Dynamic scintigraphy of primary and secondary malignant intracranial neoplasms.

Dynamic images and arteriograms were reviewed in patients with proved primary and secondary malignant intracranial neoplasms. In 44% of the patients with glioblastomas and 23% of those with metastatic lesions, radioactivity appeared early in the dynamic imaging sequence. This was related to the presence of arteriovenous shunting on arteriography rather than to a tumor stain. Neither characteristic dynamic imaging patterns nor rapid arteriovenous shunting was seen in patients with astrocytomas.     

Laparoscopic Roux-en-Y gastric bypass: results and learning curve of a high-volume academic program

HYPOTHESIS: Laparoscopic Roux-en-Y gastric bypass is a complex procedure performed on a high-risk patient population. Good results can be attained with experience and volume. DESIGN: Retrospective study. SETTING: Tertiary care academic hospital. PATIENTS: Seven hundred fifty consecutive morbidly obese patients undergoing surgery from March 1998 to April 2004. INTERVENTIONS: All patients underwent laparoscopic Roux-en-Y gastric bypass. MAIN OUTCOME MEASURES: Perioperative deaths and complications. RESULTS: The patient population was 85% women and had a mean body mass index of 47 kg/m2 (range, 32-86 kg/m2). The overall complication rate was 15% and the mortality was 0.3%. For the first 100 cases, the overall complication rate was 26% with a mortality of 1%. This complication rate decreased to approximately 13% and was stable for the next 650 patients. The incidence of major complications has also decreased since the first 100 cases. Leak decreased from 3% to 1.1%. Small-bowel obstruction decreased from 5% to 1.1%. Overall mean operating time was 138 minutes (range, 65-310 minutes). It decreased from 212 minutes for the first 100 cases to 132 minutes for the next 650 and 105 minutes (range, 65-200 minutes) for the last 100 cases. CONCLUSIONS: Laparoscopic Roux-en-Y gastric bypass is a technically difficult operation. This review of a large series in a high-volume program demonstrated that the morbidity and mortality could be reduced by 50% with experience. The results are similar to those reported from other major centers. In addition, as reported elsewhere, the learning curve for this procedure may be 100 cases.     

Safety and effectiveness of topiramate for the management of painful diabetic peripheral neuropathy in an open-label extension study

OBJECTIVE: The aim of this study was to further assess the long-term safety and effectiveness of open-label topiramate therapy in subjects with moderately to severely painful diabetic peripheral neuropathy (DPN). METHODS: Adults aged 18 to 75 years received open-label topiramate (25-600 mg/d for 26 weeks) in an extension of a previously published randomized, double-blind trial comparing topiramate with placebo. Safety analyses included adverse event (AE) reports and clinical laboratory tests. Metabolic end points included body weight and glycosylated hemoglobin (HbA(1c)). Effectiveness analyses included a 100-mm pain visual analog (PVA) scale, worst and current pain severity, and sleep disruption. RESULTS: Two hundred five subjects participated in this open-label extension study (118 formerly treated with topiramate and 87 who formerly received placebo). The groups did not differ in baseline demographics or disease characteristics. One hundred twenty-four (60.5%) subjects (68.6% of former topiramate recipients and 49.4% of former placebo recipients) completed the extension study; the most common reason for discontinuation was an AE (27.3% of subjects). AEs among subjects who received > or =1 dose of topiramate (n = 298) included upper respiratory tract infection (16.1%), anorexia (15.1%), diarrhea (12.8%), nausea (12.8%), paresthesia (10.7%), and headache (10.1%). Baseline pain scores were lower in those formerly treated with topiramate (n = 117) than in the former placebo group (n = 86) (PVA: 43.3 vs 52.5, P = 0.014; worst pain: 1.9 vs 2.5, P < 0.001; current pain: 1.6 vs 1.9, P = 0.026; sleep disruption: 3.6 vs 4.6, P = 0.021). At the final visit, PVA, current pain, and sleep disruption scores were not significantly different between the former topiramate and former placebo groups, but worst pain differed significantly (1.4 vs 1.8; P = 0.025). Mean weight loss from the start of topiramate therapy was 5.2 and 5.3 kg in the former topiramate and former placebo groups, respectively (P < 0.001 vs baseline). Mean HbA(1c) values before and after topiramate treatment were 7.7% and 7.4%, respectively, in the former topiramate group (P = 0.004 vs baseline), and 7.6% and 7.1%, respectively, in the former placebo group (P < 0.001 vs baseline). CONCLUSION: Although 39.5% of subjects discontinued, most often due to AEs, the results of this 26-week, open-label extension study with topiramate (up to 600 mg/d) in subjects with moderately to severely painful DPN suggest that pain relief was effective and durable.     

A study of the effects of cardiopulmonary bypass surgery on auditory function

Cardiopulmonary bypass surgery is commonplace in many medical centers and rare instances of unilateral hearing loss in these patients have been reported and have been attributed to embolism. Two more patients are reported and their discovery prompted a study of pre and postoperative hearing in 68 patients at Newark Beth Israel Medical Center, where a single team performs the cardiopulmonary bypass surgery. Previous similar studies showed no changes following CPB surgery. Almost all patients have been male and prolonged pump times (over 150 min.) were noted in 7 of 11 reports. Based on changes in hearing found on pre and postoperative testing in the 6 patients, 3 groups were developed: those with no change and those with slight changes were compared with those having average deficits of more than 10 db. Prolonged pump times occurred only twice in the series and were not associated with loss. A second milder form of hearing loss, which was bilateral and affected the high tones, was noted in significant numbers. Two of these patients had persistent tinnitus after surgery. Although the series is small, there appears to be an increased susceptibility in males to the development of high tone loss as well. Based on the preponderance of males, with their high incidence of basilar artery atherosclerosis, and the frequent prolonged pump times, perfusion failure seems to be the most likely etiology for the rare cases of hearing loss accompanying cardiopulmonary bypass surgery.     

