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PubMed1999

An international comparison of the reliability and responsiveness of the Duke Health Profile for measuring health-related quality of life of patients treated with alprostadil for erectile dysfunction.

OBJECTIVES: It is important that health measures are both reliable and responsive to clinical change. The aim of this study was to assess the reliability and responsiveness of the physical, mental, and social health scales of the Duke Health Profile (DUKE). METHODS: Impotent males self-administered the Duke Health Profile before and during treatment with alprostadil for erectile dysfunction during a 19-month period. Subjects were 490 patients in the United States and 583 patients in 12 other countries. Each of the three basic Duke Health Profile scales has only five items, and each is heterogeneous because each measures more than one health concept. RESULTS: Cronbach's alpha reliability estimates were: physical health, 0.68 for United States and 0.64 for other countries; mental health, 0.62 and 0.52, respectively; and social health, 0.53 and 0.47, respectively. Alprostadil was expected to improve mental health primarily, and results of the study were consistent with this hypothesis. For example, at approximately 14 months from therapy onset, mental health improved for patients both in the United States (standardized response mean, SRM, = 0.17) and other countries (mean SRM = 0.30), whereas physical health worsened in the United States and was unchanged in other countries, and social health was unchanged in the United States and improved in other countries. Maximum responsiveness was shown for mental health in the other countries, where the mean standardized response means at four follow-ups during a 19-month period were 0.11, 0.21, 0.30, and 0.36. CONCLUSIONS: This study provides support for the responsiveness of the Duke Health Profile mental health scale.

Adult↗
PubMed2000

Safety and efficacy of alprostadil sterile powder (S. Po., CAVERJECT) in diabetic patients with erectile dysfunction.

OBJECTIVES: To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT((R))) in diabetic patients with erectile dysfunction (ED). PATIENTS AND METHODS: This study included 31 diabetic men (aged 44-75 years) with ED of >/=4 months duration. All patients were initially instructed in the self-injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 microg. After the optimal dose was determined and the patient was well trained, the self-injection home phase was followed for 6 months. The efficacy and adverse events were documented. RESULTS: An optimal dose was determined for 29 men (93.5%) and in 16 men (55%) it was >/=20 microg. During the home phase, 76.5% of injections assessed by the patients resulted in satisfactory sexual activity and 72.5% of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61%) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5%), and no priapism was noted. Penile fibrosis occurred in 1 patient (3. 2%). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related. CONCLUSION: Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision.

Adult↗
PubMed1996

Alprostadil sterile powder formulation for intracavernous treatment of erectile dysfunction.

The main aim of this double-blind randomized crossover study was to compare the efficacy and safety of alprostadil sterile powder (Caverject) (PGE1) in a new sterile powder formulation versus placebo in producing erection in patients with erectile dysfunction. Each patient was treated with 5 or 10 micrograms PGE1 and placebo in random order. If the results of the three injections were unsatisfactory, 20 micrograms PGE1 was administered in an open fashion. A total of 45 patients were recruited and evaluated; 31/45 patients (68.8%) responded to at least one injection of alprostadil. A dose-response relation was observed during the double-blind phase; the 10-micrograms dose was effective in 55.5% of patients. The acceptability and tolerability of the preparation, evaluated both clinically and by laboratory tests, was very good. In particular, only four drug-related side effects were observed, three (penile burning, penile pain and pain after injection) after 10 micrograms and one (hematoma) after 5 micrograms PGE.

Adolescent↗
PubMed2004

Topical alprostadil cream for the treatment of erectile dysfunction.

