Intracranial migration of a halo pin during distraction osteogenesis for maxillary hypoplasia: case report and literature review.
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Adult↗
Biomedical subjects
Terry Taylor
Publications and source records attributed to Terry Taylor.
Uncialamycin, a new enediyne antibiotic.
[structure: see text] Laboratory cultures of an undescribed streptomycete obtained from the surface of a British Columbia lichen produce uncialamycin (1), a new enediyne antibiotic. The structure of uncialamycin (1) has been elucidated by analysis of spectroscopic data. Uncialamycin (1) exhibits potent in vitro antibacterial activity against gram-positive and gram-negative human pathogens, including Burkholderia cepacia, a major cause of morbidity and mortality in patients with cystic fibrosis.
Anthraquinones↗
Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis.
OBJECTIVE: To assess success rates in ability to penetrate (Sexual Encounter Profile question 2 [SEP2]) and maintain erections to completion of intercourse (SEP3) from time of dosing to start of sexual activity in a retrospective analysis of two pivotal trials. METHODS: In two randomized, double-blind studies, men with ED for > 6 months received vardenafil 5 mg, 10 mg, or 20 mg or placebo for 12-26 weeks. Patients were instructed to start sexual activity 1 hour after dosing. In this retrospective pooled analysis, patient diary questions through week 12 were analyzed, providing attempt data was recorded 0-12 hours post-dose. Mean per-patient SEP2 and SEP3 success rates (intent-to-treat population) were calculated by time between dosing and start of sexual activity, from 0-12 hours through week 12. Least-square means and nominal p-values for differences versus placebo were derived by analysis of covariance with terms for baseline, study and treatment. RESULTS: Most attempts at sexual intercourse occurred 30-90 minutes after dosing: 88%-93% of attempts occurred within 120 minutes. SEP2 success rates in patients choosing to attempt sexual activity in each interval from < or = 15 minutes through the 4-8-hour interval were higher with vardenafil compared with placebo, while SEP3 success rates were greater with vardenafil for patients choosing to initiate sexual activity from < or = 15 min through the 8-12-hour interval. The most commonly reported treatment-emergent adverse events in patients receiving vardenafil included headache (11%-22%), flushing (6%-13%), rhinitis (5%-13%), and dyspepsia (2%-7%). CONCLUSION: In this retrospective analysis of two pivotal trials, vardenafil improved success rates compared with placebo in ED patients who attempted intercourse from as early as 15 minutes or less and through 4-8 hours after dosing in ability to penetrate (SEP2) and from as early as 15 minutes or less and through 8-12 hours after dosing in maintenance of erection (SEP3).
Coitus↗
Vardenafil provides reliable efficacy over time in men with erectile dysfunction.
OBJECTIVES: To evaluate the reliability of vardenafil efficacy and tolerability within 12 weeks in a broad population of men with erectile dysfunction (ED). METHODS: In a retrospective analysis of two pivotal, Phase III, randomized, double-blind, placebo-controlled trials conducted in 107 centers, 1650 men aged 18 years or older with ED received vardenafil 5 mg, 10 mg, or 20 mg on demand for 12 to 26 weeks. Outcome measures included the first-time and subsequent overall success rate until week 12 for diary entries regarding vaginal penetration (Sexual Encounter Profile [SEP]-2), erection maintenance (SEP-3), satisfaction with erection hardness, and overall satisfaction with the sexual experience. Mean efficacy was calculated for each patient during 12 weeks and then averaged for all patients within each treatment group. RESULTS: At baseline, the intention-to-treat population had moderate ED (International Index of Erectile Function-Erectile Function domain score of 13). For SEP-2 (penetration), the first-attempt and subsequent success rate was 44% and 74% for placebo, 71% and 81% for vardenafil 5 mg, 76% and 86% for vardenafil 10 mg, and 76% and 91% for vardenafil 20 mg, respectively. For SEP-3 (maintenance), first-attempt and subsequent success rate was 25% and 56% for placebo, 51% and 76% for vardenafil 5 mg, 65% and 76% for vardenafil 10 mg, and 59% and 84% for vardenafil 20 mg, respectively. For overall satisfaction with the sexual experience, the first-attempt and subsequent success rate was 19% and 48% for placebo, 48% and 68% for vardenafil 5 mg, 57% and 72% for vardenafil 10 mg, and 56% and 79% for vardenafil 20 mg, respectively. The reliability of vardenafil was similar or slightly greater in sildenafil-naive subjects compared with prior sildenafil responders. The most common adverse events were mild-to-moderate headache, flushing, and rhinitis. CONCLUSIONS: Vardenafil provides reliable efficacy for key erectile function parameters important to patients when continuing oral treatment for ED.
