Pasireotide versus octreotide in acromegaly: a head-to-head superiority study.

CONTEXT: Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control. OBJECTIVE: Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly. DESIGN AND SETTING: We conducted a prospective, randomized, double-blind study at 84 sites in 27 countries. PATIENTS: A total of 358 patients with medically naive acromegaly (GH >5 µg/L or GH nadir ≥1 µg/L after an oral glucose tolerance test (OGTT) and IGF-1 above the upper limit of normal) were enrolled. Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging. INTERVENTIONS: Patients received pasireotide LAR 40 mg/28 days (n = 176) or octreotide LAR 20 mg/28 days (n = 182) for 12 months. At months 3 and 7, titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, if GH ≥2.5µg/L and/or IGF-1 was above the upper limit of normal. MAIN OUTCOME MEASURE: The main outcome measure was the proportion of patients in each treatment arm with biochemical control (GH <2.5 µg/L and normal IGF-1) at month 12. RESULTS: Biochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients (31.3% vs 19.2%; P = .007; 35.8% vs 20.9% when including patients with IGF-1 below the lower normal limit). In pasireotide LAR and octreotide LAR patients, respectively, 38.6% and 23.6% (P = .002) achieved normal IGF-1, and 48.3% and 51.6% achieved GH <2.5 µg/L. 31.0% of pasireotide LAR and 22.2% of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase. Hyperglycemia-related adverse events were more common with pasireotide LAR (57.3% vs 21.7%). CONCLUSIONS: Pasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly.

[Comparison of the usefulness of intraoperative examination and fine needle aspiration biopsy in thyroid lesions. Analysis of discordant cases in aspiration biopsy]. / Comparación de la utilidad del estudio transoperatorio y la biopsia por aspiración con aguja delgada en lesiones de tiroides. Análisis de casos discordantes en biopsias por aspiración.

INTRODUCTION: Fine-needle aspiration biopsy (FNAB) is currently considered the most reliable and cost effective examination for diagnosis of solitary thyroid nodules prior to surgery. Because of its great utility the indication of intraoperative examination (IOE) (macroscopic examination, cytology and frozen section), has recently been questioned. OBJECTIVE: To compare the accuracy of the FNAB and IOE, in those patients with nodular thyroid disease who undergo thyroidectomy. As well as to analyse the, discrepant cases by FNAB. MATERIAL AND METHODS: The results of IOE and FNAB were compared in a period of two years (1997-98) at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ). In all cases the diagnosis established from paraffin embedded tissue sections was considered to be the gold standard. The cytologyc smears and the histologic sections of the discrepant cases were reviewed. RESULTS: One thousand and fourteen IOE were done during two consecutive years; from these cases, 136 (13.4%) were thyroid lesions. Half of the thyroid lesions (69 cases) corresponded to carcinomas, the others were follicular adenomas (13 cases) and non-neoplasic lesions (54 cases). The analysis of the copacity to discriminate between malignant and benign diseases with IOE and FNAB demonstrated sensitivity of 89% (CI: 78.2-95.1) and 97.7% (CI: 86.8-99.9), specificity of 100% (CI: 93.1-100) and 90% (CI: 90.4-96.7). The positive predictive value of 100% and 91.6%, negative predictive value of 90.4% and 97.3%, and equal accuracy (94.6% and 94.1% respectively). When the analysis of capacity to stratify diseases was performed, IOE and FNAB showed similar percentages in all the cases, including the follicular adenomas and carcinomas. The causes of false positive and false negative cases by FNAB, reproduce what has been written in the literature. CONCLUSIONS: FNAB preoperative examination is adequate for the selection of patients that undergo thyroidectomy. Nevertheless, IOE should be done in most of the cases, and routinely in those cases with inconclusive FNAB results and in cases of follicular tumor.