Quality of life and fecal incontinence after transanal endoscopic microsurgery for benign and malignant rectal lesions.

Background: Transanal endoscopic microsurgery (TEM) is a minimally invasive treatment used to excise a variety of rectal lesions. Potential overstretching of the sphincter's musculature due to dilation of the anal canal to allow placement of a 40-mm-wide scope combined with partial resection of the rectum and subsequent loss of rectal volume creates a concern regarding anorectal function postoperatively. Data regarding patient satisfaction with anorectal function and quality of life after TEM are scant.

Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study.

Background: Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death.

Methods And Results: Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study.

Celivarone in patients with an implantable cardioverter-defibrillator: adjunctive therapy for the reduction of ventricular arrhythmia-triggered implantable cardioverter-defibrillator interventions.

Background: Implantable cardioverter-defibrillators (ICDs) remain the treatment of choice for the prevention of life-threatening arrhythmias. However, many patients with ICDs require additional antiarrhythmic therapy to reduce the morbidity associated with recurrent arrhythmia-triggered ICD interventions.

Objective: Our study aimed to evaluate the safety and efficacy of celivarone in reducing these interventions.

Cardiovascular safety profile of dapoxetine during the premarketing evaluation.

The cardiovascular safety profile of dapoxetine, a novel selective serotonin reuptake inhibitor (SSRI) developed as an on-demand oral treatment for premature ejaculation (PE) in men, is evaluated. The cardiovascular assessment of dapoxetine was conducted throughout all stages of drug development, with findings from preclinical safety pharmacology studies, phase I clinical pharmacology studies investigating the effect of dapoxetine on QT/corrected QT (QTc) intervals in healthy men, and phase III, randomized, placebo-controlled studies evaluating the safety (and efficacy) of the drug. Preclinical safety pharmacology studies did not suggest an adverse electrophysiologic or hemodynamic effect with concentrations of dapoxetine up to 2-fold greater than recommended doses.

Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial.

Background: Postoperative atrial arrhythmias are common and are associated with considerable morbidity. This study was designed to evaluate the efficacy and safety of vernakalant for the conversion of atrial fibrillation (AF) or atrial flutter (AFL) after cardiac surgery.

Methods And Results: This was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both.

Transanal endoscopic microsurgery for the treatment of rectal cancer: comparison of wound complication rates with and without neoadjuvant radiation therapy.

Background: Neoadjuvant therapy for rectal cancer has led to improved tumor downstaging and higher complete pathologic response rates. At the same time, the introduction of transanal endoscopic microsurgery (TEM) technique has renewed interest in local excision of rectal cancer. There has been concern that radiation may make the more radical local excision with TEM unsuitable.