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PubMed1997

Construction of scales for the Center for Marital and Sexual Health (CMASH) Sexual Functioning Questionnaire.

The objective of this study was to identify a set of scales for summarizing the results of the Center for Marital and Sexual Health Sexual Functioning Questionnaire (CMASH SFQ). Scales for this instrument were constructed using patients' responses to the CMASH SFQ in a recent clinical trial of prostaglandin E1 (PGE1, alprostadil), an injectable vasodilator used to treat erectile dysfunction. A set of items was identified as a scale if they met predetermined standards of internal consistency, discriminant validity, and convergent validity. The reproducibility of the scales was then evaluated, and the extent to which the scales reliably measured change in treatment-related quality of life was assessed. Reliable and responsive scales for four domains related to sexual functioning were identified. Items in these scales were generally internally consistent; items in the scales and the scores for the scales generally satisfied criteria of discriminant validity; and the scales generally satisfied the standard for convergent validity. Evaluating patients' responses to the CMASH SFQ with scores for four reliable and responsive scales allows easier summarization of patients' sexual functioning and increases the statistical power of evaluations of the effects of interventions designed to improve sexual functioning.

Adult↗
PubMed2000

Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group.

BACKGROUND: Acute renal failure following the administration of radiocontrast media (RCM) is a complication found especially in patients with impaired renal function. Within the limits of a pilot study, the objective was to (a) show the effectiveness and compatibility of prostaglandin E(1) (PGE(1)=Alprostadil) in preventing acute renal failure in patients with elevated levels of serum creatinine and (b) to identify the most appropriate PGE(1)-dose. METHODS: 130 patients with renal impairment (serum creatinine >/=1.5 mg/dl) were included in the study prior to intravascular RCM injection. The patients received one of three different doses of PGE(1) (10, 20, or 40 ng/kg bodyweight/min) or placebo (physiologic sodium chloride solution) intravenously over a time period of 6 h (beginning 1 h prior to RCM application). Serum creatinine was measured 12, 24, and 48 h post RCM-application and creatinine clearance was determined with two 12 h collection periods, as well as one 24 h collection within 48 h post RCM administration. Adverse events during PGE(1) administration were recorded. RESULTS: In the placebo group, the mean elevation of serum creatinine was markedly higher (0.72 mg/dl) 48 h after RCM administration compared with the three PGE(1) groups (0.3 mg/dl in the 10 ng/kg/min group, 0. 12 mg in the 20 ng/kg/min group, and 0.29 mg/dl in the 40 ng/kg/min group). No clinically relevant changes were seen regarding the creatinine clearance in the four groups examined. CONCLUSIONS: Results from this pilot-study suggest that intravenous PGE(1) may be used efficaciously and safely to prevent RCM-induced renal dysfunction in patients with pre-existing impaired renal function.

Acute Kidney Injury↗
PubMed1998

Anticoagulation with prostaglandin E1 and unfractionated heparin during continuous venovenous hemofiltration.

OBJECTIVE: To determine the effect of two doses of prostaglandin E1 (PGE1, alprostadil) combined with unfractionated heparin on the hemofilter life-span and the coagulation profile during continuous venovenous hemofiltration. DESIGN: Prospective, randomized, controlled trial. SETTING: Intensive care unit at a university-affiliated hospital. PATIENTS: Twenty-four critically ill, mechanically ventilated patients with postoperative acute renal failure who require continuous venovenous hemofiltration. INTERVENTIONS: The patients were anticoagulated with 5 ng/kg/min PGE1 and 6 IU/kg/hr heparin or 20 ng/kg/min PGE1 and 6 IU/kg/hr heparin, injected into the extracorporeal circuit before the hemofilter. MEASUREMENTS AND MAIN RESULTS: The life-span of 43 hemofilters was evaluated. They were used until extracorporeal line pressure exceeded 250 mm Hg, ultrafiltration rate decreased to 16 mL/min, or grossly visible extracorporeal clotting occurred. Blood was sampled from the afferent (prefilter) and efferent (postfilter) lines of the extracorporeal circuit. Platelet counts, in vitro platelet function, plasma concentrations of platelet factor 4, prothrombin fragment F1+2, thrombin-antithrombin complex, routine plasma coagulation tests, and hemodynamic profile were determined before and during hemofiltration. Hemofilter usage was significantly longer in patients anticoagulated with 20 ng/kg/min PGE1 (32 +/- 3 [SEM] hrs) than with 5 ng/kg/min PGE1 (22 +/- 3 hrs). In vitro bleeding parameters were significantly prolonged in postfilter blood in patients receiving 20 ng/kg/min PGE1. Prefilter, there was no antiplatelet activity in either group and platelet counts remained stable. No intra- or intergroup differences in plasma coagulation profile or hemodynamic parameters were detected. CONCLUSION: Extracorporeal administration of PGE1, combined with low-dose heparinization, inhibits platelet reactivity and preserves hemofilter life dose-dependently.

