A cost analysis of the treatment of patients with post-thrombotic syndrome in Brazil.

INTRODUCTION: Post-thrombotic syndrome (PTS) occurs in 15-50% of patients with deep vein thrombosis (DVT), and is associated with substantial medical costs. This prospective observational study investigated the costs associated with the treatment of PTS in Brazil. MATERIALS AND METHODS: A total of 157 patients diagnosed with PTS and with a history of DVT were recruited from nine centers in Brazil. The costs of investigations and treatment for PTS over a 1-year follow-up period were analyzed. Ninety patients were available for this analysis. RESULTS: Of the 90 patients, 17 had mild-to-moderate PTS, and 73 had severe PTS. The patients with severe PTS tended to undergo more investigations and hospitalizations for PTS than those with mild-to-moderate PTS, although the differences between the two groups did not reach statistical significance. The mean annual cost of treating PTS in Brazilian Reais was 1214 R dollars (426 US dollars) for mild-to-moderate PTS and 3386 R dollars (1188 US dollars) for severe PTS. The difference was mainly due to significantly higher hospitalization costs in patients with severe PTS (704 R dollars/247 US dollars vs. 0 R dollars; p=0.044). CONCLUSION: These results suggest that PTS imposes substantial demands on health care resources in Brazil. The implementation of effective thromboprophylactic strategies could significantly reduce the incidence of DVT, and hence of PTS, potentially resulting in significant cost savings.

An open-label, comparative study of the efficacy and safety of once-daily dose of enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis.

BACKGROUND: Treatment of deep-vein thrombosis (DVT) with a once-daily regimen of enoxaparin, rather than a continuous infusion of unfractionated heparin (UFH) is more convenient and allows for home care in some patients. This study was designed to compare the efficacy and safety of these two regimens for the treatment of patients with proximal lower limb DVT. METHODS: 201 patients with proximal lower limb DVT from 13 centers in Brazil were randomized in an open manner to receive either enoxaparin [1.5 mg/kg subcutaneous (s.c.) OD] or intravenous (i.v.) UFH (adjusted to aPTT 1.5-2.5 times control) for 5-10 days. All patients also received warfarin (INR 2-3) for at least 3 months. The primary efficacy endpoint was recurrent DVT (confirmed by venography or ultrasonography), and safety endpoints included bleeding and serious adverse events. The rate of pulmonary embolism (PE) was also collected. Hospitalization was at the physician's discretion. RESULTS: Baseline patient characteristics were comparable between groups. The duration of hospital stay was significantly shorter with enoxaparin than with UFH (3 versus 7 days). In addition, 36% of patients receiving enoxaparin did not need to be hospitalized, whereas all of the patients receiving UFH were hospitalized. The treatment duration was slightly longer with enoxaparin (8 versus 7 days). There was a nonsignificant trend toward a reduction in the rate of recurrent DVT with enoxaparin versus UFH, and similar safety. CONCLUSIONS: A once-daily regimen of enoxaparin 1.5 mg/kg subcutaneous is at least as effective and safe as conventional treatment with a continuous intravenous infusion of UFH. However, the once daily enoxaparin regimen is easier to administer (subcutaneous versus intravenous), does not require aPTT monitoring, and leads to both a reduced number of hospital admissions and an average 4-day-shorter hospital stay.

Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.

BACKGROUND: Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown. METHODS: We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during the three-week period after randomization. The patients were followed for three months. RESULTS: The intention-to-treat analysis of efficacy included 332 patients. The rates of venous thromboembolism at the end of the double-blind phase were 12.0 percent in the placebo group and 4.8 percent in the enoxaparin group (P=0.02). This difference persisted at three months (13.8 percent vs. 5.5 percent, P=0.01). Three patients in the enoxaparin group and six in the placebo group died within three months after surgery. There were no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods. CONCLUSIONS: Enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis, as compared with enoxaparin prophylaxis for one week.

