Keogh Institute for Medical Research

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Rubio-Aurioles E.,Asociacion Mexicana para la Salud Sexual A.C. AMSSAC | Kim E.D.,University of Tennessee at Knoxville | Montorsi F.,San Raffaele Hospital | Hackett G.,The Good | And 8 more authors.
Journal of Sexual Medicine | Year: 2012

Aim. To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5mg once a day (OaD) vs. tadalafil 20mg or sildenafil 100mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). Methods. A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. Main Outcome Measures. The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. Secondary Outcomes Included. Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. Results. Men naive to tadalafil OaD were enrolled (N=378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P<0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50±0.78 following tadalafil OaD, 0.5±0.72 for tadalafil PRN, and 0.39±0.67 for sildenafil PRN. The difference in least-squares mean was 0.12±0.04 (confidence interval [CI]=0.04, 0.19; P=0.001) between tadalafil OaD and sildenafil PRN and 0.01±0.04 (CI=-0.06, 0.08; P=0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P<0.001). There were no differences in SEAR scores between treatments. Conclusions. Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar. © 2012 International Society for Sexual Medicine.


Chew K.-K.,Keogh Institute for Medical Research | Finn J.,Sir Charles Gairdner Hospital | Stuckey B.,University of Western Australia | Gibson N.,University of Western Australia | And 5 more authors.
Journal of Sexual Medicine | Year: 2010

Introduction: In spite of the mounting interest in the nexus between erectile dysfunction (ED) and cardiovascular (CV) diseases, there is little published information on the role of ED as a predictor for subsequent CV events. Aim: This study aimed to investigate the role of ED as a predictor for atherosclerotic CV events subsequent to the manifestation of ED. Method: The investigation involved the retrospective study of data on a cohort of men with ED linked to hospital morbidity data and death registrations. By using the linked data, the incidence rates of atherosclerotic CV events subsequent to the manifestation of ED were estimated in men with ED and no atherosclerotic CV disease reported prior to the manifestation of ED. The risk of subsequent atherosclerotic CV events in men with ED was assessed by comparing these incidence rates with those in the general male population. Main Outcome Measure: Standardized incidence rate ratio (SIRR), comparing the incidence of atherosclerotic CV events subsequent to the manifestation of ED in a cohort of 1,660 men with ED to the incidence in the general male population. Results: On the basis of hospital admissions and death registrations, men with ED had a statistically significantly higher incidence of atherosclerotic CV events (SIRR 2.2; 95% confidence interval 1.9, 2.4). There were significantly increased incidence rate ratios in all age groups younger than 70 years, with a statistically highly significant downward trend with increase of age (P < 0.0001) across these age groups. Younger age at first manifestation of ED, cigarette smoking, presence of comorbidities and socioeconomic disadvantage were all associated with higher hazard ratios for subsequent atherosclerotic CV events. Conclusions: The findings show that ED is not only significantly associated with but is also strongly predictive of subsequent atherosclerotic CV events. This is even more striking when ED presents at a younger age. © 2009 International Society for Sexual Medicine.


Kim D.D.,Zafgen | Krishnarajah J.,Linear Clinical Research Ltd. | Lillioja S.,University of Wollongong | de Looze F.,AusTrials Pty Ltd. | And 9 more authors.
Diabetes, Obesity and Metabolism | Year: 2015

Aim: To assess the efficacy, safety and tolerability of beloranib treatment for obesity. Methods: This phase II, double-blind, randomized study investigated the effects of beloranib suspension (0.6, 1.2 and 2.4mg) or placebo, administered subcutaneously, for 12weeks in 147 participants (primarily white women) with obesity. No diet or exercise advice was administered. Results: At week 12, beloranib resulted in dose-dependent progressive weight loss of -5.5±0.5, -6.9±0.6 and -10.9±1.1kg for the 0.6, 1.2 and 2.4mg beloranib doses, respectively, compared with -0.4±0.4kg with placebo (all p<0.0001 vs placebo). Weight loss with beloranib was associated with corresponding reductions in waist circumference and body fat mass, as well as improvements in lipids, high-sensitivity C-reactive protein and blood pressure. Sleep disturbance and gastrointestinal adverse events were more common with beloranib than with placebo; these were generally mild to moderate, transient and dose-related, and led to more early study withdrawals in participants in the group with the highest dose of beloranib. Conclusions: In this 12-week phase II study, beloranib produced clinically and statistically significant weight loss and corresponding improvements in cardiometabolic risk factors. Beloranib appeared safe, and the 0.6 and 1.2mg doses were generally well tolerated. The 2.4mg dose was associated with increased sleep latency and mild to moderate gastrointestinal adverse events over the first month of treatment. These findings represent a novel mechanism for producing clinically meaningful weight loss. © 2015 John Wiley & Sons Ltd.