Clinical Trials, Phase III as Topic↗
Amniotic band sequence: the use of bone grafting and distraction osteogenesis.
Distraction has proven to be a useful technique in cases of severe bone deficiency in the craniofacial skeleton. This is a report of its use in the treatment of a child affected by amniotic band sequence. This 5 year old Hispanic female presented with transverse deficiences of one lower extremity and both upper extremities. Additionally, she was missing the mandible and overlying soft tissue from ramus to ramus. Although free fibula transfer was a possibility, due to the presence of only one lower extremity, it was elected to utilize the technique of distraction. After preliminary bone grafting to unite these two hemimanibles, the bone graft was distracted bilaterally to create a neomandible. Following consolidation and removal of the distraction devices, the child was markedly improved despite what appeared to be a pathologic fracture in the region of the mandibular angle. Repeat distraction was planned.
Amniotic Band Syndrome↗
Vertical facial distraction in the treatment of arhinia.
Arhinia is a rare congenital malformation characterized by lack of the formation of external and internal nasal structures. Restricted midfacial growth is secondary to the loss of the midfacial growth centers. Staged reconstruction of the nasal passage and external nose is required. Vertical distraction osteogenesis is a beneficial step in the overall reconstructive program. This provides for additional bone and soft tissue for both improved aesthetic facial proportions and later surgical interventions.
Child, Preschool↗
Vardenafil improves patient satisfaction with erection hardness, orgasmic function, and overall sexual experience, while improving quality of life in men with erectile dysfunction.
PURPOSE: The North American Pivotal Trial was designed to investigate the efficacy and safety of vardenafil in males with erectile dysfunction (ED). MATERIALS AND METHODS: In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month study, vardenafil at three doses (5 mg, 10 mg, and 20 mg) was compared to placebo with the primary efficacy variables being the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score and per patient diary response success rates for penetration and maintenance of erection through completion of intercourse. Additional efficacy variables included IIEF domain scores measuring intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Diary entries for overall per patient satisfaction rates for hardness and sexual experience were also measured. Improvements in quality of sexual life were assessed using the Fugl-Meyer quality of life (QoL) questionnaire. RESULTS: Compared to placebo, patients taking 10 mg and 20 mg doses of vardenafil showed statistically significantly greater improvement in IIEF domain scores measuring intercourse satisfaction (10.3 and 10.3 vs. 7.7), orgasmic function (7.1 and 6.9 vs. 5.3), overall satisfaction. (7.1 and 7.1 vs. 5.2) for vardenafil 10 mg and 20 mg vs. placebo, respectively, at last observation carried forward (LOCF). Vardenafil 5 mg was statistically significantly better than placebo for the secondary IIEF domain variables of intercourse satisfaction (8.9 vs. 7.7) and overall satisfaction (6.3 vs. 5.2) for vardenafil vs. placebo, respectively, at LOCF. Per patient satisfaction rates for the secondary diary variables measuring erection hardness (38%, 52%, 58% and 18%) and overall satisfaction (45%, 58%, 62% and 23%) were dose dependent and statistically significantly superior for vardenafil at 5 mg, 10 mg and 20 mg compared with placebo, respectively. Patients' answers to the Fugl-Meyer QoL questionnaire assessing improvement in sexual life also indicated statistically significant superiority for all doses of vardenafil vs. placebo treatment. The most frequent adverse events (AE) in the 5 mg, 10 mg, and 20 mg of vardenafil and placebo groups, respectively, were: headache (10%, 22%, 21% and 4%), flushing (5%, 10%, 13% and 0%), dyspepsia (1%, 4%, 6% and < 1%), and rhinitis (9%, 14%, 17% and 5%). Most AEs were mild or moderate in severity and transient in nature. CONCLUSION: Vardenafil was superior to placebo for IIEF domain scores, per patient success rates for diary questions, and assessment of quality of sexual life, in a broad range of patients with ED irrespective of etiology or severity. Vardenafil was generally well tolerated, with most AEs being mild or moderate in severity and transient in nature.
Adult↗
Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial.
