Residual contamination in antineoplastic drug packaging.

INTRODUCTION: The handling of antineoplastic drugs should follow strict supervision and safety rules to minimize the occupational exposure risks to professionals involved. The external surface contamination of drug vials is recognized as a health risk. So, our goal was to determine if there is residual contamination on the vials and containers surface of the antineoplastic drugs doxorubicin (DOX) and cyclophosphamide (CP). METHODS: A cross-sectional study was conducted. Samples were collected using a uniform sampling procedure on the inner surfaces of the packages/boxes and the outer surfaces of the vials. The analyzes were executed by high-performance liquid chromatography/mass spectrometry (UHPLC-MS/MS). RESULTS: A total of 209 samples were analyzed, 66 of CP and 143 of DOX. CP levels were detected in nine samples (13.63%), three were below the lower limit of quantification (LLQ) and the other six had contamination levels ranging from 1.24 to 28.04 ng/filter. DOX levels were detected in 36 samples (25.17%), two were below the LLQ and the others had levels between 1.32 and 664.84 ng/filter. The majority of samples with residual contamination were in vials (80.0%), however, boxes also showed contamination. CONCLUSIONS: The results revealed the presence of residual contamination in the vials and packages of CP and DOX drugs. Although the residues found in each sample are small, special care should be taken in the handling and disposal of the antineoplastic drugs. The use of personal protective equipment is fundamental while handling the vials and packaging of cytotoxic drugs.

Impacto da unitarização de ceftazidima + avibactam em um hospital público universitário durante a pandemia de COVID-19 / Impact of ceftazidime + avibactam unitarization in a university public hospital during the COVID-19 pandemic

Introdução: A pandemia de COVID-19 fez aumentar a demanda de medicamentos utilizados em hospitais, como a Ceftazidima + Avibactam. Nesse contexto, a Central de Misturas Intravenosas (CMIV) de um hospital público universitário passou a unitarizar as doses prescritas. O objetivo deste trabalho foi avaliar o impacto da unitarização no consumo deste antibacteriano de alto custo em um hospital público universitário. Métodos: Trata-se de uma análise farmacoeconômica de custos diretos, sobre a utilização de frascos-ampola de Ceftazidima + Avibactam no período de 01/07/2020 a 31/05/2021. Foram unitarizadas todas as doses que correspondiam a uma fração da dose total do frasco-ampola, em Cabine de Segurança Biológica classe II B2. Os frascos-ampola foram utilizados à exaustão, através do compartilhamento e organização dos horários de manipulação. Resultados: O número total de preparos realizados pela CMIV do referido hospital no período foi de 837. O consumo projetado sem a centralização dos preparos seria de 837 (um frasco por dose). Entretanto, o consumo real foi de 437 frascos. A eficiência de unitarização foi de 101%, com economia real de 400 frascos (R$ 244.832,00) para a instituição. Conclusão: A pandemia de COVID-19 sobrecarregou os sistemas de saúde do mundo todo, sendo que a atuação farmacêutica foi fundamental para garantir o acesso aos medicamentos essenciais. A CMIV assumiu a unitarização da Ceftazidima + Avibactam, antibiótico em risco de desabastecimento, gerando um consumo 47,8% menor, contribuindo para o acesso deste medicamento de forma ininterrupta durante os 11 meses avaliados na referida instituição.