APACHE↗
PubMed2003

Prostaglandin E1 improves endothelial function in critical limb ischemia.

Prostaglandin E1 (PGE1) may relieve rest pain and heal ulcers in critical limb ischemia, but its mechanism of action is still incompletely understood. To investigate the effects of PGE1 treatment on endothelial function evaluated as brachial artery flow-mediated vasodilation (FMV) and on soluble adhesion molecule plasma levels (vascular adhesion molecule-1 [sVCAM-1] and intercellular adhesion molecule-1 [sICAM-1]), 12 patients with critical limb ischemia were treated with daily PGE IV infusion (alprostadil 60 microg) for 2 weeks. FMV and plasma sICAM-1 and sVCAM-1 concentrations were determined at baseline, after the first infusion, and after 1 and 2 weeks. Compared with 30 healthy control subjects, patients had higher baseline sVCAM-1 (2.402 +/- 296 ng/ml vs 972 +/- 117 ng/ml) and sICAM-1 levels (464 +/- 51 ng/ml vs 206 +/- 37 ng/ml, both p < 0.05) and lower FMV (1.0 +/- 1.1% vs 5.6 +/- 1.6%, p < 0.05). sICAM-1 concentration progressively decreased with treatment (from 464 +/- 51 ng/ml to 326 +/- 56 ng/ml, 288 +/- 42 ng/ml, and 279 +/- 44 ng/ml after the first dose and, respectively, after 1 and 2 weeks; all p < 0.05). sVCAM-1 showed a reduction after 2 weeks (from 2.402 +/- 296 ng/ml to 1.916 +/- 176 ng/ml; p < 0.05). FMV improved after 1 and 2 weeks (from 1.0 +/- 1.1% to 3.1 +/- 0.6% and 5.2 +/- 2.1%, both p < 0.05). In conclusion, treatment with PGE1 determines a significant improvement in endothelial function in patients with critical limb ischemia.

Aged↗
PubMed1999

Topical prostaglandin E1 SEPA gel for the treatment of erectile dysfunction.

PURPOSE: We compare the systemic effects, local tolerance and effectiveness of topical gel formulations on the penis containing alprostadil (prostaglandin E1) plus 5% SEPA versus SEPA alone (placebo) in men with erectile dysfunction. MATERIALS AND METHODS: Erectile response, skin discomfort and erythema were measured in 48 men with erectile dysfunction secondary to vascular, neurogenic, psychogenic or mixed etiologies in this single-blind, placebo controlled trial. RESULTS: Application of prostaglandin E1 gel correlated positively with erectile response as 67 to 75% of patients had an erection compared to 17% of controls (p<0.001). Blood pressure and heart rate varied minimally. No serious adverse effects were observed in the 48 patients, although the majority had skin discomfort. CONCLUSIONS: Topical prostaglandin E1 gel applied to the penis appears to be safe, and facilitates audiovisual and tactile stimulation resulting in an erection when given in a clinic setting. Consequences to the female partner remain unknown.

Adjuvants, Pharmaceutic↗
PubMed2003

Viability and safety of combination drug therapies for erectile dysfunction.

PURPOSE: In some patients with erectile dysfunction (ED) oral, topical or intracavernous drug therapy fails. However, several classes of drugs demonstrate efficacy for ED, creating the potential for pharmacological combinations preferable to implantation of a penile prosthesis. MATERIALS AND METHODS: Preliminary reports suggest that combining oral, topical or intracavernous drugs may salvage patients in whom monotherapy fails. RESULTS: Agents that lead to activation or increases in cyclic nucleotides (cyclic adenosine monophosphate and guanosine monophosphate) with or without nitric oxide donors or nitrates, or alpha-adrenergic antagonists have been used to treat ED. The phosphodiesterase-5 inhibitor sildenafil has been combined with alprostadil (prostaglandin E1) and administered by either the intraurethral or intracavernous route. Successful intercourse following this combination varies from 47% to 100% when monotherapy with each has failed. The introduction of apomorphine has led to its unapproved use in combination with sildenafil in Europe. Combination strategies may allow lower drug doses and reduced adverse effects. CONCLUSIONS: The encouraging preliminary observations combined with the potential for adverse events provide a scientific rationale for prospective, randomized clinical trials with adequate numbers of subjects.

Alprostadil↗
PubMed1994

Prostaglandin E1 as treatment for erectile failure in elderly men.

OBJECTIVE: To determine the efficacy of intracavernosal injection of prostaglandin E1 (alprostadil) in elderly men with erectile failure. DESIGN: Prospective study. SETTING: Outpatients at a university-affiliated VA Medical Center. PARTICIPANTS: Ten subjects aged 65 years and older with duration of erectile failure of 6 months or longer. INTERVENTIONS: Subjects received intracavernosal injections of prostaglandin E1 in the office and self-administered intracavernosal prostaglandin E1 at home. MEASUREMENTS: Penile rigidity was measured by palpation and by the Rigiscan rigidity monitor. RESULTS: Intracavernosal injection of prostaglandin E1 produced erections adequate for intercourse in 9 of the 10 subjects. Attempts at intercourse were rated satisfactory by two-thirds of the subjects and their spouses. CONCLUSIONS: Intracavernosal injection of prostaglandin E1 is safe and effective for erectile failure in elderly men.

Age Factors↗
PubMed2005

Use of a visual analog scale to assess pain of injection with intracavernous injection therapy.

AIM: Fear of pain with intracavernosal injection (ICI) therapy may discourage its use in patients with erectile dysfunction (ED). METHODS: We prospectively analyzed patient self-report of discomfort with ICI therapy for ED utilizing a visual analog scale from 0 to 10. RESULTS: Patient self-report using a visual analog scale revealed minimal discomfort, with 59 consecutive patients reporting an average pain score of 1.93 +/- 1.76. There was no statistical difference between self-administered or nurse-administered injections. The volume of the injection also had no statistical effect on pain score, and there was no difference observed between those who received alprostadil alone or combination treatment. Patients with diabetes mellitus did have significantly higher pain scores than other patients (3.31 +/- 2.25 vs. 1.62 +/- 1.39, P = 0.009), even when controlling for other factors. CONCLUSION: Clinicians should be aware of the greater potential for discomfort in ED patients with diabetes. In the majority of ED patients, however, discomfort is minimal, and this information should be helpful in alleviating fear of injection in those who may benefit from this therapy.

Adult↗
PubMed1984

Prostaglandin E1 in suspected ductus dependent cardiac malformation.

Fifty two sick neonates with major duct dependent cardiac defects were given short term intravenous infusions of prostaglandin E1 (alprostadil) in doses varying between 0.005 and 0.1 micrograms/kg/minute. The object of the study was to try to achieve an effective but safe regiment that could be instituted as soon as such a diagnosis was suspected. Effective clinical improvement was achieved at each dosage but the incidence of side effects seemed to be dose related, and no serious side effects were noted at a dosage of 0.005 to 0.01 micrograms/kg/minute. It is recommended that a low dosage regimen be started before transfer to a paediatric cardiac centre.

Alprostadil↗
PubMed1985

A multiclinic, placebo-controlled, double-blind study of prostaglandin E1 in Raynaud's syndrome.

