Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial.

BACKGROUND: The COMPASS trial demonstrated that in patients with peripheral arterial disease, the combination of rivaroxaban and aspirin compared with aspirin reduces the risk of major adverse limb events, but it is not known whether this combination can also improve symptoms in patients with intermittent claudication. The primary objective of this study is to evaluate the effect of the combination on claudication distance. STUDY DESIGN: Eighty-eight patients with intermittent claudication will be randomized to receive rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once daily for 24 weeks. The primary outcome is the change in claudication distance from the baseline to 24 weeks, measured by 6 min walking test and treadmill test. The primary safety outcome is the incidence of major bleeding and clinically relevant non-major bleeding according to the International Society on Thrombosis and Hemostasis criteria. SUMMARY: The COMPASS CLAUDICATION trial will provide high-quality evidence regarding the effect of the combination of rivaroxaban and aspirin on claudication distance in patients with peripheral arterial disease.

Effect of Creatine Supplementation on Functional Capacity and Muscle Oxygen Saturation in Patients with Symptomatic Peripheral Arterial Disease: A Pilot Study of a Randomized, Double-Blind Placebo-Controlled Clinical Trial.

The aim of the study was to verify the effects of creatine (Cr) supplementation on functional capacity (walking capacity; primary outcome) and calf muscle oxygen saturation (StO2) (secondary outcome) in symptomatic peripheral arterial disease (PAD) patients. Twenty-nine patients, of both sexes, were randomized (1:1) in a double-blind manner for administration of placebo (PLA, n = 15) or creatine monohydrate (Cr, n = 14). The supplementation protocol consisted of 20 g/day for 1 week divided into four equal doses (loading phase), followed by single daily doses of 5 g in the subsequent 7 weeks (maintenance phase). Functional capacity (total walking distance) was assessed by the 6 min walk test, and calf muscle StO2 was assessed through near infrared spectroscopy. The measurements were collected before and after loading and after the maintenance phase. The level of significance was p < 0.05. No significant differences were found for function capacity (total walking distance (PLA: pre 389 ± 123 m vs. post loading 413 ± 131 m vs. post maintenance 382 ± 99 m; Cr: pre 373 ± 149 m vs. post loading 390 ± 115 m vs. post maintenance 369 ± 115 m, p = 0.170) and the calf muscle StO2 parameters (p > 0.05). Short- and long-term Cr supplementation does not influence functional capacity and calf muscle StO2 parameters in patients with symptomatic PAD.

Does Creatine Supplementation Affect Renal Function in Patients with Peripheral Artery Disease? A Randomized, Double Blind, Placebo-controlled, Clinical Trial.

BACKGROUND: Case studies and reviews have shown that creatine supplementation can affect kidney function. The objective of this study is to verify the effects of 8 weeks of creatine supplementation on renal function (creatinine clearance: primary outcome) in patients with symptomatic peripheral arterial disease. METHODS: Twenty-nine patients, of both genders, were randomized (1:1) in a double-blind manner for administration of Placebo (PLA; n = 15) or creatine monohydrate (Cr; n = 14). The supplementation protocol consisted of 20 g/day for 1 week divided into 4 equal doses (loading phase), followed by single daily doses of 5 g in the subsequent 7 weeks (maintenance phase). Before and after the supplementation period, markers of renal function, serum creatinine, creatinine excretion rate, and creatinine clearance were evaluated. The Generalized Estimation Equation Model was used for comparison between groups. The level of significance was P < 0.05. RESULTS: No significant differences were found between groups before and after the intervention for serum creatinine (Cr: pre 1.00 ± 0.15 mL/dL vs. post 1.07 ± 0.16 mL/dL; PLA: pre 1.30 ± 0.53 mL/dL vs. post 1.36 ± 0.47 mL/dL, P = 0.590), creatinine excretion rate (Cr: pre 81.73 ± 43.80 mg/dL vs. post 102.92 ± 59.57 mg/dL; PLA: pre 74.37 ± 38.90 mg/dL vs. post 86.22 ± 39.94 mg/dL, P = 0.560), or creatinine clearance (Cr; pre 108 ± 59 mL/min/1.73 m2 vs. post 117 ± 52 mL/min/1.73 m2; PLA: pre 88 ± 49 mL/min/1.73 m2 vs. post 82 ± 47 mL/min/1.73 m2, P = 0.366). CONCLUSIONS: Eight weeks of creatine supplementation is safe and does not compromise the renal function of patients with peripheral arterial disease.

