Safety experience with bosentan in 146 children 2-11 years old with pulmonary arterial hypertension: results from the European Postmarketing Surveillance program

The oral dual endothelin receptor antagonist bosentan has been shown to improve the short- and medium-term course of adult pulmonary arterial hypertension (PAH); however, data from clinical studies in children are limited. This analysis investigated the safety profile of bosentan in pediatric patients in a European, prospective, noninterventional, Internet-based postmarketing surveillance database (Tracleer PMS). Pediatric patients (aged 2-11 y) were compared with patients aged > or =12 y. Over a 30-mo period, 4994 patients, including 146 bosentan-na?ve pediatric patients (51.4% males), were captured in the database. Predominant etiologies in children were idiopathic PAH (40.4%) and PAH related to congenital heart disease (45.2%). The majority of children were in New York Heart Association functional class II (28.1%) or III (50.7%), and median exposure to bosentan was 29.1 wk. Elevated aminotransferases were reported in 2.7% of children versus 7.8% of patients > or =12 y. The discontinuation rate was 14.4% in children versus 28.1% in patients > or =12 y. The Tracleer PMS results provide unique information on pediatric PAH in Europe. They also suggest that Tracleer may be better tolerated in children than in adults. This observation confirms the value of monthly monitoring of liver function for the duration of bosentan treatment.     

A diet rich in long chain omega-3 fatty acids modulates satiety in overweight and obese volunteers during weight loss

Long chain omega-3 fatty acids (LC n-3 FA) are considered nutritional factors with a potential to modulate food intake. Thus, the aim of the current study was to determine whether appetite could be affected by LC n-3 FA when included in a calorie-restricted diet to treat overweight or obesity. Appetite was explored in volunteers (31+/-5 years; BMI: 28.3+/-1.5kg/m(2)) during the last 2 weeks of an 8-week energy-restricted balanced diet (weight loss=-5.9+/-3.1%) providing either a low (<260mg/day; n=112) or a high amount (>1300mg/day; n=121) of LC n-3 FA. Erythrocyte membrane fatty acids were measured to detect diet-related changes in fatty acids and a validated visual analogue scale (VAS) was used to measure hunger sensations directly after and 2h after a test dinner. The LC n-3 FA content in erythrocyte membrane was lower in the low LC n-3 FA group (10.5+/-2.5% vs. 12.5+/-2.6%; p<0.001) after the intervention. The VAS assessment revealed lower hunger sensations in the high LC n-3 FA group immediately after the test dinner (fullness: p=0.045) and after 120min (fullness: p=0.008; hunger: p=0.039). Correlation analysis showed a positive relation between n-3FA/n-6 FA ratio in erythrocyte membrane and fullness 2h postprandial (r=0.139; p=0.032). In conclusion, LC n-3 FA intake modulates postprandial satiety in overweight and obese volunteers during weight loss. Further research is needed to investigate whether LC n-3 FA improve compliance to the nutritional treatment of overweight and obesity as well as weight loss maintenance.     

Upper abdominal teratomas in infants: radiological findings and importance of the vascular anatomy

BACKGROUND: Primary upper abdominal teratomas are extremely rare tumours, most commonly arising in infants. The radiological literature relating to them is sparse. Surgical resection is difficult due to distortion of the vascular anatomy. OBJECTIVE: To reassess the value of preoperative imaging with specific reference to the presence/absence of typical features of teratoma, anatomical location and adjacent vascular anatomy. MATERIALS AND METHODS: The histopathology database was used to identify infants with upper abdominal teratoma. Pathological, surgical and radiological data were reviewed. RESULTS: The search of the database identified 12 infants (10 girls, 2 boys) with an abdominal/retroperitoneal teratoma during the period 1993 to 2006. All teratomas were benign. In the majority of infants, typical radiological features of teratoma were demonstrated (fat, calcium). Identification of the major abdominal vessels on CT scan (most commonly the inferior vena cava) was not possible in all infants. Distortion (and commonly encasement) of the adjacent major abdominal vessels was usually evident. CONCLUSION: Upper abdominal teratomas in infants have typical radiological features. Preoperative delineation of the major vascular anatomy is often imprecise. Significant distortion of vascular anatomy was present in all infants and awareness of this feature impacts on surgical planning.