Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity.

BACKGROUND: The BioEnterics Intragastric Balloon (BIB) has been proposed as an adjuvant therapy for the short-term treatment of obesity. The temporal pattern of BIB-induced satiety and whether this effect is mediated by modification of ghrelin levels is unknown. METHODS: Patients with treatment-resistant morbid obesity were invited to participate in a randomized, double-blind, sham-controlled trial of 4-month duration. Anthropometric and biochemical parameters, estimation of energy intake, and pre- and postprandial evaluation of satiety were required monthly. Ghrelin response after a standard mixed meal was scheduled prior to and 4 weeks after the endoscopic procedure. RESULTS: 21 out of 22 enrolled patients completed the study (17 women, 5 men; 35.9 +/- 9.9 years; BMI 50.4 +/- 7.8 kg/m2). Pre-intervention weight decreased from 143.8 +/- 31.2 kg to 131.1 +/- 32.6 kg in Group Balloon (P < 0.001) and from 138.8 +/- 24.5 kg to 129.9 +/- 25.6 kg in Group Sham (P < 0.01) at the end of the study. Weight loss was not significantly different in Group Balloon and Group Sham at any time-point of the follow-up. Only patients from Group Balloon showed a temporary increased pre- and postprandial satiety, which was maximal at 4 weeks after the intervention. Total area under the curve, fasting and postprandial plasma ghrelin were not significantly different between groups at inclusion or 4 weeks after follow-up. No correlation was found between any of the satiety scores at any time-point with their comparable ghrelin levels. CONCLUSION: BIB induces a temporary sense of satiety in morbidly obese patients which is not mediated by modification of fasting or postprandial levels of plasma ghrelin.

Epidemiology, clinical characteristics, outcome, morbidity and mortality in acromegaly based on the Spanish Acromegaly Registry (Registro Espanol de Acromegalia, REA).

OBJECTIVE: To undertake a multicentre epidemiological study reflecting acromegaly in Spain. DESIGN: Voluntary reporting of data on patients with acromegaly to an online database, by the managing physician. METHODS: Data on demographics, diagnosis, estimated date of initial symptoms and diagnosis, pituitary imaging, visual fields, GH and IGF-I concentrations (requested locally), medical, radiotherapy and neurosurgical treatments, morbidity and mortality were collected. RESULTS: Data were included for 1219 patients (60.8% women) with a mean age at diagnosis of 45 years (s.d. 14 years). Reporting was maximal in 1997 (2.1 cases per million inhabitants (c.p.m.) per year); prevalence was globally 36 c.p.m., but varied between 15.7 and 75.8 c.p.m. in different regions. Of 1196 pituitary tumours, most were macroadenomas (73%); 81% of these patients underwent surgery, 45% received radiotherapy and 65% were given medical treatment (somatostatin analogues in 68.3% and dopamine agonists in 31.4%). Cures (GH values (basal or after an oral glucose tolerance test) <2 ng/ml, normal IGF-I, or both) were observed in 40.3% after surgery and 28.2% after radiotherapy. Hypertension (39.1%), diabetes mellitus (37.6%), hypopituitarism (25.7%), goitre (22.4%), carpal tunnel syndrome (18.7%) and sleep apnoea (13.2%) were reported as most frequent morbidities; 6.8% of the patients had cancer (breast in 3.1% of the women and colon in 1.2% of the cohort). Fifty-six patients died at a mean age of 60 years (s.d. 14 years), most commonly of a cardiovascular cause (39.4%); mortality was greater in patients given radiotherapy (hazard ratio 2.29; 95% confidence interval 1.03 to 5.08; P=0.026), and in those in whom GH and IGF-I concentrations were never normal (P<0.001). CONCLUSIONS: This acromegaly registry offers a realistic overview of the epidemiological characteristics, treatment outcome and morbidity of acromegaly in Spain. As active disease and treatment with radiotherapy are associated with an increase in mortality, efforts to control the disease early are desirable.

Preoperative lanreotide treatment for GH-secreting pituitary adenomas: effect on tumour volume and predictive factors of significant tumour shrinkage.