Erectile dysfunction (ED) has serious negative consequences on both sexual experience and emotional well being and affects a broad range of age groups. The prevalence of ED is associated with increasing age and has been reported to be as high as 70%. Although the disorder is common and underdiagnosed, its treatment can significantly improve patients' quality of life. Systemic treatment with oral phosphodiesterase type-5 (PDE-5) inhibitors is the current standard of care for patients with ED. Some patients, however, have absolute contraindications for PDE-5 inhibitors. In addition, these agents can be associated with adverse effects. Furthermore, because PDE-5 inhibitors are not as effective in patients who have undergone radical prostatectomy or who have severe vascular disease, a substantial unmet medical need exists among patients who have ED as a result of these conditions. Consequently, PDE-5 inhibitor therapy is associated with a high rate of discontinuation, as are intracavernosal or transurethral therapies, which are inconvenient and invasive. Several studies, including four double-blind, placebo-controlled, Phase II trials, show that alprostadil topical cream is efficacious and well-tolerated in ED in patients with mild-to-severe symptoms, in those undergoing treatment for cardiovascular diseases and diabetes and in otherwise healthy ED patients. Thus, alprostadil topical cream is a potential first-choice alternative for ED in patients who do not respond or who cannot tolerate or do not accept PDE-5 inhibitor therapy.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2000

Evaluation of transurethral application of alprostadil for erectile dysfunction in Indonesians.

AIM: To evaluate the efficacy and safety of transurethral application of alprostadil (MUSE) for the treatment of erectile dysfunction in Indonesians. METHODS: Twenty erectile dysfunction patients aged between 32-74 years old were recruited in this study. The inclusion criteria were as follows: 1) adult males 18 years or older with a subjective complaint or erectile dysfunction, 2) to provide written informed consent, 3) to agree not to use other forms of treatment for erectile dysfunction, 4) fulfill the screening laboratory values. Part 1, eligible patients were titrated in the clinic starting with a dose of 250 microg and proceed in a stepwise manner to 500 microg and 1,000 microg on separate clinic visits until they identified a dose that produced a satisfactory response. The interval between each in-clinic titration was 2-3 days. Each in-clinic titration dose was evaluated at 15 min intervals over a one hour period for erection assessment, blood pressure and pulse. Part 2, patients used MUSE at home for three months at the dose identified during the in-clinic titration. Monthly interim visits were required for patient follow-up and drug distribution. At the end of the study, patients had another laboratory (except testosterone, only assayed in screening procedure) and physical examination. RESULTS: The etiology of erectile dysfunction was psychological in 5 patients and organic in 15 patients. The 65% of the patients achieved the erection scale of 4 or 5 either in the clinic or at home, 10% achieved the scale of 4 at home, but not in the clinic, and 25% only achieved the scale of 2 or 3 with the highest dose of 1,000 microg either in the clinic or at home. No significant differences were found in biochemical examination before and after the study. The 60% of the patients who achieved erection scale 4 or 5 continued to use MUSE until the end of the study, while 40% of them complained of pain at the time of MUSE application, during erection and/or during intercourse. They withdrew from the study. CONCLUSION: Transurethral application of alprostadil (MUSE) is effective and safe to produce erection sufficient for intercourse in erectile dysfunction of various etiologies. Pain during application, erection and intercourse is a common side effect and a cause of withdrawal.

Adult↗
PubMed2005

[Determination of apomorphine, sildenafil and alprostadil in medicines for erectile dysfunction by high performance liquid chromatography-mass spectrometry].

A high performance liquid chromatography-mass spectrometry (LC-MS) analytical method for illicit drugs, apomorphine, sildenafil and alprostadil, in medicines for erectile dysfunction has been developed. The samples were extracted with methanol using ultrasound-assisted extraction. The chromatographic separation was performed on a Zorbax Eclipse XDB-C18 column using acetonitrile-0.5% formic acid aqueous solution as mobile phase. The three compounds were identified by retention time and m/z and quantified by peak area. The results demonstrated that the linear ranges were 50.0 - 5 000.0 microg/L, 10.0 - 1 000.0 microg/L, 40.0 - 4 000.0 microg/L, with detection limits of 20.0, 4.0, 10.0 microg/L for apomorphine, sildenafil and alprostadil, respectively. The average recoveries and the relative standard deviations were 89% - 95% and 9.5% - 11%. The method is simple, rapid, accurate and suitable for the simultaneous determination of these drugs in medicines for erectile dysfunction.

Alprostadil↗
PubMed1997

Quality of life effects of alprostadil therapy for erectile dysfunction.

