Outcomes after intensive chemotherapy for secondary and myeloid-related changes acute myeloid leukemia patients aged 60 to 75 years old: a retrospective analysis from the PETHEMA registry.

Treatment options for patients with secondary acute myeloid leukemia (sAML) and AML with myeloid-related changes (AMLMRC) aged 60 to 75 years are scarce and unsuitable. A pivotal trial showed that CPX-351 improved complete remission with/without incomplete recovery (CR/CRi) and overall survival (OS) as compared with standard "3+7" regimens. We retrospectively analyze outcomes of 765 patients with sAML and AML-MRC aged 60 to 75 years treated with intensive chemotherapy, reported to the PETHEMA registry before CPX-351 became available. The CR/CRi rate was 48%, median OS was 7.6 months (95% confidence interval [CI]: 6.7-8.5) and event-free survival (EFS) 2.7 months (95% CI: 2-3.3), without differences between intensive chemotherapy regimens and AML type. Multivariate analyses identified age ≥70 years, Eastern Cooperative Oncology Group performance status ≥1 as independent adverse prognostic factors for CR/CRi and OS, while favorable/intermediate cytogenetic risk and NPM1 were favorable prognostic factors. Patients receiving allogeneic stem cell transplant (HSCT), autologous HSCT, and those who completed more consolidation cycles showed improved OS. This large study suggests that classical intensive chemotherapy could lead to similar CR/CRi rates with slightly shorter median OS than CPX-351.

Multivariate Analysis on the Properties of Intact Cereal Kernels and Their Association with Viscoelasticity at Different Moisture Contents.

The viscoelastic properties of cereal kernels are strongly related to their quality, which can be applied to the development of a more selective and objective classification process. In this study, the association between the biophysical and viscoelastic properties of wheat, rye, and triticale kernels was investigated at different moisture contents (12% and 16%). A uniaxial compression test was performed under a small strain (5%), and the increase in viscoelasticity at 16% moisture content corresponded to proportional increases in biophysical properties such as the appearance and geometry. The biophysical and viscoelastic behaviors of triticale were between those of wheat and rye. A multivariate analysis showed that the appearance and geometric properties significantly influenced kernel features. The maximum force showed strong correlations with all viscoelastic properties, and it can be used to distinguish between cereal types and moisture contents. A principal component analysis was performed to discriminate the effect of the moisture content on different types of cereals and to evaluate the biophysical and viscoelastic properties. The uniaxial compression test under a small strain and the multivariate analysis can be considered a simple and non-destructive tool for assessing the quality of intact cereal kernels.

Characteristics and Outcomes of Adult Patients in the PETHEMA Registry with Relapsed or Refractory FLT3-ITD Mutation-Positive Acute Myeloid Leukemia.

This retrospective study investigated outcomes of 404 patients with relapsed/refractory (R/R) FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) acute myeloid leukemia (AML) enrolled in the PETHEMA registry, pre-approval of tyrosine kinase inhibitors. Most patients (63%) had received first-line intensive therapy with 3 + 7. Subsequently, patients received salvage with intensive therapy (n = 261), non-intensive therapy (n = 63) or supportive care only (n = 80). Active salvage therapy (i.e., intensive or non-intensive therapy) resulted in a complete remission (CR) or CR without hematological recovery (CRi) rate of 42%. More patients achieved a CR/CRi with intensive (48%) compared with non-intensive (19%) salvage therapy (p < 0.001). In the overall population, median overall survival (OS) was 5.5 months; 1- and 5-year OS rates were 25% and 7%. OS was significantly (p < 0.001) prolonged with intensive or non-intensive salvage therapy compared with supportive therapy, and in those achieving CR/CRi versus no responders. Of 280 evaluable patients, 61 (22%) had an allogeneic stem-cell transplant after they had achieved CR/CRi. In conclusion, in this large cohort study, salvage treatment approaches for patients with FLT3-ITD mutated R/R AML were heterogeneous. Median OS was poor with both non-intensive and intensive salvage therapy, with best long-term outcomes obtained in patients who achieved CR/CRi and subsequently underwent allogeneic stem-cell transplant.