Introduction: COVID-19 pandemic has increased the demand for drugs used in hospitals, such as Ceftazidime + Avibactam. In this context, the Central of Intravenous Admixtures (CMIV) of a public university hospital started to unitarize the prescribed doses. The objective of this study was to evaluate the impact of unitarization on the consumption of this high-cost antibacterial in a public university hospital. Methods: This is a pharmacoeconomic analysis of direct costs, on the Ceftazidime + Avibactam vials use, in the period from 07/01/2020 to 05/31/2021. All doses that corresponded to a fraction of the entire vial were unitarized in a Class II B2 Biological Safety Cabin. The vials were used to exhaustion, by sharing them, and organizing the manipulation schedules. Results: The total number of preparations made by the CMIV of that hospital in the period was 837 doses. The projected consumption would be 837 vials (one vial per dose). However, the actual consumption was 437 vials. The unitarization efficiency was of 101%, with real savings of 400 vials (R$ 244,832.00) for the institution. Conclusion: COVID-19 pandemic has overburdened health systems around the world, and pharmaceutical actions have been fundamental to guaranteeing access to essential medicines. CMIV took over the unitarization of Ceftazidime + Avibactam, an antibiotic at risk of shortages, leading to a 47.8% lower consumption, contributing to uninterrupted access to this drug during the 11 months evaluated at that institution.

Acompanhamento clínico farmacêutico no cuidado ao paciente adulto-cirúrgico em um hospital universitário de Porto Alegre / Clinical pharmacist follow-up in adult surgical patient care in a university hospital of Porto Alegre

Introdução: O farmacêutico clínico já está bem estabelecido em algumas instituições e muitos serviços de saúde contam com este profissional em suas equipes, entretanto, poucos conseguem sistematizar o seu trabalho e mapear os dados das atividades desenvolvidas, demonstrando a relevância do profissional na equipe de saúde. O objetivo deste trabalho foi avaliar o acompanhamento clínico-farmacêutico em uma unidade de internação adulto-cirúrgica em um hospital universitário de Porto Alegre. Métodos: Estudo descritivo retrospectivo que quantificou as principais atividades do farmacêutico clínico em uma unidade de internação adulto-cirúrgica no período de janeiro a maio de 2019. Este projeto foi aprovado no Comitê de Ética em Pesquisa da referida instituição. Resultados: 859 pacientes foram admitidos na unidade cirúrgica avaliada, dos quais 490 foram revisados pelo farmacêutico na admissão hospitalar, correspondendo à taxa média de 57,27%. A taxa média de conciliação medicamentosa realizada foi de 14,83%, totalizando 73 pacientes conciliados por entrevista. 361 intervenções farmacêuticas foram realizadas no período estudado, sendo 54 relacionadas a conciliação medicamentosa, com o número total de adesões de 232. As principais especialidades cirúrgicas que internam pacientes na unidade em questão foram a Ortopedia, Cirurgia do Aparelho Digestivo, Urologia e Cirurgia Vascular. Conclusões: Foi possível avaliar o acompanhamento clínico farmacêutico em uma unidade de internação adulto-cirúrgica em um hospital universitário de Porto Alegre, através da quantificação das taxas de pacientes revisados e de conciliação medicamentosa, do número de intervenções farmacêuticas e suas adesões, além de caracterizar as principais especialidades médicas cirúrgicas envolvidas. (AU)

Introduction: Clinical pharmacists are already well established in some institutions, and many health services have these professionals in their teams. However, few are able to systematize their work and map data from the developed activities, demonstrating the relevance of these professionals in the health team. This study aimed to evaluate the clinical pharmacist follow-up in an adult surgical inpatient unit in a university hospital in Porto Alegre. Methods: This is a retrospective, descriptive study that quantified the main activities of the clinical pharmacist in an adult surgical inpatient unit from January to May 2019. This project was approved by the Research Ethics Committee of the institution. Results: Of 859 patients admitted to the s rgical unit, 490 were reviewed by the pharmacist on hospital admission, corresponding to an average rate of 57.27%. The average medication reconciliation rate was 14.83%, totaling 73 patients reconciled per interview. Of 361 pharmaceutical interventions performed during the study period, 54 were related to medication reconciliation, and the total number of adhesions was 232. The main surgical specialties associated with admission to the study unit were Orthopedics, Digestive System Surgery, Urology, and Vascular Surgery. Conclusions: It was possible to evaluate the clinical pharmacist follow-up in an adult surgical inpatient unit in a university hospital in Porto Alegre by quantifying the rates of reviewed patients and medication reconciliations as well as the number of pharmaceutical interventions and their adherences, in addition to characterizing the main medical-surgical specialties involved. (AU)

Clinical and Toxicological Profile of NBOMes: A Systematic Review.

