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PubMed2003

Alprostadil suppresses angiogenesis in vitro and in vivo in the murine Matrigel plug assay.

1. Prostaglandin E(1) (PGE(1), alprostadil) is used as a vasodilator for the treatment of peripheral vascular diseases. 2. Previous reports suggested a pro-angiogenic effect for PGE(1). 3. We studied the in vitro and in vivo effect of PGE(1), complexed with alpha-cyclodextrin, on the angiogenic process. Contrary to what was expected, we found that, in human umbilical vein endothelial cells (HUVECs), PGE(1) inhibited proliferation, migration and capillary-like structure formation in Matrigel. 4. By RT-PCR studies, the expression of the EP(2) and EP(3) subtypes of the PG receptor was detected in HUVECs. 5. PGE(1) alone stimulated adenylate cyclase activity at micromolar concentrations, while at nanomolar concentrations potentiated the forskolin-induced cAMP accumulation. 6. 8-Bromoadenosine-3':5'-cyclic monophosphate (Br-cAMP) mimicked the inhibitory effect of PGE(1) on endothelial cell growth, motility and tube formation. 7. Sulprostone, an agonist at the EP(3) subtype of PG receptors, mimicked the in vitro anti-angiogenic effects of PGE(1), while butaprost, an EP(2) receptor agonist, had no effect. 8. Finally, in the plug assay model of angiogenesis in mice, PGE(1) showed a strong inhibitory effect on Matrigel neovascularization. 9. Thus, PGE(1) possesses strong anti-angiogenic activity in vitro and in vivo.

Alprostadil↗
PubMed2000

Use of transurethral alprostadil (MUSE) (prostaglandin E1) for glans tumescence in a patient with penile prosthesis.

The presence of communication between the emissary veins from the corpora cavernosa and the circumflex veins draining the corpus spongiosum makes it possible for the transfer of alprostadil (prostaglandin E1) in MUSE from the spongiosal compartment to the cavernosal compartment of the penis after its absorption through the urethral mucosa. This leads to engorgement and tumescence of the corpus spongiosum as well as the corpora cavernosa. Lack of tumescence of the glans penis and poor penile girth can be a cause for disappointment and frustration in patients following penile prosthetic surgery. MUSE was used successfully in a patient with a Dynaflex penile prosthesis to enhance the tumescence of the glans penis. It will be a useful adjunct for patients in similar circumstances.

Alprostadil↗
PubMed2000

Optimizing the therapeutic approach of transurethral alprostadil.

OBJECTIVE: To investigate the efficacy and safety of two different starting doses of transurethral alprostadil (250 microg and 500 microg, MUSE, Vivus Inc., Menlo Park, CA, USA, and Astra Läkemedel AB, Södertälje, Sweden) and the need for dose titration in a general population with erectile dysfunction. PATIENTS AND METHODS: In a 12-week randomized and open multicentre study with parallel groups, 166 patients were randomised to a starting dose of either 250 or 500 microg of MUSE and evaluated for safety. Of these patients, 142 were included in the analysis of efficacy. MUSE marked in four doses (125, 250, 500 and 1000 microg) was supplied and during the trial the dose could be increased or decreased step-wise until a satisfactory response was attained. The efficacy was assessed using the Erection Assessment Scale (EAS), as coitus (by diary) and the International Index of Erectile Function. RESULTS: The lowest dose of MUSE with which the patients achieved at least one EAS score of 4 or 5 was 125 microg for 1% of participants, 250 ++microg for 27%, 500 microg for 32%, 1000 microg for 6%, and finally 1000 microg plus a pubic band for 8%. Thirty-five of the 142 patients (25%) did not report an EAS of 4 or 5. Most patients (> 60%) achieved an EAS of 4 or 5 on the lower doses (125, 250 and 500 microg). Almost all patients who had an EAS score of 4 or 5 also had intercourse. In all, 68% reported sexual intercourse at least once in course of the study. More patients reported penile pain while treated with 500 microg than with 250 microg (P < 0.05) during the first 4 weeks. However, the penile pain was severe in very few men and it was a minor problem. Hypotensive symptoms were reported six times, independently of dose level. The administration of MUSE was generally rated as comfortable. No patients reported urethral stricture, penile fibrosis, or priapism either in the clinic or at home. CONCLUSION: Recommending 500 microg as a starting dose increased the percentage of patients reporting at least one EAS of 4-5, with or without sexual intercourse, from 28% to 60%. No serious dose-related systemic effects were seen. When starting on 500 microg, patients were more likely to find directly the dose that gave sufficient response and treatment satisfaction. We suggest that the appropriate starting dose of MUSE should be 500 microg.

