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1.
G Ital Nefrol ; 36(4)2019 Jul 24.
Artigo em Italiano | MEDLINE | ID: mdl-31373471

RESUMO

Lithium is a largely used and effective therapy in the treatment of bipolar disorder. Its toxic effects on kidneys are mostly diabetes insipidus, hyperchloremic metabolic acidosis and tubulointerstitial nephritis. Also, a correlation between lithium and minimal change disease has sometimes been described. We report here the case of a patient with severe bipolar disorder on lithium therapy who, without any pre-existing nephropathy, developed nephrotic syndrome and AKI with histopathologic findings pointing to minimal change disease. The patient was treated with symptomatic therapy; the discontinuation of lithium therapy resulted in the remission of AKI and of the nephrotic syndrome, thus suggesting a close relationship between lithium and minimal change disease.


Assuntos
Antimaníacos/efeitos adversos , Transtorno Bipolar/tratamento farmacológico , Compostos de Lítio/efeitos adversos , Nefrose Lipoide/induzido quimicamente , Síndrome Nefrótica/induzido quimicamente , Lesão Renal Aguda/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Nefrose Lipoide/patologia , Suspensão de Tratamento
3.
Expert Opin Drug Saf ; 18(8): 703-717, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31203678

RESUMO

INTRODUCTION: To compare common side effects of mood stabilizers (MSs) and antipsychotics in pediatric and adult bipolar disorder (BD). AREAS COVERED: MEDLINE, EMBASE, PsycINFO was searched for randomized, double-blind, placebo-controlled trials (RCTs) in the treatment of pediatric and adult BD. Twelve RCTs for pediatric patients and 30 for adult patients were included. The risk for the discontinuation due to adverse events, ≥7% weight gain, somnolence, akathisia, nausea and vomiting from a medication relative to placebo was estimated with absolute risk increase and the number needed to harm. The relative risk of these measures in pediatric and adult patients was compared. EXPERT OPINION: Overall, the relative risk for ≥7% weight gain, somnolence, nausea, or vomiting was higher, and akathisia was lower in pediatric patients than in adults. The magnitude of difference among MSs and antipsychotics and between pediatrics and adults varied widely. The risk for pediatric patients could be underestimated because in most pediatric studies, doses of studied medications were lower and flexibly dosed, and titration speeds were slower than in adult studies. Clinicians should pay attention to differences in study designs to understand the risk for common side effects when prescribing a medication for BD.


Assuntos
Antimaníacos/efeitos adversos , Antipsicóticos/efeitos adversos , Transtorno Bipolar/tratamento farmacológico , Adulto , Fatores Etários , Anticonvulsivantes/administração & dosagem , Anticonvulsivantes/efeitos adversos , Antimaníacos/administração & dosagem , Antipsicóticos/administração & dosagem , Criança , Relação Dose-Resposta a Droga , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Risco
4.
Pan Afr Med J ; 32: 78, 2019.
Artigo em Francês | MEDLINE | ID: mdl-31223369

RESUMO

The inappropriate antidiuretic hormone secretion Syndrome (ADHS) accounts for approximately 50% of all diagnosed cases of hyponatremia while drug-induced ADHS accounts for a small proportion of cases. We report the case of a female patient, treated for schizoaffective disorder, who developed ADHS following the initiation of risperidone and carbamazepine. Biochemical test results suggested risperidone and carbamazepine-induced ADHS. The patient was successfully treated by stopping drug use and by fluid restriction. After correcting the serum sodium levels, the patient was treated with clozapine. She is currently on clozapine 400mg with stable serum sodium rates. Psychiatrists should be aware of the risk of severe hyponatremia associated with psychotropic drug use. It is therefore essential to monitor electrolyte levels, in particular sodium levels, in patients taking antipsychotics and anticonvulsants.