BACKGROUND: NBOMes are a new class of potent hallucinogens widely present in illicit drugs. Little is known about this class of drugs, regarding its detection and clinical manifestations of intoxication. OBJECTIVE: This study aims to enhance care involving NBOMes by reviewing the literature on their clinical manifestations and laboratorydetection. METHODS: A systematic review was performed on the clinical manifestations and laboratory tests of NBOMEs ingestion. Embase, Pubmed, PsycINFO, and Cochrane databases were employed in this analysis. RESULTS: Forty-five articles met the inclusion criteria out of the 2814 nonduplicated studies on the theme. Seventy case reports of intoxication were found in the analyzed articles (64.3% were men and 11.4% were women, mean age of 22.5). The technique most employed for NBOMes identification was chromatography of blood, urine, and oral fluids. Moreover, the studies identified 13 chemical structures differentfrom the NBOMes on their toxicological analyses.According to these studies, most of these drugs were ingested orally-nasal use was the second preferred administration route, followed by intravenous administration. CONCLUSION: Better identification of the clinicalmanifestations and laboratory profile of NBOMes is crucial to the recognition of intoxication as well as to its effective treatment.

Investigation of inflammatory profile in MSUD patients: benefit of L-carnitine supplementation.

Maple Syrup Urine Disease (MSUD) is a metabolic disorder caused by a severe deficiency of the branched-chain α-keto acid dehydrogenase complex activity which leads to the accumulation of branched-chain amino acids (BCAA) leucine (Leu), isoleucine and valine and their respective α-keto-acids in body fluids. The main symptomatology presented by MSUD patients includes ketoacidosis, failure to thrive, poor feeding, apnea, ataxia, seizures, coma, psychomotor delay and mental retardation, but, the neurological pathophysiologic mechanisms are poorly understood. The treatment consists of a low protein diet and a semi-synthetic formula restricted in BCAA and supplemented with essential amino acids. It was verified that MSUD patients present L-carnitine (L-car) deficiency and this compound has demonstrated an antioxidant and anti-inflammatory role in metabolic diseases. Since there are no studies in the literature reporting the inflammatory profile of MSUD patients and the L-car role on the inflammatory response in this disorder, the present study evaluates the effect of L-car supplementation on plasma inflammatory cytokines interleukin-1ß (IL-1ß), interleukin-6 (IL-6), interferon-gamma (INF-É£), and a correlation with malondialdehyde (MDA), as a marker of oxidative damage, and with free L-car plasma levels in treated MSUD patients. Significant increases of IL-1ß, IL-6, and INF-É£ were observed before the treatment with L-car. Moreover, there is a negative correlation between all cytokines tested and L-car concentrations and a positive correlation among the MDA content and IL-1ß and IL-6 values. Our data show that L-car supplementation can improve cellular defense against inflammation and oxidative stress in MSUD patients and may represent an additional therapeutic approach to the patients affected by this disease.

L-Carnitine supplementation decreases DNA damage in treated MSUD patients.