Prostaglandin E1 (alprostadil, Prostin VR Sterile Solution, PGE1) was evaluated in patients with Raynaud's syndrome in a multiclinic, placebo-controlled, double-blind study. A total of 55 patients with either primary Raynaud's disease or Raynaud's disease secondary to systemic sclerosis were randomly assigned to receive either PGE1 administered intravenously at 10 ng/kg/min for 72 hours or placebo administered in the same manner. The frequency and severity of Raynaud's attacks were then monitored for up to four weeks by use of in-clinic questionnaires and patients' daily diaries. Haemodynamic assessments included measurements of skin temperature and the finger systolic pressure response to localised digital cooling. Immediately after the infusion the overall symptoms in both the PGE1 and the placebo group showed marked improvement; by four weeks after infusion, in some cases, values had not returned to pretreatment levels. There was, however, no marked benefit of PGE1 treatment over that of placebo. Although PGE1 significantly increased skin temperature during and immediately after infusion, the effect did not persist at two- and four-week follow-up evaluations. The finger systolic pressure response to localised digital cooling (15 degrees C) increased more in the PGE1-treated group than in the placebo-treated group, but the difference was not statistically significant. There was no difference in ulcer healing between the two treatment groups. These results failed to substantiate earlier open-label reports that a 72-hour intravenous infusion of PGE1 in patients with Raynaud's syndrome produced significant clinical benefit.

Adult↗
PubMed2002

MUSE: clinical experience.

INTRODUCTION: In the UK, an estimated 17-19% of men suffer from erectile dysfunction (ED). Until the introduction of sildenafil, the medical treatment of ED mainly depended on intracavernosal injections. The introduction of MUSE has generated interest, since it obviates the use of 'needles'. MUSE is an intra-urethral method of alprostadil (prostaglandin E1 analogue) administration. We investigated the safety and efficacy of MUSE in 100 patients. PATIENTS AND METHODS: After confirming the diagnosis of ED, treatment was started with MUSE. Once we were satisfied that the patients could self-administer MUSE, they were discharged from our clinic. They were contacted six months later and asked to complete a questionnaire. RESULTS: Only 35% of the 100 patients (aged 46-73 years) with ED of mixed aetiology were initially successfully treated with MUSE. All but two of them needed 1,000 microg. After six months, only 43% of these initially successfully treated patients continued to use MUSE; of these, 33% only found it effective on every third occasion, or worse. The remaining 57% of the initially successfully treated patients stopped taking MUSE because it was no longer effective or it caused side-effects (such as urethral bleeding and/or irritation). DISCUSSION: MUSE, in our experience, is moderately effective in treating ED. However, MUSE is an alternative in some patients with ED who do not respond to other treatments or where these options are contraindicated. Owing to the high dropout rate, patients treated with MUSE should be followed-up closely.

Administration, Topical↗
PubMed2002

Pharmacological aspects of erectile dysfunction.

Erectile dysfunction (ED) is a common problem with a prevalence of approximately 50% in men aged 40 to 70. There are several etiologies for ED including vasculogenic, neurogenic, hormonal and/or psychogenic factors; one-fourth of ED cases can be drug-related. Penile erection involves a complex interaction between the CNS and local factors. It is a neurovascular event modulated by psychological and hormonal factors. Pharmacologically, neural modulation and endocrine status are very important to attaining penile erection. There have been several significant advances for the pharmacologic treatment of ED. Treatments include agents that are not only orally effective, but possess either local or central acting mechanisms of action. Apomorphine, a centrally-acting agent, is effective in the treatment of ED. Sildenafil, another orally effective agent, acts by inhibiting cyclic GMP-specific phosphodiesterase Type V. Testosterone can be effective transdermally. Non-orally active agents include alprostadil and papaverine. Phentolamine and trazodone are effective in selected cases. Some agents can interact with other medications. Several pharmacological agents, some with central-acting mechanisms and some with Iocally-acting vascular effects, are therapeutically useful in the treatment of ED.

Adult↗
PubMed2006

Treatment of erectile dysfunction in multiple sclerosis.

Erectile dysfunction in men with multiple sclerosis (MS) is a very common symptom that often leads to a reduced quality of life. It is related to neurological dysfunction, psychological factors, side effects of medication or generalized MS symptoms, such as fatigue or micturition problems, usually in combination. The question of sexual dysfunction should always be broached during routine follow-up, regardless of age and social status. The possibility that erection problems can be a side-effect of drugs commonly used in MS must also be remembered. There are several effective pharmacological treatments, such as phosphodiesterase inhibitors and prostaglandin E(1) (alprostadil). The contraindications and side effects should be familiar to the MS doctor. Dose titration in the initial stages is recommended to avoid priapism. In the future, combinations of impotence drugs may be tested.