Assuntos
Carbamazepina/efeitos adversos , Síndrome de Secreção Inadequada de HAD/induzido quimicamente , Risperidona/efeitos adversos , Antimaníacos/administração & dosagem , Antimaníacos/efeitos adversos , Antipsicóticos/administração & dosagem , Antipsicóticos/efeitos adversos , Carbamazepina/administração & dosagem , Feminino , Humanos , Síndrome de Secreção Inadequada de HAD/terapia , Pessoa de Meia-Idade , Transtornos Psicóticos/tratamento farmacológico , Risperidona/administração & dosagem
5.
J Affect Disord ; 252: 201-211, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-30986735

RESUMO

BACKGROUND: This study compared the largest set of bipolar disorder pharmacotherapies to date (71 drugs and drug combinations) for risk of kidney disorders (KDs). METHODS: This retrospective observational study used the IBM MarketScan® database to analyze data on 591,052 adults with bipolar disorder without prior nephropathy, for onset of KDs (of "moderate" or "high" severity) following psychopharmacotherapy (lithium, mood stabilizing anticonvulsants [MSAs], antipsychotics, antidepressants), or "No drug". Cox regression models included fixed pre-treatment covariates and time-varying drug exposure covariates to estimate the hazard ratio (HR) of each treatment versus "No drug". RESULTS: Newly observed KD occurred in 14,713 patients. No regimen had significantly lower risk of KDs than "No drug". The HR estimates ranged 0.86-2.66 for "all" KDs and 0.87-5.30 for "severe" KDs. As additional drugs were combined to compare more complex polypharmacies, higher HRs were consistently observed. Most regimens containing lithium, MSAs, or antipsychotics had a higher risk than "No drug" (p < 0.05). The risk for "all" and "severe" KDs was highest respectively on monoamine oxidase inhibitors (MAOIs) (HR = 2.66, p = 5.73 × 10-5), and a lithium-containing four-class combination (HR = 5.30, p = 2.46 × 10-9). The HR for lithium monotherapy was 1.82 (p = 4.73 × 10-17) for "severe" KDs. LIMITATIONS: The limitations inherent for an observational study were non-randomized assignment of patients to treatment groups, non-standardization of diagnostic decisions, and non-uniform quality of data collection. No correction was made for medication dosage. CONCLUSIONS: The findings support literature concerns about lithium nephrotoxicity and highlight the potential risks of MAOIs, MSAs, antipsychotics and psychotropic polypharmacy.


Assuntos
Transtorno Bipolar/tratamento farmacológico , Nefropatias/induzido quimicamente , Polimedicação , Psicotrópicos/efeitos adversos , Adulto , Anticonvulsivantes/efeitos adversos , Antidepressivos/efeitos adversos , Antimaníacos/efeitos adversos , Antipsicóticos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco
6.
J Clin Psychopharmacol ; 39(3): 238-242, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30932947

RESUMO

BACKGROUND: Lithium in the form of lithium carbonate (Li2CO3) has become one of the most effective and widely prescribed drugs for mood stabilization. However, lithium has adverse effects on renal tubular functions, such as decreased concentrating function of the kidneys, and even occasional symptoms of nephrogenous diabetes insipidus occur with additional evidence of glomerular disruption in lithium-treated patients. METHODS: We assessed the kidney function of patients with bipolar disorder who are under long-term lithium treatment using novel markers of kidney damage such as plasma neutrophil gelatinase-associated lipocalin, cystatin C, albuminuria, estimated glomerular filtration rate, Chronic Kidney Disease-Epidemiology Investigation using creatinine and cystatin C, and serum and urinary osmolality, and compared the results with those of age-matched patients with bipolar disorder not treated with lithium. The study enrolled 120 patients with bipolar disorder, consisting of 80 (30 male and 50 female patients) who have been receiving lithium for 0.5 to 20 (mean, 7) years and 40 (10 male and 30 female patients) who had never been exposed to lithium treatment. RESULTS: Patients treated with lithium had significantly decreased urine osmolality (mean ± SD, 405 ± 164 vs 667 ± 174 mmol/kg) and urine-to-serum osmolality ratio (1.35 ± 0.61 vs 2.25 ± 0.96). No significant difference was found in creatinine, estimated glomerular filtration rate values calculated using the Chronic Kidney Disease-Epidemiology Investigation using creatinine and cystatin C, neutrophil gelatinase-associated lipocalin, cystatin C, and albuminuria between both groups. We found no significant difference in renal biomarkers between patients treated with lithium for 6 to 24 months and those treated for 25 to 240 months. CONCLUSIONS: We found significantly decreased kidney concentrating ability in the long-term lithium-treated patients compared with the control group. Other renal function markers did not indicate any significant signs of renal dysfunction.


Assuntos
Antimaníacos/administração & dosagem , Transtorno Bipolar/tratamento farmacológico , Nefropatias/induzido quimicamente , Carbonato de Lítio/administração & dosagem , Adulto , Idoso , Antimaníacos/efeitos adversos , Biomarcadores/metabolismo , Feminino , Taxa de Filtração Glomerular , Humanos , Nefropatias/epidemiologia , Testes de Função Renal , Carbonato de Lítio/efeitos adversos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
7.
J Clin Psychopharmacol ; 39(3): 249-253, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30932950

RESUMO

OBJECTIVE: The aim of this study was to use a visual analog scale (VAS) longitudinally measuring somnolence severity in patients with bipolar disorder. METHODS: A data set of patients with bipolar spectrum disorders who were randomized to lithium or quetiapine-IR for 16 weeks was used. The somnolence severity was measured with a VAS from 0 to 100 (VAS based), and somnolence frequency was recorded according to incident report (incidence based) at each visit. The rates of VAS-based and incidence-based somnolence and changes in somnolence severity from baseline to the end of study were compared between the lithium and quetiapine groups. Longitudinal changes in somnolence severity were analyzed with linear regression analysis. RESULTS: Of 42 patients randomized, only 3 scored 0 on the VAS at baseline. The rates of incidence-based and VAS-based somnolence were similar in the lithium and quetiapine-IR groups. The VAS change scores from baseline to each visit varied in both groups with significant decreases at weeks 6 and 12 in the quetiapine-IR group only. The decrease at week 6 in the quetiapine-IR group was significantly different from that in the lithium group. Patterns of changes in somnolence severity were inconsistent in both groups. A significant interaction between time course and the decrease in VAS scores was observed in the quetiapine-IR group, but not in the lithium group. CONCLUSIONS: Baseline somnolence was highly prevalent in patients with bipolar disorder. The change in somnolence severity was different between lithium-treated and quetiapine-treated patients. Quantifying somnolence longitudinally is important in clinical trials and practice.


Assuntos
Transtorno Bipolar/tratamento farmacológico , Compostos de Lítio/administração & dosagem , Fumarato de Quetiapina/administração & dosagem , Sonolência , Adulto , Antimaníacos/administração & dosagem , Antimaníacos/efeitos adversos , Antipsicóticos/administração & dosagem , Antipsicóticos/efeitos adversos , Feminino , Humanos , Compostos de Lítio/efeitos adversos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Fumarato de Quetiapina/efeitos adversos , Índice de Gravidade de Doença , Escala Visual Analógica , Adulto Jovem
8.
Metabolism ; 95: 65-76, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30954559

RESUMO

Changes of sphingolipid metabolism were suggested to contribute to the patho-etiology of major depression (MD) and bipolar disorder (BD). In a pilot study we assessed if lipid allostasis manifested in pathological plasma concentrations of bioactive lipids i.e. endocannabinoids, sphingolipids, ceramides, and lysophosphatidic acids. METHODS: Targeted and untargeted lipidomic analyses were performed according to GLP guidelines in 67 patients with unipolar or bipolar disorders (20-67 years, 36 male, 31 female) and 405 healthy controls (18-79 years, 142 m, 263 f), who were matched according to gender, age and body mass index. Multivariate analyses were used to identify major components, which accounted for the variance between groups and were able to predict group membership. RESULTS: Differences between MD and BP patients versus controls mainly originated from ceramides and their hexosyl-metabolites (C16Cer, C18Cer, C20Cer, C22Cer, C24Cer and C24:1Cer; C24:1GluCer, C24LacCer), which were strongly increased, particularly in male patients. Ceramide levels were neither associated with the current episode, nor with the therapeutic improvement of the Montgomery Åsberg Depression Rating Scale (MARDS). However, long-chain ceramides were linearly associated with age, stronger in patients than controls, and with high plasma levels of diacyl- and triacylglycerols. Patients receiving antidepressants had higher ceramide levels than patients not taking these drugs. There was no such association with lithium or antipsychotics except for olanzapine. CONCLUSION: Our data suggest that high plasma ceramides in patients with major depression and bipolar disorder are indicative of a high metabolic burden, likely aggravated by certain medications.