Acute leukemia arising from myeloproliferative or myelodysplastic/myeloproliferative neoplasms: A series of 372 patients from the PETHEMA AML registry.

Treatment of acute myeloid leukemia (AML) evolving from myeloproliferative (MPN) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN) is challenging. We evaluated disease characteristics, treatment patterns and outcomes in 372 patients diagnosed with AML after MPN or MDS/MPN over a 27-year period. Frontline treatment was intensive chemotherapy (38%), hypomethylating agents [HMAs] (17%), non-intensive chemotherapy (14%), and supportive care (31%). Median overall survival was 4.8 months, with a 5-year survival rate of 4%. Median survival was 2.8, 3.9 and 8.3 months for the 1992-2010, 2011-2015 and 2016-2019 periods, respectively (test for trend p < 0.001). Complete response (CR) rate was higher with intensive chemotherapy (43%) than with non-intensive chemotherapy (12%) or HMAs (8.5%) [p < 0.001], but responses were short-lived without allogeneic hematopoietic cell transplantation. Patients treated with intensive chemotherapy or HMAs had superior survival than those receiving non-intensive chemotherapy (median: 8.5 vs. 8.6 vs. 4.2 months, respectively). No differences in treatment response or survival were observed according to prior disease subtypes. Patients undergoing transplantation in CR had better survival than those transplanted in other response categories (3-year survival rate of 64% vs. 22%, p = 0.002). Our results support the use of intensive chemotherapy followed by transplant whenever possible, and the preferential use of HMAs over attenuated chemotherapy regimens in unfit patients. In spite of the survival improvement in recent years, this subset of AML constitutes an unmet medical need and deserves systematic incorporation in clinical trials.

Evolving patterns of care and outcomes in relapsed/refractory FLT3 mutated acute myeloid leukemia adult patients.

We have analyzed treatment patterns and outcomes of relapsed/refractory(R/R) FLT3mut AML adult patients registered in our institutional data base between 1998 and 2018. Overall, 147 patients were evaluable: 34 from 1998 to 2009, 113 from 2010 to 2018. Salvage treatments were intensive chemotherapy (n = 25, 74%), and supportive care (n = 9, 26%) in the 1998-2009 period, and intensive chemotherapy (n = 63, 56%), hypomethylating agent (n = 7, 6%), low-dose cytarabine-based (n = 8, 7%), clinical trial (n = 16, 14%) and supportive care (n = 19, 17%) in the 2010-2018 period. Complete remission (CR) or with incomplete recovery (CRi) rate was 44%, 49% among patients treated intensively (vs 30% with non-intensive p = 0.005). Median overall survival since first R/R was 5.8 months, and 16.3 months in subjects receiving an allo-HSCT in CR/CRi after first salvage (vs 3.8 in the remaining patients p < 0.0001). Clinical outcomes of R/R FLT3mut AML remain unsatisfactory. Inclusion in clinical trials and expanding options could lead to improved outcomes.

Pomalidomide, Cyclophosphamide, and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma: Real-World Analysis of the Pethema-GEM Experience.

INTRODUCTION: Treatment of relapsed/refractory multiple myeloma (RRMM) is highly challenging, especially for patients with disease refractory to initial therapy, and in particular for disease developing refractoriness to lenalidomide. Indeed, with currently approved treatments, median progression-free survival (PFS) in the lenalidomide-refractory setting is less than 10 months, reflecting the difficulty in treating this patient population. Pomalidomide is a second-generation immunomodulatory drug that has shown activity in lenalidomide-refractory disease in the setting of different combinations. PATIENTS AND METHODS: A real-world study was conducted by the Spanish Myeloma group in a cohort of patients with RRMM treated with pomalidomide, cyclophosphamide, and dexamethasone (PomCiDex). One hundred patients were treated with a median of 3 prior lines of therapy. RESULTS: Overall response rate was 39%, with a clinical benefit rate of 93%. Median PFS was 7.6 months; median overall survival (OS) was 12.6 months. Median PFS and OS survival were consistent across the different subgroups analyzed. Prolonged PFS and OS were found in patients with responsive disease. CONCLUSION: Our results compared favorably with those obtained with different pomalidomide-based combinations in a similar patient population. PomCiDex remains a manageable, cost-effective, and all-oral triplet combination for RRMM patients.

