Biomedical subjects

Craig Donatucci

Publications and source records attributed to Craig Donatucci.

7 recordsLinked to original sources

PubMed2007

Facilitating research participation and improving quality of life for African American prostate cancer survivors and their intimate partners. A pilot study of telephone-based coping skills training.

African American men experience worse prostate cancer outcomes compared with those of Caucasian men, not only in incidence and mortality rates, but also in coping with the side effects of treatment. Unfortunately, African American men have been significantly under-represented in research evaluating the efficacy of psychosocial interventions for improving coping in prostate cancer survivors. This pilot study explored the feasibility and efficacy of coping skills training (CST), an intervention developed to enhance coping with treatment side effects in a sample of African American prostate cancer survivors and their intimate partners. The intervention was delivered in a telephone-based format designed to facilitate research participation. A total of 40 couples were randomized to either 6 sessions of CST or usual care. Survivors completed measures of disease-specific quality of life (QOL) related to urinary, sexual, bowel, and hormonal symptom domains, as well as measures of global QOL (i.e., physical functioning and mental health). Partners completed measures of caregiver strain, mood, and vigor. Analysis of data from 30 couples (12 couples in CST, 18 couples in usual care) indicated that CST produced moderate to large treatment effects for QOL related to bowel, urinary, sexual, and hormonal symptoms. Partners who underwent CST reported less caregiver strain, depression, and fatigue, and more vigor, with moderate effect sizes observed that approached conventional levels of statistical significance. These preliminary findings suggest that telephone-based CST is a feasible approach that can successfully enhance coping inAfrican American prostate cancer survivors and their intimate partners. Cancer 2007. (c) 2006 American Cancer Society.

Adaptation, Psychological↗

PubMed2006

Efficacy and safety of tadalafil across ethnic groups and various risk factors in men with erectile dysfunction: Use of a novel noninferiority study design.

AIM: This U.S. multicenter open-label study used a noninferiority trial design to assess the efficacy of tadalafil 20 mg to treat erectile dysfunction (ED) in the black American and Hispanic groups compared with a reference group of Caucasians. A secondary objective was to demonstrate the efficacy and safety of tadalafil 20 mg in various populations of men with ED. METHODS: A total of 1,911 patients with ED were enrolled into eight predefined groups: (1-3) Caucasian (Reference group), Black American, or Hispanic patients, < or =65 years of age with no diabetes mellitus or depression; (4) patients with depression, < or =65 years of age, no diabetes; (5) patients with diabetes, < or =65 years of age, no depression; (6) patients >65 years of age, no diabetes or depression; (7) patients who met enrollment criteria but were not included in any other group; and (8) patients with ED due to traumatic spinal cord injury. The study had a 4-week run-in period, followed by a 12-week treatment period with tadalafil taken as needed, up to one dose/day, prior to sexual activity. Change from baseline to endpoint in the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) was used to determine noninferiority of groups 2 and 3 from group 1. Secondary efficacy measures included other IIEF domains and Sexual Encounter Profile (SEP). RESULTS: Noninferiority analyses based on the EF domain score showed that tadalafil was as efficacious in the Hispanic and Black American groups as in the Reference group. Patients in each of the eight groups had a significant change from baseline (P < 0.001) in the IIEF EF domain score and positive responses to SEP Questions 1-5. The most common treatment-emergent adverse events reported by patients in all eight groups were headache, nasal congestion, dyspepsia, flushing, and back pain. CONCLUSION: Tadalafil 20 mg was as efficacious in the Hispanic and black American groups as in the Caucasian/Reference group. Tadalafil was efficacious and well tolerated in each of the groups studied in this trial.

Adult↗

PubMed2005

Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age.