PURPOSE: We evaluated the quality of life effects of self-administered intracavernosal injection of alprostadil sterile powder for erectile dysfunction when used by patients for up to 18 months. MATERIALS AND METHODS: Clinical and self-reported measurements were used to assess physiological and psychological status at baseline, and at 3, 6, 12 and 18 months for 579 patients who entered the self-injection phase of an open label, flexible dose clinical trial. Quality of life was measured using the Center for Marital and Sexual Health Sexual Functioning Questionnaire, which focuses on the psychosocial and physical dimensions of erectile dysfunction; the Brief Symptom Inventory, which measures mental health, and the Duke Health Profile, which measures general quality of life. The primary evaluations were quality of life changes from baseline to post-initiation periods and reasons for treatment discontinuation. RESULTS: The Center for Marital and Sexual Health Sexual Functioning Questionnaire displayed improvements at all post-initiation periods in 10 questions (p < 0.001, Student's paired t-tests) grouped into scales representing frequency of sexual activity, erection, orgasm and satisfaction domains. On the Brief Symptom Inventory interpersonal sensitivity, anxiety and depression as well as global scores improved (p < 0.001). Overall mental health as measured by the Duke Health Profile also improved (p < 0.01) between baseline and 6 months. The reasons most frequently cited for treatment discontinuation were nonfirm erections and injection site pain. CONCLUSIONS: Clinical improvements in erectile function due to alprostadil therapy were associated with improvements in sexual activity, sexual satisfaction and overall mental health.

Adult↗
PubMed1998

Factors in predicting initial in-office therapeutic dosages of alprostadil for the treatment of organic impotence.

The use of intracavernous penile injections of alprostadil for treating organic impotence is well-established. Using blood pressure measurements, especially systolic BP and MABP as measured in a flat supine position, the dosage of alprostadil required to achieve satisfactory erections in men with organic impotence can be predicted. This guidance can significantly influence the outcome of therapy by reducing the number of titrated diagnostic injections and the time required for the patient to achieve satisfactory results.

Adult↗
PubMed1981

Intra-arterial alprostadil for nonatherosclerotic vasculopathy.

A 33-year-old man with a nonatherosclerotic vasculopathy of undetermined origin had progressive occlusive disease of the lower limb vessels. The resultant severe rest pain and ischemic ulceration of his foot were inoperable and unresponsive to conventional drug therapy. Treatment was begun with intra-arterially administered alprostadil (prostaglandin E1), a vasodilator and inhibitor of platelet aggregation. Although immediate benefit was equivocal, his rest pain had disappeared six weeks after infusion, and the ischemic ulcer almost healed completely. Blood flow studies showed increased flow to the feet, consistent with the subjective improvement. The beneficial effect of alprostadil suggests that further studies with this agent are warranted for patients with nonatherosclerotic vasculopathy.

Adult↗
PubMed2005

Determination of the binding constant between alprostadil and alpha-cyclodextrin by capillary electrophoresis: implications for a freeze-dried formulation.

The binding constant between alprostadil (PGE1) and alpha-cyclodextrin (alpha-CD) was determined at three temperatures by capillary electrophoresis. alpha-CD is an excipient material in Caverject Dual Chamber Syringe (DCS), added to enhance stability. The binding constant was used to calculate the amount of PGE1 free upon reconstitution and injection, the latter of which is critical to product performance. Measurement was made in a pH 7.2 separation buffer to ensure a negative charge on PGE1. The concentration of PGE1 was fixed while the concentration of alpha-CD was varied over a suitable range. As the amount of PGE1 bound to alpha-CD increases, the weighted average of the resultant mobility decreases, thereby allowing a binding isotherm to be generated from which the stability constant was extracted via nonlinear regression analysis. A value of 708 +/- 64 M(-1) was obtained at 27 degrees C, while at physiological temperature (37 degrees C) the value was 537 +/- 27 M(-1). These results compare favorably to values previously obtained by NMR. Calculation of the percent PGE1 free upon reconstitution and injection show it to be near the desired outcome of 100%. Hence, we were able to conclude that the amount of free drug delivered by Caverject DCS is nominally the same as for Caverject S. Po., an earlier-developed product that contains no alpha-CD.