Alprostadil↗
PubMed2005

Retrospective evaluation of inhaled prostaglandins in patients with acute respiratory distress syndrome.

STUDY OBJECTIVES: To determine whether use of inhaled alprostadil (PGE 1 ) or epoprostenol (PGI 2 ) significantly improved oxygenation in patients with acute respiratory distress syndrome (ARDS), and to determine whether differences between the two drugs exist with regard to oxygenation, duration of mechanical ventilation and hospitalization, adverse effects, and survival. DESIGN: Retrospective chart review. SETTING: A 360-bed tertiary care teaching facility with medical and surgical intensive care units. PATIENTS: Twenty-seven patients admitted to the hospital who received either PGI 2 or PGE 1 for a primary or secondary diagnosis of ARDS. MEASUREMENTS AND MAIN RESULTS: Seventeen patients received inhaled PGE 1 and 10 received inhaled PGI 2 . There were no significant changes in the ratio of arterial partial pressure of oxygen (PaO 2 ):fraction of inspired oxygen (FiO 2 ) and in the PaO 2 , from baseline to any time point that was analyzed during treatment, for patients receiving either PGE 1 (p=0.2120 and 0.3399, respectively) or PGI 2 (p=0.1655 and 0.0784, respectively). CONCLUSION: No statistically significant improvement in oxygenation was observed in patients receiving either PGE 1 or PGI 2 . In addition, no significant differences were found between the two prostaglandins for the variables studied. Until positive results from large, prospective studies are available, we recommend that these inhaled prostaglandins not be used to treat ARDS.

Administration, Inhalation↗
PubMed2004

Future options for combination therapy in the management of erectile dysfunction in older men.

The prevalence of erectile dysfunction (ED) has dramatically increased in parallel with the aging of the Western industrialised population. The estimated prevalence of ED worldwide in 1995 was 152 million men. As the population in industrial nations ages, an estimated 322 million men will be affected by ED by the year 2025. Oral drug therapy with the phosphodiesterase (PDE) type 5 inhibitor sildenafil fails in some patients with ED; however, several different classes of drugs demonstrate efficacy in treating ED, creating the potential for pharmacological combination therapy. Pharmaceutical products that lead to the activation of or an increase in cyclic nucleotides (cyclic adenosine monophosphate and cyclic guanosine monophosphate), with or without nitric oxide donors or nitrates, as well as alpha-adrenoceptor antagonists, have been used to treat ED. Sildenafil has been used in combination with alprostadil (prostaglandin E1) and administered via intraurethral or intracavernous route. Successful intercourse using this combination of agents varies from 47% to 100% following failed monotherapy. Various combination therapies for ED are being studied using PDE5 inhibitors, together with other agents, alpha-adrenoceptor antagonists, and testosterone replacement therapy for men with hypogonadism. The combination of centrally acting agents with PDE5 inhibitors, e.g. a regimen of apomorphine plus PDE5 inhibitor, is an attractive approach because the two therapies target different mechanisms. New PDE5 inhibitors such as vardenafil should be tried first as therapy for sildenafil nonresponders before exploring any combination therapy options. Preliminary observations of combination therapy have been encouraging and provide a scientific rationale for prospective, randomised clinical trials with adequate numbers of patients.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2006

Erectile dysfunction following radical retropubic prostatectomy: epidemiology, pathophysiology and pharmacological management.