Evolving treatment patterns and outcomes in older patients (≥60 years) with AML: changing everything to change nothing?

There are no studies analyzing how therapeutic changes impact on outcomes of older AML patients. This study analyzes patient´s and disease characteristics, treatment patterns, and outcomes of 3637 AML patients aged ≥60 years reported to the PETHEMA registry. Study periods were 1999-2006 (before hypomethylating agents-HMAs availability) vs 2007-2013, and treatments were intensive chemotherapy (IC), non-intensive, clinical trial (CT), and supportive care only (SC). Median age was 72 (range, 60-99), 57% male, median ECOG 1 (range, 0-4), secondary AML 914 (30%), with adverse-risk genetic in 720 (32%). Treatment differed between study periods (1999-2006 vs 2007-2013): IC 58% vs 32%, non-intensive 1 vs 23%, CT 0 vs 2%, SC 27 vs 28% (p < 0.001). Median OS was 4.7 months (1-year OS 29% and 5-years 7%, without differences between periods), 1.2 for SC, 7.8 for non-intensive, 8.6 for IC, and 10.4 for CT (p < 0.001). OS improved in the 2007-2013 period for IC patients (10.3 vs 7.5 months, p = 0.004), but worsened for SC patients (1.2 vs 1.6 months, p = 0.03). Our real-life study shows that, despite evolving treatment for elderly patients during the last decade, OS has remained unchanged. Epidemiologic registries will critically assess whether novel therapies lead to noteworthy advances in the near future (#NCT02606825).

Treatment of Frail Older Adults and Elderly Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia: Results of a Prospective Trial With Minimal Chemotherapy.

BACKGROUND: The treatment of acute lymphoblastic leukemia (ALL) in older adults and elderly patients is a challenge, and modern protocols include targeted therapy and immunotherapy in combination with attenuated or minimal chemotherapy. However, frail patients are excluded from these trials, and reports on the outcome of this subgroup of patients are scarce. Our objective was to analyze the outcome of unfit older adults and elderly patients with Philadelphia chromosome-negative ALL included in a prospective trial (ALL-07FRAIL). PATIENTS AND METHODS: Older adults and elderly patients with Charlson Comorbidity Index (CCI) ≥ 4 were included. Induction therapy consisted of vincristine and dexamethasone, and maintenance therapy with mercaptopurine and methotrexate for 2 years. RESULTS: Seventy-two patients with a median age of 67 years (range, 57-89 years) and a median CCI of 5 (range, 4-12) were included. The rates of early withdrawal, early death, resistance, and complete response (CR) were 5%, 10%, 31%, and 54%, respectively. Six patients with CR abandoned the study, 5 died in CR, and 23 relapsed (cumulative relapse incidence 75%). The medians of disease-free and overall survival (OS) were 6.9 months (95% confidence interval [CI], 0.3-13.5 months) and 7.6 months (95% CI, 6.3-8.9 months), respectively. The most frequent toxic events were hematologic (neutropenia 77% and thrombocytopenia 54%, of grade III-IV in all cases). Eastern Cooperative Oncology Group score but not the CCI had significant impact on OS. CONCLUSION: Complete remission with very attenuated chemotherapy can be attained in one-half of older or elderly infirm patients with ALL. These results suggest that some of these patients could benefit from the concomitant or subsequent use of immunotherapy and/or targeted therapy.

Bendamustine as part of conditioning of autologous stem cell transplantation in patients with aggressive lymphoma: a phase 2 study from the GELTAMO group.

