Sildenafil is increasingly being marketed to younger healthcare consumers. The purpose of this study was to profile sildenafil use in commercially insured, adult beneficiaries. Annual ambulatory prescription claims data from 1998 to 2002, for a nationwide, random sample of over 5 million life-years of commercially insured adults (aged ≥18 y), were examined retrospectively. The overall prevalence of sildenafil use increased from 0.8% (1998) to 1.4% (2002), an 84% increase. While the growth in use slowed in older males, use became more pronounced in younger males and females and decreased in older females. The fastest growing segment of users was found to be males aged 18–45 y. The proportion of users who had two or more claims for a medication that is suspected of inducing erectile dysfunction (ED) and/or a marker for a suspected ED-inducing disease decreased over the study period. Our findings suggest that use may increase among younger male and female patients and those without an underlying etiologic reason for use.
Sexual dysfunctions are marked by impairment in sexual desire and the psychophysiological alterations associated with sexual response.1 Both sexes experience sexual dysfunction; however, females (43%) are estimated to be at a higher risk than males (31%).2 Little research on the epidemiology and treatment of sexual dysfunction has been focused on females, perhaps due to the multicausal and multidimensional aspects of this disorder in females.3 Conversely, there has been substantial research performed on sexual dysfunction, particularly erectile dysfunction (ED), epidemiology, and treatment in males.4, 5, 6, 7, 8
ED is an age-related condition that can be associated with health conditions such as vascular disease, diabetes mellitus, depression, prostate disease, renal failure, Parkinson's disease and spinal cord injury.9, 10, 11 The causes of ED can be organic, psychogenic, and/or iatrogenic.7 Regardless of cause, intracavernosal/transurethral prostaglandin E1 injections, oral medications, surgery, and vacuum constriction devices are available as treatments. Understandably, patients have demonstrated a preference for oral therapies.12, 13
In 1998, sildenafil (Viagra®) became the first oral impotence agent to receive marketing approval from the United States (US) Food and Drug Administration for the treatment of sexual dysfunction in males.14 During clinical trials, sildenafil was found to be effective in relieving symptoms of ED in approximately 70% of subjects.15 Initial studies found sildenafil to provide results similar to placebo for the treatment of sexual dysfunction in postmenopausal women,16 but indicated improvements in sexual function in premenopausal women.17
With a direct to consumer advertising (DTCA) campaign, sildenafil has brought the recognition and treatment of ED to the forefront of public awareness.18, 19 Originally, sildenafil DTCA in the US was targeted to older males (eg using Bob Dole as spokesperson, print ad featuring gray-haired male dancing with gray-haired female), but it has been increasingly marketed to younger consumers (eg baseball player Rafael Palmeiro as a spokesperson, sponsoring Earth, Wind, and Fire concert tour).20 Already concerned with the impact sildenafil has had on their pharmacy budgets,21, 22, 23, 24 health plan sponsors now face the prospect of increased use among a younger generation of ED patients. In addition, marketing approval of other impotence products (eg vardenafil, tadalafil) is forthcoming. Approval will likely increase utilization of oral impotence agents classwise.25, 26
Sildenafil use is not without risks owing to its vasodilatory properties. Caution should be excercised in patients with one or more risk factors for cardiovascular or cerebrovascular disease, as cardiovascular events related to sildenafil include myocardial infarction, cardiac arrest, angina, ventricular tachycardia, hypertension, and other cardiac symptoms.27 Concomitant use with organic nitrates (eg glyceryl trinitrate, isosorbide dinitrate) has resulted in cardiac deaths, possibly due to sildenafil potentiating the nitrate's hypotensive effects.28, 29
Few, if any, nationwide studies profiling sildenafil use are available. Little is known about the characteristics of sildenafil users and prescribers and the use of sildenafil for underlying etiologic reasons. In addition, there is a dearth of information on the effect of messaging on sildenafil use, whether through DTCA of sildenafil to younger males or reports of cardiac deaths related to sildenafil use. Thus, the purpose of this study was to profile sildenafil use in a random, nationwide sample of commercially insured, adult beneficiaries from 1998 to 2002.
Materials and methods
Data were extracted from five 1-year databases (1998–2002) constructed for research purposes by Express Scripts, Inc. (ESI). ESI provides pharmacy benefit management services, including network pharmacy claims processing, mail pharmacy services, and other pharmacy consultive services, to small and large employer, third-party administrator, government, union, and managed care organization health plans. The databases were constructed annually with ambulatory pharmacy claims and eligibility information from a random sample of ESI commercially insured (ie not Medicare+Choice, Medicaid) beneficiaries with integrated mail order and network pharmacy benefits. Each random sample was composed of approximately 14% of ESI beneficiaries with an integrated benefit. For example, in 2002, a random sample of 3 million subjects was drawn from approximately 21 million beneficiaries enrolled in over 1000 commercially insured health plans representing all 50 US states and the District of Columbia.