Radical prostatectomy has been the time-honoured and standard treatment option for prostate cancer. Erectile dysfunction (ED) is one of the common quality-of-life issues following radical prostatectomy. The recovery of potency following radical prostatectomy varies from 16% to 86%. Although major modifications in surgical technique appear to be promising, the reported ED rates are still high. The time period required for the recovery of erectile function after surgery varies from 6 to 24 months. During this period of neuropraxia lack of natural erections produces cavernosal hypoxia. This cavernosal hypoxia has been implicated as one of the most important factors in the pathophysiology of ED. Cavernosal hypoxia predisposes to cavernosal fibrosis, ultimately producing venous leak and long-term ED. Interruption of this cascade of events has been the major challenge for physicians. Physicians have several options available for the treatment of ED. However, oral treatment options have quickly become established as first-line treatment options. Sildenafil has been most extensively studied in the radical prostatectomy population. In patients who do not respond to oral therapy alone, standard treatment options (intracavernosal injections, vacuum constriction devices and intraurethral alprostadil) are useful. Use of penile prostheses is one of the oldest treatment options available for the treatment of ED but is used only as a last resort. Initial attempts to promote the earlier recovery of erectile function appear to be promising. However, further confirmatory studies are essential. The roles of gene transfer and growth factors are still in experimental stages. In this review we discuss the epidemiology, pathophysiology and treatment options available for ED following radical prostatectomy.

Administration, Oral↗
PubMed2005

A comparative review of the options for treatment of erectile dysfunction: which treatment for which patient?

The field of erectile dysfunction (ED) has been revolutionised over the last two decades. Several treatment options are available today, most of which are associated with high efficacy rates and favourable safety profiles. A MEDLINE search was undertaken in order to evaluate all currently available data on treatment modalities for ED. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first-choice of most physicians and patients for the treatment of ED. PDE5 inhibitors have differences in their pharmacological profiles, the most obvious being the long duration of action of tadalafil, but there are no data supporting superiority for any one of them in terms of efficacy or safety. Sublingual apomorphine has limited efficacy compared with the PDE5 inhibitors, and its use is limited to patients with mild ED. Treatment failures with oral drugs may be due to medication, clinician and patient issues. The physician needs to address all of these issues in order to identify true treatment failures. Patients who are truly unresponsive to oral drugs may be offered other treatment options.Intracavernous injections of alprostadil alone, or in combination with other vasoactive agents (papaverine and phentolamine), remain an excellent treatment option, with proven efficacy and safety over time. Topical pharmacotherapy is appealing in nature, but currently available formulations have limited efficacy. Vacuum constriction devices may be offered mainly to elderly patients with occasional intercourse attempts, as younger patients show limited preference because of the unnatural erection that is associated with this treatment modality. Penile prostheses are generally the last treatment option offered, because of invasiveness, cost and non-reversibility; however, they are associated with high satisfaction rates in properly selected patients. All treatment options are associated with particular strengths and weaknesses. A patient-centred approach based on patient needs and expectations is necessary for the management of ED. The clinician must educate the patient and provide a supportive environment for shared decision making. The management strategy must be supplemented by careful follow-up in order to identify changes in patient health and relationship/emotional status that may necessitate treatment optimisation.

Administration, Oral↗
PubMed2007

Limaprost.

Limaprost, an alprostadil (prostaglandin E1) analogue, is a vasodilator that increases blood flow and inhibits platelet aggregation. The efficacy of oral limaprost was evaluated in adult Japanese patients in three randomised, double-blind, 6-week trials. One study included patients with thromboangiitis obliterans and two trials included patients with lumbar spinal canal stenosis. Limaprost was generally well tolerated and serious adverse events were uncommon. THROMBOANGIITIS OBLITERANS: In a randomised, double-blind trial in Japanese patients primarily with thromboangiitis obliterans (n=136), there was no significant difference between patients receiving limaprost 30 microg/day and those receiving oral ticlopidine 500 microg/day in the improvement of ischaemic symptoms. LUMBAR SPINAL CANAL STENOSIS: Limaprost 15 microg/day was superior to limaprost 3 microg/day for overall drug usefulness and overall improvement from baseline to study end in a phase III trial in 146 patients with lumbar spinal canal stenosis. Assessment of overall improvement considered various objective symptoms (e.g. muscle strength, walking ability) and subjective symptoms (e.g. pain or numbness in extremities), while overall usefulness also considered safety issues. The efficacy of limaprost 15 microg/day was not significantly different from that of 30 microg/day, but tended to be better than that of 6 microg/day in a phase II trial in patients with lumbar spinal canal stenosis and normal straight leg raise test results. The optimal dosage of limaprost for this indication was therefore deemed to be 15 microg/day.

Alprostadil↗