Adult↗
PubMed2002

Inhibitory effects of alprostadil (prostaglandin E1) incorporated in lipid microspheres of soybean oil on intimal hyperplasia following balloon injury in rabbits.

The present study was performed to assess the inhibitory effects of alprostadil (CAS 745-65-3, prostaglandin E1, PGE1) incorporated in lipid microspheres (here-in-after referred to as lipo PGE1; Palux inj.) on intimal thickening following balloon injury in the carotid artery of normal rabbits. Lipo PGE1 was given intravenously to animals twice a day at doses of 20 or 40 micrograms/kg/day from ballooning (day 1) until day 3, and at half these doses from day 4 to day 20. The carotid artery was removed for histopathological staining on the next day (day 21) after the last administration. Lipo PGE1 significantly reduced both the intimal/medial are (I/M) ratio and stenosis ratio by about half in the 40 micrograms/kg/day on day 21 after ballooning, compared with the vehicle group. Infiltration of macrophage, expression of proliferating cell nuclear antigen (PCNA)-positive cells was inhibited by the administration of lipo PGE1 on day 3 after ballooning. Adhesion of platelets to injured arterial walls was also inhibited on day 3. Lipo PGE1 at 40 micrograms/kg/day exerted more potent inhibitory effects on I/M and stenosis ratios and histopathological changes such as infiltration of macrophage and expression of PCNA-positive cells than at 20 micrograms/kg/day. These findings suggest that lipo PGE1 inhibits the intimal hyperplasia after balloon injury in rabbit carotid artery, possibly by inhibiting platelet functions.

Alprostadil↗
PubMed2003

Duplex Doppler ultrasound assessment of clitoral hemodynamics after topical administration of alprostadil in women with arousal and orgasmic disorders.

There are limited hemodynamic data in women with arousal or orgasmic disorders and even fewer normative control hemodynamic data in women without sexual dysfunction. In addition, there is limited experience with topical vasoactive agents (used to maximize genital smooth muscle relaxation) applied to the external genitalia during hemodynamic evaluations. The aim of this study was to report duplex Doppler ultrasound clitoral cavernosal arterial changes before and after topical PGE-1 (Alprostadil) administration in control women and in patients with arousal and orgasmic sexual disorders. We found that women with sexual arousal and orgasmic disorders had significantly (p < 0.05) diminished clitoral peak systolic and end diastolic velocity responses compared to controls. Further research is needed to establish the diagnostic role of topical vasoactive agents in the hemodynamic evaluation of women with sexual dysfunction.

Administration, Topical↗
PubMed1998

Disappointing initial results with transurethral alprostadil for erectile dysfunction in a urology practice setting.

PURPOSE: We evaluate the response to intraurethral alprostadil administration using the Medicated Urethral System for Erection (MUSE) in unselect men with a history of erectile dysfunction. We determine the effects on blood pressure during in office monitoring and assess safety of this form of treatment. We compare the efficacy of MUSE in an office setting with the placebo controlled pivotal study. MATERIALS AND METHODS: A total of 115 men with erectile dysfunction underwent in office testing with MUSE following the algorithm recommended by the manufacturer and outlined in the original pivotal study. Patients were asked to rate the rigidity of erection from 1 to 5 with scores 4 and 5 for erections sufficient for intercourse, and level of discomfort from 1 (very uncomfortable) to 5 (very comfortable) at 15-minute intervals. Patients who did not achieve a sufficient erection were scheduled to return for in office testing using the next higher dose up to 1,000 microg. Patient supine and sitting blood pressures were recorded by a nurse before and every 15 minutes after administration. Telephone contact with patients 2 to 3 months after the last in office testing was made to determine whether they were using the system. RESULTS: Mean plus or minus standard deviation rigidity scores independent of dosage increased from 2.34+/-0.99 at 15 minutes to 2.49+/-0.96 at 30 minutes and decreased thereafter. Although the 1,000 microg. dosage resulted in highest mean score at all times, the differences between dosages were not significant. Rigidity score 4 or 5 was achieved in 13.2% (500 microg.) and 30% (1,000 microg.) of patients at 30 minutes. Mean level of discomfort was 3.6+/-1.2 at 15 minutes and improved thereafter. Comfort levels were not significantly different among dosages. Overall, at 15 minutes 16.8% of patients were uncomfortable (score 1 or 2) and 41.3% were somewhat uncomfortable (1, 2 or 3). For all dosages supine and sitting systolic and diastolic blood pressures decreased significantly from before treatment to 15 minutes and stayed lower during monitoring. Defined by strict criteria 41.2% of patients experienced orthostatic hypotension during in office testing. A total of 21 patients had adverse events, including pain, discomfort and burning in the penis (the most common), dizziness and chest pain. One patient had a syncopal episode and fell in the office. At last followup only 18.6% of the tested patients continued to use MUSE at home, while the remainder discontinued treatment due to pain, insufficient erections for intercourse and cost. CONCLUSIONS: We were unable to achieve similar results to the pivotal study following manufacturer instructions and the algorithm provided by that study. Independent of age and etiology no more than 30% of patients at any given time using any dose achieved erections sufficient for intercourse during in office testing. Because of this limited efficacy, discomfort, pain and burning associated with treatment, and cost, more than 80% of patients did not continue to use MUSE at home.

