Advancing the Science of Better Sex

Sexual Health
Sexual health:
Is a state of physical, emotional, mental and social wellbeing in relation to sexuality. It is not merely the absence of disease, dysfunction or infirmity.

Sexual health:
Requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence.

UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP). Progress in Reproductive Health Research; 2004.

Erectile Dysfunction: A Global Problem

Hundreds of millions of men worldwide have some degree of ED, and this will only increase with the ageing population

Region
Northern Europe (N=2151)

Percent 13.3

Southern Europe (N=2160)

Non-European West (N=2205) Central/South America (N=639) Middle East (N=1349)

12.9
20.6 13.7 14.1

East Asia (N=1731)

Southeast Asia (N=970)
Note: Age range 40-80. Respondents considered themselves sexually active

27.1
28.1

Data on file. Pfizer Inc, New York, NY. Laumann EO, et al. Int J of Impot Res. 2005;17:39-57.

What Did You Do to Help Your Sexual Difficulties in the Last 12 Months?
Talked to your partner Looked for information in books or magazines Talked to family members or friends Talked to a medical doctor (other than a psychiatrist) Taken prescription drugs or used prescription devices Looked for information via the Internet Taken non-prescription drugs or used devices prescribed by a doctor
3% 5%
% of Respondents Answering Yes

39% 15% 14% 19% 9%

Based on those who experienced problems for 2 months or longer within last 12 months
Global Study of Sexual Attitudes and Behaviors funded by Pfizer Inc, New York, NY. Copyright 2002 Pfizer Inc. All rights reserved.

Erectile Dysfunction: The Old Paradigm

Erectile dysfunction is the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
National Institutes of Health

NIH Consensus Statement. 1992 Dec 7-9;10(4):1-31.

Erectile Dysfunction: The New Paradigm

Erectile dysfunction is the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
National Institutes of Health

NIH Consensus Statement. 1992 Dec 7-9;10(4):1-31.

Erectile Dysfunction by Severity

No ED Mild ED Moderate ED Severe ED

Sexual activity per month Full erections Awaken with erection No activity in last 6 months Trouble getting an erection* Trouble keeping an erection* Satisfaction with frequency of activity Satisfaction with sex life Satisfaction with partner Partner satisfaction

8 30 10 2% 5% 5% 65% 1.6 1.3 1.5

7 30 10 7% 50% 63% 46% 3.0 2.2 2.6

3 4 3 20% 85% 95% 15% 4.1 3.2 3.5

0 0 0 61% 90% 96% 17% 4.6 3.7 4.1

* Among those reporting some sexual activity within the last 6 months. Mean on scale from 1 (extremely satisfied) through 5 (extremely dissatisfied). (N = 303)
Feldman HA, et al. J Urol. 1994;151:54-61.

Erectile Dysfunction by Severity

No ED Mild ED Moderate ED Severe ED

Sexual activity per month Full erections Awaken with erection No activity in last 6 months Trouble getting an erection* Trouble keeping an erection* Satisfaction with frequency of activity Satisfaction with sex life Satisfaction with partner Partner satisfaction

8 30 10 2% 5% 5% 65% 1.6 1.3 1.5

7 30 10 7% 50% 63% 46% 3.0 2.2 2.6

3 4 3 20% 85% 95% 15% 4.1 3.2 3.5

0 0 0 61% 90% 96% 17% 4.6 3.7 4.1

* Among those reporting some sexual activity within the last 6 months. Mean on scale from 1 (extremely satisfied) through 5 (extremely dissatisfied). (N = 303)
Feldman HA, et al. J Urol. 1994;151:54-61.

Erectile Dysfunction by Severity

No ED Mild ED Moderate ED Severe ED

Sexual activity per month Full erections Awaken with erection No activity in last 6 months Trouble getting an erection* Trouble keeping an erection* Satisfaction with frequency of activity Satisfaction with sex life Satisfaction with partner Partner satisfaction

8 30 10 2% 5% 5% 65% 1.6 1.3 1.5

7 30 10 7% 50% 63% 46% 3.0 2.2 2.6

3 4 3 20% 85% 95% 15% 4.1 3.2 3.5

0 0 0 61% 90% 96% 17% 4.6 3.7 4.1

* Among those reporting some sexual activity within the last 6 months. Mean on scale from 1 (extremely satisfied) through 5 (extremely dissatisfied). (N = 303)
Feldman HA, et al. J Urol. 1994;151:54-61.