We conducted a phase 2 trial to evaluate the safety and efficacy of bendamustine instead of BCNU (carmustine) in the BEAM (BCNU, etoposide, cytarabine and melphalan) regimen (BendaEAM) as conditioning for autologous stem-cell transplantation (ASCT) in patients with aggressive lymphomas. The primary endpoint was 3-year progression-free survival (PFS). Sixty patients (median age 55 [28-71] years) were included. All patients (except one who died early) engrafted after a median of 11 (9-72) and 14 (4-53) days to achieve neutrophil and platelet counts of >0.5 × 109 /l and >20 × 109 /l, respectively. Non-relapse mortality at 100 days and 1 year were 3.3% and 6.7%, respectively. With a median follow-up of 67 (40-77) months, the estimated 3-year PFS and overall survival (OS) were 58% and 75%, respectively. Patients in partial response at study entry had significantly worse PFS and OS than patients who underwent ASCT in complete metabolic remission, and this was the only prognostic factor associated with both PFS (Relative risk [RR], 0.27 [95% confidence interval {CI} [0.12-0.56]) and OS (RR, 0.40 [95% CI 0.17-0.97]) in the multivariate analysis. BendaEAM conditioning is therefore a feasible and effective regimen in patients with aggressive lymphomas. However, patients not in complete metabolic remission at the time of transplant had poorer survival and so should be considered for alternative treatment strategies.

Comparison of intensive, pediatric-inspired therapy with non-intensive therapy in older adults aged 55-65 years with Philadelphia chromosome-negative acute lymphoblastic leukemia.

BACKGROUND AND OBJECTIVE: The standardization of treatment of older adults with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) is challenging, especially in the age range of 55-65 years. This study aimed to compare intensive, pediatric-inspired therapy with non-intensive therapy in this population of patients. PATIENTS AND METHODS: The outcomes of 67 patients prospectively included in two consecutive pediatric-inspired intensive protocols (ALL-HR03 and ALL-HR11) from the Spanish PETHEMA Group were compared with those from 44 patients included in a contemporary semi-intensive protocol (ALL-OLD07). RESULTS: Baseline patient and ALL characteristics were similar in both groups, except for a younger median age in the intensive group (medians: 58 vs. 62 years). Patients treated intensively had a higher complete remission rate (85% vs. 64%, p = 0.005), a lower cumulative incidence of relapse (39% [95%CI, 25% to 52%] vs. 60% [95%CI, 38% to 77%], p = .003), a similar cumulative incidence of treatment-related mortality (28% [95% CI, 18%, 40%] vs. 21% [95% CI, 10%, 34%]) and superior event-free survival at 2 years (37% [95%CI, 25%-49%) vs. 21% [8%-34%], p = 0.002). On multivariable analysis the type of protocol was the only variable with independent significance for event-free survival (HR [95% CI]: 2 [1.3, 3], p = .002). CONCLUSIONS: Compared with less intensive chemotherapy, pediatric-inspired intensive chemotherapy significantly improves the outcome of older adults with Ph-negative ALL in the age range of 55-65 years.

Depressive symptoms in early- and late-onset older bipolar patients compared with younger ones.

OBJECTIVES: The aim of this study was to determine clinical and outcome differences between older bipolar patients with early onset (EO) and late onset (LO) of the illness and between younger and EO older patients with a bipolar disorder under long-term treatment in an outpatient clinical setting. METHODS: Three hundred ninety-five bipolar I and II outpatients were followed up for up to 7.7 years. Of these, 213 younger (<50 years) and 88 older (>60 years) patients were included. In the older subsample, 50 EO patients (onset <50 years) versus 38 LO patients (≥50 years) were analyzed. Likewise, younger versus EO older patients were compared. RESULTS: The likelihood of LO older patients of being bipolar II was higher than for EO older patients. They were also diagnosed earlier than EO older patients. No other clinical differences at baseline and at the prospective follow-up were found. Compared with younger patients, EO older patients had more frequent depressive symptoms at baseline, suffered more major depressive episodes in the previous year and in the prospective follow-up, received more antidepressants at baseline, had higher rates of medical comorbid conditions and were less likely to be tobacco smokers. CONCLUSIONS: Older patients constitute a meaningful proportion of bipolar patients under treatment. EO older patients suffered significantly from more frequent depressive symptoms than younger ones. LO older patients were predominantly bipolar II. So as bipolar illness progressed, depressive symptomatology became more frequent and manic episodes were less severe. Copyright © 2016 John Wiley & Sons, Ltd.