Adult↗
PubMedDate not supplied

Prostaglandin E1 : electrophysiological safety in patients with congestive heart failure and peripheral arterial occlusive disease. The Alprostadil Investigators.

Prostaglandin E ( 1 ) (PGE ( 1 ) ), the active ingredient of the drug alprostadil-alpha-cyclodextrin, has been effective in mitigating the clinical manifestations of peripheral arterial occlusive disease (PAOD). PGE ( 1 ) often is administered to patients with the potential for developing serious arrhythmias, presenting potential safety hazards if the drug caused or potentiated arrhythmias. However, PGE ( 1 ) has antiadrenergic properties and, theoretically, might have an antiarrhythmic action. Therefore, the effect of PGE ( 1 ) on frequency and severity of atrial and ventricular arrhythmias was evaluated from 48-hour electrocardiographic recordings in patients receiving PGE ( 1 ) therapy for severe PAOD. No significant effects on arrhythmia frequency or severity, and no evidence of proarrhythmia, was apparent after PGE ( 1 ) administration.

Alprostadil↗
PubMed2004

The patient's self-evaluation better predicts the degree of erectile dysfunction than the response to intracavernous alprostadil testing.

OBJECTIVES: A modern baseline assessment of erectile dysfunction (ED) should be individualized, reliable, noninvasive and cost-efficient. Appraisal based on the patient's self-evaluation may be the method of choice. METHODS: Using a self-report method, 63 consecutive ED patients were prospectively investigated. Semiquantitative parameters on 7 criteria were assessed, and an intracavernous injection test with alprostadil was performed. Performances of self-reporting and intracavernous testing in predicting penetrative ability were compared. RESULTS: Twenty-three (37%) men had erection insufficient for penetration even with manual assistance, 26 (41%) men needed manual assistance and 14 (22%) could penetrate without manual assistance but erection was not sufficient for satisfaction. In addition to impaired penetrative ability, 6 criteria (intercourse frequency, patient's and partner's satisfaction, penile rigidity, duration of erection and need for extra stimulation) deteriorated over time (p < 0.006). Patient self-evaluation criteria such as intercourse per week, patient satisfaction, penile rigidity, duration of erection and time between consultation and last satisfactory intercourse showed discriminating differences in accordance with the 3 subgroups of penetrative ability (p < 0.02). Intracavernous testing could not reproduce the degree of erectile deficit as experienced during intercourse (p = 0.21). In a logistic regression model, criteria best characterizing penetrative ability were penile rigidity, time between consultation and last unsuccessful intercourse, and degree of satisfaction (p < 0.0001). CONCLUSIONS: The patient's self-evaluation by semiquantitative parameters on criteria characterizing sexual erections better predicts the penetrative ability than the response to an intracavernous injection. These criteria quantify both the objective degree of ED and the patient's apprehension. Consequently, patients may undergo immediate treatment without further testing.

Adult↗
PubMed2000

Differentiated therapy with prostaglandin E1 (alprostadil) after orthotopic liver transplantation: the usefulness of procalcitonin (PCT) and hepatic artery resistive index (RI) for the evaluation of early graft function and clinical course.

