Men With Diabetes May Need More Aggressive Treatment for ED
Men With Diabetes May Need More Aggressive Treatment for ED
DM and ED are common and costly health conditions that occur more frequently with advancing age. The present study is the first to assess differences in ED treatment between men with and without DM. After diagnosis or initiation of oral therapy, men with DM are 1.6–2.1 times more likely to undergo more aggressive treatments within 5 years of initial ED diagnosis or treatment with oral medications. These data suggest that DM-associated ED may be less responsive to first-line pharmacologic treatment, worsen more rapidly, or both.
These data are particularly important given that the incidence of diabetes is rising in the United States. The increased severity of ED in men with diabetes may lead to higher health-care utilization, and thus appropriate resource allocation and policy regarding coverage may require reassessment. In 2001, ED accounted for over 400 million dollars in Medicare annual medical expenditures. The additional unmeasured costs related to over-the counter remedies, prescription drugs for ED, and complications of penile implant surgery such as prosthetic infection and lost work time far exceed the direct costs of treatment. In the United States, the total cost of ED treatments for the 10–20 million affected men in the United States exceeds $3 billion. Although unknown, the per capita cost of treatment for diabetes-associated ED is likely to be higher than in nondiabetic patients given the increased severity of symptoms and earlier onset of disease.
This study is unique by being the first to use claims-based data to examine ED in a large community-based cohort of men. Claims-based data analyses have been used extensively to investigate other aspects of urologic care, but there is little data related to ED. While it has been shown that a single question can reliably predict ED, it is often difficult to obtain this data from more generalized longitudinal cohort studies and there may still be significant inter-individual variability in self-assessment of ED when queried. As a result, this research technique may allow for more accurate assessment of the disease outcome by identifying men who are actually treated for the disease. Further, this approach creates a cohort that is genuinely representative of the general population, thus enhancing the generalizability of our results.
Claims-based data analysis allows us to single out men with severe ED by assessing their use of sequentially more invasive therapeutic modalities. This makes it a potentially innovative tool for examining the progression of ED over time and the severity of ED in different sub-populations of men without the need for expensive urology or ED-specific longitudinal cohort studies. It also allows us to compare ED progression and treatment in men with DM to those without DM who had similar access to care under the Inovus I3 health-care system.
This study does have limitations. Despite our efforts to clearly identify a cohort of men with and without ED and those with and without DM, there is likely still some misclassification between the groups, particularly related to the diagnosis of ED. Specifically, we cannot identify men with ED who did not disclose the ED to a health-care provider or seek any form of treatment. By utilizing outcomes that are defined by treatment modality, we believe that such bias is reduced. The limited length of follow-up in this study also reduces our ability to identify differences in ED treatment between men with and without DM. Further, it is possible that some cases of ED treated by second- and third-line therapies are not truly incident but may have failed treatment with PDE-5 inhibitors or second therapies years earlier (prior to the period of the study).
Despite these limitations, the novel finding of a significantly more progressive and less responsive course for ED in men with DM argues for earlier and possibly more aggressive interventions in men with DM. For example, one approach would be to target all men with DM at an early age (30 years) for a discussion of how their DM may impact their ED in the future and utilize this to motivate compliance with tight DM control therapeutic regimens.
Discussion
DM and ED are common and costly health conditions that occur more frequently with advancing age. The present study is the first to assess differences in ED treatment between men with and without DM. After diagnosis or initiation of oral therapy, men with DM are 1.6–2.1 times more likely to undergo more aggressive treatments within 5 years of initial ED diagnosis or treatment with oral medications. These data suggest that DM-associated ED may be less responsive to first-line pharmacologic treatment, worsen more rapidly, or both.
These data are particularly important given that the incidence of diabetes is rising in the United States. The increased severity of ED in men with diabetes may lead to higher health-care utilization, and thus appropriate resource allocation and policy regarding coverage may require reassessment. In 2001, ED accounted for over 400 million dollars in Medicare annual medical expenditures. The additional unmeasured costs related to over-the counter remedies, prescription drugs for ED, and complications of penile implant surgery such as prosthetic infection and lost work time far exceed the direct costs of treatment. In the United States, the total cost of ED treatments for the 10–20 million affected men in the United States exceeds $3 billion. Although unknown, the per capita cost of treatment for diabetes-associated ED is likely to be higher than in nondiabetic patients given the increased severity of symptoms and earlier onset of disease.
This study is unique by being the first to use claims-based data to examine ED in a large community-based cohort of men. Claims-based data analyses have been used extensively to investigate other aspects of urologic care, but there is little data related to ED. While it has been shown that a single question can reliably predict ED, it is often difficult to obtain this data from more generalized longitudinal cohort studies and there may still be significant inter-individual variability in self-assessment of ED when queried. As a result, this research technique may allow for more accurate assessment of the disease outcome by identifying men who are actually treated for the disease. Further, this approach creates a cohort that is genuinely representative of the general population, thus enhancing the generalizability of our results.
Claims-based data analysis allows us to single out men with severe ED by assessing their use of sequentially more invasive therapeutic modalities. This makes it a potentially innovative tool for examining the progression of ED over time and the severity of ED in different sub-populations of men without the need for expensive urology or ED-specific longitudinal cohort studies. It also allows us to compare ED progression and treatment in men with DM to those without DM who had similar access to care under the Inovus I3 health-care system.
This study does have limitations. Despite our efforts to clearly identify a cohort of men with and without ED and those with and without DM, there is likely still some misclassification between the groups, particularly related to the diagnosis of ED. Specifically, we cannot identify men with ED who did not disclose the ED to a health-care provider or seek any form of treatment. By utilizing outcomes that are defined by treatment modality, we believe that such bias is reduced. The limited length of follow-up in this study also reduces our ability to identify differences in ED treatment between men with and without DM. Further, it is possible that some cases of ED treated by second- and third-line therapies are not truly incident but may have failed treatment with PDE-5 inhibitors or second therapies years earlier (prior to the period of the study).
Despite these limitations, the novel finding of a significantly more progressive and less responsive course for ED in men with DM argues for earlier and possibly more aggressive interventions in men with DM. For example, one approach would be to target all men with DM at an early age (30 years) for a discussion of how their DM may impact their ED in the future and utilize this to motivate compliance with tight DM control therapeutic regimens.