The durability of key efficacy response parameters and safety of vardenafil was evaluated in a pivotal trial conducted in a broad population of men with erectile dysfunction (ED) in North America. In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel-group, 6-month comparison study, men >18 years of age with ED for >6 months received 5-mg, 10-mg, and 20-mg doses of vardenafil as needed for up to 26 weeks. The primary efficacy variables were the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain scores, and the Sexual Encounter Profile (SEP) mean per-patient success rates for penetration (SEP question 2) and maintenance of erections (SEP question 3). Safety data were also collected over time. Improvement in all primary efficacy variables was observed in all vardenafil groups versus placebo. These improvements occurred early and were either sustained or increased through week 26. Vardenafil in 10-mg and 20-mg doses was significantly superior to placebo at all time points for all efficacy variables (P <0.01), and all doses were superior to placebo at endpoint (P <0.001). Most treatment-emergent adverse events (headache, flushing, dyspepsia, and rhinitis) were mild or moderate in intensity, and incidence generally decreased over time. All 3 doses of vardenafil were superior to placebo across all primary efficacy variables and all study time points in a broad range of patients with ED, regardless of etiology or severity. Vardenafil was well tolerated. These results demonstrate that vardenafil provides sustained efficacy with reduced incidence of nuisance side effects over time. High resolution video, medium resolution video, low resolution video.
Aged↗
Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study.
OBJECTIVE: This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction (ED) in men with diabetes. RESEARCH DESIGN AND METHODS: In this prospective multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial, 452 patients with diabetes (type 1 or type 2) and ED were randomized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks. Efficacy responses were assessed by International Index of Erectile Function domain scores, rates of vaginal penetration and successful intercourse, and a global assessment question (GAQ) about erection improvement during the previous 4 weeks. RESULTS: After 12 weeks of treatment, a dose-dependent (P = 0.02) improvement in erections was noted for the GAQ, with 57 and 72% of men taking 10 mg or 20 mg vardenafil, respectively, reporting improved erections, in contrast to 13% after taking placebo (P < 0.0001). For the erectile function domain, dose-dependent (P = 0.03) final scores for the 10- and 20-mg dose were 17.1 and 19.0 compared with 12.6 for placebo (P < 0.0001). Both vardenafil doses significantly enhanced the rates of successful penetration (P < 0.0001) and successful intercourse (P < 0.0001) compared with placebo. Vardenafil treatment was effective in increasing intercourse success rates at all levels of baseline ED severity, at each level of plasma HbA(1c), and for type 1 and 2 diabetes. Treatment-emergent adverse events were primarily mild to moderate headache (<or=13%), flushing (<or=10%), and rhinitis (<or=10%). CONCLUSIONS: Vardenafil statistically improved erectile function and was generally well tolerated in these diabetic patients with ED.
Administration, Oral↗
Minimally invasive Le Fort III distraction.
Recent applications of distraction osteogenesis to the Le Fort III osteotomy in patients with craniofacial dysostosis have proven promising (1-3). Distraction has allowed the midfacial segment to be brought further forward and maintained in position with greater stability when compared with the standard technique of intraoperative advancement. Because no bone grafts or plates must be placed, access incisions are necessary only for performance of the osteotomy. In an effort to minimize the morbidity of the procedure, we have begun performing the Le Fort III osteotomy without the coronal incision. Instead, the nasofrontal junction is approached using the medial aspect of an upper blepharoplasty incision. A lower eyelid and gingivobuccal sulcus incision are also used to complete the osteotomy. This technique has resulted in a shorter operative time and decreased blood loss when compared with the Le Fort III distraction procedure using the standard coronal incision.
Adolescent↗
Vardenafil in patients with erectile dysfunction: achieving treatment optimization.
This post hoc analysis of data from a multicenter, randomized, double-blind study determined how many attempts were needed to record at least 1 successful penetration and maintenance of erection long enough for successful intercourse in a broad population of men with erectile dysfunction taking vardenafil at 5, 10, or 20 mg or placebo. The cumulative probability of achieving successful penetration and of maintaining an erection increased with the number of attempts for all 3 vardenafil groups. For the first attempt, the probability of achieving successful penetration was higher in all 3 vardenafil groups compared with placebo; 67% in the 5-mg vardenafil group, 77% in the 10-mg vardenafil group, and 74% in the 20-mg vardenafil group compared with 46% for placebo. By the third attempt, the probability of at least 1 success was 82% for 5, 88% for 10, and 85% for 20 mg vardenafil compared with 68% for placebo. The probability of maintaining an erection long enough to complete intercourse at the first attempt was 51% for 5, 69% for 10, and 61% for 20 mg vardenafil compared with 28% for the placebo group. By the third attempt, the probability of maintaining an erection was 66% for 5, 81% for 10, and 77% for 20 mg vardenafil in contrast to 53% for placebo. The results of this analysis indicate that patients without initial treatment success should continue treatment or increase the dose because the cumulative probability of success increases with additional attempts with vardenafil, with a plateau at about the fourth dose.
Adult↗
Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double-blind, placebo-controlled trial.
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Double-Blind Method↗