Maple syrup urine disease (MSUD) is an inherited disorder caused by severe deficient activity of the branched-chain α-keto acid dehydrogenase complex involved in the degradation pathway of branched-chain amino acids (BCAAs) and their α-ketoacid derivatives. MSUD patients generally present ketoacidosis, poor feeding, ataxia, coma, psychomotor delay, mental retardation and brain abnormalites. Treatment consists of dietary restriction of the BCAA (low protein intake) supplemented by a BCAA-free amino acid mixture. Although the mechanisms of brain damage in MSUD are poorly known, previous studies have shown that oxidative stress may be involved in the neuropathology of this disorder. In this regard, it was recently reported that MSUD patients have deficiency of l-carnitine (l-car), a compound with antioxidant properties that is used as adjuvant therapy in various inborn errors of metabolism. In this work, we investigated DNA damage determined by the alkaline comet assay in peripheral whole blood leukocytes of MSUD patients submitted to a BCAA-restricted diet supplemented or not with l-car. We observed a significant increase of DNA damage index (DI) in leukocytes from MSUD patients under BCAA-restricted diet as compared to controls and that l-car supplementation significantly decreased DNA DI levels. It was also found a positive correlation between DI and MDA content, a marker of lipid peroxidation, and an inverse correlation between DI and l-car levels. Taken together, our present results suggest a role for reactive species and the involvement of oxidative stress in DNA damage in this disorder. Since l-car reduced DNA damage, it is presumed that dietary supplementation of this compound may serve as an adjuvant therapeutic strategy for MSUD patients in addition to other therapies.

Increased oxidative stress in patients with 3-hydroxy-3-methylglutaric aciduria.

3-hydroxy-3-methylglutaric aciduria (HMGA; OMIM 246450) is a rare autosomal recessive disorder, caused by the deficiency of 3-hydroxy-3-methylglutaryl-CoA lyase (4.1.3.4), which results in the accumulation of 3-hydroxy-3-methylglutaric (HMG) and 3-methylglutaric (MGA) acids in tissues and biological fluids of affected individuals. Recent in vivo and in vitro animal studies have demonstrated that the accumulation of these metabolites can disturb the cellular redox homeostasis, which can contribute to the neurological manifestations presented by the patients. So, in the present work, we investigated oxidative stress parameters in plasma and urine samples from HMGA patients, obtained at the moment of diagnosis of this disorder and during therapy with low-protein diet and L-carnitine supplementation. It was verified that untreated HMGA patients presented higher levels of urinary di-tyrosine and plasma thiobarbituric acid-reactive substances (TBA-RS), which are markers of protein and lipid oxidative damage, respectively, as well as a reduction of the urinary antioxidant capacity. Treated HMGA patients also presented an increased protein oxidative damage, as demonstrated by their higher concentrations of plasma protein carbonyl groups and urinary di-tyrosine, as well as by the reduction of total sulfhydryl groups in plasma, in relation to controls. On the other hand, HMGA patients under therapy presented normal levels of TBA-RS and urinary antioxidant capacity, which can be related, at least in part, to the antioxidant and antiperoxidative effects exerted by L-carnitine. The results of this work are the first report showing that a redox imbalance occurs in patients with HMGA what reinforces the importance of the antioxidant therapy in this disorder.

Diabetic encephalopathy-related depression: experimental evidence that insulin and clonazepam restore antioxidant status in rat brain.

There is increasing evidence suggesting that oxidative stress plays an important role in the development of many chronic and degenerative conditions such as diabetic encephalopathy and depression. Considering that diabetic rats and mice present higher depressive-like behaviour when submitted to the forced swimming test and that treatment with insulin and/or clonazepam is able to reverse the behavioural changes of the diabetic rats, the present work investigated the antioxidant status, specifically total antioxidant reactivity and antioxidant potential of insulin and clonazepam, as well as the effect of this drugs upon protein oxidative damage and reactive species formation in cortex, hippocampus and striatum from diabetic rats submitted to forced swimming test. It was verified that longer immobility time in diabetic rats and insulin plus clonazepam treatment reversed this depressive-like behaviour. Moreover, data obtained in this study allowed to demonstrate through different parameters such as protein carbonyl content, 2'7'-dichlorofluorescein oxidation, catalase, superoxide dismutase, glutathione peroxidase assay, total radical-trapping antioxidant potential and total antioxidant reactivity that there is oxidative stress in cortex, hippocampus and striatum from diabetic rats under depressive-like behaviour and highlight the insulin and/or clonazepam effect in these different brain areas, restoring antioxidant status and protein damage.