Assuntos
Transtorno Bipolar/metabolismo , Ceramidas/metabolismo , Transtorno Depressivo Maior/metabolismo , Metabolismo dos Lipídeos/genética , Adolescente , Adulto , Fatores Etários , Idoso , Antidepressivos/efeitos adversos , Antidepressivos/uso terapêutico , Antimaníacos/efeitos adversos , Antimaníacos/uso terapêutico , Antipsicóticos/efeitos adversos , Antipsicóticos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Transtorno Bipolar/psicologia , Índice de Massa Corporal , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/psicologia , Diglicerídeos/metabolismo , Feminino , Humanos , Lítio/efeitos adversos , Lítio/uso terapêutico , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Escalas de Graduação Psiquiátrica , Caracteres Sexuais , Triglicerídeos/metabolismo , Adulto Jovem
9.
J Affect Disord ; 245: 812-818, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30699864

RESUMO

BACKGROUND: Divalproex has become the most prevalent mood stabilizer for bipolar disorder. However, little is known its effects in the prevention of suicide in patients with bipolar disorder, and recent FDA announcement indicated an increased risk of suicidality when using anti-epileptic agents such as divalproex. The aim of this study is to investigate the effect of divalproex on suicide risk in patients with bipolar disorder. METHODS: A search strategy was used for the PubMed, Embase, ProQuest, ScienceDirect, Cochrane Library, ClinicalKey, Web of Science, and ClinicalTrials.gov until June 13th, 2018. Peer-reviewed observationally clinical studies in humans, investigating the association of divalproex and suicidality in patients with bipolar disorder were included. A random-effects meta-analysis was implemented to calculate the relative risk (RR) and 95% confidence intervals (CIs) for suicidality among patients receiving divalproex and those without. RESULTS: Total 6 studies were included in the final meta-analysis. There was no significant difference in the incidence rates (reported as [RR]; 95% CI) of suicide attempts (0.921; 0.383-2.215) or completed suicides (0.607; 0.180-2.043) between participants receiving divalproex vs. no medication. There was no significant difference in the incidence rates of suicide attempts (0.815; 0.453-1.466) or completed suicides (1.009; 0.410-2.484) between participants receiving divalproex and carbamazepine. LIMITATIONS: The significantly heterogeneous sample sources and study design amount the included trials. CONCLUSIONS: Treatment with divalproex did not reduce or increase the incidence of suicide-related events in patients with bipolar disorder.


Assuntos
Antimaníacos/efeitos adversos , Transtorno Bipolar/tratamento farmacológico , Internacionalidade , Estudos Observacionais como Assunto , Tentativa de Suicídio/estatística & dados numéricos , Suicídio/estatística & dados numéricos , Ácido Valproico/efeitos adversos , Antimaníacos/uso terapêutico , Humanos , Ácido Valproico/uso terapêutico
10.
Australas Psychiatry ; 27(2): 125-128, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30763123

RESUMO

OBJECTIVES: To describe prescription of sodium valproate (SV) for bipolar mood disorder to potentially child-bearing women within one public mental health service and describe risks of fetal exposure, and safe prescribing practices among psychiatrists. METHODS: A 24-month retrospective chart review with descriptive analysis; narrative review of literature and guidelines. RESULTS: Review of 383 charts demonstrated prescription of valproate to 20% of 98 women aged 15-45, with little evidence of advice regarding risk and contraception. Robust evidence of teratogenic and neurodevelopmental risk underpins increased regulation, and recommendations that valproate not be prescribed to this cohort. CONCLUSIONS: The significant risks associated with SV oblige all prescribers to proactively access authoritative guidelines such as those published by the Centre of Perinatal Excellence.


Assuntos
Anormalidades Induzidas por Medicamentos/etiologia , Padrões de Prática Médica , Complicações na Gravidez/tratamento farmacológico , Teratogênios , Ácido Valproico/uso terapêutico , Anticonvulsivantes/efeitos adversos , Anticonvulsivantes/uso terapêutico , Antimaníacos/efeitos adversos , Antimaníacos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Epilepsia/tratamento farmacológico , Feminino , Humanos , Gravidez , Complicações na Gravidez/psicologia , Fatores de Risco , Ácido Valproico/efeitos adversos
13.
Eur J Drug Metab Pharmacokinet ; 44(3): 329-338, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30536114