Carbon Dioxide as Contrast Medium to Guide Endovascular Aortic Aneurysm Repair.

BACKGROUND: Iodine contrast medium (ICM) is considered to be gold standard in endovascular procedures, but its nephrotoxicity and hypersensitivity limit the widespread use. Carbon dioxide (CO2) is considered as an alternative for endovascular procedures in patients with contraindication to ICM. However, no studies have compared the outcomes of endovascular aneurysm repair (EVAR) performed with ICM or CO2 among patients with no contraindication to ICM. METHODS: From May 2012 to April 2014, 36 patients with abdominal aortic aneurysms underwent EVAR in a prospective, randomized, and controlled study. Patients were randomized into 2 groups, CO2 or ICM group. RESULTS: We were able to perform the proposed procedures in all patients in this study. There were no conversions to open surgery and no CO2-related complications. Endovascular material costs, duration of surgery, and time of fluoroscopy were similar between groups, and the cost of the contrast media was smaller in the CO2 group than in the ICM group. Among CO2 group procedures, 62.5% of the patients needed ICM complementary use. CONCLUSIONS: The use of CO2 as a contrast medium for EVAR is an alternative in patients with no restriction for ICM, with similar outcomes when compared to ICM, regarding duration of surgery, duration of fluoroscopy, and endovascular material costs. Using CO2, there were no changes in creatinine clearance and no risk of hypersensitivity reactions; moreover, there was a reduction in contrast-related costs for EVAR procedures. However, in our study, additional use of ICM to visualize the internal iliac artery was needed in most procedures.

Oral Rivaroxaban for the Treatment of Symptomatic Venous Thromboembolism in 400 Patients With Active Cancer: A Single-Center Experience.

PURPOSE: To study the safety and efficacy of rivaroxaban-a direct oral anticoagulant-use in patients with active cancer and venous thromboembolism (VTE). PATIENTS AND METHODS: Retrospective cohort study of 400 patients with active cancer and associated VTE, defined as deep venous thrombosis and/or pulmonary embolism. This single-center study was carried out from January 2012 to June 2015. The aim of this study was to determine the efficacy and safety, using the incidence of recurrent symptomatic VTE and major bleeding, respectively, throughout the treatment with rivaroxaban. RESULTS: Of the 400 patients enrolled, 223 (55.8%) were female. A total of 362 (90.5%) patients had solid tumors and 244 (61%) had metastatic disease. A total of 302 (75.5%) received initial parenteral therapy with enoxaparin (median: 3, mean: 5.6, standard deviation [SD]: 6.4 days) followed by rivaroxaban. Ninety-eight patients (24.5%) were treated with on label rivaroxaban treatment. Recurrence rates were 3.25% with major bleeding occurring in 5.5% during the anticoagulant therapy (median: 118, mean: 163.9, SD: 159.9 days). CONCLUSION: Rivaroxaban can be an attractive alternative for the treatment of cancer-associated thrombosis.

Endovascular revascularization of TASC C and D femoropopliteal occlusive disease using carbon dioxide as contrast.