Algorithms↗
PubMed1981

Binding of prostaglandins E1 (alprostadil), E2 (dinoprostone), F1 alpha, and F2 alpha (dinoprost) to human serum proteins.

Prostaglandins E1 (alprostadil), E2 (dinoprostone), F1 alpha, and F2 alpha (dinoprost) were characterized in terms of binding to human serum, albumin, gamma-globulin II, beta-globulin III, alpha-globulin IV-1, and alpha-globulin IV-4. By using equilibrium dialysis and tritium-labeled ligands, the percent binding for all four ligands was found to decrease in the following order: human serum, albumin, and alpha-globulin IV-4. For the other three proteins, the order was not consistent with the four ligands, and less than 10% binding was observed. In general, prostaglandins E1 and E2 showed a higher percent binding for all fractions than prostaglandins F1 alpha and F2 alpha. All four ligands can be characterized as showing significant binding to human serum, albumin, and alpha-globulin IV-4.

Alprostadil↗
PubMed1998

Comparison of Alprostadil (Caverject) and a combination of vasoactive drugs as local injections for the treatment of erectile dysfunction.

The efficiency and side effects of a single dose of 20 mcg of intracorporeally applied Alprostadil (Caverject, Upjohn), a prostaglandin E1, in inducing penile erection were examined in 30 patients. In addition, the effect of this dose of prostaglandin E1 was compared to that of 30 mg of papaverine plus 0.5 mg of regitine (phentolamine). All patients received a first injection of the combination of the vasoactive drugs and a second injection of the prescribed dose of Caverject. The degree of erection, time interval between injections and achievement of full erection as well as side effects during and after injection were compared. All patients had a burning sensation during the injection of Caverject. Two patients given the vasoactive combination got priapism and were evacuated; this complication was not reported for Caverject. In the doses used Caverject was superior to papaverine plus phentolamine in inducing penile erection and in achieving a higher grade of erection.

Alprostadil↗
PubMed2006

Rapid improvement of distal vasculitis in PAN related to hepatitis B with alprostadil infusion: a case report.

Polyarteritis nodosa (PAN) related to hepatitis B is an uncommon vasculitis that is sometimes associated with the rapid progression of distal ischemia. A few recent reports have proposed the use of antiviral therapy. However, there is not yet a consensus for the standard treatment of this disease entity and none of these treatments have been focused on fast symptomatic improvement. We describe here a 39-year-old female patient with PAN related to hepatitis B infection who completely recovered from the acutely progressing ischemic manifestations of her distal extremities with the use of alprostadil infusion (prostaglandin E1). The reactivation of her hepatitis B infection after glucocorticoid and cyclophosphamide therapy was successfully managed by the antiviral lamuvudine therapy. Most importantly, the vasodilator together with the conventional therapy may be desirable in the early stages of the disease before irreversible ischemic tissue damage can occur.

Adult↗
PubMedDate not supplied

[Alprostadil (PGE 1) and cyclosporin A in treatment of vasculitis in rheumatoid arthritis].

A 56-year old female patient with rheumatoid arthritis and histologically verifiable vasculitis with necrosis around the nail bed and distal phalanx gangrene on both hands as well as skin ulcers on both thighs was treated over 16 weeks with Cyclosporin A, glucocorticoids and Alprostadil. This immunosuppressive therapy resulted in a clinically relevant improvement of acral microperfusion with complete remission of nail bed necrosis and of gangrenous distal phalanxes. Due to improved tissue perfusion the deep ulcers on both thighs could granulate and were closed by proliferative connective tissue, and the high-positive immunological parameters CIC, CRP and the number of activated T-cells normalized.

Alprostadil↗
PubMed2005

Determination by NMR of the binding constant for the molecular complex between alprostadil and alpha-cyclodextrin. Implications for a freeze-dried formulation.