Erectile Dysfunction by Severity

No ED Mild ED Moderate ED Severe ED

Sexual activity per month Full erections Awaken with erection No activity in last 6 months Trouble getting an erection* Trouble keeping an erection* Satisfaction with frequency of activity Satisfaction with sex life Satisfaction with partner Partner satisfaction

8 30 10 2% 5% 5% 65% 1.6 1.3 1.5

7 30 10 7% 50% 63% 46% 3.0 2.2 2.6

3 4 3 20% 85% 95% 15% 4.1 3.2 3.5

0 0 0 61% 90% 96% 17% 4.6 3.7 4.1

* Among those reporting some sexual activity within the last 6 months. Mean on scale from 1 (extremely satisfied) through 5 (extremely dissatisfied). (N = 303)
Feldman HA, et al. J Urol. 1994;151:54-61.

Erection Distress Scale (EDS)

Patient concerns about erectile problems were assessed using the 5-item, Erection Distress Scale:

Q1 Frustrated: Were you frustrated about your erection problems? Q2 Feeling weighed down: Did you feel weighed down by your erection problems? Q3 Discouraged: Were you discouraged by your erection problems? Q4 Feeling despair: Did you feel despair over your erection problems? Q5 A worry: Were your erection problems a worry in your life?

Responses are rated from 1 (all of the time) to 6 (none of the time); higher scores indicate less impact of ED

Levinson IP. Abstract # 544. European Association of Urology; 2005.

ED Treatment Reduces Bother

Placebo Baseline Placebo EOT VIAGRA Baseline VIAGRA EOT

6 EDS Score 5 4
31%* 64%* 12% 9% 10% 46%* 7%

24%* 7%

23%*

3
2 1

Q1 Frustrated

Q2 Weighed Down

Q3 Discouraged

Q4 Despair

Q5 A worry

EDS Question
* P < .0001 for change from baseline for VIAGRA (sildenafil citrate) vs. placebo at EOT (N = 1,128)
Levinson IP. Abstract # 544. European Association of Urology; 2005.

What Do Men With ED Want?

Hard, long lasting erections

Consistent, dependable erections

Ability to satisfy themselves and their partners

Self-confidence
There remains high resistance to discussing ED openly or to admitting having ED, which results in delayed treatment or complete avoidance of the problem

Synovate Consumer Attitudes and Usage Study on ED medications, Mar-Jul 2004. (N = 1,526 in 6 countries) Greenfield Consulting & Exolutions. Various qualitative research projects, 2003-2004.

Men Are Looking for Better Sex Rather Than Treatment of Their ED
Proportion of target men who would be at least somewhat interested in asking their doctor for an Rx for

ED: 47%

Better Sex: 66%

(N = 674)
SRBI. VIAGRA Market Sizing Study; January-March 2003. Knowledge Networks. VIAGRA Market Expansion Study; February-April 2004.

How Do Men With ED Define Better Sex?

Firmness, no worry Longer lasting, stamina, better quality of intercourse Sharing and caring; closer intimate moment with your spouse More fulfilling to both partners, happiness on both parties

Greenfield Consulting. The Lexicon of Love: ED Category Terminology Definitions. July 2004.

Better Sex Cycle

Confidence

Initiation
Orgasm / Ejaculation Partner Satisfaction Patient Satisfaction Self-esteem

Foreplay / Intimacy Desire

Control
Shorter Refractory Period Frequency

Reward

Sexual Act
Hard Erection Sustained Erection

Physiology of Erections: The Importance of nNos and eNos

Sexual Stimulation

nNOS
L-Arginine

eNOS
L-Arginine

Nitric Oxide Guanylate Cyclase GTP GMP PDE5

GTP, guanosine triphosphate; GMP, guanosine monophosphate; cGMP, cyclic GMP; nNOS, neuronal nitric oxide synthase; cGK 1, cGMP-dependent protein kinase; eNOS, endothelial nitric oxide synthase.
Burnett AL. Int J Impot Res. 2004;16:S15-S19.