OBJECTIVE: To analyze the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with no formal contraindication to iodine, aiming to decrease allergic reactions and potential nephrotoxicity in high-risk patients. METHODS: We describe the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with high risk for open revascularization and no formal contraindication to iodine. We analyzed feasibility of the procedures, complications, quality of the angiographic images, clinical and surgical outcomes, and costs of C and D lesions treated using CO2 as contrast medium. RESULTS: The use of CO2 in C and D lesions needed iodine complementation in most of the cases (nine cases) but decreased the potential nephrotoxicity of iodine contrast medium by the reduction of its volume in this group of high-risk patients. The extension of the arterial lesions was the factor that most contributed to the need for iodine supplementation due to the difficulty to visualize the refill after a long arterial occlusion. CONCLUSION: The use of CO2 as contrast in patients with C and D lesions with no restriction for iodine contrast medium was an alternative that did not dismiss the need of iodine supplementation in most of the cases, but could decrease the potential nephrotoxicity of iodine constrast medium. OBJETIVO: Analisar os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes sem restrição ao meio de contraste iodado com o objetivo de diminuir reações alérgicas e potencial de nefrotoxicidade em pacientes de alto risco. MÉTODOS: Descrevemos os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes de alto risco para revascularização aberta e sem contraindicação formal a iodo. Analisamos possibilidade de execução dos procedimentos, complicações, qualidade das imagens obtidas, desfechos clínicos e cirúrgicos e custos das lesões C e D tratadas com CO2 como meio de contraste. RESULTADOS: O uso de CO2 nas lesões C e D necessitou de complementação de iodo na maioria dos casos (nove casos), porém reduziu o potencial de nefrotoxicidade do meio de contraste iodado, diminuindo seu volume nesse grupo de pacientes de alto risco. A extensão das lesões arteriais foi o fator que mais contribuiu para necessidade de suplementação de iodo, devido à dificuldade de visualizar o reenchimento após oclusão arterial longa. CONCLUSÃO: O uso de CO2 como contraste em pacientes com lesões C e D sem restrição ao meio de contraste iodado foi uma alternativa que não excluiu a necessidade de suplementação com iodo na maioria dos casos, porém pôde diminuir o potencial de nefrotoxicidade do meio de contraste iodado.

Endovascular revascularization of TASC C and D femoropopliteal occlusive disease using carbon dioxide as contrast / Revascularização endovascular de doença oclusiva fêmoro-poplítea TASC C e D com o uso de dióxido de carbono como meio de contraste

ABSTRACT Objective To analyze the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with no formal contraindication to iodine, aiming to decrease allergic reactions and potential nephrotoxicity in high-risk patients. Methods We describe the results of ten angioplasties of TASC C and D femoropopliteal lesions using CO2 as primary contrast in patients with high risk for open revascularization and no formal contraindication to iodine. We analyzed feasibility of the procedures, complications, quality of the angiographic images, clinical and surgical outcomes, and costs of C and D lesions treated using CO2 as contrast medium. Results The use of CO2 in C and D lesions needed iodine complementation in most of the cases (nine cases) but decreased the potential nephrotoxicity of iodine contrast medium by the reduction of its volume in this group of high-risk patients. The extension of the arterial lesions was the factor that most contributed to the need for iodine supplementation due to the difficulty to visualize the refill after a long arterial occlusion. Conclusion The use of CO2 as contrast in patients with C and D lesions with no restriction for iodine contrast medium was an alternative that did not dismiss the need of iodine supplementation in most of the cases, but could decrease the potential nephrotoxicity of iodine constrast medium.

RESUMO Objetivo Analisar os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes sem restrição ao meio de contraste iodado com o objetivo de diminuir reações alérgicas e potencial de nefrotoxicidade em pacientes de alto risco. Métodos Descrevemos os resultados de dez angioplastias de lesões fêmoro-poplíteas TASC C e D utilizando CO2 como meio de contraste primário em pacientes de alto risco para revascularização aberta e sem contraindicação formal a iodo. Analisamos possibilidade de execução dos procedimentos, complicações, qualidade das imagens obtidas, desfechos clínicos e cirúrgicos e custos das lesões C e D tratadas com CO2 como meio de contraste. Resultados O uso de CO2 nas lesões C e D necessitou de complementação de iodo na maioria dos casos (nove casos), porém reduziu o potencial de nefrotoxicidade do meio de contraste iodado, diminuindo seu volume nesse grupo de pacientes de alto risco. A extensão das lesões arteriais foi o fator que mais contribuiu para necessidade de suplementação de iodo, devido à dificuldade de visualizar o reenchimento após oclusão arterial longa. Conclusão O uso de CO2 como contraste em pacientes com lesões C e D sem restrição ao meio de contraste iodado foi uma alternativa que não excluiu a necessidade de suplementação com iodo na maioria dos casos, porém pôde diminuir o potencial de nefrotoxicidade do meio de contraste iodado.