OBJECTIVES: To assess the efficacy and safety of vardenafil in the treatment of erectile dysfunction (ED) in men of different age groups. PATIENTS AND METHODS: In a retrospective pooled subgroup analysis of randomized, double-blind, placebo-controlled studies, men from the general population with ED received either placebo or vardenafil 5, 10 or 20 mg over 12 weeks. Efficacy variables included the erectile function (EF) domain score from The International Index of Erectile Function, diary response rates to questions on vaginal penetration and maintenance of erection, and positive responses to the Global Assessment Question (GAQ) "Has the treatment you have been taking over the past 4 weeks improved your erections?'. The 1385 men were grouped by age (< 45, 45-64 and > or =65 years). RESULTS: At 12 weeks the EF domain scores approached 20 with vardenafil and 14 with placebo in men aged > or = 65 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). The corresponding scores were 22 and 14 in men aged 45-64 years and up to 24 and 16 in those aged <45 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). Vardenafil generated positive GAQ responses in approximately 71%, 76% and 85% of men aged <45, 45-64 and > or = 65 years (P < or = 0.001 vardenafil vs placebo). The corresponding placebo rates were 23%, 25% and 34%. The most common treatment-emergent adverse events were headache, rhinitis, flushing and dyspepsia, which were mild to moderate, transient and unrelated to age. CONCLUSION: Vardenafil is an effective and generally well-tolerated treatment for ED, irrespective of age.

Adult↗

PubMed2004

Central nervous system control of the lower urinary tract: new pharmacological approaches to stress urinary incontinence in women.

PURPOSE: Despite the prevalence of stress urinary incontinence in women there are no approved drugs for the disease. MATERIALS AND METHODS: Designing medical therapies requires a comprehensive understanding of how the internal and external sphincters are neurologically controlled. In this review recent advances in mapping storage and micturition reflexes, and the association of serotonergic and noradrenergic systems with these reflexes are discussed. RESULTS: Urine storage and micturition are controlled by a series of hard wired reflexes that are under the modulatory influence of serotonin and norepinephrine. Augmentation of the serotonergic and noradrenergic systems with duloxetine increases bladder capacity and urethral rhabdosphincter activity. The increase in sphincter activity is mediated by alpha1 adrenergic receptors and 5-hydroxytryptamine receptors. CONCLUSIONS: Increasing rhabdosphincter activity with duloxetine may offer a therapeutic benefit in women with stress urinary incontinence.

Central Nervous System↗

PubMed2004

Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification.

BACKGROUND: Vardenafil (Levitra) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. METHODS: Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). RESULTS: Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41% of patients had severe ED, 30-34% moderate, 22% mild-to-moderate and 6-8% mild ED. At baseline, 46-51% of patients were considered to have an organic cause for ED, 13-16% psychogenic ED, and 36-38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. CONCLUSIONS: Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

3',5'-Cyclic-GMP Phosphodiesterases↗

PubMed2004

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↗

PubMed2004

Standards for clinical trials in male sexual dysfunction: erectile dysfunction and rapid ejaculation.

INTRODUCTION: The introduction of safe and effective therapies for sexual dysfunctions depend upon appropriate clinical protocol design, study procedures, data collection and analysis. AIM: To provide recommendations/guidelines concerning state-of-the-art knowledge for standards for clinical trials in sexual dysfunction in men, particularly in the areas of erectile dysfunction and rapid ejaculation. METHODS: An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Standards for Clinical Trials in Male Sexual Dysfunction Committee, there were six experts from four countries. MAIN OUTCOME MEASURE: Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. RESULTS: Drug development requires a multiphased approach. Phase 1 studies investigate multiple-dose safety, tolerability and pharmacokinetic issues. Phase 2 programs explore dose ranging (lowest effective, maximally tolerated and toxic doses). Phase 3 trials provide the substantial evidence including drug-drug interaction data and studies in special populations. Clinical studies require validated outcome assessment instruments conducted in defined but representative patient populations. Daily diaries or per-event questionnaires are patient-reported outcomes that assist in retrospective questionnaire interpretation. A qualified biostatistician should calculate the sample power for the trial, type of statistical model and design employed, use of covariate or subgroup analyses, and calculation of effect sizes. CONCLUSIONS: More research is needed in developing standards for use in the development of clinical trials and outcomes assessment researching either erectile dysfunction or rapid ejaculation.

Consensus↗