OBJECTIVE: The objective of this open study of 104 patients was to determine whether the somatostatin analogue lanreotide shrinks GH-secreting adenomas and to identify the predictive factors of a significant tumour volume reduction (> 20%). PATIENTS: A total of 104 previously untreated and newly diagnosed acromegalic patients received the prolonged release (PR) formulation of lanreotide (lanreotide 30 mg, one intramuscular injection every 10 days) for either 1 (n = 84), 2 (n = 13), or 3 or more (n = 7) months before transsphenoidal surgery. MEASUREMENTS: Pituitary tumour volumes, tumour extension grade and possible cavernous sinus invasion were assessed in blinded conditions by a centralized team of radiologists. Factors such as demographics, tumour characteristics, GH and IGF-I levels were evaluated as possible predictive factors of a significant tumour volume reduction. The clinical activity and random GH, IGF-I, IGFBP-3, PRL, TSH, free T4 and lanreotide levels serum concentrations were measured under basal conditions and in the 10 days before surgery. All analyses were done in a centralized laboratory. The tolerability of preoperative PR lanreotide and the surgical outcome at the 6th month after surgery were assessed. RESULTS: The presurgical treatment improved the symptoms of acromegaly and induced a statistically significant reduction of GH, IGF-I and IGFBP-3. Despite the short duration of the preoperative lanreotide 30 mg treatment, IGF-I levels were normalized in 25% of patients. A statistically significant reduction in tumour volume (P < 0.001) was observed. The median value of the differences was -152 mm3. A reduction in tumour volume was observed in 66% of patients and was > 20% in 29% of all patients included. Both the univariate analyses and the logistic regression model demonstrated that a positive hormone response to preoperative lanreotide 30 mg was the sole predictive factor of a significant tumour shrinkage (odds ratio of 7.8, 95% confidence interval 1.6-37.1). Preoperative PR lanreotide did not modify the expected soft consistence of the tumour. The main adverse events consisted of minor gastrointestinal problems. Univariate analyses revealed that younger age, higher GH and IGF-I levels at diagnosis, higher preoperative tumour volume, more than one tumour extrasellar extension and the presence of cavernous sinus invasion were statistically significant determinants of persistent disease at the 6th month after surgery. The multivariate analysis revealed that higher IGF-I levels at diagnosis and the preoperative cavernous sinus invasion were each statistically significant prognostic factors of persistent disease. CONCLUSIONS: A short administration of preoperative lanreotide 30 mg induced a statistically significant shrinkage of GH-secreting pituitary adenomas where this reduction was > 20% of the pretreatment value in 29% of the whole population. Among the factors considered was the fact that positive hormone response to preoperative lanreotide 30 mg was the sole predictive factor of this significant tumour volume reduction.

Effects of human recombinant growth hormone on donor-site healing in burned adults.

Patients suffering severe burns have an accelerated catabolism with a highly negative nitrogen balance that may worsen their prognosis. Somatropin treatment has been shown to improve this balance in different hypercatabolic situations. Moreover, in children with extensive burns it also reduces the healing time of the skin graft donor site and shortens the hospital stay. In the existing literature there are no controlled prospective clinical trials in adult patients that confirm these data. Our aim was to demonstrate the efficacy of recombinant growth hormone (somatropin) in reducing the healing time of the skin graft donor sites and the length of stay in the burn unit in adult patients with severe burns. A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 adult patients with severe burns (more than 40% of the total body surface burned or more than 15% full-thickness burns). Patients received placebo (n = 11) or somatropin (n = 13) at a dosage of 0.15 mg/kg/day divided into two equal doses (every 12 hours) via intramuscular injection. Treatment was initiated the day the first autograft was performed and terminated the day the patient was discharged from the burn unit. The mean number (+/- SD) of skin grafts per patient was similar between the two groups (4.2 +/- 1.8 vs 3.4 +/- 1.8 in the placebo and somatropin groups, respectively). No reduction in the healing time of the skin graft donor site was observed in the somatropin group compared to the placebo group. Likewise, the time admitted to the burn unit was not significantly different, either in the absolute number of days (36.2 +/- 19.7 vs 30.1 +/- 16.8 days in the placebo and somatropin groups, respectively) or in relation to the percentage of the total body surface burned or the body surface with full-thickness burns. Growth hormone and insulin-like growth factor I (IGF-I) levels were three and five times higher, respectively, in the somatropin group than in the placebo group. Ten of the patients treated with somatropin experienced hyperglycemia, and seven of them required insulin treatment. No other adverse side effect was observed. One patient in the placebo group died as a result of sepsis and multiple organ failure. Somatropin, with the treatment regimen and dosage used in these studies, did not reduce the healing time of the skin graft donor sites or the length of hospitalization in the burn unit in adult patients with severe burns.

[Study of heart valve function on obese patients treated with sibutramine]. / Estudio de la función valvular cardíaca en pacientes obesos tratados con sibutramina.

BACKGROUND: Some anorectic drugs have been related with he development of heart valve lesions. Sibutramine is a new anorectic drug used for the treatment of obesity. Although data reported to date suggest that sibutramine does not induce heart valve lesions, there are no published reports performing longitudinal echocardiographic studies before and after treatment with sibutramine. PATIENTS AND METHODS: Consecutive series of 16 obese patients who underwent Doppler-echocardiography before and after treatment with sibutramine. RESULTS: After 6 months of treatment, at 10 mg/day dose, sibutramine does noe appear to induce heart valve lesions. CONCLUSIONS: Sibutramine does not induce heart valve lesions when it is used in short-term treatment courses.

Estudio de la función valvular cardíaca en pacientes obesos tratados con sibutramina / Study of heart valve function on obese patients treated with sibutramine

FUNDAMENTO: Ciertos anorexígenos se han relacionado con el desarrollo de lesiones valvulares cardíacas. La sibutramina es un nuevo fármaco anorexígeno para el tratamiento de la obesidad. Hasta el momento parece que no induce lesiones valvulares cardíacas, pero no existen publicaciones con estudios ecocardiográficos longitudinales antes y después del tratamiento con sibutramina. PACIENTES Y MÉTODO: Presentamos una serie consecutiva de 16 pacientes obesos que recibieron tratamiento continuo con sibutramina durante 6 meses, en los que realizamos ecocardiografía Doppler antes y después del tratamiento. RESULTADOS: En nuestro estudio no se observaron alteraciones valvulares tras 6 meses de tratamiento. CONCLUSIONES: La sibutramina no induce alteraciones valvulares en pacientes obesos en tratamientos a corto plazo (AU)