cGMP

cGK 1

Erection

eNOS Is Essential for Maintenance of Penile Erection

1. Stimulus
Psychogenic Reflexogenic Neuronal Depolarisation Ca++

2. Initiation by nNOS

CaM-nNOS NO Relaxation and Shear Stress

Continued Relaxation
NO

3. Prolongation by eNOS

PI3K Akt

eNOS P

nNOS, neuronal nitric oxide synthase; eNOS, endothelial nitric oxide synthase; PI3K, phosphatidylinositol 3-kinase; Akt, protein kinase B.
Hurt KJ, et al. Proc Natl Acad Sci USA. 2002;99:4061-4066.

eNOS Is Essential for Maintenance of Penile Erection

eNOS Knockout Mice = Animal Model of Endothelial Dysfunction
60 50

Maximal ICP (mm Hg)

Wild Type nNOS/ eNOS/

60 50 40 30 20 10 60 5 4 4

ICP (mm Hg)

40 30 20 10 60 60 300 400 500 600 700 800 900 1000 1100 Time (sec)
PAP, papaverine

eNOS/ PAP

Wild Type nNOS/ eNOS/

* P < 0.01 vs. wild-type response

Hurt KJ, et al. Proc Natl Acad Sci USA. 2002;99:4061-4066.

Better Sex Cycle

Confidence

Initiation
Orgasm / Ejaculation

Foreplay / Intimacy Desire

Partner Satisfaction
Patient Satisfaction Self-esteem Control Shorter Refractory Period Frequency

Reward

Sexual Act
Hard Erection Sustained Erection

VIAGRA (sildenafil citrate) Improves Confidence

Mean IIEF Q15 Score Increase From Baseline (%) 100 80 60 40 20 0

77%

18%

Placebo
P

VIAGRA

Pooled analysis from 26 double-blind placebo-controlled studies. (N > 6,000)

.0001 vs. placebo IIEF Q15. How do you rate your confidence that you could get and keep an erection?
Data on file. Pfizer Inc, New York, NY.

Basic Intimacy
Intimacy is a key component of a successful and satisfactory sexual experience ED reduces the desire for basic intimacy (hug, kiss, cuddle)
Reduces desire for sexual intercourse

VIAGRA amplifies the erectile response to sexual stimuli

Riley A, Riley E. Int J Clin Pract. 2000;54(4):220224. Shabsigh R, Klien LT, Seidman S, et al. Urology. 1998;52:848852.

ED Treatment With VIAGRA Increased the Desire for Basic Intimacy

10 Percent increase from baseline

Basic Intimacy

8 6 4 2 1

27%*

Baseline
(N = 117)

Follow-up

* P < .001 at follow-up vs. baseline Basic intimacy defined as desire to kiss, hug, and cuddle. Assessed by sexual intimacy and satisfaction questionnaire ranging from 1 (lowest/worst) to 10 (highest/best) NOTE: three-month study
Swierzewski M, et al. Abstract #7639, European Society for Sexual Medicine; 2004.

Effect of ED Treatment on Sexual Desire

ED treatment with VIAGRA (sildenafil citrate) increased the desire for sexual intercourse by 48%* Sexual Intercourse Attempts (in last month) ED treatment with VIAGRA (sildenafil citrate) increased sexual intercourse attempts by 48%* 16 12 8 4 0 Baseline

Desire for Sexual Intercourse

10 8 6 4 2 0 Baseline

Follow-up

Follow-up

(N = 117)
* P < .001 at follow-up vs. baseline

(N = 117)

Adapted from: Swierzewski M, et al. Abstract #7639, European Society for Sexual Medicine; 2004.

Better Sex Cycle

Confidence

Initiation
Orgasm / Ejaculation Partner Satisfaction Patient Satisfaction Self-esteem

Foreplay / Intimacy Desire

Control
Shorter Refractory Period Frequency

Reward

Sexual Act
Hard Erection Sustained Erection

IIEF 2: When You Had Erections With Sexual Stimulation, How Often Were Your Erections Hard Enough for Penetration?
Percent increase from baseline
26 double-blind, placebo-controlled studies with >6000 men with ED

5
Mean IIEF Score

4 3 2 1
Baseline Endpoint Baseline Endpoint

86%* 20%*

Placebo
P < .0001

V IAGRA

Data on file. Pfizer Inc, New York, NY.

Hardness Is Effectively Sustained With VIAGRA

40

33 min
Duration (minutes) 30

20

10

7 min

0 Placebo
(N = 16)

VIAGRA 100

One Hour Post-Dose

P .0001 NOTE: Visual sexual stimulation utilized
Gingell C, Sultana SR, Hodgson G, et al. J Sex Med. 2004;1(2): 179-184.

IIEF 4: Frequency of Maintained Erections

Percent increase from baseline

Mean IIEF Score

4 3 2 1
Baseline Endpoint

101%*
25%*

Baseline Endpoint

Placebo
P < 0.0001

VIAGRA

26 double-blind, placebo-controlled studies with >6000 men with ED

Data on file. Pfizer Inc, New York, NY.

Assessment of Erection Hardness

In response to the question: How would you rate the hardness of your erection?
GRADE 1 GRADE 2 GRADE 3 GRADE 4

Penis is larger but not hard

Penis is hard, but not hard enough for penetration

Penis is hard enough for penetration, but not completely hard

Penis is completely hard and fully rigid

Goldstein I, Lue TF, Padma-Nathan H, et al. N Engl J Med. 1998;338:13971404.

VIAGRA Produces Hard Erections

Number of Grade 4 Erections per Month

Mean No. of Erections

5 4
Per Month

4.2

3 2 1 0
Placebo
(N = 205)

0.7

VIAGRA 50 mg
(N = 105)

P < .0001

Adapted from: Goldstein I, Lue TF, Padma-Nathan H, et al. N Engl J Med. 1998;338:13971404.

Percentage of Men With ED Who Have Shifted From Grade 1 Erections to Grade 4 Erections
Percentage of Shifted Patients

75
62%

50

47%*

25
12%

0
Placebo
(N = 216)

VIAGRA 50 mg
(N = 107)

VIAGRA 100 mg
(N = 107)

* P = .0005 vs placebo P < .0001 vs placebo

Levinson IP. Abstract # 074. European Society for Sexual Medicine; 2004.

Percentage of Men With ED Who Have Shifted From Grade 3 Erections to Grade 4 Erections
Percentage of Shifted Patients

80

76%

60
40 20
17%

0
Placebo VIAGRA 100 mg

(N = 70)

(N = 38)

Data on file. Pfizer Inc, New York, NY.

The Science of Hardness

Protein Structure of PDE5

3-D x-ray crystal structure of recombinant PDE5 construct comprising the catalytic domain Surface representation of atomic structure with cGMP bound Globular structure and deep active site cleft Very specific structural requirements required for inhibitors
cGMP-binding sites
P

Catalytic domain

Data on file. Pfizer Inc, New York, NY.

VIAGRA: Access to PDE5 Catalytic Domain

Very specific structural requirements required for access to catalytic domain

Data on file. Pfizer Inc, New York, NY.

Structural Differences Among Various PDE5 Inhibitors and cGMP

Corbin JD, Francis SH. J Biol Chem. 1999;274:13729-13732.

VIAGRA Binding Helps Explain Why It Is Such a Potent (and Selective) PDE5 Inhibitor
Gln 817 3.2 2.8 Phe 820 Ile 824

Leu 725

Leu 804 Tyr 612 Phe 786

VIAGRA (sildenafil citrate) is not planar

Data on file. Pfizer Inc, New York, NY.

Better Sex Cycle

Confidence

Initiation
Orgasm / Ejaculation

Foreplay / Intimacy Desire

Partner Satisfaction
Patient Satisfaction Self-esteem Control Shorter Refractory Period Frequency

Reward

Sexual Act
Hard Erection Sustained Erection

Treating ED Improves Health-Related QoL (HRQoL)

Better HRQoL Change in QoL From Baseline

Psychological Impact of Erectile Dysfunction (PIED): Sexual Experience

*

Treatment Responder (N=40) Non-responder (N=49)

Worse HRQoL

3m

6m

12 m

Follow-up Time Points

* P = 0.0014
Adapted from. Latini DM, et al. J Urol. 2003;169(4):1437-1442.