Enoxaparin Treatment Followed by Rivaroxaban for the Treatment of Acute Lower Limb Venous Thromboembolism: Initial Experience in a Single Center.

Rivaroxaban is a target-specific oral anticoagulant approved for the treatment of venous thromboembolism (VTE). On its major clinical trials, treatment was initiated directly with a 3-week dose of oral 15 mg twice daily followed by 20 mg every day for at least 3 months. We retrospectively evaluated an initial therapy for confirmed VTE with 1 to 18 days of enoxaparin (1 mg/kg twice daily parenteral) followed by oral rivaroxaban 20 mg every day. Of 49 patients, we found no symptomatic recurrence, no major bleeding, and only 1 clinically relevant nonmajor bleeding. We concluded in this pilot study that it is safe and effective to treat patients with enoxaparin course followed directly by a dose of 20 mg of rivaroxaban.

Carbon dioxide contrast medium for endovascular treatment of ilio-femoral occlusive disease.

OBJECTIVES: Compare the use of carbon dioxide contrast medium with iodine contrast medium for the endovascular treatment of ilio-femoral occlusive disease in patients without contraindications to iodine. MATERIALS AND METHODS: From August 2012 to August 2014, 21 consecutive patients with ilio-femoral occlusive disease who were eligible for endovascular treatment and lacked contraindications to either iodine contrast or carbon dioxide were randomized into the carbon dioxide or iodine groups and subjected to ilio-femoral angioplasty.We analyzed the feasibility of the procedures, the surgical and clinical outcomes, the procedure lengths, the endovascular material costs, the contrast costs and the quality of the angiographic images in each group. RESULTS: No conversions to open surgery and no contrast media related complications were noted in either group. A post-operative femoral pulse was present in 88.9% of the iodine group and 80% of the carbon dioxide group. No differences in procedure length, endovascular material cost or renal function variation were noted between the groups. Four patients in the carbon dioxide group required iodine supplementation to complete the procedure. Contrast media expenses were reduced in the carbon dioxide group. Regarding angiographic image quality, 82% of the carbon dioxide images were graded as either good or fair by observers. CONCLUSIONS: The use of carbon dioxide contrast medium is a good option for ilio-femoral angioplasty in patients without contraindications to iodine and is not characterized by differences in endovascular material costs, procedure duration and surgical outcomes. In addition, carbon dioxide has lower contrast expenses compared with iodine.

Carbon dioxide contrast medium for endovascular treatment of ilio-femoral occlusive disease

OBJECTIVES:Compare the use of carbon dioxide contrast medium with iodine contrast medium for the endovascular treatment of ilio-femoral occlusive disease in patients without contraindications to iodine.MATERIALS AND METHODS:From August 2012 to August 2014, 21 consecutive patients with ilio-femoral occlusive disease who were eligible for endovascular treatment and lacked contraindications to either iodine contrast or carbon dioxide were randomized into the carbon dioxide or iodine groups and subjected to ilio-femoral angioplasty.We analyzed the feasibility of the procedures, the surgical and clinical outcomes, the procedure lengths, the endovascular material costs, the contrast costs and the quality of the angiographic images in each group.RESULTS:No conversions to open surgery and no contrast media related complications were noted in either group. A post-operative femoral pulse was present in 88.9% of the iodine group and 80% of the carbon dioxide group. No differences in procedure length, endovascular material cost or renal function variation were noted between the groups. Four patients in the carbon dioxide group required iodine supplementation to complete the procedure. Contrast media expenses were reduced in the carbon dioxide group. Regarding angiographic image quality, 82% of the carbon dioxide images were graded as either good or fair by observers.CONCLUSIONS:The use of carbon dioxide contrast medium is a good option for ilio-femoral angioplasty in patients without contraindications to iodine and is not characterized by differences in endovascular material costs, procedure duration and surgical outcomes. In addition, carbon dioxide has lower contrast expenses compared with iodine.

Treatment of uncommon sites of focal primary hyperhidrosis: experience with pharmacological therapy using oxybutynin.