RESUMO

BACKGROUND AND OBJECTIVE: Lithium, which is used to treat bipolar disorder, has a narrow therapeutic blood concentration range and quickly reaches clinically toxic levels. We performed a population pharmacokinetic analysis with a lithium tubular reabsorption model including urinary pH and investigated the relationship between blood lithium concentration and tremor as a side effect. METHODS: Routine clinical data, including 389 serum concentrations, were collected from 214 patients orally administered an adjusted amount of lithium carbonate. Pharmacokinetics were described using a one-compartment distribution model with first-order absorption and elimination. The fractions of the MID (Li+ + LiCO3-) and ION (2Li+ + CO32-) forms were calculated using the Henderson-Hasselbalch equation, and the influences of these fractions on clearance (CL) were evaluated. The rate of tremor development was analyzed using a logit model. RESULTS: Oral apparent CL (CL/F) was explained by nonrenal CL and renal CL, and renal CL was varied by the fractions of lithium forms influenced by urinary pH. The contribution of MID to CL was slightly larger than that of ION. The rate of tremor development was estimated to be more than 30% when the trough lithium concentration was greater than 1.26 mEq L-1. CONCLUSION: Renal function and urinary pH are important indices in lithium treatment, so the serum concentration of lithium may be predicted based on the renal function and urinary pH.


Assuntos
Antimaníacos/efeitos adversos , Antimaníacos/farmacocinética , Túbulos Renais/metabolismo , Carbonato de Lítio/efeitos adversos , Carbonato de Lítio/farmacocinética , Modelos Biológicos , Antimaníacos/uso terapêutico , Feminino , Meia-Vida , Humanos , Testes de Função Renal , Carbonato de Lítio/uso terapêutico , Masculino , Taxa de Depuração Metabólica , Pessoa de Meia-Idade , Tremor/induzido quimicamente
15.
Obes Surg ; 29(2): 735-738, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30448980

RESUMO

Lithium is one of the major treatment options in bipolar disorder. Bariatric surgery can significantly modify the oral bioavailability of drugs, and lithium is no exception; although in most cases drug absorption seems to decrease, in the case of lithium, toxicity is the risk. In this article, we describe a 61-year-old male patient presented with lithium toxicity, including newly diagnosed severe bradycardia requiring a permanent pacemaker, after undergoing sleeve gastrectomy. We discuss the mechanisms behind this case, provide potential solutions for clinicians treating bariatric patients with lithium, and review previous reports of lithium toxicity post bariatric surgery. Awareness of changes in drug absorption, particularly lithium, following bariatric surgery, is prudent and essential for optimal patient care. Close clinical and drug levels monitoring is strongly advised.


Assuntos
Antimaníacos/efeitos adversos , Bradicardia/induzido quimicamente , Gastrectomia , Compostos de Lítio/efeitos adversos , Complicações Pós-Operatórias , Antimaníacos/sangue , Transtorno Bipolar/tratamento farmacológico , Humanos , Compostos de Lítio/sangue , Masculino , Pessoa de Meia-Idade
16.
Curr Neuropharmacol ; 17(4): 318-341, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-29256353

RESUMO

BACKGROUND: Lithium is a first-line treatment for bipolar disorder in adults, but its mechanism of action is still far from clear. Furthermore, evidences of its use in pediatric populations are sparse, not only for bipolar disorders, but also for other possible indications. OBJECTIVES: To provide a synthesis of published data on the possible mechanisms of action of lithium, as well as on its use in pediatric samples, including pharmacokinetics, efficacy, and safety data. METHODS: Clinical trials in pediatric samples with at least one standardized measure of efficacy/ effectiveness were included in this review. We considered: i) randomized and open label trials, ii) combination studies iii) augmentation studies iv) case series including at least 5 patients. RESULTS: Different and non-alternative mechanisms of action can explain the clinical efficacy of lithium. Clinical studies in pediatric samples suggest that lithium is effective in managing manic symptoms/episodes of bipolar disorder, both in the acute phase and as maintenance strategy. Efficacy on depressive symptoms/phases of bipolar disorder is much less clear, while studies do not support its use in unipolar depression and severe mood dysregulation. Conversely, it may be effective on aggression in the context of conduct disorder. Other possible indications, with limited published evidence, are the acute attacks in Kleine-Levin syndrome, behavioral symptoms of X-fragile syndrome, and the management of clozapine- or chemotherapy- induced neutropenia. Generally, lithium resulted relatively safe. CONCLUSIONS: Lithium seems an effective and well-tolerated medication in pediatric bipolar disorder and aggression, while further evidences are needed for other clinical indications.