Amyotrophic lateral sclerosis in Brazil: 1998 national survey

OBJECTIVES: To assess the epidemiologic characteristics of amyotrophic lateral sclerosis (ALS) in Brazil in 1998. METHOD: Structured Clinical Report Forms (CRFs) sent to 2,505 Brazilian neurologists from January to September 1998 to be filled with demographic and clinical data regarding any ALS patient seen at any time during that year. RESULTS: Five hundred and forty CRFs were returned by 168 neurologists. Data on 443 patients meeting the criteria of probable or definite ALS according to El Escorial definition were analysed: 63 probable (14.2 percent) and 380 definite (85.8 percent). Two hundred and fifty-nine (58.5 percent) of the patients were male, mean age of onset was 52. Spinal onset occurred in 306 patients (69 percent); bulbar onset in 82 (18.5 percent), and both in 52 (11.7 percent). Twenty-six (5.9 percent) had a family history of ALS. Two hundred and fifty-nine (58.6 percent) were seen by private practitioners, and 178 (40.2 percent) at a hospital clinic. Age-ajusted incidence shows a peak incidence at the 65-74 years old range. CONCLUSIONS: The disease's characteristics are similar to those described in international studies, except for age of onset (Brazilian patients are younger). This difference is not confirmed when figures are age-adjusted

Avaliaçäo da profilaxia medicamentosa para tromboembolismo venoso (Tev) e índice de suspeita de Tev em pacientes submetidos à cirurgia de prótese total de quadril, eletiva e näo eletiva, em 16 Hospitais Brasileiros / Survey on drug prophylaxis for venous thromboembolism (VTE) and VTE suspicion rates in patients undergoing elective and non-elective total hip replacement (THR) in 16 Brazilian hospitals

O tromboembolismo venoso (TEV, trombose venosa profunda e embolia pulmonar) é uma séria complicaçäo dos procedimentos cirúrgicos de grande porte, especialmente nas cirurgias de quadril e joelho.Com o objetivo de avaliar o uso da profilaxia medicamentosa para TVP, bem como o índice de suspeita e o manuseio desta complicaçäo nos pacientes submetidos à prótese total de quadril, realizou-se estudo retrospectivo baseado nos prontuáarios de pacientes de 16 hospitais brasileiros, 7 públicos e 9 privados, durante os anos de 1997 e 1998.Os centros de ortopedia convidados a participar preencheram um formulário especificando sexo, idade, data da cirurgia, principal indicaçäo para prótese de quadril, doenças concomitantes e o uso de prodilaxia medicamentosa, incluindo o tipo de droga e a posologia.Outros dados coletados foram volume de transfusäo sanguínea, suspeita de TVP até 15 dias após a alta e o manuseio da TVP após a suspeita.Resultados:dados de 386 pacientes de 16 hospitais foram coletados; 310 (80 por cento) receberam algum tipo de profilaxia medicamentosa, 20 por cento nenhuma.Dos que receberam profilaxia, heparina näo fracionada (HNF) foi a droga mais comumente usada, em 55 (14 por cento) dos pacientes.Seu uso combinado ou associado à aspirina foi encontrado em 7 (2 por cento) dos pacientes.Nos 248 pacientes em que HFN foi prescrita, 17 (7por cento) receberam 5000 UI 3x/dia, e 93 por cento receberam 2x/dia...

Comparative study of the efficacy and tolerability of Secnidazole suspension (single dose) and Tinidazole suspension (two days dosage) in the treatment of amebiasis in children

Amebiasis caused by Entamoeba histolytica may be considered the most aggressive parasitic disease affecting human intestine, causing acute amoebic colitis and extra-intestinal diseases of high morbidity and mortality. 5-nitroimidazoles are the drugs of choice. In this multicenter, open and randon clinical trial, the efficacy and tolerability of secnidazole suspension in a single oral dose of 1ml/kg was compared with 0.5ml/kg doses of tinidazole suspension given for 2 consecutive days to 303 Entamoeba histolytica-positive children aged 2 to 13. Patients with extra-intestinal complications were excluded from the study. Clinical and parasitological follow-up using the Faus and Kato-Katz method were carried out 7, 14, and 21 days after treatment. Clinical improvement/cure was observed in 93 percent of the patients in the secnidazole group and 91 percent in the tinidaloze group. Parasitological sucess was reported for 77 percent and 63 percent of the secnidazole and tinidazole patients, respectively, showing a significant statistical difference between the two groups (p=0.007). Both drugs were well tolerated, and the adverse effects reported were mild, consisting mainly of digestive disturbances. This comparative study showed that a single oral dose of 1ml/kg of secnidazole produced a significantly higher parasitological cure rate than 2 doses of tinidazole. Secnidazole is a safe and effective drug for the treatment of uncomplicated intestinal amebiasis.