Wheatley S.,Monash University | Bell R.J.,Monash University | Stuckey B.G.A.,Keogh Institute for Medical Research | Robinson P.J.,Monash University | Davis S.R.,Monash University
Maturitas | Year: 2016

We audited the files of 114 postmenopausal women who had been treated with subcutaneous Estrapel (50 mg oestradiol implants). Of the 92 women who received more than one implant, the median number of days between implants was 223.5 (range 49–875), with an estimated median time to return to baseline of 311 days (range 108–1228). Although oestradiol implants can provide an excellent non-oral treatment option, their prolonged action makes patient selection important, as the implants cannot easily be removed. In women with an intact uterus, the continuation of progestin therapy after cessation of implant therapy is imperative. © 2016 Elsevier Ireland Ltd


Chew K.-K.,Keogh Institute for Medical Research | Gibson N.,University of Western Australia | Sanfilippo F.,University of Western Australia | Stuckey B.,Keogh Institute for Medical Research | And 3 more authors.
Journal of Sexual Medicine | Year: 2011

Introduction. It is unclear whether men with erectile dysfunction (ED) ultimately die of cardiovascular (CV) causes. Aim. This study examined the causes of death in men with ED and their risk of CV death. Methods. Based on statutory death registrations and hospital morbidity data, the risk of CV death in men with ED in a linked-data study was assessed against the CV mortality risk in a reference male population. Main Outcome Measures. Deaths from CV causes as proportions of all deaths. Age-specific rate, mortality rate ratio (MRR), standardized mortality rate ratio (SMRR), and adjusted hazard ratio (HR). Results. CV mortality was 4.0%. Compared with the reference population, the risk of CV death was higher in men with ED (SMRR 2.2; 95% confidence interval [CI] 1.6, 3.0). Risk of CV mortality was higher in men with CV disease prior to ED (adjusted HR 1.7; 95% CI 1.1, 2.6) or with history of hospital admissions for CV events (adjusted HR 2.2; 95% CI 1.3, 3.8), compared with those without the respective history. MRR was significantly increased in the 40-69 years age group (MRR 4.1; 95% CI 3.2, 5.2). The median time interval between manifestation of ED and CV death was 10.0 years. A greater proportion of deaths from oncological than from CV causes (25.0% vs. 10.8%) occurred within the first 5 years of the manifestation of ED. Conclusions. Although the risk of CV mortality is greater in men with ED, almost as many men die of oncological as of CV causes, with a higher proportion of oncological deaths occurring sooner subsequent to the first manifestation of ED. © 2011 International Society for Sexual Medicine.


Leddy L.S.,University of Washington | Yang C.C.,University of Washington | Stuckey B.G.,Keogh Institute for Medical Research | Sudworth M.,Pfizer | And 3 more authors.
Journal of Sexual Medicine | Year: 2012

Introduction. We previously described dynamic, noncontrast magnetic resonance imaging (MRI) of the female genitalia as a reproducible, nonintrusive, objective means of quantifying sexual arousal response in women without sexual difficulties. These studies showed an increase in clitoral engorgement ranging from 50 to 300% in healthy women during sexual arousal. Aim. This study sought to evaluate the genital arousal response in women with female sexual arousal disorder (FSAD) after administration of sildenafil and placebo. We performed a multicenter, double-blind, placebo-controlled, cross-over study to assess the clitoral engorgement response using dynamic MRI in women with FSAD after administering sildenafil and placebo followed by audiovisual sexual stimulation (AVSS). Methods. Nineteen premenopausal women with FSAD underwent two MRI sessions. Subjects were randomized to receive either (i) sildenafil 100mg during the first session followed by placebo during the second session, or (ii) placebo followed by sildenafil. During each session, baseline MR images were obtained while subjects viewed a neutral video. Subjects then ingested sildenafil or placebo. After 30 minutes, a series of MRIs were obtained at 3-minute intervals for 10 time points while subjects viewed AVSS. Main Outcome Measures. A positive sexual arousal response was achieved if clitoral volume increased ≥50% from baseline. Results. Thirteen of 19 (68%) subjects achieved a ≥50% increase in clitoral engorgement from baseline when administered sildenafil or placebo 30 minutes after dose administration. At 60 minutes after administration, 17/19 (89%) subjects receiving sildenafil and 16/19 (84%) subjects receiving placebo had responded (P value 0.3173). Conclusions. Sildenafil did not augment the genital response in women with FSAD. Secondarily, a majority of women in this study did not have impaired clitoral engorgement as measured by MRI, suggesting that FSAD is not predominantly a disorder of genital engorgement. © 2012 International Society for Sexual Medicine.


