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At least 127 records · Page 7Linked to original sources

Feline penile erection induced by topical glans penis application of combination alprostadil and SEPA (Topiglan).

The objective of this study was to evaluate the efficacy of topically applied prostaglandin E1 (PGE(1))+5% SEPA (soft enhancement of percutaneous absorption) on the glans penis in a feline erection model. Erectile response after glans penis administration of PGE(1)+5% SEPA cream (Topiglan, MacroChem Co., Lexington, MA, USA) was compared to the erectile response after intracavernosal administration of the triple-drug combination (1.65 mg papaverine, 25 microg phentolamine, and 0.5 microg PGE(1)). The placebo cream and increasing concentrations (0.25%, 2.5 mg/ml; 0.5%, 5 mg/ml; and 1%, 10 mg/ml) of PGE(1)+5% SEPA were applied in a total volume of 0.1 ml via a plastic needle-less syringe. The control triple-drug combination was administrated intracavernosally via a 30-gauge needle at the completion of each experiment to serve as a control reference. With each application of placebo, PGE(1)+SEPA, and the triple-drug combination, changes in intracavernosal pressure and systemic blood pressure were continuously monitored. Topical application of PGE(1)+SEPA induced increases in intracavernosal pressure in a dose-dependent manner, with minimal effects on systemic blood pressure. The increases obtained with 1% PGE(1) Topiglan cream were similar to the intracavernosal pressure values elicited by the standard intracavernosal triple-drug combination. These data demonstrate that topical glans penis application of PGE(1)+SEPA can induce an erectile response in cats with minimal systemic adverse effects. Oral pharmacological agents are the first-line treatment for male ED. Studies investigating the effectiveness of noninvasive modalities such as topical therapy should continue, because these agents have the potential to avoid the systemic effects commonly seen with oral therapies. Additionally, topical therapy may also benefit patients who are unresponsive to oral agents or have explicit contraindications. Topical PGE(1) application to the glans penis may become an important treatment option in selected patients suffering from erectile dysfunction.

Adjuvants, Pharmaceutic↗

Intracavernosal versus intraurethral alprostadil: a prospective randomized study.

OBJECTIVE: To compare the medicated urethral system for erection (MUSE) with standard intracavernosal prostaglandin E1 (PGE1) in the treatment of erectile dysfunction. PATIENTS AND METHODS: Sixty consecutive men with organic erectile dysfunction were prospectively randomized to receive either 20 microg of intracavernosal PGE1 (group 1, 30 patients) or 1 mg MUSE (group 2, 30 patients). Response to the drugs was recorded in the outpatient clinic and all patients continued a home-treatment programme for 3 months. After each home administration, patients recorded the grade of erection in diaries, whether or not sexual intercourse occurred and any adverse reactions to the drugs. Comfort and ease of administration were also recorded. RESULTS: The characteristics of the patients of both groups were similar; 10 patients in group 1 and 25 in group 2 completed the 3-month treatment programme, i.e. a withdrawal rate of 67% and 17% for groups 1 and 2, respectively (P<0.05). During outpatient dosing, 27 (90%) patients in group 1 and 18 (60%) patients in group 2 achieved a good erection (P<0.05). Intercourse during the 3 months of home treatment was reported at least once in 26 (87%) patients in group 1, compared with 16 (53%) patients in group 2 (P<0.05). After 3 months of home treatment, patients had administered a total of 242 doses of intracavernosal PGE1 and 360 doses of MUSE; intercourse was reported after 206 (85%) and 198 (55%) administrations of PGE1 and MUSE, respectively (P<0.05). The most common adverse reaction was urogenital pain, reported by 14 (47%) patients in group 1 and two (7%) patients in group 2 (P<0.05). Home treatment was assessed as easy by 12 (40%) patients in group 1 and 27 (90%) in group 2 (P<0. 05). CONCLUSION: Although MUSE is less effective than intracavernosal PGE1, it is more attractive and accepted well by most patients as an easy method of treatment with minimal or no discomfort.

Alprostadil↗

Safety of prostaglandin E1 for the treatment of peripheral arterial occlusive disease in patients with congestive heart failure. The Alprostadil Investigators.

OBJECTIVES: To confirm the safety of prostaglandin E ( 1 ) (PGE ( 1 ) ) when administered in 100 mL normal saline to patients with severe peripheral occlusive disease (PAOD; Fontaine class III or IV) and concomitant compensated chronic congestive heart failure (CHF) and to explore possible hemodynamic benefits of PGE ( 1 ) in CHF. BACKGROUND: PGE ( 1 ) has been found to be effective in the treatment of severe PAOD. The agent may beneficially affect left ventricular performance or hemodynamics in patients with CHF. However, it must be administered intravenously (in saline diluent, adding potential hazard in patients with volume CHF). METHODS: In a randomized, double-blinded protocol, 50 patients received intravenous (i.v.) infusion of either 60 microg PGE ( 1 ) or placebo, each dissolved in 100 mL saline solution administered over 2 hours each day for 14 days. During the succeeding 14 days, i.v. PGE ( 1 ) was administered to all patients in open-label fashion. Safety was assessed by clinical evaluation of symptoms and signs of CHF or other adverse events, by catheter-based and echocardiographic search for objective cardiac functional influences, and by echocardiogram monitoring for cardiac rhythm. PAOD status also was defined. RESULTS: No evidence of clinical or objective cardiac functional influence was detected. With the usual dosage approved in PAOD, no significant influence on cardiac performance was observed. CONCLUSION: PGE ( 1 ) is safe for treatment of PAOD in patients with concomitant chronic, compensated CHF.

Adult↗

Dose proportional pharmacokinetics of alprostadil (prostaglandin E1) in healthy volunteers following intravenous infusion.

Prostaglandin E1 (PGE1) (30, 60, 120 micrograms) was administered by intravenous infusion over a 120 min period in an open, three way randomized, cross-over study to 12 healthy male volunteers. For the evaluation of PGE1, PGE0 and 15-keto-PGE0, blood samples were drawn prior to, during and after the infusion. Analytical measurements were performed by gas chromatography/negative ion chemical ionization triple stage quadruple mass spectrometry, a highly specific and sensitive GC/MS/MS-method. During intravenous infusion of 30, 60 and 120 micrograms PGE1, endogenous plasma PGE1 concentrations increased from 1.7 +/- 0.8 to 4.2 +/- 1.1, 6.7 +/- 1.0 and 11.0 +/- 1.9 pg ml-1 respectively. PGE0 plasma concentrations increased from endogenous levels of 1.3 +/- 1.0 pg ml-1 to 7.6 +/- 2.1, 14.1 +/- 3.7 and 28.0 +/- 3.0 pg ml-1 respectively, whilst 15-keto-PGE0 plasma concentrations increased from endogenous levels of 10.2 +/- 13.9 pg ml-1 to 99.3 +/- 27.9, 190.4 +/- 52.5 and 357.2 +/- 72.6 pg ml-1 respectively. Within the dose range of 30-120 micrograms PGE1 2 h-1 there was a linear increase of Cmax and AUC with the dose. The results of the analysis of variance after baseline and dose-correction show a 90% confidence interval in the bioequivalence acceptance range of 80 to 125%.

Adult↗