Current and future disease progression of the chronic HCV population in the United States.

Chronic hepatitis C virus (HCV) infection can lead to advanced liver disease (AdvLD), including cirrhosis, decompensated cirrhosis, and liver cancer. The aim of this study was to determine recent historical rates of HCV patient progression to AdvLD and to project AdvLD prevalence through 2015. We first determined total 2008 US chronic HCV prevalence from the National Health and Nutrition Evaluation Surveys. Next, we examined disease progression and associated non-pharmacological costs of diagnosed chronic HCV-infected patients between 2007-2009 in the IMS LifeLink and CMS Medicare claims databases. A projection model was developed to estimate AdvLD population growth through 2015 in patients diagnosed and undiagnosed as of 2008, using the 2007-2009 progression rates to generate a "worst case" projection of the HCV-related AdvLD population (i.e., scenario where HCV treatment is the same in the forecasted period as it was before 2009). We found that the total diagnosed chronic HCV population grew from 983,000 to 1.19 million in 2007-2009, with patients born from 1945-1964 accounting for 75.0% of all patients, 83.7% of AdvLD patients, and 79.2% of costs in 2009, indicating that HCV is primarily a disease of the "baby boomer" population. Non-pharmacological costs grew from $7.22 billion to $8.63 billion, with the majority of growth derived from the 60,000 new patients that developed AdvLD in 2007-2009, 91.5% of whom were born between 1945 and 1964. The projection model estimated the total AdvLD population would grow from 195,000 in 2008 to 601,000 in 2015, with 73.5% of new AdvLD cases from patients undiagnosed as of 2008. AdvLD prevalence in patients diagnosed as of 2008 was projected to grow 6.5% annually to 303,000 patients in 2015. These findings suggest that strategies to diagnose and treat HCV-infected patients are urgently needed to increase the likelihood that progression is interrupted, particularly for patients born from 1945-1964.

Effects of a Medicaid prior authorization policy for pregabalin.

OBJECTIVE: To explore the effect of a prior authorization (PA) policy restricting access to pregabalin for the management of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) on the overall utilization of pharmacologic therapy and healthcare services among fee-for-service Medicaid plan beneficiaries. STUDY DESIGN: Retrospective claims data were obtained for 2005 and 2006 from 6 state Medicaid programs. Two states that had implemented pregabalin PAs beginning in 2006 were compared in terms of drug utilization and costs with 4 states having no such restrictions. METHODS: Patients at least 18 years old in a Medicaid fee-for-service program having a diagnosis of DPN or PHN and at least 1 claim for DPN- or PHN-specific pain medication were selected. Pharmacologic therapy, healthcare utilization, and expenditures were analyzed using bivariate statistics and generalized linear models in a difference-in-difference approach for comparing outcomes between cohorts year over year. RESULTS: The 2 cohorts included 424 patients in the restricted states and 5153 patients in the unrestricted states. Compared with the use in the unrestricted states, the probability of pregabalin use in the restricted states decreased by 4.0 percentage points (P = .02) from 2005 to 2006, while the probability of opioid use increased by 6.5 percentage points (P <.01).The DPN- or PHN-related total healthcare costs were $418 higher for the restricted states versus the unrestricted states (P <.001). CONCLUSION: Although the PA was shown to effectively control access to pregabalin, the overall effect was an increase in the use of opioids and alternative pain management therapies associated with increased disease-related healthcare costs.

The erection hardness score and its relationship to successful sexual intercourse.

INTRODUCTION: The Erection Hardness Score (EHS), recently validated, was developed in 1998 as a simple (one-item) method to quantify erection outcome data. Although it is intuitive that erection hardness and successful sexual intercourse (SSI) are related, the link has not been directly established. OBJECTIVE: To evaluate the relationship between erection hardness (assessed by EHS) and SSI, establishing the EHS as a clinically useful tool. METHODS: The data set (N = 307) was from a multinational, double-blind, placebo-controlled trial (with open-label extension) of sildenafil citrate in men with erectile dysfunction. MAIN OUTCOME MEASURES: Event-based modeling used every intercourse attempt and the EHS to estimate the odds ratio of SSI between adjacent EHS categories. Mean-based modeling used mean EHS per patient to determine its relationship to percentage of SSI. Mediation-based modeling used mean EHS and mean percentage of SSI over the double-blind phase to estimate the direct effect of sildenafil treatment on SSI and the indirect effect of sildenafil treatment on SSI via erection hardness. RESULTS: The odds of SSI for EHS 3 (hard enough for penetration but not completely hard) were 41.9 times (95% confidence interval [CI], 33.0-53.2; P < 0.0001) that for EHS 2 (hard but not hard enough for penetration), and the odds of SSI for EHS 4 (completely hard and fully rigid) were 23.7 times (95% CI, 19.5-28.9; P < 0.0001) that for EHS 3. The percentage of SSI increased approximately curvilinearly with the increase in mean EHS, from almost 60% at EHS 3 to 78.5% at EHS 3.5 and to 93.1% at EHS 4. The indirect effect of sildenafil treatment on SSI via erection hardness accounted for almost 90% of the total effect on SSI (P < 0.0001). CONCLUSION: The close and direct relationship between erection hardness and SSI supports the broader use of the EHS-a simple, valid, reliable, and responsive measure-in clinical practice.