Treating ED Improves Health-Related QoL (HRQoL)

Better HRQoL

Psychological Impact of Erectile Dysfunction (PIED): Emotional Life

*

Change in QoL From Baseline

Treatment Responder (N=40) Non-responder (N=49)

Worse HRQoL

3m

6m

12 m

Follow-up Time Points

* P =0.001
Adapted from: Latini DM, et al. J Urol 2003;169(4):1437-42.

When Engaging in Sex, Men Say That Connection to the Partner Is Highly Important to Them
% Very Important % Somewhat Important

Feeling Emotionally Close to Partner Expressing Love/Affection for Partner Feeling Physically Close to Partner Achieving Partner's Satisfaction Helping to Keep Partner in Relationship Achieving Own Sexual Satisfaction Feeling Desirable Making up After Fight/Disagreement Fulfilling Sexual Duty/Obligation Feeling More Masculine Getting Partner Pregnant

60 60 59 58 55 42 42 43 22 28 10
0 10

29 29
29 29

29 29 29 29 27 27 39 39 36 36 25 25 29 30

9 9
20 30 40 50 60 70 80 90 100

Pfizer, GSSAB, Jun-Dec 01.

Partners of Men With ED Reported Satisfaction With His Ongoing Treatment With VIAGRA (sildenafil citrate)

100 Partners (%) 80 60 40 20 0

92%

95%

Satisfied or very satisfied with partners VIAGRA treatment

Desire for him to continue VIAGRA treatment

(N = 677)
Gil A, Martinez E, Oyaguez I, et al. Int J Impot Res. 2001:13:338347.

ED Treatment With VIAGRA Delivers Improvements in Confidence and Self-Esteem

Self-Esteem And Relationship (SEAR) questionnaire (N = 93)

Domain Sexual relationship Confidence Self-esteem Overall relationship

Baseline 42.1 21.7 55.0 25.5 51.6 26.9

End of Treatment 77.8 21.1 80.7 21.2 81.0 22.4

Change* 35.7 23.0 25.7 26.1 29.4 27.6

61.8 29.9

80.2 24.4

18.4 32.4

* P .0001 for VIAGRA vs. baseline in all domains

Althof SE, et al. Urology. 2003;61:888-892.

VIAGRA (sildenafil citrate) Treatment for ED Improves Satisfaction With Overall Sex Life
IIEF Q13: How satisfied have you been with your overall sex life? Mean IIEF Score Q13 Increase From Baseline (%) 100 80

94%

60
40

22%
20 0

Placebo
P

VIAGRA

Pooled analysis from 26 double-blind placebo-controlled studies. (N > 6,000)

.0001 vs placebo
Data on file. Pfizer Inc, New York, NY.

VIAGRA Treatment for ED Improves Sexual Enjoyment

IIEF Q8: How much have you enjoyed sexual intercourse? Mean IIEF Q8 Score Increase From Baseline (%) 100 80 60

70%

40
20 0

19%

Placebo
P

VIAGRA

Pooled analysis from 26 double-blind placebo-controlled studies. (N > 6,000)

.0001 vs placebo
Data on file. Pfizer Inc, New York, NY.

VIAGRA Treatment for ED Improves Sexual Relationship Satisfaction

IIEF Q14: How satisfied have you been with your sexual relationship with your partner? 100 Mean IIEF Q14 Score Increase From Baseline (%) 80 60

55%

40

22%
20 0

Placebo
P

VIAGRA

Pooled analysis from 26 double-blind placebo-controlled studies. (N > 6,000)

.0001 vs placebo
Data on file. Pfizer Inc, New York, NY.

Sexual Relationship Satisfaction Positively Correlated With Erectile Function, Enjoyment of Sex and Sexual Confidence

Question 2: Erection Hard Enough Question 14: Satisfaction With Sexual Relationship

Question 3: Question 4: Maintained Frequency Erection of Erection Until Completion

Question 8: Question 15: Enjoyment Sexual of Sex Confidence

0.48

0.47

0.50

0.51

0.51

Pooled analysis from 26 randomised, double-blind placebo-controlled studies. (N > 6,000)

P < 0.0001
Levinson IP. Abstract # 073. European Society for Sexual Medicine; 2004.

