I

Calt

d

TOT

MU

a

b

WZV

E(BdgoMpM6wsPnqqSRwpsotvSmvLatcvTsfiCnp

d

EFTC

H

a

oW

E(BtmoMIcpiaamE3RiOaurbL12E1dwv(idnsCw

d

G

3

SMH Congress 2010 Abstracts

onclusions: At one-year follow-up, International Prostate Symptom Scoresre not meaningfully impacted by placement of a 3-piece IPP; further,arger-scale prospective studies are warranted to confirm these observa-ions.

oi:10.1016/j.jomh.2010.09.153

ISMH World Congress 2010 Abstract 153HE POTENT II RANDOMISED TRIAL: EFFICACY AND SAFETYF AN ORODISPERSIBLE VARDENAFIL FORMULATION FOR THEREATMENT OF ERECTILE DYSFUNCTION

. Gittelmana,∗, C.G. McMahonb, J.A. Rodríguez-Riverac, M. Beneked, E.lbriche, S. Ewaldd

Department of Urology, South Florida Medical Research, Aventura, FL, USA,Australian Centre for Sexual Health, University of Sydney, Sydney, New Southales, Australia, c Hospital General Occidente de Zapopan, Secretaría de Salud,apopan, Jalisco, Mexico, d Bayer HealthCare AG, Wuppertal, Germany, e Bayerital GmbH, Leverkusen, Germany

-mail address: mgittelman@southfloridamedicalresearch.comM. Gittelman).ackground: This study investigated the efficacy and safety of 10mg var-enafil orodispersible tablet (ODT), taken on demand, versus placebo in aeneral population of men with erectile dysfunction (ED), in which ∼50%f men on active treatment were aged ≥65 years.ethods: Thiswas a double-blind,multicentre, randomised, parallel-group,lacebo-controlled study conducted at 35 centres in Australia, Canada,exico and the United States. Subjects aged≥18 years, with ED for at leastmonths, were randomised to receive 12 weeks of on-demand treatmentith either 10mg vardenafil ODT or placebo. Each treatment group wastratified such that approximately half of the subjects were ≥65 years.rimary efficacy variables were the erectile function domain of the Inter-ational Index of Erectile Function (IIEF-EF) and Sexual Encounter Profileuestions 2 (SEP2) and 3 (SEP3). Secondary variables included SEP diaryuestions 1, 4, 5 and 6, the patient version of the Treatment Satisfactioncale (TSS) and the Global Assessment Question.esults: Of the 473 men enrolled in the study (51.4% aged ≥65 years), 331ere included in the intent-to-treat population (vardenafil ODT, n = 169;lacebo, n = 162). Vardenafil ODT therapy was statistically significantlyuperior to placebo for all primary (i.e. IIEF-EF, SEP2, SEP3) and sec-ndary efficacy variables (p<0.0001; nominal statistical significance forhe latter). Baseline least squares (LS) mean values were (vardenafil ODTs placebo): IIEF-EF scores, 11.7 vs 12.8 (both indicative of moderate ED);EP2 success rates, 36.4% vs 38.3%; SEP3 success rates, 12.5% vs 15.2%. LSean IIEF-EF scores at week 12/last observation carried forward were 20.8s 13.9; overall LS mean SEP2 success rates were 69.0% vs 43.0%; overallS mean SEP3 success rates were 60.0% vs 26.6% (all p<0.0001). Scores forll individual domains of the TSS (i.e. ease with erection, erectile func-ion satisfaction, pleasure from sexual activity, satisfaction with orgasm,onfidence to complete sexual activity) were significantly higher withardenafil ODT than with placebo.reatment-emergent adverse events were mostly mild to moderate ineverity, and comparable in both incidence and type to those of the

lm-coated tablet formulation.onclusions: Treatment with 10mg vardenafil ODT, taken on demand, sig-ificantly improved erectile function and was well tolerated in a broadopulation of men with ED.

oi:10.1016/j.jomh.2010.09.154

C

V

EBblaacTTMopT

30 jmh Vol. 7, No. 3, pp. 282–351, October 2010

ISMH World Congress 2010 Abstract 154FFICACY AND SAFETY OF AN ORODISPERSIBLE VARDENAFILORMULATION FOR THE TREATMENT OF ERECTILE DYSFUNC-ION IN ELDERLY MEN AND THOSE WITH UNDERLYINGONDITIONS