Importance of and satisfaction with sex among men and women worldwide: results of the global better sex survey.

INTRODUCTION: It is now increasingly recognized that sexual health is important to overall good health and well-being. AIM: The Global Better Sex Survey (GBSS) explored the sexual aspirations and unmet needs of men and women worldwide. MAIN OUTCOME MEASURES: Participant responses to survey questions. METHODS: Data were collected during 2005 in 27 countries by phone, door-to-door, and street-intercept interview. Data were weighted by demographic characteristics to accurately reflect the general population of each country. RESULTS: Of the 12,563 respondents (men = 6,291, women = 6,272), 46% of men and 48% of women were younger than 40 years, 41% were 40-59 years, and 11% were 60 years or older. Nearly all men (91%) and women (94%) were married, living with a partner, or in a relationship. All aspects of sex (intercourse, foreplay, orgasm, attraction to partner) were important to men and women. Nearly half (48%) of men surveyed reported some degree of erectile dysfunction (ED). A significant proportion of men (65%) were not very satisfied with their erection hardness (63% of women were not very satisfied with their partner's erection hardness). An association existed between satisfaction with erection hardness and satisfaction with sex life, love and romance, and overall health. Only 7% of men reported using a prescription medication for ED. However, 74% of men were willing to take medication to improve their erections if they thought they had ED; 64% of women would support such a decision. CONCLUSIONS: The GBSS reports the sexual needs and desires of men and women worldwide. Erectile function and the effect of ED on aspects of the sexual experience emerged as the most pressing concerns among male participants.

Evaluating the sexual experience in men: validation of the sexual experience questionnaire.

INTRODUCTION: The absence of a single brief measure that assesses function and health-related quality of life (HRQoL) hinders evaluation of the sexual experience in men with erectile dysfunction (ED). AIM: To psychometrically analyze the Sexual Experience Questionnaire (SEX-Q). METHODS: Two data sets were studied. A randomized, double-blind, placebo-controlled trial of flexible-dose sildenafil for ED treatment provided the final clinical trial data set (213 men enrolled, 4 of whom did not receive treatment) and the interim clinical trial data set (190 men screened and 165 men enrolled). The survey data set consisted of 902 respondents to a U.S. community health survey, of whom two-thirds had ED and one-third did not. MAIN OUTCOME MEASURES: Quality and distribution of responses, comparative fit, item-level discriminant testing, internal consistency (Cronbach alpha), test-retest reliability (intraclass correlation coefficient), known-groups validity (vs. International Index of Erectile Function [IIEF] ED severity groups), convergent validity (Pearson correlation coefficients with scores on the IIEF, Self-Esteem and Relationship [SEAR] questionnaire, and Quality of Erection Questionnaire [QEQ]), responsiveness, and clinically important difference (CID). RESULTS: The original 15 items were reduced to 12 items in three domains (erection, individual satisfaction, and couple satisfaction), which demonstrated good quality responses for all items; a strong factor structure; excellent internal consistency; good test-retest reliability; clear known-groups validity across the severity groups; moderate to strong convergent validity against the IIEF, SEAR, and QEQ; and high treatment responsiveness. The estimated CID ranged from 16.0 to 22.3 across domains. CONCLUSIONS: The SEX-Q is the first questionnaire to solely and exclusively combine functional and HRQoL concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience, making it a potentially useful measure for clinical trial research.

Validation of the erection hardness score.

INTRODUCTION: Erection hardness is a fundamental component of erectile function, and is a very specific and easily monitored outcome. The Erection Hardness Score (EHS) is a single-item, patient-reported outcome (PRO) for scoring erection hardness. AIMS: The aim of this article is to report the psychometric validation of the EHS. METHODS: The dataset (N = 307) was from a multinational sildenafil trial (efficacy in the treatment of erectile dysfunction [ED]) with a 2-week screening phase, a 6-week double-blind, placebo-controlled treatment phase, and a 6-week open-label extension. MAIN OUTCOME MEASURES: Test-retest reliability (intraclass correlation coefficient), quality and distribution of responses, known-groups validity (ability to differentiate between ED severity groups defined by the International Index of Erectile Function [IIEF] questionnaire), convergent validity (Pearson correlation coefficients with domain scores of the IIEF and the Quality of Erection Questionnaire [QEQ]), treatment responsiveness, and clinically important difference. RESULTS: The EHS demonstrated good test-retest reliability, acceptable quality and distribution of responses, known-groups validity against the IIEF (including clear differentiation between normal and impaired erectile function), moderate-to-strong convergent validity against the prespecified domains of the IIEF and QEQ, and high treatment responsiveness. CONCLUSION: The EHS has desirable measurement properties, including being highly responsive to treatment. This one-item PRO is robust and easy to use for evaluating erection hardness. Psychometric analysis supports the use of the EHS as a simple, reliable, and valid tool for the assessment of erection hardness in clinical trials research.

