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Biomedical subjects

Geoff Hackett

Publications and source records attributed to Geoff Hackett.

4 recordsLinked to original sources
PubMed2006

Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): a randomized, double-blind, placebo-controlled trial in PDE5 inhibitor-naïve men with ED and their partners.

INTRODUCTION: Erectile dysfunction (ED) is a common condition with diverse sequelae affecting men and their women partners. AIM: The FINDER study aimed to evaluate the efficacy and tolerability of the phosphodiesterase type-5 (PDE5) inhibitor, vardenafil, in a broad population of PDE5-naïve men with ED of different etiologies and severity and included their partners' assessments of treatment with vardenafil. METHODS: Men with ED (N = 260) were randomized to receive either vardenafil or placebo in a multicenter, flexible-dose study. MAIN OUTCOME MEASURES: Primary efficacy variables were patients' responses to the Global Assessment Question (GAQ), and Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3). RESULTS: Compared with placebo, vardenafil significantly improved rates of successful "Yes" responses to SEP3 ("Did your erection last long enough for you to have successful intercourse?") (49% placebo vs. 78% vardenafil at last period carried forward [LPCF]; P < 0.0001), SEP2 ("Were you able to insert your penis into your partner's vagina?") (65% placebo vs. 85% vardenafil at LPCF; P < 0.0001), and GAQ (36% placebo vs. 83% vardenafil at last observation carried forward; P < 0.0001). In addition, patients' and their partners' Treatment Satisfaction Scale (TSS) scores were statistically significantly improved across each of the TSS domains (satisfaction with orgasm, ease with erection, confidence, pleasure, erectile function satisfaction, and satisfaction with medication) in the vardenafil group compared with the placebo group. CONCLUSIONS: Vardenafil improved sexual function to the extent that both patients and their partners expressed a considerable and agreed level of satisfaction with treatment.

Adult↗
PubMed2004

Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction.

OBJECTIVE: To evaluate, in a randomized, double-blind, placebo-controlled, multicentre trial, the safety and efficacy of on-demand tadalafil (an oral phosphodiesterase type-5 inhibitor approved in many countries for treating erectile dysfunction, ED) in a Western European population of men with mild-to-severe ED. PATIENTS AND METHODS: Patients were randomized according to baseline severity of ED in a ratio of 3 : 1 to receive either tadalafil 20 mg or placebo for 12 weeks. Primary efficacy endpoints were mean changes from baseline to endpoint (12 weeks) in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and percentages of 'Yes' responses to Sexual Encounter Profile (SEP) diary Question 2 ('Were you able to insert your penis into your partner's vagina?') and Question 3 ('Did your erection last long enough for you to have successful intercourse?'). Secondary endpoints included mean changes from baseline to endpoint in IIEF Intercourse Satisfaction and Overall Satisfaction domains, selected questions of the IIEF, and the percentage of 'Yes' responses to Global Assessment Questions (GAQ) at the last visit. Other analyses included the percentage of patients in each treatment group at endpoint with IIEF EF domain scores in the normal range (>26), the frequency of intercourse attempts and mean per-patient intercourse success rate at various times after dosing. RESULTS: The mean age of the patients was 53 years and 80% had a history of ED of > or = 1 year. The mean baseline EF domain score was 13.5, with 40.5% of patients in the severe category. Tadalafil improved mean EF domain scores by 11.1, vs 0.4 for placebo (P < 0.001). In addition, 73.9% of sexual intercourse attempts were successful (SEP-Q3) in tadalafil-treated patients, compared with 29.9% in placebo-treated patients during the period after baseline (P < 0.001). Tadalafil significantly improved the mean IIEF intercourse satisfaction (5.1, tadalafil; 1.1, placebo) and overall satisfaction domain scores (3.9, tadalafil; 0.5, placebo), P < 0.001. GAQs used to assess the overall effect of the treatment indicated that tadalafil was superior to placebo (P < 0.001) in improving erections (82.1%, tadalafil; 23.1%, placebo) and sexual activity (78.6% and 17.3%). The most common treatment-emergent adverse events more frequent (>2%) with tadalafil than placebo were headache, dyspepsia, flushing, back pain, pain in limb and myalgia. These adverse events were mostly mild to moderate. CONCLUSIONS: Tadalafil improved erectile function and was well tolerated when taken by men from Western Europe with mild-to-severe ED.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2002

The cost to the United Kingdom National Health Service of managing erectile dysfunction: the impact of sildenafil and prescribing restrictions.

OBJECTIVE: To estimate the annual direct cost of managing erectile dysfunction (ED) to the UK National Health Service (NHS) and to examine the impact of the introduction of sildenafil in 1998 and Schedule 11 restrictions in 1999. DESIGN: A prevalence-based cost-of-illness approach was used. The period 1997 to 2000 was covered. The numbers of ED prescriptions, prosthesis implantations and general practitioner (GP) consultations were retrieved retrospectively from UK resource utilisation databases. The number of specialist consultations and psychosexual therapy sessions were estimated from NHS clinic data. National resource unit costs were applied. MAIN OUTCOMES AND RESULTS: Between 1997 and 2000 the number of men presenting with ED increased from 79,800 to 257,984. The cost to the NHS increased from pounds sterling 29.4 million to pounds sterling 73.8 million (2000 estimates). The cost per patient fell from pounds sterling 368 to pounds sterling 286. In 1997, most NHS costs came from psychosexual therapy (30.7%), specialist consultations (20.2%) and intracavernosal injections (26.6%). By 2000, NHS costs came primarily from specialist consultations (32.0%), sildenafil prescriptions (26.2%), psychosexual therapy (13.6%) and GP consultations (12.0%). The annual cost was most sensitive to the number of drug prescriptions and specialist consultations. CONCLUSIONS: The increased NHS cost of managing ED was due mainly to a three-fold increase in the number of men presenting to GPs, substantial numbers of whom were then referred for specialist consultations under Schedule 11 restrictions. This naturally resulted in the increased use of all resources including sildenafil. The cost effectiveness of transferring prescribing responsibility in cases of severe distress from specialists to GPs in primary care remains to be determined.

Cost of Illness↗