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Sexually Transmitted Diseases Among Users of Erectile Dysfunction Drugs: Analysis of Claims Data

Anupam B. Jena, MD, PhD; Dana P. Goldman, PhD; Amee Kamdar, PhD; Darius N. Lakdawalla, PhD; and Yang Lu, PhD
[+] Article and Author Information

From Harvard Medical School, Boston, Massachusetts; University of Southern California, Los Angeles, California; University of Chicago Booth Graduate School of Business, Chicago, Illinois; and RAND, Santa Monica, California.


Acknowledgment: The authors thank Steven Levitt, David Meltzer, and Tomas Philipson for their useful comments and Mark Totten for programming assistance.

Grant Support: By the Bing Center for Health Economics and RAND Roybal Center for Health Policy Simulation (grant P30AG024968), a National Institutes of Health Medical Scientist National Research Award (grant 5 T32 GM07281 to Dr. Jena), the Agency for Healthcare Research and Quality through a University of California, Los Angeles/RAND Training Grant (grant T32 HS 000046 to Dr. Jena), and the National Institute for Child Health and Human Development (grant 1R01HD054877 to Dr. Jena).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-2577.

Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Jena (e-mail, jena.anupam@mgh.harvard.edu). Data set: Available with approval of analysis plan by Drs. Jena and Goldman (e-mail, jena.anupam@mgh.harvard.edu and dana.goldman@usc.edu).

Requests for Single Reprints: Anupam B. Jena, MD, PhD, Department of Medicine, Massachusetts General Hospital, Wang Ambulatory Care Center, 15 Parkman Street, Boston, MA 02114; e-mail, jena.anupam@mgh.harvard.edu.

Current Author Addresses: Dr. Jena: Department of Medicine, Massachusetts General Hospital, Wang Ambulatory Care Center, 15 Parkman Street, Boston, MA 02114.

Drs. Goldman and Lakdawalla: Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, 650 Childs Way, RGL 214, Los Angeles, CA 90089.

Dr. Kamdar: Associate Director of Research, Becker Center, University of Chicago Booth Graduate School of Business, 5807 South Woodlawn Avenue, Chicago, IL 60637.

Dr. Lu: RAND, 1776 Main Street, Santa Monica, CA 90407-2138.

Author Contributions: Conception and design: A.B. Jena, D.P. Goldman, A. Kamdar, D.N. Lakdawalla, Y. Lu.

Analysis and interpretation of the data: A.B. Jena, D.P. Goldman, A. Kamdar, D.N. Lakdawalla, Y. Lu.

Drafting of the article: A.B. Jena, A. Kamdar.

Critical revision of the article for important intellectual content: A.B. Jena, A. Kamdar, D.N. Lakdawalla.

Final approval of the article: A.B. Jena, D.P. Goldman, D.N. Lakdawalla.

Statistical expertise: A.B. Jena, D.P. Goldman, D.N. Lakdawalla.

Administrative, technical, or logistic support: A.B. Jena, D.P. Goldman.

Collection and assembly of data: A.B. Jena, D.P. Goldman.


Ann Intern Med. 2010;153(1):1-7. doi:10.7326/0003-4819-153-1-201007060-00003
Text Size: A A A

Background: Pharmacologic treatments for erectile dysfunction (ED) have gained popularity among middle-aged and older men. Increased sexual activity among those who use these drugs raises concerns about sexually transmitted diseases (STDs).

Objective: To examine the rates of STDs in men who use and do not use ED drugs.

Design: Retrospective cohort study.

Setting: Database of claims from 1997 to 2006 for 1 410 806 men older than age 40 years with private, employer-based insurance from 44 large companies.

Patients: 33 968 men with at least 1 filled prescription for an ED drug and 1 376 838 patients with no prescription.

Measurements: STD prevalence among users and nonusers of ED drugs.

Results: Users of ED drugs had higher rates of STDs than nonusers the year before initiating ED drug therapy (214 vs. 106 annually per 100 000 persons; P = 0.003) and the year after (105 vs. 65; P = 0.004). After adjustment for age and other comorbid conditions, users of ED drugs had an odds ratio (OR) for an STD of 2.80 (95% CI, 2.10 to 3.75) in the year before initiating drug therapy; the OR was 2.65 (CI, 1.84 to 3.81) in the year after. These differences were largely due to infections with HIV. The OR for HIV infection was 3.32 (CI, 2.38 to 4.36) in the year before and 3.19 (CI, 2.11 to 4.83) in the year after an ED drug prescription was filled. Significant changes in STD rates from the year before to the year after the first ED drug prescription was filled were not documented (adjusted OR for STD for users before vs. after the first ED drug prescription was filled, 0.96 [CI, 0.87 to 1.06]).

Limitation: Selection bias precludes conclusions about whether use of ED treatments directly leads to increases in STDs.

Conclusion: Men who use ED drugs have higher rates of STDs, particularly HIV infection, both in the year before and after use of these drugs. The observed association between ED drug use and STDs may have more to do with the types of patients using ED drugs rather than a direct effect of ED drug availability on STD rates. Counseling about safe sexual practices and screening for STDs should accompany the prescription of ED drugs.

Primary Funding Source: RAND Roybal Center, National Institutes of Health, and Agency for Healthcare Research and Quality.

Figures

Grahic Jump Location
Figure 1.
Observed and predicted STD rates (per 100 000 men) among users and nonusers of ED drugs before and after the first ED drug prescription was filled.

Sexually transmitted disease rates were calculated for users (n = 33 968) and nonusers (n = 1 376 838) of ED drugs over 24 months: 12 months before and 12 months after reference users filled their first ED drug prescription. Predicted rates were obtained from an estimated logistic model. Data are shown at the quarterly level, and rates are per 100 000 male beneficiaries. Open circles represent data points, solid lines represent the fitted (i.e., adjusted) data, and dashed lines indicate the transition between the period before and the period after ED drug prescriptions were filled. ED = erectile dysfunction; STD = sexually transmitted disease.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Crude and adjusted relative STD rates among users and nonusers of ED drugs before and after the first ED drug prescription was filled.

Crude relative rates (open circles) reflect STD rates between users (n = 33 968) and nonusers (n = 1 376 838) of ED drugs over 24 months: 12 months before and 12 months after reference users filled their first ED drug prescription. Adjusted relative rates (solid lines) were obtained from an estimated logistic model. Dashed lines indicate the transition between the period before and the period after ED drug prescriptions were filled. ED = erectile dysfunction; STD = sexually transmitted disease.

Grahic Jump Location

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Comments

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This may be due to increased testosterone.
Posted on July 6, 2010
James M. Howard
independent
Conflict of Interest: None Declared

It is my hypothesis that the testosterone to DHEA ratio influences the function of all tissues. It is known that testosterone reduces the immune system; I suggest this is due to an excessive testosterone to DHEA ratio. DHEA supports the immune system. In some tests, "chronic" treatment with sildenafil significantly increased testosterone levels (Int J Exp Pathol. 2009 Aug;90(4):454-62).

DHEA naturally begins to decline around the ages of twenty to twenty- five, reaching very low levels in old age. I suggest this loss of DHEA of aging and the increase of testosterone caused by sildenafil increases the testosterone to DHEA ratio and, therefore, increases the infection rate.

Conflict of Interest:

None declared

Response to: Sexually Transmitted Diseases Among Users of Erectile Dysfunction Drugs: Analysis of Claims Data
Posted on July 20, 2010
Siobhan Sutcliffe
Washington University School of Medicine
Conflict of Interest: None Declared