OBJECTIVES: Primary hyperhidrosis usually affects the hands, armpits, feet and cranio-facial region. Sweating in other areas is common in secondary hyperhidrosis (after surgery or in specific clinical conditions). Oxybutynin has provided good results and is an alternative for treating hyperhidrosis at common sites. Our aim was to evaluate the efficacy of oxybutynin as a treatment for primary sweating at uncommon sites (e.g., the back and groin). METHODS: This retrospective study analyzed 20 patients (10 females) who received oxybutynin for primary focal hyperhidrosis at uncommon sites. The subjects were evaluated to determine quality of life before beginning oxybutynin and six weeks afterward and they were assigned grades (on a scale from 0 to 10) to measure their improvement at each site of excessive sweating after six weeks and at the last consult. RESULTS: The median follow-up time with oxybutynin was 385 days (133-1526 days). The most common sites were the back (n = 7) and groin (n = 5). After six weeks, the quality of life improved in 85% of the subjects. Dry mouth was very common and was reported by 16 patients, 12 of whom reported moderate/severe dry mouth. Five patients stopped treatment (two: unbearable dry mouth, two: excessive somnolence and one: palpitations). At the last visit, 80% of patients presented with moderate/great improvement at the main sites of sweating. CONCLUSION: After six weeks, more than 80% of the patients presented with improvements in their overall quality of life and at the most important site of sweating. Side effects were common (80% reported at least one side effect) and caused 25% of the patients to discontinue treatment. Oxybutynin is effective for treating bothersome hyperhidrosis, even at atypical locations and most patients cope well with the side effects.

Treatment of uncommon sites of focal primary hyperhidrosis: experience with pharmacological therapy using oxybutynin

OBJECTIVES: Primary hyperhidrosis usually affects the hands, armpits, feet and cranio-facial region. Sweating in other areas is common in secondary hyperhidrosis (after surgery or in specific clinical conditions). Oxybutynin has provided good results and is an alternative for treating hyperhidrosis at common sites. Our aim was to evaluate the efficacy of oxybutynin as a treatment for primary sweating at uncommon sites (e.g., the back and groin). METHODS: This retrospective study analyzed 20 patients (10 females) who received oxybutynin for primary focal hyperhidrosis at uncommon sites. The subjects were evaluated to determine quality of life before beginning oxybutynin and six weeks afterward and they were assigned grades (on a scale from 0 to 10) to measure their improvement at each site of excessive sweating after six weeks and at the last consult. RESULTS: The median follow-up time with oxybutynin was 385 days (133-1526 days). The most common sites were the back (n = 7) and groin (n = 5). After six weeks, the quality of life improved in 85% of the subjects. Dry mouth was very common and was reported by 16 patients, 12 of whom reported moderate/severe dry mouth. Five patients stopped treatment (two: unbearable dry mouth, two: excessive somnolence and one: palpitations). At the last visit, 80% of patients presented with moderate/great improvement at the main sites of sweating. CONCLUSION: After six weeks, more than 80% of the patients presented with improvements in their overall quality of life and at the most important site of sweating. Side effects were common (80% reported at least one side effect) and caused 25% of the patients to discontinue treatment. Oxybutynin is effective for treating bothersome hyperhidrosis, even at atypical locations and most patients cope well with the side effects. .

Ethanol sclerotherapy of head and neck venous malformations.

OBJECTIVE: This retrospective study evaluated the results of sclerotherapy with low doses of ethanol for treatment of head and neck venous malformations. METHODS: We treated 51 patients, 37 females. Median age was 23 years. Patients were treated with percutaneous intralesional injection of alcohol every two weeks and followed up prospectively for a median period of 18 months. Most lesions affected the face and cosmetic disfigurement was the most frequent complaint. RESULTS: We performed a median of 7 sessions of sclerotherapy. Complete resolution or improvement was observed in 48 patients presented. Five cases of small skin ulceration, two cases of hyperpigmentation and two of paresthesia were documented; all of them were treated conservatively. CONCLUSION: Percutaneous sclerotherapy with low doses of ethanol is a safe and effective treatment modality for venous malformations affecting the head and neck.