Summary
VIAGRA has a unique chemical structure and binding properties

VIAGRA delivers hard, sustained erections

Data presented suggest a link between improved erectile function in men with ED, increased desire for intimacy and increased sexual satisfaction and frequency Hard erections correlate strongly with the emotional benefits of confidence, self-esteem, enjoyment of sex and overall sexual relationship satisfaction Partners of patients treated with VIAGRA report increased levels of satisfaction.

VIAGRA effectively reduced bother as assessed by the Erectile Distress Scale (EDS)

VIAGRA Delivers Better Erections for Better Sex

Confidence

Initiation
Orgasm / Ejaculation

Foreplay / Intimacy Desire

Partner Satisfaction
Patient Satisfaction Self-esteem Control Shorter Refractory Period Frequency

Better Sex For Men with Reduced Quality of Erections

Reward

Sexual Act
Hard Erection

Sustained Erection

Improved Erection Function* Correlates With:

Improved Confidence
Positive Correlation

Improved Improved Sexual Sexual Intercourse Satisfaction Intercourse Enjoyment

Positive Correlation Positive Correlation

Improved Sexual Relationship Satisfaction

Positive Correlation

+1.0

+1.0

+1.0

+1.0

0.55

+0.5

0.60

0.63
+0.5 +0.5

0.51

+0.5

0.5

0.5

0.5

0.5

1.0
Negative Correlation

1.0
Negative Correlation

1.0
Negative Correlation

1.0
Negative Correlation

Pooled analysis from 26 double-blind placebo-controlled studies (N > 6,000)

* Hardness measured using the erectile function (EF) domain of the IIEF
Data on file. Pfizer Inc, New York, NY.

Partner and Patient Satisfaction* Are Linked

Partner and Patient EDITS Index Scores
80 Partner Patient
70.1* 61.8*

Percent Satisfied*

60

40
26.5 28.1

20

Without VIAGRA
(N = 930)

With VIAGRA

* Satisfaction assessed using Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) P .0001 vs. placebo Placebo
Montorsi F, et al. Urology. 2004;63:762-767.

Partner Satisfaction Correlates With Patient Satisfaction*

Positive Correlation

+1.0

0.51

+0.5

0.5

1.0
Negative Correlation

(N = 930)
P < 0.0001 * Satisfaction assessed using Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)
Data on file. Pfizer Inc, New York, NY.

EF Domain of the IIEF in Men With ED Treated With VIAGRA Correlates Strongly With Improvements in the SEAR*
Mean SE Change in Score (1100)

60
40 20
18 38 39 42 34 20 5 8 39

+1.0

0.64

+0.5 0 -0.5 -1.0

16 2

18

0
-20
-6 Sexual Confidence Self-esteem Overall Overall Score Relationship Domain Domain Relationship Domain Domain -3 -1

EF did not improve (N = 39) EF improved by 1 EF severity category (N = 47) EF improved by 1 or more EF severity categories (N = 217)
* SEAR = Self-esteem and relationship questionnaire

Correlation with overall SEAR score

Stecher V. A1481118 European Association of Urology; 2005.

ED Treatment With VIAGRA (sildenafil citrate) Delivers Consistent Satisfaction

Patients Reporting Satisfaction and Improvement (%) 100

98.1%

96.6%

94.8%

96.3%

80
60 40 20 0 1 year (N = 806) 2 years (N = 672) 3 years (N = 551) 4 years (N = 550)

McMurray JG, Feldman RA, Auerbach SM, et al. Int J Impot Res. 2002;14(suppl 3):S104.

Advancing the Science of Better Sex

Appendix
100 mg Dosing

Approximately 2/3 of Patients With Mild and Mild-to-Moderate ED Titrated to 100 mg

Number of patients in a 26-study pool who finished double-blind, placebo-controlled, flexible-dose studies taking 50 mg or 100 mg dose of VIAGRA (sildenafil citrate)
VIAGRA 50 mg VIAGRA 100 mg

500 400

(N = 457)

Patients (n)

300 0 200 100 0 0

(N = 282)

IIEF Domain 17-25

Levinson IP. Abstract # MP-5-6. European Society for Sexual Medicine; 2004

No Safety Concerns Were Reported: Majority of AEs Were Mild

AEs presented are treatment-related, treatment-emergent
Open-label Phase*
DB Phase (N = 782) Placebo (N = 747) VIAGRA 50 mg (N = 91) VIAGRA 100mg (N = 621)

Headache Flushing Gastrointestinal upset Dyspepsia Nausea Visual changes Abnormal vision Chromatopsia
DB = double-blind.

10% 9%

11% 8%

8% 6%

7% 7%

4% 1% 2% 2%

3% 1% 3% 3%

6% 3% 1% 3%

4% 1% 2% 2%

* Placebo, 50 mg and 100 mg refer to the final dosage during the double-blind phase. VIAGRA open-label dose started at 50 mg and was flexible
Levinson IP. Abstract # MP-5-6. European Society for Sexual Medicine; 2004.

Treatment Options

Appendix

ED Treatment Options
Lifestyle Changes/Education Risk factor management Sexual education/counseling

Oral Agents (PDE5 Inhibitors) VIAGRA (sildenafil citrate) Levitra (vardenafil HCl) Cialis (tadalafil)

Devices Vacuum constriction devices

Injectible Agents Intracavernosal injections (alprostadil) Intraurethral medications (alprostadil)

Surgical Options Penile implants Vascular surgery

1st International Consultation on Erectile Dysfunction. Paris, France: World Health Organisation; 1999.

VIAGRA (sildenafil citrate)

Description Peripheral acting agent Inhibits breakdown of cGMP, enhances smooth muscle relaxation Enhances effect of sexual stimulation 25 mg 50 mg 100 mg Improves erections across all severities of ED

Dosing Efficacy

Data in a variety of patient subgroups Avg. Onset of Action

Half-life

30-60 minutes
3-5 hours

Adverse Effects

Headache, flushing, dyspepsia, and visual effects

VIAGRA [package insert]. Sandwich, Kent, UK: Pfizer, Ltd; 2004

Levitra (vardenafil HCl)

Description Peripheral acting agent NO mediated increases in cGMP are prolonged by PDE5 inhibition Enhances effect of sexual stimulation 5 mg 10 mg 20 mg Improves erections across all severities of ED 30-60 minutes 4-6 hours Headache, flushing, rhinitis

Dosing Efficacy Avg. Onset of Action Half-life Adverse Effects

Levitra [package insert]. Leverkusen, Germany: Bayer AG; 2004

Cialis (tadalafil)
Description Peripheral acting agent NO-mediated increases in cGMP are prolonged by PDE-5 inhibition Enhances effect of sexual stimulation 10 mg 20 mg Improves erections across all severities of ED 15-45 minutes 17.5 hours Headache, indigestion, back pain, muscle aches, flushing, stuffy or runny nose, rare cases of priapism

Dosing Efficacy Avg. Onset of Action Half-life Adverse Effects

Cialis [package insert]. London, UK: Lilly ICOS, Ltd; 2004

Appendix
Additional Slides

The Impact of ED on Quality of Life (QoL)

SF-36 Mental and Physical Summary Component Mean Values
75
Non-ED subjects ED patients

% Subjects

P <0.01
50

P <0.01

25

0
Physical Component
Note: higher is better (N = 2,476)
Sanchez-Cruz JJ, et al. Eur Urol. 2003;44(2):245-253.

Mental Component

VIAGRA Stands for

FUNCTIONAL EMOTIONAL

A treatment that provides hard erections A treatment that works consistently A treatment that provides long lasting erections A treatment that enables men to satisfy their sexual partners A treatment that enhances mens confidence

Goldstein I, Lue TF, Padma-Nathan H, et al. N Engl J Med. 1998;338:13971404. Gingell C, Sultana SR, Hodgson G, et al. J Sex Med. In press. Data on file. Pfizer Inc, New York, NY. Gil A, Martinez E, Oyaguez I, et al. Int J Impot Res. 2001:13:338347.