Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd Study)

BACKGROUND: Studies in bipolar disorder (BD) to date are limited in their ability to provide a whole-disease perspective--their scope has generally been confined to a single disease phase and/or a specific treatment. Moreover, most clinical trials have focused on the manic phase of disease, and not on depression, which is associated with the greatest disease burden. There are few longitudinal studies covering both types of patients with BD (I and II) and the whole course of the disease, regardless of patients' symptomatology. Therefore, the Wide AmbispectiVE study of the clinical management and burden of Bipolar Disorder (WAVE-bd) (NCT01062607) aims to provide reliable information on the management of patients with BD in daily clinical practice. It also seeks to determine factors influencing clinical outcomes and resource use in relation to the management of BD. METHODS: WAVE-bd is a multinational, multicentre, non-interventional, longitudinal study. Approximately 3000 patients diagnosed with BD type I or II with at least one mood event in the preceding 12 months were recruited at centres in Austria, Belgium, Brazil, France, Germany, Portugal, Romania, Turkey, Ukraine and Venezuela. Site selection methodology aimed to provide a balanced cross-section of patients cared for by different types of providers of medical aid (e.g. academic hospitals, private practices) in each country. Target recruitment percentages were derived either from scientific publications or from expert panels in each participating country. The minimum follow-up period will be 12 months, with a maximum of 27 months, taking into account the retrospective and the prospective parts of the study. Data on demographics, diagnosis, medical history, clinical management, clinical and functional outcomes (CGI-BP and FAST scales), adherence to treatment (DAI-10 scale and Medication Possession Ratio), quality of life (EQ-5D scale), healthcare resources, and caregiver burden (BAS scale) will be collected. Descriptive analysis with common statistics will be performed. DISCUSSION: This study will provide detailed descriptions of the management of BD in different countries, particularly in terms of clinical outcomes and resources used. Thus, it should provide psychiatrists with reliable and up-to-date information about those factors associated with different management patterns of BD. TRIAL REGISTRATION NO: ClinicalTrials.gov: NCT01062607.

Noves perspectives en el diagnòstic del deteriorament cognitiu lleu i la malaltia de l'Alzheimer

Els criteris per al diagnòstic clínic de la malaltia d’Alzheimer es van establir el 1984 pel National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) i la Alzheimer’s Disease and Related Disorders Association (ADRDA). D’aplicació continuada fins a l’actualitat, aquests criteris estan quedant obsolets i per tant des de diversos àmbits s’ha abogat per una revisió profunda dels mateixos. Tres grups d’experts formats per reconeguts especialistes del National Institute on Aging (NIA) i la Alzheimer’s Association proposen un conjunt de recomanacions per modificar aquests criteris en l’àmbit de la investigació clínica. Dues diferències remarcables s’inclouen en aquests nous criteris: la incorporació de biomarcadors i la formalització de diferents estadis de la malaltia d’Alzheimer. D’aquesta manera, el deteriorament cognitiu lleu s’incorpora al procés diagnòstic com un estadi més de la patologia. Tanmateix, aquests criteris es troben en revisió i, de moment sols son aplicables en l’àmbit de recerca per tal d’arribar a un consens definitiu que permeti la modificació definitiva dels criteris clínics universals a aplicar. En aquest article es presenten els principals avenços en la investigació referents a la malaltia d’Alzheimer i al Deteriorament Cognitiu lleu per tal d’emmarcar els nous criteris de recerca.

Aplicació de verificació i control de codi de barres i datamatrix

A les línies de producció de l’empresa Laboratorios Hipra, s’ha plantejat imprimir els codis de les caixes mitjançant nous làsers amb la tècnica de delineat làser, amb aquests nous models de làser es vol imprimir codis datamatrix. Per tal que això sigui possible, és molt important poder tenir un control de les impressions realitzades pel làser, ja que en cas contrari, podrien empaquetar-se caixes amb un marcatge erroni. S’ha dissenyatuna aplicació capaç de verificar i controlar les impressions realitzades pels làsers. Aquesta aplicació ha de ser capaç de verificar i controlar les caixes marcades tant amb codis de barres com amb datamatrix, a més a més de mostrar totes les dades dels marcatges per una pantalla SCADA. L’aplicació també incorpora un sistema d’expulsió de les caixes amb un marcatge d’inferior qualitat a la desitjada en cada moment

Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder:a meta-analysis of randomized controlled trials

The purpose of this meta-analysis was to examine the efficacy of maintenance treatments for bipolar disorder. Placebo-controlled or active comparator bipolar maintenance clinical trials of ≥6 months' duration with at least 15 patients/treatment group were identified using Medline, EMBASE, clinicaltrials.gov, and Cochrane databases (1993 to July 2010). The main outcome measure was relative risk for relapse for patients in remission. Twenty trials (5,364 patients) were identified. Overall, lithium and quetiapine were the most studied agents (eight and five trials, respectively). The majority of studies included patients who had previously responded to treatment for an acute episode. All interventions, with the exception of perphenazine+mood stabilizer, showed a relative risk for manic/mixed or depressive relapse below 1.0, although there was variation in the statistical significance of the findings vs. placebo. No monotherapy was associated with a significantly reduced risk for both manic/mixed and depressed relapse. Of the combination treatments, only quetiapine+lithium/divalproex, was associated with a significantly reduced risk vs. comparator (placebo+lithium/valproate) for relapse at both the manic/mixed and depressed poles of bipolar illness. Limitations for the analysis include differences in study durations and definitions of relapse. In conclusion, available maintenance therapies show considerable variation in efficacy. The efficacy of lithium and divalproex has been confirmed, but newer therapies, such as a number of atypical antipsychotics were also shown to be effective in bipolar disorder. Efficacy of all maintenance interventions needs to be balanced against the safety and tolerability profiles of individual agents.

Effectiveness of a drug dosing service provided by community pharmacists in polymedicated elderly patients with renal impairment a comparative study

Background: Drug dosing errors are common in renal-impaired patients. Appropriate dosing adjustment and drug selection is important to ensure patients" safety and to avoid adverse drug effects and poor outcomes. There are few studies on this issue in community pharmacies. The aims of this study were, firstly, to determine the prevalence of dosing inadequacy as a consequence of renal impairment in patients over 65 taking 3 or more drug products who were being attended in community pharmacies and, secondly, to evaluate the effectiveness of the community pharmacist"s intervention in improving dosing inadequacy in these patients when compared with usual care. Methods: The study was carried out in 40 Spanish community pharmacies. The study had two phases: the first, with an observational, multicentre, cross sectional design, served to determine the dosing inadequacy, the drug-related problems per patient and to obtain the control group. The second phase, with a controlled study with historical control group, was the intervention phase. When dosing adjustments were needed, the pharmacists made recommendations to the physicians. A comparison was made between the control and the intervention group regarding the prevalence of drug dosing inadequacy and the mean number of drug-related problems per patient. Results: The mean of the prevalence of drug dosing inadequacy was 17.5% [95% CI 14.6-21.5] in phase 1 and 15.5% [95% CI 14.5-16.6] in phase 2. The mean number of drug-related problems per patient was 0.7 [95% CI 0.5-0.8] in phase 1 and 0.50 [95% CI 0.4-0.6] in phase 2. The difference in the prevalence of dosing inadequacy between the control and intervention group before the pharmacists" intervention was 0.73% [95% CI (−6.0) - 7.5] and after the pharmacists" intervention it was 13.5% [95% CI 8.0 - 19.5] (p < 0.001) while the difference in the mean of drug-related problems per patient before the pharmacists" intervention was 0.05 [95% CI( -0.2) - 0.3] and following the intervention it was 0.5 [95% CI 0.3 - 0.7] (p < 0.001). Conclusion: A drug dosing adjustment service for elderly patients with renal impairment in community pharmacies can increase the proportion of adequate drug dosing, and improve the drug-related problems per patient. Collaborative practice with physicians can improve these results.

Class effect of pharmacotherapy in bipolar disorder: fact or misbelieff?