Hamilton S.J.,University of Western Australia | Chew G.T.,University of Western Australia | Davis T.M.E.,University of Western Australia | Stuckey B.G.A.,University of Western Australia | And 2 more authors.
Practical Diabetes International | Year: 2011

In this cross-sectional study, we investigated the prevalence of hypertriglyceridaemia (hyperTG) in 182 statin-treated type 2 diabetic (T2DM) patients. Predictors of hyperTG (≥2.3mmol/L) were investigated using logistic regression. The prevalence of hyperTG was 20.9%, with lower prevalence in patients with low-density lipoprotein (LDL)-cholesterol <2.5mmol/L (13.7%), and LDL-cholesterol <2.0mmol/L (8.8%). The prevalence of hyperTG plus low high-density lipoprotein (HDL)-cholesterol (≤0.9mmol/L) was lower at 6.0%. The independent predictors of hyperTG were waist circumference (odds ratio [OR] 1.033 [95% confidence interval 1.004-1.063], p=0.027) and glucose (OR 1.30 [1.05-1.61], p=0.01), with glucose being the sole predictor in patients with LDL-cholesterol <2.5mmol/L (OR 1.45 [1.11-1.89], p=0.01) and LDL-cholesterol <2.0mmol/L (OR 1.59 [1.12-2.26], p=0.01). In this group of statin-treated T2DM patients, the prevalence of hyperTG was relatively high, but lower in patients with lower LDL-cholesterol levels. Residual hyperTG in statin-treated patients could be addressed by therapeutic lifestyle interventions aimed at weight loss and improved glycaemic control and by further lowering of LDL-cholesterol. Copyright © 2011 John Wiley & Sons.


Kahapola Arachchige K.M.,Western Diagnostic Pathology | Wardrop R.,Sir Charles Gairdner Hospital | Lim E.M.,Sir Charles Gairdner Hospital | Stuckey B.,Sir Charles Gairdner Hospital | And 4 more authors.
Australian and New Zealand Journal of Obstetrics and Gynaecology | Year: 2012

Aim To assess age at which median follicle-stimulating hormone (FSH) is elevated above 10 U/L. Background Fertility and ovarian reserve decrease over the 4th decade with evidence that sensitive markers such as anti-Mullerian hormone fall even earlier. Despite its limitations, a basal or day 2-3 FSH is commonly used to assess ovarian reserve with levels over 10 U/L often used as a cut-point for further investigations. Methods Women referred to a community laboratory for 'hormone testing', including FSH and oestradiol (n = 40 254), were included in a retrospective analysis. Cases excluded were those with suppressed FSH (<1 U/L) who were likely on the oral contraceptive pill or pregnant and those with increased oestradiol (>500 pmol/L) who were likely approaching mid-cycle or pregnant. Remaining cases (n = 32 445) were analysed in five-year age bands for FSH median, mean, and 2.5 and 97.5 percentiles. Results Median FSH remained consistently low (≤5 U/L) in women a;circ35 years of age and was 6 U/L in 35- to 40-year-olds. The mean FSH and 97.5 percentile increased steadily. The 97.5th percentile was 10 U/L or lower in women up to 30 years of age. Conclusions Follicle-stimulating hormone is a late indicator of known reducing ovarian reserve, and in this study, median FSH did not increase over 10 U/L until >45 years of age. FSH levels >9 U/L were above the 97.5th percentile in those <25 years of age. If fertility is a concern, FSH levels persistently above age-specific medians in women under 40 years may prompt earlier follow-up with more sensitive tests for ovarian reserve. © 2012 The Authors ANZJOG © 2012 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.


PubMed | Keogh Institute for Medical Research
Type: Journal Article | Journal: The journal of sexual medicine | Year: 2010

In spite of the mounting interest in the nexus between erectile dysfunction (ED) and cardiovascular (CV) diseases, there is little published information on the role of ED as a predictor for subsequent CV events.This study aimed to investigate the role of ED as a predictor for atherosclerotic CV events subsequent to the manifestation of ED. Method. The investigation involved the retrospective study of data on a cohort of men with ED linked to hospital morbidity data and death registrations. By using the linked data, the incidence rates of atherosclerotic CV events subsequent to the manifestation of ED were estimated in men with ED and no atherosclerotic CV disease reported prior to the manifestation of ED. The risk of subsequent atherosclerotic CV events in men with ED was assessed by comparing these incidence rates with those in the general male population.Standardized incidence rate ratio (SIRR), comparing the incidence of atherosclerotic CV events subsequent to the manifestation of ED in a cohort of 1,660 men with ED to the incidence in the general male population.On the basis of hospital admissions and death registrations, men with ED had a statistically significantly higher incidence of atherosclerotic CV events (SIRR 2.2; 95% confidence interval 1.9, 2.4). There were significantly increased incidence rate ratios in all age groups younger than 70 years, with a statistically highly significant downward trend with increase of age (P < 0.0001) across these age groups. Younger age at first manifestation of ED, cigarette smoking, presence of comorbidities and socioeconomic disadvantage were all associated with higher hazard ratios for subsequent atherosclerotic CV events.The findings show that ED is not only significantly associated with but is also strongly predictive of subsequent atherosclerotic CV events. This is even more striking when ED presents at a younger age.

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