A binding constant was determined for the complexation reaction between alprostadil (PGE1) and alpha-cyclodextrin (alpha-CD). This constant was used to calculate the fraction PGE1 free upon reconstitution of Caverject dual chamber syringe, indicated for the treatment of erectile dysfunction. The determination was based on the measurement of the chemical shift of the C20 methyl protons of PGE1. The observed chemical shift varies as a linear function of the amount of PGE1 bound. The binding constant was obtained from the binding isotherm, a curve of the observed chemical shift versus free ligand (alpha-CD) concentration, through the application of non-linear regression analysis. A value K11 = 966 M(-1) +/- 130 M(-1) (2s), measured at 27 degrees C, was obtained. This value is in good agreement with those reported in the literature. The percent PGE1 free was subsequently calculated for the reconstituted solution and in the corpora cavernosum after injection. The latter showed PGE1 to be delivered essentially quantitatively to the targeted site.

Alprostadil↗
PubMed1984

Quantitative determination of prostaglandins A1 and B1 in alprostadil (PGE1) by high-performance liquid chromatography.

An absorption high-performance liquid chromatography assay for the quantitative determination of prostaglandins A1 and B1 in alprostadil (prostaglandin E1) and in Prostin VR Pediatric Sterile Solution was developed. Prostaglandins A1 and B1 have been shown to be the major degradation products of prostaglandin E1. The adsorption system provided baseline resolution of the 2-naphthacyl esters of prostaglandin A1 from prostaglandin B1. Derivatization conditions providing maximal response for prostaglandins A1 and B1 while minimizing the conversion of prostaglandin E1 to prostaglandins A1 and B1 were established.

Alprostadil↗
PubMed2001

A double-blind, placebo-controlled, efficacy and safety study of topical gel formulation of 1% alprostadil (Topiglan) for the in-office treatment of erectile dysfunction.

OBJECTIVES: To asses the efficacy and safety of Topiglan (1% alprostadil in a formulation with 5% SEPA [soft enhancer of percutaneous absorption]) or placebo gel (0.25 mL) applied to the glans penis only in 60 patients with moderate to severe erectile dysfunction in a two-visit, in-office clinical trial. METHODS: During the first visit, open-label placebo gel was applied. At the second visit, blind, random allocation to Topiglan (n = 31) or placebo gel (n = 29) occurred. Thirty minutes after application, an erotic movie showing heterosexual sex began; at 45 minutes, a penile vibrator was used. Audiovisual and tactile stimulation were discontinued at 65 minutes, and the patient was observed until 90 minutes after application. At the scheduled time points, the erection response was assessed by both the investigator and the patient and signs and symptoms of tolerance were evaluated. RESULTS: Topiglan produced a greater angle of erection (P = 0.003) and maximum rigidity (P = 0.033) compared with the placebo gel. The responses to Topiglan were greater than to placebo gel at all time points after application, with the greatest differences observed at 45 and 60 minutes. Of the 31 patients treated with Topiglan, 12 (38.9%) achieved an erection judged sufficient for vaginal penetration (P = 0.005); 2 (6.9%) of the 29 patients who received placebo gel did so. Penile erythema was more common with Topiglan; symptoms of minor to mild warmth or burning and, less commonly, tingling and coolness were reported by most patients after both Topiglan and placebo gel application. No significant changes in vital signs were noted. CONCLUSIONS: Topiglan applied to the glans penis increased penile rigidity and expectations regarding vaginal penetration in patients with erectile dysfunction.

Administration, Cutaneous↗
PubMed1998

Can alprostadil improve liver failure in HIV-infected patients with severe acute viral hepatitis?

Liver failure with hepatic encephalopathy during an acute viral hepatitis carries a very high mortality. Liver transplantation is the usual treatment, but for poor candidates for transplantation only supportive therapy is available. Two patients with HIV infection developed an acute B hepatitis with liver insufficiency and hepatic encephalopathy. After an alprostadil infusion was begun they improved quickly and made a full recovery. This drug merits further investigation.

Adult↗