piperidines and Polyps

The aim of this study was to report the gynecologic safety findings from the Generations trial, a phase 3 study of the selective estrogen receptor modulator (SERM), arzoxifene.. A predefined objective of the trial was to evaluate the effects of arzoxifene on the genital tract. Gynecologic examinations were performed yearly, and further gynecologic assessment, including endometrial biopsy, was performed in a predefined subset of women and in those who developed vaginal bleeding.. Overall, 9,354 women were randomized (4,678 to placebo, 4,676 to arzoxifene 20 mg/d). There were 13 adjudicated cases of endometrial cancer (placebo, 4 cases; arzoxifene, 9 cases: P = 0.165) and 6 cases of endometrial hyperplasia (placebo, 2 cases; arzoxifene, 4 cases). Endometrial thickness, assessed at 24- and 36-month transvaginal ultrasounds in a subset of women, increased slightly in women assigned to arzoxifene compared with baseline and women in placebo. At the last measurement, 3 (1.7%) women assigned to placebo and 21 (10.2%) assigned to arzoxifene had an endometrial thickness greater than 5 mm (P < 0.001 for difference between treatment groups). Endometrial polyps were more common in women treated with arzoxifene (n = 37) than in women treated with placebo (n = 18; P < 0.05). Vulvular and vaginal inflammation, including mycotic infections, and vaginal discharge were reported more frequently in women treated with arzoxifene than in women treated with placebo, as were urinary tract infections.. Gynecologic events were generally more common in women treated with arzoxifene than in women treated with placebo. The gynecologic effects of arzoxifene seem to differ from those of raloxifene, although both SERMs have a benzothiophene structure. Although all SERMs influence cells through the estrogen receptor, they need to be evaluated independently in terms of their effects on various tissues, including the genital tract.

Topics: Aged; Aged, 80 and over; Endometrial Neoplasms; Endometrium; Female; Genital Diseases, Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Piperidines; Placebos; Polyps; Postmenopause; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators; Thiophenes; Uterine Hemorrhage; Vaginitis; Vulvitis

Topics: Adult; Alopecia Areata; Female; Follow-Up Studies; Hair; Humans; Male; Middle Aged; Piperidines; Polyps; Protein Kinase Inhibitors; Pyrimidines; Pyrroles; Scalp; Treatment Outcome; Young Adult

We describe a case of a very difficult intubation which was safely navigated through careful planning. Our patient presented initially with increasing hoarseness and shortness of breath over a 6-month period. This was investigated and the patient was found to have a large vocal cord mass and was referred for urgent microlaryngoscopy and vocal cord polypectomy. On the day of surgery the obstruction was noted and awake fiberoptic bronchoscopy was used with a remifentanil infusion. Given the mass was large and increased in size with expiration, the time frame to pass the tube was extremely short. We delivered a transtracheal injection of local anaesthesia. This approach allowed for safe passage of the endotracheal tube. In patients such as this it may be worth considering the use of a transtracheal injection in the first instance.

Topics: Anesthetics, Local; Dyspnea; Female; Fiber Optic Technology; Hoarseness; Humans; Intubation, Intratracheal; Laryngeal Diseases; Laryngoscopy; Middle Aged; Piperidines; Polyps; Remifentanil; Treatment Outcome; Vocal Cords

We report a case of delayed awakening with characteristic repeated loss of consciousness after remifentanil infusion complicated by leakage from an intravenous catheter. A 30-year-old male underwent microlaryngeal surgery for a vocal cord polyp. During anesthetic induction, infiltration from an intravenous (IV) line in the left forearm was observed 10 min after initiating a continuous infusion of remifentanil 0.5 microg x kg-1 x min -1. A second peripheral IV catheter was placed in the right forearm and general anesthesia was induced with remifentanil infusion at 0.3 microg x kg-1 x min- 1, propofol 120mg, fentanyl 100 microg, and rocuronium 70 mg. Anesthesia was maintained with remifentanil 0.05-0.3 microg x kg-1 x min -1and sevoflurane (1.5% in oxygen) for the 4 min of surgery. A few minutes after tracheal extubation, the patient developed respiratory arrest and loss of consciousness. We immediately ventilated him with a bag-valve-mask and administered naloxone 0.04 mg. Thereafter, he repeatedly awoke and was drowsy three times over the next 5hr. It was followed by an uneventful postoperative period. No remarkable deficit was observed in the patient. Blood gases, electrolytes, glucose values, and body temperature were within normal ranges throughout the perioperative period. Brain computed tomography, mag- netic resonance imaging, and electroencephalography showed no abnormalities. It was considered that the incidental subcutaneous remifentanil accumulation may have caused the respiratory suppression and delayed awakening.

Topics: Adult; Anesthesia Recovery Period; Anesthesia, Intravenous; Anesthetics, Intravenous; Equipment Failure; Humans; Laryngeal Neoplasms; Male; Piperidines; Polyps; Remifentanil; Vascular Access Devices

Topics: Animals; Bronchial Neoplasms; Cricetinae; Epithelial Cells; Epithelium; Female; Laryngeal Neoplasms; Lethal Dose 50; Male; Microscopy, Electron, Scanning; Morpholines; Neoplasms, Experimental; Nitroso Compounds; Nose Neoplasms; Piperidines; Polyps; Respiratory Tract Neoplasms; Trachea; Tracheal Neoplasms