Prevention of DNA damage by L-carnitine induced by metabolites accumulated in maple syrup urine disease in human peripheral leukocytes in vitro.

Maple syrup urine disease (MSUD) is an inherited aminoacidopathy caused by a deficiency in branched-chain α-keto acid dehydrogenase complex activity that leads to the accumulation of the branched-chain amino acids (BCAAs) leucine (Leu), isoleucine, and valine and their respective α-keto-acids, α-ketoisocaproic acid (KIC), α keto-ß-methylvaleric acid, and α-ketoisovaleric acid. The major clinical features presented by MSUD patients include ketoacidosis, failure to thrive, poor feeding, apnea, ataxia, seizures, coma, psychomotor delay, and mental retardation; however, the pathophysiology of this disease is poorly understood. MSUD treatment consists of a low protein diet supplemented with a mixture containing micronutrients and essential amino acids but excluding BCAAs. Studies have shown that oxidative stress may be involved in the neuropathology of MSUD, with the existence of lipid and protein oxidative damage in affected patients. In recent years, studies have demonstrated the antioxidant role of L-carnitine (L-Car), which plays a central function in cellular energy metabolism and for which MSUD patients have a deficiency. In this work, we investigated the in vitro effect of Leu and KIC in the presence or absence of L-Car on DNA damage in peripheral whole blood leukocytes using the alkaline comet assay with silver staining and visual scoring. Leu and KIC resulted in a DNA damage index that was significantly higher than that of the control group, and L-Car was able to significantly prevent this damage, mainly that due to KIC.

Brain effect of insulin and clonazepam in diabetic rats under depressive-like behavior.

Diabetes mellitus is characterized by hyperglycemia resulting from defects on insulin secretion, insulin action, or both. It has recently become clear that the central nervous system is not spared from the deleterious effects of diabetes, since diabetic encephalopathy was recognized as a complication of this heterogeneous metabolic disorder. There is a well recognized association between depression and diabetes, once prevalence of depression in diabetic patients is higher than in general population, and clonazepam is being used to treat this complication. Oxidative stress is widely accepted as playing a key mediatory role in the development and progression of diabetes and its complications. In this work we analyzed DNA damage by comet assay and lipid damage in prefrontal cortex, hippocampus and striatum of streptozotocin-induced diabetic rats submitted to the forced swimming test. It was verified that the diabetic group presented DNA and lipid damage in the brain areas evaluated, when compared to the control groups. Additionally, a significant reduction of the DNA and lipid damage in animals treated with insulin and/or clonazepam was observed. These data suggest that the association of these two drugs could protect against DNA and lipid damage in diabetic rats submitted to the forced swimming test, an animal model of depression.

The association effect of insulin and clonazepam on oxidative stress in liver of an experimental animal model of diabetes and depression.

CONTEXT: It is known that oxidative stress occurs in peripheral blood in an experimental animal model of diabetes and depression, and acute treatment with insulin and clonazepam (CNZ) has a protective effect on oxidative stress in this model. OBJECTIVE: This study evaluated the effect of insulin plus CNZ on oxidative stress parameters in the liver of diabetic male rats induced with streptozotocin (STZ) and subjected to forced swimming test (FST). MATERIALS AND METHODS: Diabetes was induced by a single intraperitoneal (i.p.) dose of STZ 60 mg/kg in male Wistar rats. Insulin (4 IU/kg) plus CNZ acute i.p. treatment (0.25 mg/kg) was administered 24, 5 and 1 h before the FST. Nondiabetic control rats received i.p. injections of saline (1 mL/kg). Protein oxidative damage was evaluated by carbonyl formation and the antioxidant redox parameters were analyzed by the measurements of enzymatic activities of the superoxide dismutase (SOD), catalase and glyoxalase I (GLO). Glycemia levels also were determined. RESULTS: Our present study has shown an increase in carbonyl content from diabetic rats subjected to FST (2.04 ± 0.55), while the activity of catalase (51.83 ± 19.02) and SOD (2.30 ± 1.23) were significantly decreased in liver from these animals, which were reverted by the treatment. Also, the activity of GLO (0.15 ± 0.02) in the liver of the animals was decreased. DISCUSSION AND CONCLUSION: Our findings showed that insulin plus CNZ acute treatment ameliorate the antioxidant redox parameters and protect against protein oxidative damage in the liver of diabetic rats subjected to FST.