Prevalence of occult celiac disease in patients with iron-deficiency anemia: a prospective study

BACKGROUND: Occult celiac disease has been reported in 0 to 6% of adults presenting with iron-deficiency anemia. Most prior studies have been retrospective or screened only a selected population of patients with small bowel biopsies. To more accurately define the true prevalence of this disorder in patients presenting with iron-deficiency anemia (with or without stool hemoccult positivity), we initiated this prospective study. METHODS: Esophagogastroduodenoscopy with small bowel biopsies and colonoscopy were performed in all iron-deficiency anemia patients (including those with hemoccult-positive stools) referred to the gastroenterology service during a 2-year period (1998-2000). Inclusion criteria included iron-deficiency anemia as defined by a serum ferritin < 25 ng/ml and anemia with hemoglobin < 12 g/dl. Patients were excluded for documented prior erosive, ulcerative, or malignant disease of the gastrointestinal tract, previous gastrointestinal surgery, overt gastrointestinal bleeding within the past 3 months, or inability to access the duodenum for biopsy. All patients underwent upper endoscopy with more than two biopsies of the distal duodenum and colonoscopy. A serum immunoglobulin A antiendomysial antibody test was to be performed in those patients with a positive small bowel biopsy to confirm the diagnosis of celiac disease. RESULTS: One hundred five of 139 consecutive patients with iron-deficiency anemia met the inclusion criteria and were enrolled in the study. Fifty-seven men (mean age, 51.6 yr) and 48 women (mean age, 54.1 yr) constituted the study population. The demographics of this study population included 36 blacks, 38 Hispanics, and 22 whites. Nine patients were of mixed or unknown ethnic background. Forty-three and eight-tenths percent of the men and 37.5% of women had hemoccult-positive stools, accounting for a total of 40.9% of the study patients. Upper endoscopic findings included gastritis in 22.8%, gastric ulcers in 9.5%, duodenitis in 8.5%, esophagitis in 7.6%, Barrett's ulcer in 2.8%, duodenal ulcer in 2.8%, gastric polyp in 2.8%, and celiac disease in 2.8%. Colonoscopic findings included colon polyps in 21.9%, diverticula in 10.4%, and hemorrhoids in 16.1%. Multiple findings were found in 32.3% of patients, and there were no findings in 28.5% of patients. CONCLUSION: The prevalence of occult celiac disease in this prospective study of patients presenting with iron-deficiency anemia was 2.8%. A significant number of other gastrointestinal lesions amenable to therapy were also found on upper and lower endoscopy in these patients. Given the treatable nature of celiac disease, it should be screened for in patients with unexplained iron-deficiency anemia with or without hemoccult-positive stools.     

Incidence and duration of antidepressant-induced nausea: duloxetine compared with paroxetine and fluoxetine

OBJECTIVE: This analysis assessed the incidence, severity, onset, and duration of nausea among patients with major depressive disorder (MDD) treated with the new antidepressant duloxetine. METHODS: Data were pooled from 8 double-blind, randomized, placebo- and active comparator-controlled trials employing patients with MDD that were submitted to the US Food and Drug Administration to support duloxetine's new drug application for treatment of MDD. RESULTS: The numbers of patients receiving each regimen were as follows: placebo, n = 777; duloxetine 40 mg/d, n = 177; duloxetine 60 mg/d, n = 251; duloxetine 80 mg/d, n = 363; duloxetine 120 mg/d, n = 348; paroxetine 20 mg/d, n = 359; and fluoxetine 20 mg/d, n = 70. In acute placebo-controlled trials of duloxetine 40 to 120 mg/d, treatment-emergent nausea was reported by more duloxetine-treated patients than those receiving placebo (19.9% [227/1139] vs 6.9% [154/777], respectively; P <0.001). Among duloxetine-treated patients, the median time to onset of nausea was 1 day, and the median duration of nausea was 7 days. The incidence of nausea was similar to placebo rates after 1 week. In paroxetine-controlled studies, the incidence of treatment-emergent nausea in patients receiving duloxetine did not differ significantly from paroxetine (14.4% vs 12.0%, respectively). In head-to-head studies, the incidence of treatment-emergent nausea with duloxetine did not differ significantly from that with fluoxetine (17.1% vs 15.7%, respectively). Most duloxetine-treated patients reported nausea to be mild (52.9%) or moderate (41.4%). Treatment discontinuation secondary to nausea occurred in more duloxetine-treated patients than those receiving placebo (1.4% [16/1139] vs 0.1% [1/777], respectively; P = 0.002). Following abrupt discontinuation after acute treatment, 5.9% of duloxetine-treated patients exhibited nausea compared with 0.3% of patients receiving placebo (P < 0.001). The incidence of treatment-emergent nausea during 6-month continuation of duloxetine treatment (80 mg/d, 2.1%; 120 mg/d, 1.3%) was similar to placebo (1.6%). Following abrupt discontinuation after 8 months of treatment, nausea was reported by 1.6% of patients receiving duloxetine 120 mg/d compared with 0% for those receiving duloxetine 80 mg/d and 0% for placebo. CONCLUSIONS: Duloxetine induced mild to moderate nausea in a subset of patients with MDD during treatment initiation. Nausea resolved rapidly with continued treatment. The incidence of duloxetine-induced nausea resembled that produced by paroxetine and fluoxetine.