Ethanol sclerotherapy of head and neck venous malformations / Escleroterapia com etanol em malformações venosas da cabeça e pescoço

Objective This retrospective study evaluated the results of sclerotherapy with low doses of ethanol for treatment of head and neck venous malformations. Methods We treated 51 patients, 37 females. Median age was 23 years. Patients were treated with percutaneous intralesional injection of alcohol every two weeks and followed up prospectively for a median period of 18 months. Most lesions affected the face and cosmetic disfigurement was the most frequent complaint. Results We performed a median of 7 sessions of sclerotherapy. Complete resolution or improvement was observed in 48 patients presented. Five cases of small skin ulceration, two cases of hyperpigmentation and two of paresthesia were documented; all of them were treated conservatively. Conclusion Percutaneous sclerotherapy with low doses of ethanol is a safe and effective treatment modality for venous malformations affecting the head and neck. .

Objetivo Estudo retrospectivo que analisou os resultados da escleroterapia, com doses baixas de etanol, realizada sob anestesia local para tratamento de malformações venosas na cabeça e pescoço. Métodos Foram tratados 51 pacientes, sendo 37 do gênero feminino. A mediana de idade foi de 23 anos. Os pacientes foram tratados com injeções alcoólicas nas lesões, por via percutânea, em sessões quinzenais, e acompanhados prospectivamente por um período mediano de 18 meses. A maioria das lesões acometia a face e a queixa principal mais frequente foi deformidade estética. Resultados Foram realizadas, em média, sete sessões de escleroterapia. Resolução completa ou melhora foi observada em 48 pacientes. Cinco pacientes apresentaram pequena úlcera cutânea, dois hiperpigmentação e dois parestesia, sendo todos tratados conservadoramente. Conclusão A escleroterapia percutânea com doses baixas de etanol é um método seguro e eficaz para tratar malformações venosas na cabeça e pescoço. .

Effectiveness of oxybutynin for treatment of hyperhidrosis in overweight and obese patients / Eficácia da oxibutina no tratamento de hiperidrose em pacientes com sobrepeso e obesos

OBJECTIVE: Until the present moment, the lack of efficient therapeutic options available for hyperhidrosis treatment in obese patients has left this population without prospect of clinical or quality of life (QOL) improvements. Outcomes of oxybutynin treatment for overweight and obese patients with hyperhidrosis are unknown. This study aims to investigate the results related to clinical and QOL improvements in this specific population, submitted to a 12-week protocol treatment with oxybutynin. METHODS: 559 patients with palmar and axillary hyperhidrosis, routinely followed in this service, were divided into the groups, according to their body mass index (BMI) (< 25 kg/m²; 25 < bmi < 30 kg/m², > 30 kg/m²). Improvements in QOL and in the level of hyperhidrosis were analyzed after 12 weeks of protocol treatment with oxybutynin. These parameters were investigated using a scoring system based on a scientifically validated clinical questionnaire, applied before and after treatment. RESULTS: 67.8% of the overweight sample group and 63% of the obese patients presented "partial" or "great" improvement in the level of hyperhidrosis. Over 65% of patients demonstrated improvement in QOL ("much better" or "slightly better") for all three groups, with no statistical difference between them. The only adverse event associated with oxybutynin was dry mouth, observed in 63.0% of the patients. CONCLUSION: Overweight and obese patients with palmar or axillary hyperhidrosis present significant improvement in QOL after treatment with oxybutynin, and the results are comparable to those of normal weight individuals.