Assuntos
Transtorno Bipolar/tratamento farmacológico , Transtorno Depressivo Maior/tratamento farmacológico , Compostos de Lítio/administração & dosagem , Adolescente , Fatores Etários , Antidepressivos/administração & dosagem , Antidepressivos/efeitos adversos , Antidepressivos/farmacocinética , Antidepressivos/farmacologia , Antimaníacos/administração & dosagem , Antimaníacos/efeitos adversos , Antimaníacos/farmacocinética , Antimaníacos/farmacologia , Transtorno Bipolar/metabolismo , Criança , Ensaios Clínicos como Assunto , Transtorno Depressivo Maior/metabolismo , Humanos , Compostos de Lítio/efeitos adversos , Compostos de Lítio/farmacocinética , Compostos de Lítio/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
Int Clin Psychopharmacol ; 34(1): 27-32, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30383553

RESUMO

The aims of this study were to assess the association between gabapentin and suicidality in patients diagnosed with bipolar disorder (BD) and to determine whether the risk is greater relative to patients prescribed lithium. This retrospective observational study utilizes US population-based claims data assembled by PharMetrics Inc., comprising 47 918 patients diagnosed with BD. Patients were included if they were at least 18 years old and initiated a new monotherapy prescription of either gabapentin (n=2421) or lithium (n=3101). Patients were followed for up to 1 year. Gabapentin patients contributed 915.8 person-years (PY) of follow-up time; lithium patients contributed 1421.3 PY. There were 21 suicide/self-harm events in the gabapentin group and 16 in the lithium group. Unadjusted incidence rates were 22.9 and 11.3/1000 PY in the gabapentin and lithium groups, respectively (P=0.03). After adjusting for concomitant medications, comorbid diagnoses, age, sex, and history of suicide/self-harm, the hazard ratio was 2.3 (95% confidence interval: 1.2-4.5). A propensity score-matched analysis accounting for pre-existing illnesses and medications supports this finding, with an adjusted hazard ratio of 2.1 (95% confidence interval: 1.02-4.5). Relative to lithium, the use of gabapentin is significantly associated with a doubling of the risk of suicidality in patients diagnosed with BD.


Assuntos
Antimaníacos/efeitos adversos , Transtorno Bipolar/tratamento farmacológico , Gabapentina/efeitos adversos , Compostos de Lítio/administração & dosagem , Suicídio/estatística & dados numéricos , Adulto , Fatores Etários , Antimaníacos/uso terapêutico , Comorbidade , Feminino , Gabapentina/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Retrospectivos , Fatores Sexuais
18.
Cochrane Database Syst Rev ; 10: CD003945, 2018 10 05.
Artigo em Inglês | MEDLINE | ID: mdl-30293233

RESUMO

BACKGROUND: Agitation has been reported in up to 90% of people with dementia. Agitation in people with dementia worsens carer burden, increases the risk of injury, and adds to the need for institutionalisation. Valproate preparations have been used in an attempt to control agitation in dementia, but their safety and efficacy have been questioned. OBJECTIVES: To determine the efficacy and adverse effects of valproate preparations used to treat agitation in people with dementia, including the impact on carers. SEARCH METHODS: We searched ALOIS - the Cochrane Dementia and Cognitive Improvement Group's Specialized Register on 7 December 2017 using the terms: valproic OR valproate OR divalproex. ALOIS contains records from all major health care databases (the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, LILACS) as well as from many trials databases and grey literature sources. SELECTION CRITERIA: Randomised, placebo-controlled trials that assessed valproate preparations for agitation in people with dementia. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the retrieved studies against the inclusion criteria and extracted data and assessed methodological quality of the included studies. If necessary, we contacted trial authors to ask for additional data, including relevant subscales, or for other missing information. We pooled data in meta-analyses where possible. This is an update of a Cochrane Review last published in 2009. We found no new studies for inclusion. MAIN RESULTS: The review included five studies with 430 participants. Studies varied in the preparations of valproate, mean doses (480 mg/day to 1000 mg/day), duration of treatment (three weeks to six weeks), and outcome measures used. The studies were generally well conducted although some methodological information was missing and one study was at high risk of attrition bias.The quality of evidence related to our primary efficacy outcome of agitation varied from moderate to very low. We found moderate-quality evidence from two studies that measured behaviour with the total Brief Psychiatric Rating Scale (BPRS) score (range 0 to 108) and with the BPRS agitation factor (range 0 to 18). They found that there was probably little or no effect of valproate treatment over six weeks (total BPRS: mean difference (MD) 0.23, 95% confidence interval (CI) -2.14 to 2.59; 202 participants, 2 studies; BPRS agitation factor: MD -0.67, 95% CI -1.49 to 0.15; 202 participants, 2 studies). Very low-quality evidence from three studies which measured agitation with the Cohen-Mansfield Agitation Index (CMAI) were consistent with a lack of effect of valproate treatment on agitation. There was variable quality evidence on other behaviour outcomes reported in single studies of no difference between groups or a benefit for the placebo group.Three studies, which measured cognitive function using the Mini-Mental State Examination (MMSE), found little or no effect of valproate over six weeks, but we were uncertain about this result because the quality of the evidence was very low. Two studies that assessed functional ability using the Physical Self-Maintenance Scale (PSMS) (range 6 to 30) found that there was probably slightly worse function in the valproate-treated group, which was of uncertain clinical importance (MD 1.19, 95% CI 0.40 to 1.98; 203 participants, 2 studies; moderate-quality evidence).Analysis of adverse effects and serious adverse events (SAE) indicated a higher incidence in valproate-treated participants. A meta-analysis of three studies showed that there may have been a higher rate of adverse effects among valproate-treated participants than among controls (odds ratio (OR) 2.02, 95% CI 1.30 to 3.14; 381 participants, 3 studies, low-quality evidence). Pooled analysis of the number of SAE for the two studies that reported such data indicated that participants treated with valproate preparations were more likely to experience SAEs (OR 4.77, 95% CI 1.00 to 22.74; 228 participants, 2 studies), but the very low quality of the data made it difficult to draw any firm conclusions regarding SAEs. Individual adverse events that were more frequent in the valproate-treated group included sedation, gastrointestinal symptoms (nausea, vomiting, and diarrhoea), and urinary tract infections. AUTHORS' CONCLUSIONS: This updated review corroborates earlier findings that valproate preparations are probably ineffective in treating agitation in people with dementia, but are associated with a higher rate of adverse effects, and possibly of SAEs. On the basis of this evidence, valproate therapy cannot be recommended for management of agitation in dementia. Further research may not be justified, particularly in light of the increased risk of adverse effects in this often frail group of people. Research would be better focused on effective non-pharmacological interventions for this patient group, or, for those situations where medication may be needed, further investigation of how to use other medications as effectively and safely as possible.