BACKGROUND: Anecdotal reports suggests that most clinicians treat medications as belonging to a class with regard to all therapeutic indications; this means that the whole 'class' of drugs is considered to possesses a specific therapeutic action. The present article explores the possible existence of a true 'class effect' for agents available for the treatment of bipolar disorder. METHODS: We reviewed the available treatment data from randomized controlled trials (RCTs) and explored 16 'agent class'/'treatment issue' cases for bipolar disorder. Four classes of agents were examined: first-generation antipsychotics (FGAs), second-generation antipsychotics (SGAs), antiepileptics and antidepressants, with respect to their efficacy on four treatment issues of bipolar disorder (BD) (acute mania, acute bipolar depression, maintenance against mania, maintenance against depression). RESULTS: From the 16 'agent class'/' treatment issue' cases, only 3 possible class effects were detected, and they all concerned acute mania and antipsychotics. Four effect cases have not been adequately studied (FGAs against acute bipolar depression and in maintenance protection from depression, and antidepressants against acute mania and protection from mania) and they all concern treatment cases with a high risk of switching to the opposite pole, thus research in these areas is poor. There is no 'class effect' at all concerning antiepileptics. CONCLUSIONS: The available data suggest that a 'class effect' is the exception rather than the rule in the treatment of BD. However, the possible presence of a 'class effect' concept discourages clinicians from continued scientific training and reading. Focused educational intervention might be necessary to change this attitude.

Effectiveness of a drug dosing service provided by community pharmacists in polymedicated elderly patients with renal impairment a comparative study

Background: Drug dosing errors are common in renal-impaired patients. Appropriate dosing adjustment and drug selection is important to ensure patients" safety and to avoid adverse drug effects and poor outcomes. There are few studies on this issue in community pharmacies. The aims of this study were, firstly, to determine the prevalence of dosing inadequacy as a consequence of renal impairment in patients over 65 taking 3 or more drug products who were being attended in community pharmacies and, secondly, to evaluate the effectiveness of the community pharmacist"s intervention in improving dosing inadequacy in these patients when compared with usual care. Methods: The study was carried out in 40 Spanish community pharmacies. The study had two phases: the first, with an observational, multicentre, cross sectional design, served to determine the dosing inadequacy, the drug-related problems per patient and to obtain the control group. The second phase, with a controlled study with historical control group, was the intervention phase. When dosing adjustments were needed, the pharmacists made recommendations to the physicians. A comparison was made between the control and the intervention group regarding the prevalence of drug dosing inadequacy and the mean number of drug-related problems per patient. Results: The mean of the prevalence of drug dosing inadequacy was 17.5% [95% CI 14.6-21.5] in phase 1 and 15.5% [95% CI 14.5-16.6] in phase 2. The mean number of drug-related problems per patient was 0.7 [95% CI 0.5-0.8] in phase 1 and 0.50 [95% CI 0.4-0.6] in phase 2. The difference in the prevalence of dosing inadequacy between the control and intervention group before the pharmacists" intervention was 0.73% [95% CI (−6.0) - 7.5] and after the pharmacists" intervention it was 13.5% [95% CI 8.0 - 19.5] (p < 0.001) while the difference in the mean of drug-related problems per patient before the pharmacists" intervention was 0.05 [95% CI( -0.2) - 0.3] and following the intervention it was 0.5 [95% CI 0.3 - 0.7] (p < 0.001). Conclusion: A drug dosing adjustment service for elderly patients with renal impairment in community pharmacies can increase the proportion of adequate drug dosing, and improve the drug-related problems per patient. Collaborative practice with physicians can improve these results.

Centro de Biomedicina Experimental (CEBEGA), Santiago de Compostela

Award-winning

Efficacy of modern antipsychotics in placebo-controlled trials in bipolar depression: a meta-analysis.

Randomized, controlled trials have demonstrated efficacy for second-generation antipsychotics in the treatment of acute mania in bipolar disorder. Despite depression being considered the hallmark of bipolar disorder, there are no published systematic reviews or meta-analyses to evaluate the efficacy of modern atypical antipsychotics in bipolar depression. We systematically reviewed published or registered randomized, double-blind, placebo-controlled trials (RCTs) of modern antipsychotics in adult bipolar I and/or II depressive patients (DSM-IV criteria). Efficacy outcomes were assessed based on changes in the Montgomery-Asberg Depression Rating Scale (MADRS) during an 8-wk period. Data were combined through meta-analysis using risk ratio as an effect size with a 95% confidence interval (95% CI) and with a level of statistical significance of 5% (p<0.05). We identified five RCTs; four involved antipsychotic monotherapy and one addressed both monotherapy and combination with an antidepressant. The two quetiapine trials analysed the safety and efficacy of two doses: 300 and 600 mg/d. The only olanzapine trial assessed olanzapine monotherapy within a range of 5-20 mg/d and olanzapine-fluoxetine combination within a range of 5-20 mg/d and 6-12 mg/d, respectively. The two aripiprazole placebo-controlled trials assessed doses of 5-30 mg/d. Quetiapine and olanzapine trials (3/5, 60%) demonstrated superiority over placebo (p<0.001). Only 2/5 (40%) (both aripiprazole trials) failed in the primary efficacy measure after the first 6 wk. Some modern antipsychotics (quetiapine and olanzapine) have demonstrated efficacy in bipolar depressive patients from week 1 onwards. Rapid onset of action seems to be a common feature of atypical antipsychotics in bipolar depression. Comment in The following popper user interface control may not be accessible. Tab to the next button to revert the control to an accessible version.Destroy user interface controlEfficacy of modern antipsychotics in placebo-controlled trials in bipolar depression: a meta-analysis--results to be interpreted with caution.