OBJETIVO: A falta de alternativas terapêuticas para o tratamento de pacientes obesos com Hiperidrose hiperidrose deixa essa população sem perspectiva de melhorar suas condições clínicas e qualidade de vida. Resultados do tratamento com oxibutinina especificamenteempacientes com sobrepeso ou obesidade são desconhecidos até o presente momento. Este estudo tem como objetivo investigar os resultados relacionados à melhora clínica e qualidade de vida dessa população, após um protocolo de tratamento de 12 semanas com oxibutinina. MÉODOS: 559 pacientes com hiperidrose palmar e axilar, foram divididos em três grupos, de acordo com seu índice de massa corporal (IMC) (< 25 kg/m²; 25 < IMC < 30 kg/m², > 30 kg/m²). Dados sobre evolução na qualidade de vida e nível de hiperidrose foram avaliados com base em um questionário validado cientificamente, aplicado antes e após o tratamento com oxibutinina. RESULTADOS: 67.8% dos pacientes com sobrepeso e 63% dos obesos apresentaram melhora clínica "grande" ou "parcial" no nível da hiperidrose. Mais de 65% dos pacientes relataram melhora na qualidade de vida ("muito melhor" ou "um pouco melhor") para os três grupos, sem diferença estatística entre eles. O único efeito colateral observado foi boca seca, presente em 63.0% da amostra. CONCLUSÃO: Pacientes com sobrepeso e obesidade portadores de hiperidrose palmar ou axilar apresentaram melhora significativa na qualidade de vida após o tratamento com oxibutinina, sendo os resultados comparáveis aos de indivíduos com peso normal.

A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis.

INTRODUCTION: Video-assisted thoracic sympathectomy provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of oxybutynin, an anticholinergic medication that competitively antagonizes the muscarinic acetylcholine receptor, can be used to treat palmar hyperhidrosis with fewer side effects. OBJECTIVE: This study evaluated the effectiveness and patient satisfaction of oral oxybutynin at low doses (5 mg twice daily) compared with placebo for treating palmar hyperhidrosis. METHODS: This was prospective, randomized, and controlled study. From December 2010 to February 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, but 5 (10.0%) were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once daily in the evening. From days 8 to 21, they received 2.5 mg twice daily, and from day 22 to the end of week 6, they received 5 mg twice daily. All patients underwent two evaluations, before and after (6 weeks) the oxybutynin treatment, using a clinical questionnaire and a clinical protocol for quality of life. RESULTS: Palmar and axillary hyperhidrosis improved in >70% of the patients, and 47.8% of those presented great improvement. Plantar hyperhidrosis improved in >90% of the patients. Most patients (65.2%) showed improvements in their quality of life. The side effects were minor, with dry mouth being the most frequent (47.8%). CONCLUSIONS: Treatment of palmar and axillary hyperhidrosis with oxybutynin is a good initial alternative for treatment given that it presents good results and improves quality of life.

The use of oxybutynin for treating axillary hyperhidrosis.

BACKGROUND: To evaluate the effectiveness and patient satisfaction with the use of oxybutynin for treating axillary hyperhidrosis in a large series of patients. METHODS: One hundred two patients with axillary hyperhidrosis were treated with oxybutynin. During the first week, patients received 2.5 mg of oxybutynin once a day in the evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd day to the end of the 12th week, they received 5 mg twice a day. All of the patients underwent two evaluations: before and after (12 weeks) the oxybutynin treatment, using a clinical questionnaire; and a clinical protocol for quality of life (QOL). RESULTS: More than 80% of the patients experienced an improvement in axillary hyperhidrosis; 36.3% of them presented a great improvement, and half of the patients showed improvements at all hyperhidrosis sites. Most of the patients showed improvements in the QOL (67.5%). The patients with very poor QOL before the treatment presented greater satisfaction levels after treatment. The side effects were minor, dry mouth being the most frequent (73.5%). CONCLUSIONS: Oxybutynin is a good alternative to sympathectomy. It presents good results and improves QOL without the side effects of sympathectomy.

The use of oxybutynin for treating facial hyperhidrosis.

BACKGROUND: Facial hyperhidrosis is a disease that may lead patients to serious emotional disturbances. Video-assisted thoracic sympathectomy provides excellent resolution of facial hyperhidrosis, but is associated with certain complications. The most frequent and important complication is compensatory hyperhidrosis. Especially in patients who have undergone resection of the second thoracic ganglion, the risk of severe compensatory hyperhidrosis is higher, which may cause dissatisfaction with the procedure. OBJECTIVE: The aim of this study was to evaluate the efficacy of the use of low doses of oxybutynin in treating facial hyperhidrosis as well as the level of patient satisfaction with its use. METHODS: 25 patients with facial hyperhidrosis were treated with oxybutynin. The patients underwent 2 evaluations: before and after treatment. These evaluations were used to assess the patients' clinical improvement and quality of life. RESULTS: We observed that more than 75% of the patients evolved with an improvement in facial hyperhidrosis, and 52% of them presented a great improvement. CONCLUSION: Treatment of facial hyperhidrosis with oxybutynin is a good alternative to sympathectomy, since it presents good results and improves quality of life, in addition to not exposing patients to the risk of experiencing the side effects of sympathectomy.