Increasing demand for donor organs has led to new pharmacological concepts for reducing ischemia-reperfusion injury (I/R) of the graft after liver transplantation to prevent primary non-functioning of the organ. Prostaglandins have proved to be cytoprotective in several experimental models of ischemia and transplantation. The prophylactic administration after orthotopic liver transplantation is still a subject of controversial discussion. The aim of our study was the evaluation of the post-transplant hepatic artery resistive index (RI) measured by color Doppler imaging, in combination with postoperative elevation of transaminases, as parameters indicating the need for a differentiated systemic therapy with prostaglandin E1 (PGE1) (alprostadil). In addition, the value of serum procalcitonin (PCT) as a postoperative parameter for the extent of I/R is investigated. In the case of post-transplant elevated hepatic artery RI (RI > 0.75), the administration of PGE1 led to a significant reduction of transaminases (p < 0.05) and a decline of the RI. In addition, postoperative PCT levels could be reduced significantly by PGE1 application. These results suggest that determination of RI is feasible for indicating a need for therapy with PGE1. Its targeted application reduces hepatocellular damage due to I/R after liver transplantation.

Alprostadil↗
PubMed2002

Evaluation of transurethal alprostadil for safety and efficacy in men with erectile dysfunction.

A multicenter study conducted in 5 trial centers, for the safety and efficacy of transurethral alprostadil (Pellet) in 90 subjects. The end results show quite good and the product was satisfactory and safe for all ages. Although there are multiple side effects that seemed to discourage the participants and caused them to dropout, MUSE does work but needs good understanding of the use of the device. MUSE is another alternatives for those who unable to use oral medication or those who require immediate action but need some dexterity.

Adult↗
PubMed2005

[Reevaluation of protective effects of alprostadil on hepatic function in patients undergoing hepatectomy].

BACKGROUND: The protective effect of alprostadil (PGE1), used during hepatectomy, on hepatic function has not been clearly proven. We reevaluated this effect by measuring serum alpha-glutathione S-transferase (aGST), which detects liver injury sensitively. METHOD: Thirty hepatocellular carcinoma patients scheduled for hepatectomy were randomly assigned to control (n=12) and PGE1 (n=10) groups. In the latter group, PGE1 was administered intravenously at a rate of 0.05 microg x kg(-1) x min(-1) during surgery. For measuring alphaGST, arterial blood samples were obtained before anesthesia, following laparotomy, and immediately, 2, 4, and 6 hrs after liver resection. RESULTS: The alphaGST concentrations after liver resection were significantly higher, while mean arterial pressures were significantly lower in the PGE1 group. CONCLUSIONS: Our findings suggest that PGE1 medication during hepatectomy cannot protect hepatic function during and after liver resection.

Aged↗
PubMed1989

An alprostadil analogue and human gastric secretion. A double-blind placebo-controlled study of the effects of a capsule and tablet formulation.

The effects of single oral doses of 800 and 1200 micrograms of the new alprostadil analogue mexiprostil (prostaglandin E1 16-methyl-16-methoxy derivative, MDL 646), presented as tablet and capsule formulation, on basal and pentagastrin-stimulated acid secretion, were studied in 10 healthy volunteers, using a randomized, double-blind, placebo-controlled, 5-way crossover design. Compared to placebo, administration of mexiprostil resulted in a significant inhibition of basal gastric acid secretion, at both doses and formulations. Pentagastrin-stimulated gastric secretion was reduced to a lesser degree and the differences compared to placebo did not achieve statistical significance when adjustments were made for basal effects present before starting stimulation. Total volume of gastric secretion, under basal conditions, was decreased by both doses and formulations, though the changes were significant only at 1200 micrograms for both formulation. The decrease in volume of gastric secretion during pentagastrin infusion did not reach statistical significance. Basal intragastric pH was increased by both doses and formulation, but the changes were significant only for the capsule formulation, at either dose. Neither dose of mexiprostil prevented the decrease in intragastric pH produced by pentagastrin infusion. Tolerability of mexiprostil was excellent with no unwanted effects reported either during or after the study. No changes in heart rate and systemic blood pressure were observed. Laboratory safety parameters were not altered by mexiprostil. There was no significant difference between the effects of both formulations of mexiprostil on any pharmacodynamic parameter.