Individuals aged ≥18 y who were continuously eligible for subsidized pharmacy benefits during the year the database was constructed were used in the analysis, resulting in a final sample of over five million life-years. Subjects were categorized by age groups that were based on life stages that could affect the development of ED (ie 18–45, 46–55, 56–65 and >65 y).30 No patient-identifiable information was included in the study as only aggregate analyses were conducted.
Pharmacy claims for sildenafil were identified using the Generic Product Identifier code 40-30-40-70-10.31 Prevalence was defined as the frequency of one or more prescription claims for sildenafil (ie users) per 100 beneficiaries. Sildenafil users who had ≥2 pharmacy claims for an antidepressant, antidiabetic, anti-Parkinsonian, anticholinergic, sedating antihistamine, beta blocker, butyrophenones, clonidine, cyclobenzaprine, digoxin, finasteride, methyldopa, metoclopramide, orphenadrine, phenothiazines, propantheline, or thiazide diuretic over the respective years were classified as possibly having an underlying etiological reason (ie drug- or disease-induced ED) for being prescribed sildenafil.7, 9, 10, 11 Users whose first claim for sildenafil was in April were identified for each of the respective years and the number of tablets dispensed for the remainder of the year for these users was summed. This analysis facilitates the examination of naive users and their subsequent medication-taking behaviors (eg discontinuations due to adverse events). Healthcare providers who prescribed one or more sildenafil prescriptions were categorized as primary care (ie general practice, family practice, and internal medicine physicians), urology, and other.
Point prevalence and standard errors were estimated by gender and age groups for each year. Trend analyses (ie Poisson log-rate regression modeling), while controlling for gender, age, and possible homogeneity of subjects across random samples, was performed to determine trends in the prevalence of use over time.
Pharmacy claims from a total of 5 083 582 continuously eligible, adult beneficiaries were available for examination over the 5-year study period (Table 1). There was a slight increase in the absolute proportion of females in the sample overtime, but a 58% decrease in the proportion of females among sildenafil users over the 5 years. There was a 3.5% increase in the mean age of the sample, but a 4.6% decrease in the mean age of sildenafil users over the study period.
Overall, the prevalence of use of sildenafil grew among commercially insured beneficiaries from 0.77% in 1998 to 1.42% in 2002, an 84% increase (Table 2). A total of 162 490 prescriptions for sildenafil were dispensed to 48 164 patients over the 5 years of the study. The prevalence in males increased, while the prevalence in females decreased over the study period. The largest increase in absolute prevalence during the study period was found in males aged 46–55 y (2.32 percentage points). The largest decrease in absolute prevalence during the study period was found in females aged 56–65 y (0.08 percentage points).
After controlling for differences in gender and age and any homogeneity of subjects across random samples during the study period, there were significant trends in prevalence across age and gender strata over the 5 years (Table 3). Generally, the prevalence of use among females decreased, and males' prevalence increased relative to the first year sildenafil was marketed (1998). One exception was females aged 18-45 y, who experienced overall increased use over the study period (P<0.001). All groups except males aged 18–45 y experienced a decrease in use in 1999 (P<0.001). The largest increasing trends were found among younger males 18–45 y and 46–55 y, who experienced overall prevalence changes of 312 and 216%, respectively, over the study period (P<0.001). The largest decreasing trends were found among older females 56–65 and >65 y, who experienced overall prevalence changes of 48 and 63%, respectively, over the study period (P<0.001).
The mean number of sildenafil tablets dispensed per user per 9-month period declined slightly over the study period (Table 4). The use of sildenafil for a potential underlying etiologic reason declined in all age groups over the 5 years. Among all sildenafil users, use for a potential underlying etiologic reason decreased 11.5% from 1998 (45.2%) to 2002 (40.0%). Users aged 18–45 y had the lowest (33.1%) and >65 y had the highest (43.7%) proportion of use for a potential underlying etiologic reason in 2002. The largest absolute decrease in use for an underlying etiologic reason over the study period was found in males 18–45 y (8.5 percentage points).
The majority of sildenafil prescriptions were written by primary-care physicians in all 5 years of the study and that majority grew over the 5 years (Table 5). The proportion of sildenafil pharmacy claims attributed to urologists declined by nearly half, while the proportion attributed to other healthcare professionals increased slightly over the study period.
This is the first published study to profile trends in use of sildenafil using a diverse, nationwide database. Although the overall prevalence of sildenafil use increased substantially during the study period, certain categories of beneficiaries increased, while others decreased their prevalence of use. Use became more pronounced in younger males and females and decreased in older females, while the growth in use slowed in older males. The fastest growing segment of users was found to be males aged 18–45 y.
Our results were consistent with research in a regional sample of patients who found that prescribers of sildenafil were predominantly primary-care physicians.30 Also consistent with this research,30 we found that males in general and those aged 56 y and older specifically continued to receive the vast majority of sildenafil prescriptions. We found a decrease in prevalence among most groups in 1999, particularly among older males. This decrease coincided with the publicizing of cardiac deaths associated with the concomitant use of sildenafil and organic nitrates,28, 29 suggesting that among healthcare consumers and professionals, awareness of sildenafil's risks were heightened with this messaging.
We attempted to discern the prevalence of use for an underlying etiologic reason (ie medical necessity) in our sample by examining the concomitant use of medications that may be causative for drug-induced ED and/or are a marker for a disease that may be causative of ED. Certainly, not everyone with an ED-inducing medication claim was using sildenafil because of that medication. In addition, not all health conditions that are risk factors for ED (eg atherosclerosis, spinal cord injury) were examined. However, the decreasing proportion of sildenafil users with a claim for a suspected ED-inducing drug and/or a marker of a suspected ED-inducing disease suggests increased use of sildenafil as an enhancement/recreational agent.32, 33
Our observations of increased prevalence of use in younger beneficiaries and a decreased prevalence of concomitant use of medications that cause ED and/or are markers of ED-inducing diseases may be reflective of historical and/or healthcare reasons that may or may not be related to DTCA messaging. First, liberalization of pharmacy benefits with regard to sildenafil coverage may have stimulated use among less morbid and younger beneficiaries. This seems unlikely since plans have minimal incentive (eg pressure from patient advocacy groups) to provide less restrictive coverage for sildenafil.21 Second, a change in prescriber behavior whereby prescribers became more likely to prescribe sildenafil without the presence of a comorbid condition. This scenario may be related to healthcare providers' perceptions of patients' hopes of receiving a prescription30, 34 and/or the observed decreased proportion of sildenafil prescriptions prescribed by specialists.
Substantial debate continues in the healthcare sector over the coverage of ‘lifestyle’ medications.24, 35 With healthcare resources becoming more scarce, sildenafil has received considerable focus during this debate,25, 36, 37 perhaps owing to the perception of a low priority for ED treatment compared with other more pressing demands for healthcare dollars.22 The coverage of sildenafil by health plans remains a potpourri with some plans having no restrictions on coverage, others requiring prior authorization for ‘medical necessity’ and/or placing quantity limits, and others still offering no coverage.21, 37 Our finding of a stable mean number of tablets dispensed over the 5 years suggests that there was no substantial change in the use of quantity limits by plan sponsors.
Several factors should be considered when interpreting our findings. As in any analysis involving the use of administrative claims data, a claim does not indicate whether the patient actually took the medication. We did not have access to subjects' medical records; thus, we were unable to ascertain practitioner-reported etiologic reasons for sildenafil use. Our criteria for an underlying etiologic reason for use may not have contained an exhaustive list of medications that cause ED and/or are markers of ED-inducing diseases. However, we believe we utilized the most common and medically appropriate medications that induce ED and/or are markers of ED-inducing diseases.38 In addition, we were unable to control for changes in benefit designs, whereby health plans placed more or less restrictions on sildenafil coverage over the study period. However, there is no empirical evidence to suggest a systematic change in coverage status over these 5 years.
While research suggests the prevalence of ED ranges from 11 to 35% in males aged 40–70 y,2, 9, 39 we found that the prevalence of use of sildenafil only approached 7% in males aged 56–65 y. These findings suggest that the overall utilization of impotence agents will increase. In addition, our findings suggest that use may increase among younger male and female patients and those without an underlying etiologic reason for use. Future research is required to understand the reasons for the increased use of sildenafil among younger beneficiaries as well as to confirm a decreased use for underlying etiologic reasons.
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We express our appreciation to Dr Jagat Sheth for his assistance. This study was funded by Express Scripts, Inc.
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Delate, T., Simmons, V. & Motheral, B. Patterns of use of sildenafil among commercially insured adults in the United States: 1998–2002. Int J Impot Res 16, 313–318 (2004). https://doi.org/10.1038/sj.ijir.3901191
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