An alternative to treat palmar hyperhidrosis: use of oxybutynin.

PURPOSE: To evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses for treating palmar hyperhidrosis in a large series of patients. METHODS: From January 2007 to June 2009, 180 consecutive patients with palmar hyperhidrosis were treated with oxybutynin. Data were collected from 139 patients (41 patients were lost to follow-up). During the first week, patients received 2.5 mg of oxybutynin once per day; from the 8th to the 42nd day, 2.5 mg twice per day; and from the 43rd day to the end of the 12th week, 5 mg, twice per day. All of the patients underwent three evaluations before and after the oxybutynin treatment (at 6 and 12 weeks), using a clinical questionnaire and a clinical protocol for quality of life (QOL). RESULTS: More than 80% of the patients experienced an improvement in palmar hyperhidrosis. Most of the patients showed improvements in their QOL (74.6%). The side effects were minor, with dry mouth being the most frequent (70.5%). CONCLUSION: The use of oxybutynin is an alternative as the first step in the treatment of palmar hyperhidrosis, given that it presents good results and improves QOL.

The use of oxybutynin for treating facial hyperhidrosis / O uso da oxibutinina no tratamento da hiperidrose facial

BACKGROUND: Facial hyperhidrosis is a disease that may lead patients to serious emotional disturbances. Video-assisted thoracic sympathectomy provides excellent resolution of facial hyperhidrosis, but is associated with certain complications. The most frequent and important complication is compensatory hyperhidrosis. Especially in patients who have undergone resection of the second thoracic ganglion, the risk of severe compensatory hyperhidrosis is higher, which may cause dissatisfaction with the procedure. OBJECTIVE: The aim of this study was to evaluate the efficacy of the use of low doses of oxybutynin in treating facial hyperhidrosis as well as the level of patient satisfaction with its use. METHODS: 25 patients with facial hyperhidrosis were treated with oxybutynin. The patients underwent 2 evaluations: before and after treatment. These evaluations were used to assess the patients' clinical improvement and quality of life. RESULTS: We observed that more than 75 percent of the patients evolved with an improvement in facial hyperhidrosis, and 52 percent of them presented a great improvement. CONCLUSION: Treatment of facial hyperhidrosis with oxybutynin is a good alternative to sympathectomy, since it presents good results and improves quality of life, in addition to not exposing patients to the risk of experiencing the side effects of sympathectomy.

FUNDAMENTOS: Hiperidrose facial é uma doença que pode levar os pacientes a sérios distúrbios emocionais. A simpatectomia torácica vídeo-assistida proporciona excelente resolução da hiperidrose facial, mas está associada a algumas complicações, sendo a mais freqüente e mais importante a hiperidrose compensatória. Especialmente em pacientes submetidos à ressecção do segundo gânglio torácico, o risco de hiperidrose compensatória grave é maior, o que pode causar insatisfação com o procedimento. OBJETIVO: O objetivo deste estudo foi avaliar a eficácia e a satisfação dos pacientes com o uso da oxibutinina em doses baixas para tratar a hiperidrose facial em uma série grande de pacientes. MÉTODOS: 25 pacientes com hiperidrose facial foram tratados com oxibutinina. Os pacientes foram submetidos a duas avaliações: antes e depois do tratamento. Estas foram usadas para avaliar a melhoria clínica e a qualidade de vida. RESULTADOS: Observou-se que mais de 75 por cento dos pacientes evoluíram com melhora na hiperidrose facial, sendo que 52 por cento deles apresentaram uma grande melhora. CONCLUSÃO: O tratamento da hiperidrose facial com oxibutinina é uma boa alternativa à simpatectomia, visto que apresenta bons resultados e melhora a qualidade de vida, e os pacientes não correm o risco dos efeitos colaterais da simpatectomia.