Adult↗
PubMed1987

An alprostadil analogue and human gastric secretion. A double-blind placebo-controlled study of the effects of a tablet and lyovial formulation.

The effects of single doses of 800 micrograms and 1200 micrograms of the new alprostadil analogue (prostaglandin E1 16-methyl-16-methoxy derivative) MDL 646, presented as tablet and lyovial formulations, on basal and pentagastrin-stimulated gastric acid secretion, were studied in 10 normal male volunteers using a randomised, double-blind placebo-controlled cross-over design. Compared to placebo, both doses of MDL 646 significantly decreased acid output during the basal and pentagastrin-stimulated periods. No difference between the tablet and lyovial formulations was found. Total basal output (tablet and lyovial data pooled) was reduced by 58% and 68% following 800 micrograms and 1200 micrograms MDL 646, respectively. Stimulated output was reduced to a lesser degree (15% and 27%). Inhibition of the stimulated acid secretion was observed up to 1.5 to 1.75 h after drug administration. Tolerance was good with only one subject reporting nocturnal abdominal pain following each dose of the drug and placebo.

Adult↗
PubMed1996

[Effects of PGE1 (alprostadil alpha-cyclodestrin) in a case of probable paraneoplastic thrombocytopenic purpura].

The authors report the case of a severely vasculopathic patient with pulmonary mediastinal tumour who presented, probably on a paraneoplastic basis, the onset of severe thrombocytopenic purpura persisting for several months. The syndrome was not classifiable in any of the forms known to the authors and was completely resolved by treatment with PGE1 (alprostadil-alpha-cyclodextrine (Prostavasin, Schwarz Pharma).

Aged↗
PubMed1998

[The evaluation of efficiency of PGE 1 (alprostadil) during intracavernous injection in the treatment of erectile dysfunctions].

We have investigated the influence of PGE1 (alprostandil--"Prostavasin"--Schwarz Pharma company) on the erection in the group of 34 men with erectile disfunction (28 with and 6 without diabetes mellitus) treated in period from 1996 to 1998. Other diseases were excluded in all patients. The concentrations of FSH, LH, T, PRL, T3 and T4 were in normal range. The applied dose of PGE 1 varied from 5 mg to 20 mg maximum three times a week. The effect of the treatment was estimated according to subjective symptoms. The effectiveness of the treatment varied from 50% to 67%. The most effective dose was the maximal one (20 mg). The minimal effective dose of alprostadil was 10 mg.

Adult↗
PubMed1998

Use of intracavernosal alprostadil in erectile dysfunction.

Alprostadil (prostaglandin E1) is the most widely used, licensed vasoactive agent for intracorporeal injection in the investigation and treatment of erectile dysfunction. It has a good side-effect profile and is effective in between 70 and 80% of patients.

Alprostadil↗
PubMed1999

Reasons for discontinuing intracavernous injection therapy with prostaglandin E1 (alprostadil).

OBJECTIVES: To clarify the reasons why experience with self-injection therapy for erectile dysfunction shows high dropout rates. METHODS: We studied 86 patients 36 to 76 years old who had been on home treatment for at least 3 months. Sixty-nine patients (80%) were continuing to use injections, and 17 (20%) had discontinued the treatment. Patients were evaluated by interview and clinical examination. RESULTS: Patients still in the program used one injection every 2 weeks, and those who had given up treatment had used one injection in 3 weeks (P = 0.31). They were in the program for 39+/-27 and 16+/-22 months (P = 0.002), respectively, and had used 50 (95% confidence interval [CI] 21 to 91) versus 12 (95% CI 4 to 20) injections, respectively (P<0.0001). Injections producing unsatisfactory penile rigidity, prolonged erections, hematoma at injection site, corporal fibrosis, secondary penile deviation, and mean estimated duration of a pharmacoinduced erection showed no significant differences. Patient satisfaction (P = 0.02), estimated partner satisfaction (P = 0.02), increase in self-esteem (P = 0.01), and negligible effort in performing injections (P = 0.001) all showed significantly better results for those still in the program. CONCLUSIONS: Reasons for dropout from self-injection therapy are not based on objective side effects and discomfort. Patients leaving the program are less motivated, less satisfied with the quality of pharmacoinduced sexuality, consider the effort to perform injections to be substantial, and have not achieved improved self-esteem.

Adult↗