Use of recovered frying oils in chicken and rabbit feeds: effect on the fatty acid and tocol composition and on the oxidation levels of meat, liver and plasma

The addition of some fat co- and by-products to feeds is usual nowadays; however, the regulations of their use are not always clear and vary between countries. For instance, the use of recycled cooking oils is not allowed in the European Union, but they are used in other countries. However, oils recovered from industrial frying processes could show satisfactory quality for this purpose. Here we studied the effects of including oils recovered from the frying industry in rabbit and chicken feeds (at 30 and 60 g/kg, respectively) on the fatty acid (FA) and tocol (tocopherol1tocotrienol) compositon of meat, liver and plasma, and on their oxidative stability. Three dietary treatments (replicated eight times) were compared: fresh non-used oil (LOX); oil discarded from the frying industry, having a high content of secondary oxidation compounds (HOX); and an intermediate level (MOX) obtained by mixing 50 : 50 of LOX and HOX. The FA composition of oil diets and tissues was assessed by GC, their tocol content by HPLC, the thiobarbituric acid value was used to assess tissue oxidation status, and the ferrous oxidation-xylenol orange method was used to assess the susceptibility of tissues to oxidation. Our results indicate that FA composition of rabbit and chicken meat, liver and plasma was scarcely altered by the addition of recovered frying oils to feed. Differences were encountered in the FA composition between species, which might be attributed mainly to differences in the FA digestion, absorption and metabolism between species, and to some physiological dietary factors (i.e. coprophagy in rabbits that involves fermentation with FA structure modification). The a-tocopherol (aT) content of tissues was reduced in response to the lower aT content in the recovered frying oil. Differences in the content of other tocols were encountered between chickens and rabbits, which might be attributable to the different tocol composition of their feeds, as well as to species differences in the digestion and metabolism of tocols. Tissue oxidation and susceptibility to oxidation were in general low and were not greatly affected by the degree of oxidation of the oil added to the feeds. The relative content of polyunsaturated fatty acids/aT in these types of samples would explain the differences observed between species in the susceptibility of each tissue to oxidation. According to our results, oils recovered from the frying industry could be useful for feed uses.

Operacions bàsiques al laboratori químic en xarxa. Una nova eina per a estudiants i professors

Un conjunt de professors de les facultats de Química i Farmàcia de la Universitat de Barcelona hem elaborat un material docent en suport electrònic, d"accés lliure a la xarxa, que descriu el procediment pràctic de diverses operacions bàsiques de treball al laboratori químic. L"objectiu principal és crear un material docent que serveixi de suport a l"aprenentatge dels estudiants i a la tasca docent del professorat involucrat en l"ensenyament del treball pràctic en l"etapa d"inici dels estudis universitaris.

Alcoholisme: un cas clínic d'abordatge multidisciplinar a la Facultat de Farmàcia

A la Facultat de Farmàcia de la UB hem iniciat un projecte plurianual i multidisciplinar que té com a finalitat el desenvolupament de casos clínics transversals. En l’actualitat, l’equip docent està format per 49 professors implicats en 14 assignatures del Grau de Farmàcia. L’objectiu del grup és reforçar la transversalitat al llarg del grau, de manera que els alumnes adquireixin la percepció de que els coneixements apresos en una assignatura són la base per a les altres. Per fomentar-ho, proposem la realització de casos clínics que es vagin resolent progressivament en el context de diverses assignatures del grau. El primer cas clínic que hem dissenyat és sobre l’alcoholisme, ja que és un tema d’interès sanitari, abordable des de diferents disciplines. El grup ha desenvolupat la història d’un personatge, en Sam, que s’inicia en el consum d’alcohol des de molt jove, de manera que els alumnes a mida que cursin les diferents assignatures coneixeran la seva evolució i conseqüències (des d’un coma etílic, consum de risc, deshabituació,…), tot en l’entorn de la vida familiar i social del personatge, per aconseguir una proximitat d’en Sam amb l’estudiant. El cas va ser elaborat amb l’ajut de la Unitat d’Alcohologia de l’Hospital Clínic.

