Comparison of manual and automated measurements of the QT interval in healthy volunteers: an analysis of five thorough QT studies.

We analyzed five crossover, thorough QT (TQT) studies to compare automated, manual, and computer-assisted (CA) measurement methods. All the methods detected moxifloxacin-induced, baseline-adjusted, placebo-subtracted mean changes in Fridericia-corrected QT interval (QTcF), with peak effect ranging from 10 to 21 ms. The variability associated with manual and CA measurements was generally 5-28% greater than that associated with automated methods. The performances of automated, manual, and CA measurements were comparable for the purpose of demonstrating assay sensitivity in TQT studies with healthy volunteers.

Thorough QT study with recommended and supratherapeutic doses of tolterodine.

The objective of our study was to determine the QTc effects of tolterodine. A crossover-design thorough QT study of recommended (2 mg twice daily) and supratherapeutic (4 mg twice daily) doses of tolterodine, moxifloxacin (400 mg once daily), and placebo was performed. Electrocardiograms (ECGs) and pharmacokinetic samples were obtained on days 1-4; time-matched baseline ECGs were taken on day 0. Mean placebo-subtracted change from baseline Fridericia-corrected QT (QTcF) during peak drug exposure on day 4 was the primary end point. Mean QTcF prolongation of moxifloxacin was 8.9 ms (machine-read) and 19.3 ms (manual-read). At recommended and supratherapeutic tolterodine doses, mean QTcF prolongation was 1.2 and 5.6 ms (machine-read), respectively, and 5.0 and 11.8 ms (manual-read), respectively. The QTc effect of tolterodine was lower than moxifloxacin. No subject receiving tolterodine exceeded the clinically relevant thresholds of 500 ms absolute QTc or 60 ms change from baseline. In conclusion, tolterodine does not have a clinically significant effect on QT interval.

Advancing perioperative care.

Demands are continuing to grow for perioperative practitioners to gain more skills and higher levels of education. These pressures are resulting, in part, from the changing structures within the health service, developments in the medical sciences, the reallocation of roles and responsibilities among healthcare professionals and the recognition by perioperative nurses of their own need for further education to meet these challenges. A response has been the creation of a widening range of new courses giving practitioners opportunities to study at higher degree level. In this article, Paul Wicker and Rebecca Strachan explain how one such programme has been brought into being.

Online education demo. How to get started!

The purpose of this article is to provide a brief tutorial on how to use the online education demo that is on the NATN website.

Electrosurgery in perioperative practice.

No series looking at basics in the perioperative environment would be complete without a good look at electrosurgery. And who better to inform us than Paul Wicker, who gives us all the information and advice we need to maintain patient and staff safety whilst this potentially dangerous but essential apparatus is in use. Paul also answers some of the most common questions about diathermy and its use, and I have certainly been asked all of these myself over the past couple of years. Thanks, Paul.

Recruitment and retention. A personal issue.

Recruitment and retention has always been seen to be the sole remit of managers--that was never the case but now it has to be seen as the remit of everybody working in the operating department. The role of perioperative nurse is interesting and challenging--a truly exciting role which, used as a marketing tool, can sell itself.

Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil Diabetes Study Group.

CONTEXT: Erectile dysfunction is common in men with diabetes. OBJECTIVE: To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes. DESIGN: A multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study conducted May through November 1996. SETTING: Patients' homes and 19 clinical practice centers in the United States. PATIENTS: A total of 268 men (mean age, 57 years) with erectile dysfunction (mean duration, 5.6 years) and diabetes (mean duration, 12 years). INTERVENTIONS: Patients were randomized to receive sildenafil (n = 136) or placebo (n = 132) as needed, but not more than once daily, for 12 weeks. Patients took the study drug or placebo 1 hour before anticipated sexual activity. The starting dose of sildenafil citrate was 50 mg, with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability, to be taken as needed. MAIN OUTCOME MEASURES: Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events. RESULTS: Two hundred fifty-two patients (94%) completed the study (131/136 in the sildenafil group, 121/132 in the placebo group). By intention-to-treat analysis, at 12 weeks, 74 (56%) of 131 patients in the sildenafil group reported improved erections compared with 13 (10%) of 127 patients in the placebo group (P<.001). The proportion of men with at least 1 successful attempt at sexual intercourse was 61 % (71/ 117) for the sildenafil group vs 22% (25/114) for the placebo group (P<.001). Adverse events related to treatment were reported for 22 (16%) of 136 patients taking sildenafil and 1 (1%) of 132 patients receiving placebo. The most common adverse events were headache (11% sildenafil, 2% placebo), dyspepsia (9% sildenafil, 0% placebo), and respiratory tract disorder (6% sildenafil, 2% placebo), predominantly sinus congestion or drainage. The incidence of cardiovascular adverse events was comparable for both groups (3% sildenafil, 5% placebo). CONCLUSION: Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes.