Decision tree analyses of key patient characteristics in Middle Eastern/North African and Latin American men treated with long-acting and short-acting PDE5 inhibitors for erectile dysfunction

Abstract

Background:

Phosphodiesterase type 5 (PDE5) inhibitors have discontinuation rates as high as 60% in men with erectile dysfunction. Treatment satisfaction has been significantly associated with treatment continuation. Understanding key characteristics in terms of treatment preference, relationship, and lifestyle issues could provide direction on how to improve compliance with PDE5 inhibitor treatment globally.

Objective:

The objective was to identify subgroups of interest in the pooled database of two observational studies conducted in Latin America (LA) and Middle East/North Africa (MENA) exploring patient characteristics and prescription of either a long- or short-acting PDE5 inhibitor at baseline.

Methods:

Two identical prospective, non-interventional, observational, studies in MENA (N = 493) and LA (N = 511) treated men with an ‘on demand’ (pro re nata, PRN) PDE5 inhibitor (sildenafil, tadalafil, vardenafil, or lodenafil) during 6 months. In this post-hoc meta-analysis of two observational studies with equal design, pooled data were analyzed to determine patient characteristics and PDE5 inhibitor prescribed/used most likely to be associated with patient expectations, satisfaction, self-esteem, and patient–partner relationships. Decision tree analyses, with and without weighting, were used to identify and describe key features.

Results:

In each analysis of patient expectations, patient–partner relationship, and self-esteem, we describe the two major subgroups at baseline for each decision tree. Analyses of patient expectations and sexual self-esteem revealed that patients prescribed long-acting PDE5 inhibitors (59%) highlighted the importance of treatment effect duration, second to partner satisfaction with treatment, while patients prescribed short-acting PDE5 inhibitors (32%) placed less importance on treatment effect duration but considerable importance on treatment effect lasting until intercourse completion. Further insights regarding patients, partner relationship characteristics, and treatment expectations were identified.

Conclusion:

Our analyses have described key characteristics, such as self- and partner perceptions, sexual attitudes, and treatment expectations in relation to the patients’ country and prescribed treatment, which might guide treatment decisions in MENA and LA men with ED.

Keywords: :

• Decision tree analysis
• Erectile dysfunction
• Latin American
• Middle Eastern/North African
• PDE5 inhibitor
• Tadalafil

Transparency

Declaration of funding

Eli Lilly and Company supported these studies in their entirety.

Declaration of financial/other relationships

E.R.-A. has disclosed that he has been a speaker for, has been an advisor for, and has received research support from Eli Lilly and Company, Pfizer, Johnson & Johnson, Bayer, Morepharma, and Probiomed. A.E.-M. has disclosed that he has been a speaker for Bayer, Pfizer and Eli Lilly and Company; and has received research grants from Bayer and Johnson and Johnson. S.A. has disclosed that he is a consultant for Eli Lilly and Company. C.H., S.S., and S.G. have disclosed that they are full-time employees and minor stock shareholders of Eli Lilly and Company.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank the principal investigators and their clinical staff as well as the many patients who generously agreed to participate in these clinical trials. We would also like to thank the clinical operations staff for their excellent trial implementation and support. Further acknowledgments go to Helmut Petto (Eli Lilly Regional Operations GesmbH, Austria) and Qianyi Zhang (Eli Lilly & Co.) for contributing their statistical expertise. The authors would like to acknowledge the assistance of Gina Coviello, MS (inVentiv Health Clinical) in preparing this manuscript.

Notice of Correction:

The version of this article published online ahead of print on 29 Jul 2014 contained a number of errors in the figures and text. Details of these errors are explained below.

Figure 1: The label “Partner age older than 50 yrs and aware of consultation. Relation length greater 3yrs and has no non-sexual issues” should have read “Partner age younger than 50 yrs and aware of consultation. Relation length greater 3yrs and has no non-sexual issues.”

Figure 2: The below labels were corrected:

The top label “Very important treatment works over a long period of time” should have read “Quite to not at all important that treatment works over a long period of time”

The associated text on the right “Not very important that treatment is long acting and completing intercourse is also fairly to not at all important” should have read “Quite to not at all important that treatment is long acting and completing intercourse is very to quite important”

The middle left label “Very important partner is satisfied with treatment” should have read “Quite to not at all important that partner is satisfied with treatment”

Figure 3: The top label “Likely to initiate sex >50% of time” should have read “Likely to initiate sex ≤50% of time”

On page 6 the below sentences were corrected:

Paragraph 1: The sentence “Additionally, a coarser but supporting unadjusted decision tree for the PDE5 inhibitor choice at baseline is presented” should have read “Additionally, a coarser but supporting adjusted decision tree for the PDE5 inhibitor choice at baseline is presented”

Paragraph 2: The sentence “The first and larger group of patients (38%) included those three patients who chose lodenafil at baseline, having a 219-fold higher weight than those who chose tadalafil. This path of the decision tree is characterized by patients who are likely to initiate sex, but tend to have problems with the relationship in general, their sexual performance, and have a partner who is unhappy with the sexual quality of their relationship” should have read “The first and larger group of patients (38%) presenting characteristics of those who were prescribed sildenafil at baseline are neither likely to initiate sex nor relaxed about initiating sex, in addition to having low confidence in their erection and sometimes a feeling of failure”

Paragraph 3: The sentences “The second largest subgroup of patients (7.5%) presenting characteristics of those who were prescribed sildenafil at baseline are neither likely to initiate sex nor relaxed about initiating sex, in addition to having a low confidence in their erection during sex and a feeling of failure. In this subgroup, patients had psychogenic ED (2%) or organic ED (2%), which was lower when compared to the overall patient population” should have read “The second largest subgroup of patients (7.5%) included those three patients who chose lodenafil at baseline, having a 219-fold higher weight than those who chose tadalafil. This path of the decision tree is characterized by patients who are likely to initiate sex, but may have problems with the relationship in general, their sexual performance, and have a partner who may be unhappy with just the sexual quality of their relationship. In this subgroup, patients had psychogenic ED (2%) or organic ED (2%), which was lower when compared to the overall patient population”

These errors have been corrected for this version and did not affect any of the study results or conclusions.