Alcoholisme: un cas clínic d'abordatge multidisciplinar a la Facultat de Farmàcia

A la Facultat de Farmàcia de la UB hem iniciat un projecte plurianual i multidisciplinar que té com a finalitat el desenvolupament de casos clínics transversals. En l’actualitat, l’equip docent està format per 49 professors implicats en 14 assignatures del Grau de Farmàcia. L’objectiu del grup és reforçar la transversalitat al llarg del grau, de manera que els alumnes adquireixin la percepció de que els coneixements apresos en una assignatura són la base per a les altres. Per fomentar-ho, proposem la realització de casos clínics que es vagin resolent progressivament en el context de diverses assignatures del grau. El primer cas clínic que hem dissenyat és sobre l’alcoholisme, ja que és un tema d’interès sanitari, abordable des de diferents disciplines. El grup ha desenvolupat la història d’un personatge, en Sam, que s’inicia en el consum d’alcohol des de molt jove, de manera que els alumnes a mida que cursin les diferents assignatures coneixeran la seva evolució i conseqüències (des d’un coma etílic, consum de risc, deshabituació,…), tot en l’entorn de la vida familiar i social del personatge, per aconseguir una proximitat d’en Sam amb l’estudiant. El cas va ser elaborat amb l’ajut de la Unitat d’Alcohologia de l’Hospital Clínic.

Alcoholisme: un cas clínic d'abordatge multidisciplinar a la Facultat de Farmàcia

A la Facultat de Farmàcia de la UB hem iniciat un projecte plurianual i multidisciplinar que té com a finalitat el desenvolupament de casos clínics transversals. En l’actualitat, l’equip docent està format per 49 professors implicats en 14 assignatures del Grau de Farmàcia. L’objectiu del grup és reforçar la transversalitat al llarg del grau, de manera que els alumnes adquireixin la percepció de que els coneixements apresos en una assignatura són la base per a les altres. Per fomentar-ho, proposem la realització de casos clínics que es vagin resolent progressivament en el context de diverses assignatures del grau. El primer cas clínic que hem dissenyat és sobre l’alcoholisme, ja que és un tema d’interès sanitari, abordable des de diferents disciplines. El grup ha desenvolupat la història d’un personatge, en Sam, que s’inicia en el consum d’alcohol des de molt jove, de manera que els alumnes a mida que cursin les diferents assignatures coneixeran la seva evolució i conseqüències (des d’un coma etílic, consum de risc, deshabituació,…), tot en l’entorn de la vida familiar i social del personatge, per aconseguir una proximitat d’en Sam amb l’estudiant. El cas va ser elaborat amb l’ajut de la Unitat d’Alcohologia de l’Hospital Clínic.

Alcoholisme: un cas clínic d'abordatge multidisciplinar a la Facultat de Farmàcia

A la Facultat de Farmàcia de la UB hem iniciat un projecte plurianual i multidisciplinar que té com a finalitat el desenvolupament de casos clínics transversals. En l’actualitat, l’equip docent està format per 49 professors implicats en 14 assignatures del Grau de Farmàcia. L’objectiu del grup és reforçar la transversalitat al llarg del grau, de manera que els alumnes adquireixin la percepció de que els coneixements apresos en una assignatura són la base per a les altres. Per fomentar-ho, proposem la realització de casos clínics que es vagin resolent progressivament en el context de diverses assignatures del grau. El primer cas clínic que hem dissenyat és sobre l’alcoholisme, ja que és un tema d’interès sanitari, abordable des de diferents disciplines. El grup ha desenvolupat la història d’un personatge, en Sam, que s’inicia en el consum d’alcohol des de molt jove, de manera que els alumnes a mida que cursin les diferents assignatures coneixeran la seva evolució i conseqüències (des d’un coma etílic, consum de risc, deshabituació,…), tot en l’entorn de la vida familiar i social del personatge, per aconseguir una proximitat d’en Sam amb l’estudiant. El cas va ser elaborat amb l’ajut de la Unitat d’Alcohologia de l’Hospital Clínic.