We read with interest Jena and colleagues' recent article, "Sexually transmitted diseases among users of erectile dysfunction drugs: analysis of claims data" in the July 6th issue of the Annals of Internal Medicine (1). We are writing to make the readership aware of another possible marker of sexually transmitted infection (STI) risk or STI risk factor in middle- and older-aged men, as well as an additional opportunity for STI education and prevention in this increasingly at-risk population. In a cross-sectional analysis of middle- to older-aged American male health professionals conducted by some of us (2), we found that men who had had a vasectomy were more likely to have a history of STIs, most notably Chlamydia trachomatis and tumorigenic human papillomavirus infections, than men who had not had a vasectomy. While we could not investigate the temporal nature of this relationship, one interpretation of our findings is that, similar to use of erectile dysfunction (ED) drugs in Jena and colleagues' study (1), having a vasectomy may serve as a marker of STI risk behavior - that is, men who choose to have a vasectomy may be more likely to engage in high risk sexual behaviors than those do not choose to have a vasectomy. Another provocative and equally plausible interpretation of our findings is that men who have a vasectomy no longer rely on barrier protection (i.e., condoms) in new sexual relationships, thereby putting them at risk for acquisition of STIs. Both of these interpretations could be investigated in future studies. However, irrespective of the conclusion, STIs among middle- to older-aged men could potentially be prevented by reinforcing STI education at the time of and following a vasectomy. Thus, similar to ED drugs, vasectomy may provide an opportunity for the clinical community (e.g., urologists, primary care physicians) to identify older men at potentially higher risk of STIs, and to counsel these men about their risks.

References

1. Jena AB, Goldman DP, Kamdar A, Lakdawalla DN, Lu Y. Sexually transmitted diseases among users of erectile dysfunction drugs: analysis of claims data. Ann Intern Med. 2010;153(1):1-7.

2. Sutcliffe S, Kawachi I, Alderete JF, et al. Correlates of sexually transmitted infection histories in a cohort of American male health professionals. Cancer Causes Control. 2009;20(9):1623-34.

Conflict of Interest:

None declared

Author's response
Posted on August 13, 2010
Anupam B. Jena
Department of Medicine, Massachusetts General Hospital
Conflict of Interest: None Declared

In our recent article in Annals of Internal Medicine (1), my colleagues and I documented an association between sexually transmitted disease (STD) and the use of phosphodiesterase type 5 inhibitors to treat erectile dysfunction. At the very least, we argued, use of such erectile dysfunction (ED) drugs may identify patients at higher risk for STD who may therefore benefit from additional counseling if not screening. We found no evidence that use of ED drugs necessarily led to higher rates of STD, though we could not reject this possibility.

With this in mind, Dr. Sutcliffe and her colleagues reminded us of a directly relevant body of work which demonstrates higher rates of STD among men undergoing vasectomy (2). Estimates from the National Institutes of Health suggest that almost 500000 vasectomies are performed in the US annually. While this figure is considerably smaller than the annual number of US men who use an ED drug, higher rates of STDs among such a large population of men suggests that renewed discussion about safe sexual practices may be warranted in this group as well. Sutcliffe and colleagues highlight the possibility that lower rates of barrier- protection among men with prior vasectomy may contribute to the higher rate of STD. A similar concern was raised with the liberalization of oral contraceptive pills nearly 50 years ago, but to my knowledge no evidence exists to suggest that STD rates increased among women of childbearing age after liberalization of 'the pill.' Nevertheless, this is an intuitive hypothesis that could be tested empirically in the sort of large insurance claims database we employed. Perhaps a useful start to answering this question would be a simple survey comparison of rates of barrier- protection among men with and without vasectomy.

References

1. Jena AB, Goldman DP, Kamdar A, Lakdawalla DN, Lu Y. Sexually transmitted diseases among users of erectile dysfunction drugs: analysis of claims data. Ann Intern Med. 2010;153(1):1-7.

2. Sutcliffe S, Kawachi I, Alderete JF, et al. Correlates of sexually transmitted infection histories in a cohort of American male health professionals. Cancer Causes Control. 2009;20(9):1623-34.

Conflict of Interest:

None declared

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Summary for Patients

Sexually Transmitted Diseases Among Men Who Use Erectile Dysfunction Drugs

The summary below is from the full report titled “Sexually Transmitted Diseases Among Users of Erectile Dysfunction Drugs: Analysis of Claims Data.” It is in the 6 July 2010 issue of Annals of Internal Medicine (volume 153, pages 1-7). The authors are A.B. Jena, D.P. Goldman, A. Kamdar, D.N. Lakdawalla, and Y. Lu.

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