Avanish Mishra

Bio: Avanish Mishra is an academic researcher from Pfizer. The author has contributed to research in topics: Sexual function & Erectile dysfunction. The author has an hindex of 6, co-authored 6 publications receiving 5663 citations.

Quality of life in patients with spinal cord injury receiving Viagra (sildenafil citrate) for the treatment of erectile dysfunction.

Abstract: Study design: A multicenter, randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover study conducted June 1996 through January 1997. Objectives: To evaluate the effect of sildenafil citrate (VIAGRA®) on the quality of life (QoL) of men with erectile dysfunction (ED) caused by spinal cord injury (SCI). Setting: Study centers in Australia, Belgium, France, Germany, Norway, Sweden and the United Kingdom. Methods: Questions 13 and 14 of the 15-item International Index of Erectile Function (IIEF) addressed QoL issues directly related to ED in 178 men with SCI. A 5-item questionnaire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Several commonly used psychometric instruments, including the Medical Outcomes Survey (MOS) Short Form-12, Psychological General Well-Being Index, and MOS Family Survey, assessed general QoL issues. Results: Significant improvements were seen for overall satisfaction with sex life (IIEF Q13), sexual relationship with partner (IIEF Q14), and concerns about erectile problems (P<0.0001). Improvements were reported in scores for the generic QoL parameters of mental health, well-being, depression, and anxiety (P<0.05 sildenafil versus placebo). Conclusion: Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI. Sponsorship: This study was funded by Pfizer Inc.

Efficacy results and quality-of-life measures in men receiving sildenafil citrate for the treatment of erectile dysfunction.

Abstract: The aim of the present study was to evaluate the efficacy of sildenafil citrate and its effects on quality of life (QoL) in men with erectile dysfunction (ED) using data from three multicenter, double-blind, placebo-controlled clinical trials. Efficacy was evaluated using a global efficacy question (improvement of erections) and questions from the International Index of Erectile Function (IIEF) addressing the ability to achieve and maintain erections. QoL directly related to ED was evaluated using questions 13 and 14 of the IIEF, several psychometric instruments, and a questionnaire addressing men's concerns about their erection problems. Seventy-nine [corrected] percent of patients receiving sildenafil reported improved erections compared with 23% of patients receiving placebo (p < 0.0001); also reported were improvements in the ability to achieve and maintain erections with sildenafil but not with placebo (p < 0.0001). Improvements were also seen for other aspects of sexual function (overall satisfaction with sex life, sexual relationships with partners, concerns about erectile problems, p < 0.0001) and general mental health (well-being, self-control, satisfaction with relationship, health relative to 1 year ago, mental health; p < or = 0.05) following treatment with sildenafil. Thus, treatment of ED with sildenafil can significantly improve key QoL parameters related to sexual dysfunction and general mental health.

Some Developments on the International Index of Erectile Function (IIEF)

Abstract: This manuscript covers two complementary topics. For both topics, data from clinical studies and control samples were used. The first topic provides an overview of the development and validation of the International Index of Erectile Function (IIEF), a 15-item questionnaire, for male erectile and sexual function. A principal components analysis revealed five factors (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF demonstrated reliability, validity, and sensitivity and specificity with regard to treatment effect. The second topic presents, among men who reported having had sexual intercourse, the methodology and results on the evaluation of the erectile function (EF) domain of the IIEF, which has a range of scores from 6–30 for these men, as a diagnostic tool to help discriminate between men with and without erectile dysfunction (ED). For a prevalence rate of ED equal to 0.5 in a clinical population, the Classification and Regression Trees program gave a cutoff score of 25: men with EF scores of 25 or less were retrospectively classified as having ED, while those with scores above 25 were classified as not having ED (sensitivity = 0.97, specificity = 0.88). The IIEF has been developed and validated as a scale that is reliable, brief, self-administered, and psychometrically sound. Its EF domain showed desirable diagnostic properties. More research is encouraged in this area.

The Female Sexual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Female Sexual Function

Abstract: This article presents the development of a brief, self-report measure of female sexual function. Initial face validity testing of questionnaire items, identified by an expert panel, was followed by a study aimed at further refining the questionnaire. It was administered to 131 normal controls and 128 age-matched subjects with female sexual arousal disorder (FSAD) at five research centers. Based on clinical interpretations of a principal components analysis, a 6- domain structure was identified, which included desire, subjective arousal, lubrication, orgasm, satisfaction, and pain. Overall test-retest reliability coefficients were high for each of the individual domains (r=0.79 to 0.86) and a high degree of internal consistency was observed (Cronbach’s alpha values of 0.82 and higher) Good construct validity was demonstrated by highly significant mean difference scores between the FSAD and control groups for each of the domains (p<0.001). Additionally, divergent validity with a scale of marital satisfactio...

Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction.

Abstract: An abridged five-item version of the 15-item International Index of Erectile Function (IIEF) was developed (IIEF-5) to diagnose the presence and severity of erectile dysfunction (ED). The five items selected were based on ability to identify the presence or absence of ED and on adherence to the National Institute of Health’s definition of ED. These items focused on erectile function and intercourse satisfaction. For 1152 men (1036 with ED, 116 controls) analyzed, a receiver operating characteristic curve indicated that the IIEF-5 is an excellent diagnostic test. Based on equal misclassification rates of ED and no ED, a cutoff score of 21 (range of scores, 5‐25) discriminated best (sensitivitya 0.98, specificitya 0.88). ED was classified into five severity levels, ranging from none (22‐25) through severe (5‐7). Substantial agreement existed between the predicted and ‘true’ ED classes (weighted kappaa 0.82). These data suggest that the IIEF-5 possesses favorable properties for detecting the presence and severity of ED.

Drug repositioning: identifying and developing new uses for existing drugs

Abstract: Biopharmaceutical companies attempting to increase productivity through novel discovery technologies have fallen short of achieving the desired results. Repositioning existing drugs for new indications could deliver the productivity increases that the industry needs while shifting the locus of production to biotechnology companies. More and more companies are scanning the existing pharmacopoeia for repositioning candidates, and the number of repositioning success stories is increasing.

Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group.

Abstract: BACKGROUND Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes. METHODS In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. RESULTS In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study. CONCLUSIONS Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction.