730

HEALTH RELATED QUALITY OF LIFE OUTCOMES AFTER ANATOMIC RETROPUBIC RADICAL PROSTATECTOMY: IMPACT OF NEUROVASCULAR BUNDLE PRESERVATION

Stephen J Freedland*, Michael C Haffner, Patricia K Landis, Baltimore, MD; Christopher S Saigal, Los Angeles, CA; H Ballentine Carter, Baltimore, MD

INTRODUCTION AND OBJECTIVE: All treatment options for prostate cancer can impact upon health-related quality of life (HRQOL). The impact of neurovascular bundle preservation on longitudinal HRQOL outcomes after anatomic radical retropubic prostatectomy (RP) using validated questionnaires has been poorly studied.

METHODS: Of the 342 patients that underwent RP by a single high volume surgeon, 69 (20%) and 258 (75%) and had one or both neurovascular bundles preserved, respectively. Patient reported sexual and urinary HRQOL was assessed at baseline and at 3, 6, 12, and 24 months after surgery using the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI). Time to return to baseline urinary and sexual function and bother were compared between the nerve-sparing groups using a Cox proportional hazards regression model.

RESULTS: After adjustment for age and baseline sexual function, bilateral nerve-sparing was associated with higher sexual function scores than unilateral nerve-sparing at all time points, though the differences only approached or reached statistical significance at 3 (p=0.06) and 6 months (p=0.04) post RP. The 24-month likelihood of returning to baseline sexual function was 51% (95% CI 39 - 65%) among men who underwent bilateral nerve-sparing RP compared to 32% (95% CI 17 - 55%) among men who underwent unilateral nerve-sparing RP (p=0.06). On multivariable analysis, there was a trend for earlier return to baseline sexual function among men who received a bilateral nerve-sparing RP (HR 1.67, 95% CI 0.88 - 3.17, p=0.12), though this did not reach statistical significance. Over 90% of men returned to their baseline urinary function and bother, regardless of nerve-sparing status.

CONCLUSIONS: In the current study, bilateral neurovascular preservation was associated with better post-operative sexual HRQOL scores than unilateral neurovascular preservation, though in general the differences were slight and not statistically significant. Despite preservation of both neurovascular bundles, declines in sexual HRQOL are common after RP.

731

SILDENAFIL (VIAGRA®) IMPROVES CUTANEOUS MICROCIRCULATION IN PATIENTS WITH CORONARY ARTERY DISEASE: A PROSPECTIVE RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CROSS-OVER STUDY

Jai-Wun Park*, Christof Mrowietz, Ulrich Gerk, Friedrich Jung, Hoyerswerda, Germany

INTRODUCTION AND OBJECTIVE: Patients with coronary artery disease (CAD) present a microcirculation disturbance in finger nailfold capillaries due to endothelial dysfunction of the precapillary arterioles. Sildenafil, an effective drug for erectile as well as endothelial dysfunction, may influence the cutaneous microcirculation in CAD patients.

METHODS: To investigate the effect of sildenafil on microcirculation we measured the perfusion in finger nailfold capillaries in 20 CAD patients (age 63.5±6.3 yrs) in a prospective, randomized, double-blind, cross-over fashion (50mg of sildenafil vs placebo). Using intravital microscopy the mean erythrocyte velocity in nailfold capillaries was measured under resting conditions (Vbaseline) and after three minutes of suprasystolic upper arm compression. The confirmatory goal parameter was the difference of the amplitude of the reactive hyperemia (Vpeak) before and one hour after the application of 50mg sildenafil or placebo, respectively.

RESULTS: Sildenafil caused an increase of Vpeak in the phase of post-ischemic reactive hyperemia (0.85±0.42 mm/s vs 0.58±0.18 mm/s, p=0.0023; 46.6%) with a standardized difference (according to COHEN) of 0.81 indicating a strong biometrical relevancy. After placebo Vpeak did not change (0.62±0.18 mm/s vs 0.59±0.18 mm/s, n.s.). Furtheremore, sildenafil increased Vbaseline (0.42±0.19 mm/s vs 0.31±0.12 mm/s, p=0.005), whereas placebo did not (0.31±0.11 mm/s vs 0.29±0.08 mm/s, n.s.).

CONCLUSIONS: In CAD patients sildenafil significantly improved the endothelial dysfunction of precapillary arterioles resulting in a strong increase of the post-ischemic reactive hyperemia in cutaneous capillaries.Our results confirm the hypothesis that PDE-5 inhibitors improve the endothelial dysfunction of the human vasculature in general.

732

CO-PRESCRIPTION OF PHOSPHODIESTERASE-5 INHIBITORS AND NITRATES

Charles D Scales*, Lesley H Curtis, Raymond G Woosley, W Patrick Springhart, Roger L Sur, Regina D Norris, Kevin A Schulman, Craig F Donatucci, David M Albala, Durham, NC

INTRODUCTION AND OBJECTIVE: Recent research has highlighted the potentially serious adverse effects of medication interactions, particularly among older patients. For example, sildenafil use is contraindicated in patients taking nitrate medications because of the risk for potentially harmful decreases in blood pressure. The objective of this study was to estimate the dispensation rate of interacting medications to an outpatient population.

METHODS: De-identified prescription claims data for 4,825,345 subjects in 1999 were obtained from a large pharmacy benefits management (PBM) company. Overlapping claims (7-day) for drugs that should always be avoided (Class 1 Interactions) were identified. The frequency of such claims was tabulated by level of interaction and by specific drugs.

RESULTS: There were 808,786 patients with at least two oral prescription drug claims. Among these patients, 399 (0.05%) filed claims with a Class 1 interaction. In this group, 263 patients (65.9%) filed claims for sildenafil and a nitrate medication, the largest single group of patients. Of a total of 660 overlapping prescription claims for drug combinations with Class 1 interactions, 199 (30.2%) were for sildenafil and nitroglycerin, and 127 (19.2%) were for sildenafil and isosorbide nitrates.

CONCLUSIONS: In this patient sample, the rate of overlapping prescriptions with Level 1 interactions was low (0.05%). However, fully two-thirds of patients with overlapping claims for medications with potential Level 1 interactions received prescriptions for sildenafil and a nitrate. This finding underscores the need for physicians prescribing nitrates or phosphodiesterase-5 inhibitors to carefully review patient medical history in order to avoid potentially serious adverse interactions.

Read Male / Female Sexual Dysfunction Selected Abstracts - Part 2

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