Factors that predict changing the type of phosphodiesterase type 5 inhibitor medication among men in the UK.

OBJECTIVE: To evaluate predictors of changing the type of phosphodiesterase type 5 (PDE5) inhibitor (switching) among men with erectile dysfunction (ED) in the UK, the largest consumer of PDE5 inhibitors in Europe, as switching medication is often associated with higher resource use, and there are three oral PDE5 inhibitor medications currently available. PATIENTS AND METHODS: Patients were identified from The Health Improvement Network database in the UK; men initiating therapy with sildenafil, tadalafil or vardenafil from May 2003 to August 2004 with >/= 6 months of prescription history before and after their initial PDE5 inhibitor prescription were included. Switching was evaluated as the proportion of second PDE5 inhibitor prescriptions that were for a drug differing from the first. Logistic regression was used to adjust for factors that might be associated with switching (dose, age and the presence of hypertension, dyslipidaemia, diabetes or depression). RESULTS: Of the 2703 eligible men who initiated PDE5 inhibitor treatment during the study period, 91 (3.4%) switched to a different PDE5 inhibitor at their second prescription. The choice of initial PDE5 inhibitor therapy was a highly significant predictor of switching; men initiated on sildenafil were less likely to switch than those initiated on tadalafil (P < 0.001) or vardenafil (P < 0.003). Age and the presence of comorbidities were not significantly associated with switching (P > 0.05). CONCLUSION: Initiating ED therapy with sildenafil was associated with the lowest rate of PDE5 inhibitor switching, which might reflect treatment satisfaction and patient preference.

Development and validation of the quality of erection questionnaire.

INTRODUCTION: There are no psychometrically validated assessment tools designed to solely and specifically evaluate satisfaction with the quality of erections. AIM: To develop and psychometrically analyze the Quality of Erection Questionnaire (QEQ), a new patient-reported measure developed to evaluate men's satisfaction with the quality of their erections. METHODS: The questionnaire was developed through in-depth qualitative interviews of men with erectile dysfunction (ED) in the United States and Australia. An exploratory methodology study was conducted on 65 men with ED. Subsequently, the psychometric properties were confirmed in a larger dataset of 558 men with ED from two combined clinical trials. MAIN OUTCOME MEASURES: Identification of potential redundancy or outliers in items (Pearson inter-item correlations); exploratory factor analysis (unrotated and varimax rotated); internal consistency (Cronbach's alpha); convergent validity (Pearson correlation coefficients between the QEQ total score and domain scores of the International Index of Erectile Function); known-groups validity (ability of the QEQ scores to differentiate between ED severity groups); test-retest reliability (Pearson correlation coefficient). RESULTS: The QEQ demonstrated excellent convergent and known-groups validity. Additional analysis demonstrated high internal consistency (Cronbach's alpha, 0.92). Item analysis demonstrated a unidimensional structure and suggested that satisfaction with hardness may be the key driver for satisfaction with overall quality of erections (r = 0.8). The smaller exploratory study demonstrated good test-retest reliability (r = 0.82). CONCLUSIONS: The QEQ is a six-item, patient-reported measure with a unidimensional structure, which produces a total score that may be transformed to a 0-100 scale. Psychometric analysis confirmed reliability and validity of the QEQ, which solely and specifically evaluates satisfaction of men with the quality of their erections. The QEQ is a potentially useful measure for monitoring and evaluating treatment in those who are bothered by, or concerned about, their erectile function.

Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial.

INTRODUCTION: Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. AIM: We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR). METHODS: This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) international study of sildenafil in men > or =18 years of age in Mexico, Brazil, Australia, and Japan. MAIN OUTCOME MEASURES: The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment. RESULTS: Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60-0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy. CONCLUSIONS: Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil.

A pharmacoeconomic evaluation of 7-valent pneumococcal conjugate vaccine in Canada.

The objective of this study was to evaluate the projected health benefits, costs, and cost-effectiveness of pneumococcal conjugate vaccination for infants and children aged <5 years in Canada. A health state model incorporating incidence, vaccine efficacy, costs, and transitional probabilities for the health states (well, meningitis, bacteremia, otitis media, pneumonia, and death) was constructed for a 10-year time horizon. Implementation of a pneumococcal conjugate vaccine program in Canada for each annual birth cohort of 340,000 persons observed over 10 years would be expected to save approximately 12 lives and 100,000 cases of pneumococcal disease over 10 years, resulting in total savings of $67 million (Canadian dollars [Can$]). Vaccination of healthy infants would result in net savings for society if the vaccine costs less than Can$50 per dose. Moreover, for a vaccine purchase price of Can$67.50, infant vaccination would cost society Can$79,000 per life-year gained. Pneumococcal conjugate vaccination is a potentially cost-effective means of pneumococcal disease prevention.