mean age 65.4 years; 81.7% men; 22.4% with CKD) attended to in 1,799 primary-care centers and who had had a coronary event requiring hospitalization in the previous 6 months to 10 years were recruited. Glomerular filtration rate (GFR) was estimated using the MDRD Study equation. Results indicated that patients with CKD received more diuretics (47.6% vs 32.8%; p = 0.034), calcium channel blockers (29.3% vs 23.2%, p = 0.027); and blockers of the angiotensin-renin system (76.4% vs 65.3%; p <0.001). The lower prescription rate of antiaggregants, beta blockers, and statins in subjects with CKD did not reach statistical significance in multivariate analysis. A lower percentage of subjects with CKD achieved good control of blood pressure (39.2% vs 65.4%; p <0.001) and glycosylated hemoglobin (43.9% vs 53.4%; p <0.001) relative to patients without CKD. Only 11.8% of patients with CKD had optimum control of all risk factors. Using multivariate analysis, the presence of CKD was inversely related to the degree of risk-factor control, especially in groups with low GFR. In conclusion, patients with stable coronary heart disease and CKD attended to in primary-care centers had poorer control of coronary heart disease risk factors than those with normal GFR despite receiving a similar rate of prescription of evidence-based cardiovascular disease preventive therapies.

Evidence-based cardiovascular therapies and achievement of therapeutic goals in diabetic patients with coronary heart disease attended in primary care.

BACKGROUND: Diabetic patients have a higher rate of recurrent cardiovascular events and death than nondiabetic individuals. Although partially attributable to lower use of evidence-based preventive therapies, studies are lacking on the prescription rate during the stable phase of the disease. METHODS: Between June 1 and October 19, 2004, we obtained, from 1799 primary care centers throughout Spain, data on 8817 subjects (mean age 65.4 years, 73.7% male, 32.7% with diabetes) who had had a coronary event requiring hospitalization in the previous 6 months to 10 years. RESULTS: After adjustment for confounding variables, the diabetic patients received more frequent treatment with angiotensin-renin system blockers (73.5% vs 61%, P < .001), calcium channel blockers (29.8% vs 21.9%, P < .001), nitrates (58% vs 47.5%, P < .001), digoxin (6.6% vs 3.9%, P < .001), and diuretics (46.2% vs 32.2%, P < .001), but it is similar with respect to lipid-lowering drugs (81.1% vs 80.3%), antiplatelet drugs (80.2% vs 80.2%), or beta-blockers (45.4% vs 47.7%). The percentage of diabetic subjects attaining objectives for smoking habit, low-density lipoprotein cholesterol, blood pressure, and glycated hemoglobin were 90.7%, 29%, 38.2%, and 49.7%, respectively. Only 7% had optimum control of all their risk factors. The parameters most closely related to optimum treatment and risk-factor control were the specialist follow-up and the attending physician's awareness of appropriate treatment objectives. CONCLUSIONS: A significant percentage of diabetic patients with stable coronary disease receive evidence-based preventive medications in primary care. However, the percentage achieving adequate control of their risk factors is low and is related to the level of physician awareness of appropriate therapeutic targets.

Infants fed docosahexaenoic acid- and arachidonic acid-supplemented formula have decreased incidence of bronchiolitis/bronchitis the first year of life.

To assess the effect of docosahexaenoic acid and arachidonic acid supplementation in infant formula on the incidence of respiratory illnesses, pediatricians assigned infants to receive docosahexaenoic acid/arachidonic acid-supplemented formula or control formula. Anthropometrics, medical history, and illnesses were reported. Among 1342 infants, there was a higher incidence of bronchiolitis in control versus docosahexaenoic acid/arachidonic acid-supplemented groups at 5, 7, and 9 months (P < .01). Weight, length, and head circumference were similar for both groups. Infants fed formula supplemented with 0.32% docosahexaenoic acid and 0.64% arachidonic acid experienced a lower incidence of bronchiolitis compared with infants fed formula supplemented with no docosahexaenoic acid/arachidonic acid or lower levels of docosahexaenoic acid/arachidonic acid in the first year of life.