Protein and lipid damage in maple syrup urine disease patients: l-carnitine effect.

Maple syrup urine disease (MSUD) is an inborn error of metabolism biochemically characterized by elevated levels of the branched chain amino acids (BCAA) leucine, isoleucine, valine and the corresponding branched-chain α-keto acids. This disorder is clinically characterized by ketoacidosis, seizures, coma, psychomotor delay and mental retardation whose pathophysiology is not completely understood. Recent studies have shown that oxidative stress may be involved in neuropathology of MSUD. l-Carnitine (l-Car) plays a central role in the cellular energy metabolism because it transports long-chain fatty acids for oxidation and ATP generation. In recent years many studies have demonstrated the antioxidant role of this compound. In this work, we investigated the effect of BCAA-restricted diet supplemented or not with l-Car on lipid peroxidation and in protein oxidation in MSUD patients. We found a significant increase of malondialdehyde and of carbonyl content in plasma of MSUD patients under BCAA-restricted diet compared to controls. Furthermore, patients under BCAA-restricted diet plus l-Car supplementation presented a marked reduction of malondialdehyde content in relation to controls, reducing the lipid peroxidation. In addition, free l-Car concentrations were negatively correlated with malondialdehyde levels. Our data show that l-Car may have an antioxidant effect, protecting against the lipid peroxidation and this could represent an additional therapeutic approach to the patients affected by MSUD.

Experimental evidence of oxidative stress in plasma of homocystinuric patients: a possible role for homocysteine.

Homocystinuria is an inherited disorder biochemically characterized by high urinary excretion of homocystine and increased levels of homocysteine (Hcy) and methionine in biological fluids. Affected patients usually have a variety of clinical and pathologic manifestations. Previous experimental data have shown a relationship between Hcy and oxidative stress, although very little was reported on this process in patients with homocystinuria. Therefore, in the present study we evaluated parameters of oxidative stress, namely carbonyl formation, malondialdehyde (MDA) levels, sulfhydryl content and total antioxidant status (TAS) in patients with homocystinuria at diagnosis and under treatment with a protein restricted diet supplemented by pyridoxine, folate, betaine, and vitamin B(12). We also correlated plasma Hcy and methionine concentrations with the oxidative stress parameters examined. We found a significant increase of MDA levels and carbonyl formation, as well as a reduction of sulfhydryl groups and TAS in plasma of homocystinuric patients at diagnosis relatively to healthy individuals (controls). We also verified that Hcy levels were negatively correlated with sulfhydryl content and positively with MDA levels. Furthermore, patients under treatment presented a significant reduction of the content of MDA, Hcy and methionine concentrations relatively to patients at diagnosis. Taken together, the present data indicate that lipid and protein oxidative damages are increased and the antioxidant defenses diminished in plasma of homocystinuric patients, probably due to increased reactive species elicited by Hcy. It is therefore presumed that oxidative stress participates at least in part in the pathogenesis of homocystinuria.

Effects of insulin and clonazepam on DNA damage in diabetic rats submitted to the forced swimming test.