Electron paramagnetic resonance study of hydrogen peroxide/ascorbic acid ratio as initiator redox pair in the inulin-gallic acid molecular grafting reaction.

Gallic acid (GA) was grafted onto inulin using the free radicals method, generated by the hydrogen peroxide/ascorbic acid (H2O2/AA) redox pair. Molar ratios of H2O2/AA at 9, 20, 39 and 49 were evaluated by Electron Paramagnetic Resonance in order to find the effect of the oxidation of the inulin and the efficiency in the inulin-gallic acid grafting (IGA). The highest concentration of the inulin macro-radical was obtained with H2O2/AA molar ratios of 20 and 49 with the removal of a hydrogen atom from a methyl group of the inulin fructose monomers. The highest grafting ratio (30.4 mg GA eq/g IGA) was obtained at 9 M of H2O2/AA. UV-Vis, FT-IR-ATR and XDR results confirmed a successful IGA grafting. The efficiency of the grafting reaction depends on the concentration of the macro-radical, it depends on the molar ratio of H2O2/AA, being affected by simultaneous reactions between components of the mixture (H2O2, AA, inulin, GA and eventually atmospheric oxygen) as well.

Patterns of relapse and outcome of elderly multiple myeloma patients treated as front-line therapy with novel agents combinations.

We report the characteristics of relapse, treatment response, and outcomes of 145 elderly patients with multiple myeloma in first relapse after front-line treatment with VMP or VTP. Reappearance of CRAB symptoms (113 patients) and more aggressive forms of disease (32 patients) were the most common patterns of relapse. After second-line therapy, 75 (51.7%) patients achieved at partial response and 16 (11%) complete response (CR). Overall survival was longer among patients receiving VMP as front-line induction (21.4 vs. 14.4 months, P=0.037), in patients achieving CR (28.3 vs. 14.8 months; P=0.04), and in patients without aggressive relapse (28.6 vs. 7.6 months; P=0.0007).

Pharmacogenetic study of second-generation antipsychotic long-term treatment metabolic side effects (the SLiM Study): rationale, objectives, design and sample description.

AIM: Weight gain is an important and common side effect of second generation antipsychotics (SGAs). Furthermore, these drugs can induce other side effects associated with higher cardiovascular morbidity and mortality, such as insulin resistance, diabetes or metabolic syndrome. Preliminary studies show that inter-individual genetic differences produce varying degrees of vulnerability to the different SGA-induced side effects. The Second-generation antipsychotic Long-term treatment Metabolic side effects (SLiM) study aims to identify clinical, environmental and genetic factors that explain inter-individual differences in weight gain and metabolic changes in drug-naïve patients after six months of treatment with SGAs. MATERIALS AND METHODS: The SLIM study is a multicenter, observational, six-month pharmacogenetic study where a cohort of 307 drug-naïve paediatric and adult patients (age range 8.8-90.1 years) and a cohort of 150 age- and sex- matched healthy controls (7.8-73.2 years) were recruited. RESULTS: This paper describes the rationale, objectives and design of the study and provides a description of the sample at baseline. CONCLUSIONS: Results from the SLiM study will provide a better understanding of the clinical, environmental, and genetic factors involved in weight gain and metabolic disturbances associated with SGA treatment.