. Sperlinga, M. Gittelmanb,∗, C. Norenbergc, E. Ulbrichd, S. Ewaldc

Kliniken Maria Hilf GmbH, Mönchengladbach, Germany, b Department of Urol-gy, South Florida Medical Research, Aventura, FL, USA, c Bayer HealthCare AG,uppertal, Germany, d Bayer Vital GmbH, Leverkusen, Germany

-mail address: mgittelman@southfloridamedicalresearch.comM. Gittelman).ackground: This integrated analysis examined the efficacy and safety ofhe neworodispersible tablet (ODT) formulation of vardenafil for the treat-ent of erectile dysfunction (ED), and whether age, baseline ED severityr the presence of underlying conditions affects treatment outcomes.ethods: This is an integrated analysis of data from two phaseII, double-blind, multicentre, randomised, parallel-group, placebo-ontrolled studies comparing 10mg on-demand vardenafil ODT withlacebo in a general population of men with ED, stratified so that approx-mately 50% of patients were aged ≥65 years. Results were reported byge (<65 vs ≥65 years), baseline ED severity (mild, moderate or severe)nd presence/absence of diabetes, dyslipidemia or hypertension. Primaryeasures were the erectile function domain of the International Index ofrectile Function (IIEF-EF) and Sexual Encounter Profile questions 2 and(SEP2/SEP3).esults: Of the 701 men randomised (51% aged ≥65 years), 686 werencluded in the intent-to-treat population (placebo, n = 334; vardenafilDT, n = 352). Vardenafil ODT was significantly superior to placebo forll primary efficacy measures, regardless of age, baseline ED severity ornderlying condition (all p<0.0001). IIEF-EF scores and SEP2/3 successates in older patients andmenwith underlying conditionswere compara-le with those of younger patients or menwithout underlying conditions.east squares mean IIEF-EF scores for vardenafil ODT vs placebo (week2/last observation carried forward | baseline) were: age<65 years2.7|13.0 vs 14.7|13.3, age ≥65 years 19.6|11.7 vs 13.5|12.4; baselineD severity (mild, moderate, severe) 21.1|19.9 vs 14.2|19.9, 22.4|13.3 vs4.9|13.5, 20.1|7.5 vs 13.4|7.5; with diabetes 19.3|11.5 vs 13.9|11.6, withoutiabetes 21.8|12.7 vs 14.1|13.2; with dyslipidemia 19.8|12.6 vs 13.3|12.7,ithout dyslipidemia 21.9|12.2 vs 14.4|12.9; with hypertension 20.3|12.1s 13.4|11.9, without hypertension 21.6|12.5 vs 14.6|13.5. Adverse eventsAEs) were mostly mild to moderate in severity, occurring with higherncidence in the vardenafil ODT group. The most frequently reportedrug-related AEs in the vardenafil ODT group were headache, flushing,asal congestion, dizziness and dyspepsia, consistent with the knownafety profile of phosphodiesterase type 5 inhibitors.onclusions:VardenafilODT significantly improves erectile function inmenith ED, regardless of age, baseline ED severity or underlying condition.

oi:10.1016/j.jomh.2010.09.155

ISMH World Congress 2010 Abstract 155ENDER DIFFERENCES IN ANXIETY IN A MINDFULNESS ANDOGNITIVE THERAPY TREATMENT PROGRAM FOLLOW-UP

. Alexander ∗, C. Tatum

National University, Department of Psychology, San Diego, California, USA

-mail address: valexand@nu.edu (V. Alexander).ackground: Both mindfulness and cognitive therapy have been found toe effective treatment modalities for anxiety, a common psychiatric prob-em. This is a comparison study where three tracks of participants who allttended a cognitive outpatient program for symptoms of depression andnxiety were followed three months post discharge and assessed on theirurrent level of anxiety. The three tracks included Mindfulness Cognitive

herapy (MCT), Cognitive Therapy (CT), and Treatment As Usual (TAU).he 3 month follow up results for anxiety were separated by gender.ethods: The Beck Anxiety Scale was used to measure participants’ levelf anxiety after the participants were discharged from the outpatientrogram and then again at 3 months following their aftercare program.he aftercare MCT track was trained for four weeks in the principles of