Diabetes mellitus (DM) is a chronic hyperglycemic state. DM may be associated with moderate cognitive deficits and neurophysiologic/structural changes in the brain (diabetic encephalopathy). Psychiatric manifestations seem to accompany this encephalopathy, since the prevalence of depression in diabetic patients is much higher than in the general population, and clonazepam is being used to treat this complication. The excessive production of oxygen free radicals that may occur in diabetes induces a variety of lesions in macromolecules, including DNA. In this work, we analyzed DNA damage in leukocytes from streptozotocin-induced diabetic rats submitted to the forced swimming test. The DNA damage index was significantly elevated (DI=61.00 ± 4.95) in the diabetic group compared to the control group (34.00 ± 1.26). Significant reductions of the damage index were observed in diabetic animals treated with insulin (45.00 ± 1.82), clonazepam (52.00 ± 1.22), or both agents (39.00 ± 5.83, not significantly different from control levels). Insulin plus clonazepam can protect against DNA damage in stressed diabetic rats.

Protein and lipid oxidative damage in streptozotocin-induced diabetic rats submitted to forced swimming test: the insulin and clonazepam effect.

Diabetes may modify central nervous system functions and is associated with moderate cognitive deficits and changes in the brain, a condition that may be referred to as diabetic encephalopathy. The prevalence of depression in diabetic patients is higher than in the general population, and clonazepam is being used to treat this complication. Oxidative stress may play a role in the development of diabetes complications. We investigated oxidative stress parameters in streptozotocin-induced diabetic rats submitted to forced swimming test (STZ) and evaluated the effect of insulin (STZ-INS) and/or clonazepam (STZ-CNZ and STZ-INS-CNZ) acute treatment on these animal model. Oxidative damage to proteins measured as carbonyl content in plasma was significantly increased in STZ group compared to STZ treated groups. Malondialdehyde plasma levels were significantly reduced in STZ-INS and STZ-INS-CNZ groups when compared to STZ rats, being significantly reduced in STZ-INS-CNZ than STZ-INS rats. The activities of the antioxidant enzymes catalase, superoxide dismutase and glutathione peroxidase showed no significant differences among all groups of animals. These findings showed that protein and lipid damage occurs in this diabetes/depression animal model and that the associated treatment of insulin and clonazepam is capable to protect against oxidative damage in this experimental model.

Apolipoprotein, C-reactive protein and oxidative stress parameters in dyslipidemic type 2 diabetic patients treated or not with simvastatin.

BACKGROUND AND AIMS: Oxidative stress is considered an important factor in the development of diabetic complications that causes a variety of changes such as oxidative modification of membrane lipids, nucleic acids and cellular proteins. Dyslipidemia is frequently associated with diabetes and cardiovascular disease. In this context, the objective of this study was to evaluate oxidative modifications of plasma proteins and lipids in non dyslipidemic type 2 diabetic (T2D) patients, in dyslipidemic T2D patients treated or not with simvastatin and in healthy subjects to investigate whether treatment with low doses of simvastatin plays a protective role on the lipid and protein oxidative damage in these patients. METHODS: We determined oxidative damage of plasma proteins by carbonyl assay and total thiol group determination. We also characterized the membrane damage in terms of lipid peroxidation by measuring malonaldehyde (MDA) in nondyslipidemic T2D patients, dyslipidemic T2D patients treated with simvastatin (20 mg/day), dyslipidemic T2D patients not treated with simvastatin and in healthy age-matched control subjects. RESULTS: Our results showed that dyslipidemic T2D patients not treated with simvastatin had significantly higher plasma protein carbonyl groups and MDA when compared to dyslipidemic T2D patients treated with simvastatin and control group. Thiol concentrations from dyslipidemic T2D patients not treated with simvastatin were significantly lower than treated patients and controls. It was verified that the thiols groups were inversely correlated with apolipoprotein B and positively correlated with apolipoprotein A-I. CONCLUSIONS: These results demonstrated that treatment with low doses of simvastatin can minimize the protein and lipid oxidative damage in dyslipidemic T2D patients.