Estudio farmacogenético del tratamiento a largo plazo con antipsicóticos de segunda generación y sus efectos adversos metabólicos (Estudio SLiM): justificación, objetivos, diseño y descripción de la muestra / Pharmacogenetic study of second-generation antipsychotic long-term treatment metabolic side effects (the SLiM Study): rationale, objectives, design and sample description

Objetivo. El aumento de peso es un efecto secundario frecuente e importante de los antipsicóticos de segunda generación (ASG). Además, estos fármacos pueden inducir otros efectos secundarios que están asociados a un aumento de la morbimortalidad cardiovascular, tales como la resistencia a la insulina, la diabetes o el síndrome metabólico. Estudios preliminares indican que las diferencias genéticas interindividuales producen distintos grados de vulnerabilidad a los efectos secundarios inducidos por los ASG. El estudio SLiM (por sus siglas en inglés, Second-generation antipsychotic Long-term treatment Metabolic side effects) tiene como objetivo identificar en pacientes no tratados previamente con ASG (pacientes naive), aquellos factores clínicos, genéticos y ambientales que expliquen las diferencias interindividuales en relación con el aumento de peso y los cambios metabólicos generados tras 6 meses de tratamiento con estos fármacos. Material y métodos. El estudio SLiM es un estudio farmacogenético multicéntrico, observacional, prospectivo, de 6 meses de duración, en el que se ha reclutado una cohorte de 307 pacientes pediátricos y adultos (rango de edad entre 8,8 a 90,1 años) naive a ASG y una cohorte de 150 controles sanos (rango de edad entre 7,8 y 73,2 años) emparejados por edad y sexo. Resultados. En este artículo se presentan la justificación, los objetivos y el diseño del estudio y se ofrece una descripción de la muestra al inicio del estudio. Conclusiones. Los resultados del estudio SLiM permitirán una mejor comprensión de los factores clínicos, ambientales y genéticos implicados en el aumento de peso y los trastornos metabólicos asociados al tratamiento con ASG (AU)

Aim. Weight gain is an important and common side effect of second generation antipsychotics (SGAs). Furthermore, these drugs can induce other side effects associated with higher cardiovascular morbidity and mortality, such as insulin resistance, diabetes or metabolic syndrome. Preliminary studies show that inter-individual genetic differences produce varying degrees of vulnerability to the different SGA-induced side effects. The Second-generation antipsychotic Long-term treatment Metabolic side effects (SLiM) study aims to identify clinical, environmental and genetic factors that explain inter-individual differences in weight gain and metabolic changes in drug-naïve patients after six months of treatment with SGAs. Materials and methods. The SLIM study is a multicenter, observational, six-month pharmacogenetic study where a cohort of 307 drug-naïve paediatric and adult patients (age range 8.8-90.1 years) and a cohort of 150 age- and sex- matched healthy controls (7.8-73.2 years) were recruited. Results. This paper describes the rationale, objectives and design of the study and provides a description of the sample at baseline. Conclusions. Results from the SLiM study will provide a better understanding of the clinical, environmental, and genetic factors involved in weight gain and metabolic disturbances associated with SGA treatment (AU)

Seasonality, smoking and history of poor treatment compliance are strong predictors of dropout in a naturalistic 6 year follow-up of bipolar patients.

Bipolar disorder is a highly recurrent disease which requires long-term treatment. Dropout is a major problem, poorly understood. The objectives of this study were to know the risk of dropout of a cohort of bipolar patients under ambulatory treatment and to identify the clinical profile of patients more likely to abandon the follow-up. A sample of 285 BD I and II patients was followed up for a mean of 2.87 years. A significant proportion of patients failed regular follow-up. The dropout rates were 6.3 % at three months, 12.7 % at 6 months, and 17.6, 27.2, 37.3, 44.0, 47.2 and 49.0 % at 1, 2, 3, 4, 5 and 6 years respectively. Very few variables at baseline predicted dropout. Patients under 35 years of age were more likely to dropout than older cases. Seasonality, smoking and specially history of poor treatment compliance were strong predictors of dropout. Given the magnitude of dropout, additional early clinical interventions should be considered for high-risk patients.

Understanding bipolar disorder in late life: clinical and treatment correlates of a sample of elderly outpatients.