Assuntos
Antimaníacos/uso terapêutico , Demência/complicações , Agitação Psicomotora/tratamento farmacológico , Ácido Valproico/uso terapêutico , Idoso , Agressão/efeitos dos fármacos , Antimaníacos/efeitos adversos , Cognição/efeitos dos fármacos , Humanos , Agitação Psicomotora/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Ácido Valproico/efeitos adversos
19.
Eur J Clin Pharmacol ; 74(11): 1485-1489, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30083876

RESUMO

OBJECTIVE: To present up-to-date information and recommendations on the management of body weight changes during the use of antiepileptic mood stabilizers in bipolar disorder to help clinicians and patients make well-informed, practical decisions. DATA SOURCES: Umbrella review. Systematic reviews and meta-analyses on the prevention, treatment, and monitoring of body weight changes as a side effect of the mood stabilizers valproate, lamotrigine, topiramate, and carbamazepine were identified in Embase (2010-2015, no language restrictions). STUDY SELECTION: The search yielded 18 relevant publications on antiepileptic mood stabilizers and weight changes in bipolar disorder. DATA EXTRACTION: Relevant scientific evidence was abstracted and put into a clinical perspective by a multidisciplinary expert panel of clinicians with expertise in the treatment of bipolar disorders across all age groups and a patient representative. RESULTS: Valproate has been proven to be associated with weight gain in up to 50% of its users, and can be detected 2-3 months after initiation. Carbamazepine has been proven to have a low risk of weight gain. Lamotrigine and topiramate are associated with weight loss. Other option for this sentence = Weigth gain has been proven to be associated with valproate use in up to 50% of its users, and can be detected within 2-3 months after initiation. CONCLUSION: Each antiepileptic mood stabilizer has specific effects on body weight and accordingly requires a discrete education, prevention, monitoring, and treatment strategy. Clinicians are recommended to adopt an active, anticipatory approach, educating patients about weight change as an important side effect in order to come to informed shared decisions about the most suitable mood stabilizer.


Assuntos
Antimaníacos/efeitos adversos , Transtorno Bipolar/tratamento farmacológico , Peso Corporal/efeitos dos fármacos , Anticonvulsivantes/administração & dosagem , Anticonvulsivantes/efeitos adversos , Antimaníacos/administração & dosagem , Humanos , Ganho de Peso/efeitos dos fármacos , Perda de Peso/efeitos dos fármacos
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