The aim of this study was to examine the demographic, clinical, and treatment correlates of bipolar disorder (BD) in outpatients 65 years or older and to compare patients with BD subtype I (BD-I) versus BD subtype II (BD-II) and patients with early onset (EO; <=50 years old) versus late onset (LO; >50 years old) of the illness. Sixty-nine consecutive outpatients with BD were included. Diagnosis was delayed for a mean of 14.1 years, significantly longer in patients with EO (18.6 years) than with LO (3.3 years). Mild to moderate depressive symptoms were detected in 29% of the patients. The patients were receiving a mean of 3 different psychotropic medications. Antidepressantswere more frequently prescribed to patients with BD-II than to patients with BD-I (75.80% vs. 48.60%) and to patients with EO (71.7%) than to LO (35.3%). Geriatric BD has similar clinical characteristics with those of younger ages, and these do not seem to greatly differ with subtype or age of onset.

Discapacidad en pacientes bipolares ancianos en tratamiento ambulatorio. Variables asociadas(AU) / Variables associated with disability in elderly bipolar patients on ambulatory treatment

Discapacidad en pacientes bipolares ancianos en tratamiento ambulatorio. Variables asociadas(AU)

Introduction. Studies on adult bipolar patients have demonstrated a disability associated with the bipolar disorder, even in euthymic patients, but there is a lack of data in the elderly population. Material and method. A cross-sectional, multicentre study on a consecutive sample of ambulatory bipolar patients (DSM-IV-TR criteria), aged 65 years or over. Retrospective and cross-sectional sociodemographic and clinical data were collected, as well as the Clinical Global Impression for Bipolar Modified scale (CGI-BP-M) and the level of disability using the World Health Organisation Disability Assessment Schedule (WHO/DAS). The disability was assessed globally and by areas. The presence of a moderate to maximum disability compared to a mild to no disability was considered a dependent variable. Results. A moderate to maximum global disability was present in 43.6% of the sample. By areas, occupational functioning was the area most frequently affected, and personal care the least affected. The only variables which were associated with disability were the presence of medical comorbidity (P = .01), increased age (P = .005) global clinical severity (P = .0001) and in the depressive pole (P = .03). There was no relationship between clinical subtype, duration of the disease, number of previous episodes, number of hospitalisations, or other clinical variables and the degree of disability. Conclusions. These data underline the need to establish specific therapeutic strategies in the approach to depressive symptoms and medical comorbidity, with the aim of minimising the disability in elderly bipolar patients. Given the lack of current data, new studies are needed with larger samples and control groups(AU)

[Variables associated with disability in elderly bipolar patients on ambulatory treatment]. / Discapacidad en pacientes bipolares ancianos en tratamiento ambulatorio. Variables asociadas.

INTRODUCTION: Studies on adult bipolar patients have demonstrated a disability associated with the bipolar disorder, even in euthymic patients, but there is a lack of data in the elderly population. MATERIAL AND METHOD: A cross-sectional, multicentre study on a consecutive sample of ambulatory bipolar patients (DSM-IV-TR criteria), aged 65 years or over. Retrospective and cross-sectional sociodemographic and clinical data were collected, as well as the Clinical Global Impression for Bipolar Modified scale (CGI-BP-M) and the level of disability using the World Health Organisation Disability Assessment Schedule (WHO/DAS). The disability was assessed globally and by areas. The presence of a moderate to maximum disability compared to a mild to no disability was considered a dependent variable. RESULTS: A moderate to maximum global disability was present in 43.6% of the sample. By areas, occupational functioning was the area most frequently affected, and personal care the least affected. The only variables which were associated with disability were the presence of medical comorbidity (P = .01), increased age (P = .005) global clinical severity (P = .0001) and in the depressive pole (P = .03). There was no relationship between clinical subtype, duration of the disease, number of previous episodes, number of hospitalisations, or other clinical variables and the degree of disability. CONCLUSIONS: These data underline the need to establish specific therapeutic strategies in the approach to depressive symptoms and medical comorbidity, with the aim of minimising the disability in elderly bipolar patients. Given the lack of current data, new studies are needed with larger samples and control groups.

Tasas de prevalencia de depresión en atención primaria en relación con las características metodológicas de los estudios / Prevalence of depression in primary care according to the methodology of the studies

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