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PubMed2006

Cutaneous polyarteritis nodosa presented with digital gangrene: a case report.

Cutaneous polyarteritis nodosa (CPAN) is an uncommon form of vasculitis involving small and medium sized arteries of unknown etiology. The disease can be differentiated from polyarteritis nodosa by its limitation to the skin and lack of progression to visceral involvement. The characteristic manifestations are subcutaneous nodule, livedo reticularis, and ulceration, mostly localized on the lower extremity. Arthralgia, myalgia, peripheral neuropathy, and constitutional symptoms such as fever and malaise may also be present. We describe a 34-yr-old woman presented with severe ischemic change of the fingertip and subcutaneous nodules without systemic manifestations as an unusual initial manifestation of CPAN. Therapy with corticosteroid and alprostadil induce a moderate improvement of skin lesions. However, necrosis of the finger got worse and the finger was amputated.

Adrenal Cortex Hormones↗
PubMed2006

Evaluation and medical management of erectile dysfunction.

Most men older than 60 years experience some degree of erectile dysfunction (ED). The physiology of erections is complex, with contributions from hormonal, vascular, psychological, neurologic, and cellular components. ED is strongly associated with cardiovascular risk factors, and this fact plays a major role in the prevention and treatment of ED. In this article, we review the evaluation of ED in terms of history, physical examination, and common laboratory studies. Additionally, we review major considerations when prescribing phosphodiesterase type 5 inhibitors and other medical treatments, including intraurethral alprostadil, penile injection therapy, and testosterone replacement.

Adrenergic alpha-Antagonists↗
PubMed1999

Clinical and haemostatic effects of intravenous prostaglandin E1 therapy in patients with peripheral arterial occlusive disease.

BACKGROUND: In this study the action of an antiaggregatory prostaglandin, PGE1, was studied in a group of patients with peripheral arterial occlusive disease (PAOD). METHODS: In 16 patients with PAOD Fontaine stage IIb and III the clinical and haemostatic effects of the endovenous administration of 60 micrograms/die of alprostadil-PGE1 for four weeks, were evaluated. Before and after pharmacological treatment, were evaluated the clinical symptoms (claudicatio intermittens and rest pain) and the following haemostatic parameters: plasma thrombomodulin (TM), beta-thromboglobulin (beta-TG), D-dimer (DD), tissue-type plasminogen activator (t-PA) and plasminogen activator-inhibitor (PAI-1). RESULTS: No significant difference in plasma TM, t-PA and PAI-1 levels was observed after the treatment. On the other hand the patients showed plasma levels of beta-TG and DD significantly decreased at the end of the treatment. From the clinical point of view both claudicatio intermittens and rest pain satisfactorily improved in all patients. CONCLUSIONS: This data confirmed the therapeutic efficacy of PGE1 in the treatment of PAOD patients.

Aged↗
PubMed1999

Study of thrombinic activation indexes, in patients with lower limb critic ischaemia, before and after prostaglandin E1 therapy.

BACKGROUND: In this study the action of a prostaglandin, PGE1, was studied in a group of patients with peripheral arterial occlusive disease (PAOD). METHODS: In 16 patients (14 men and 2 women, aged 47-70 years, mean 57 +/- 7) with PAOD, Fontaine stage IIb and III in critical ischemia, the effects on two indexes of thrombin generation and action of the endovenous administration (2 hours) of 60 micrograms of Alprostadil-PGE1 for four weeks were evaluated. In all artheriopathic patients, before and after pharmacological treatment, the following haemostatic parameters were evaluated: the prothrombin fragment 1 + 2 (F1 + 2) and the fibrinopeptide A(FPA). RESULTS: The patients showed plasma levels of FPA significantly decreased at the end of the treatment. On the other hand, no significant difference in plasma F1 + 2 levels was observed after treatment. CONCLUSIONS: These results seem to indicate that plasma F1 + 2 levels are significantly elevated, as a marker of thrombosis status, in patients with PAOD before and after treatment with PGE1.

Aged↗
PubMed1999

Outcome of managing impotence in clinical practice.

AIMS: Outside of controlled clinical trials, the outcome of treatment for unselected men with impotence is uncertain. This study aims to describe the clinical course of consecutive, unselected men referred to a specialist endocrinology private practice with a primary diagnosis of impotence. METHODS: Consecutive men referred with a primary diagnosis of impotence between June 1995 and December 1997 were studied. After initial evaluation and appropriate investigation, treatment with testosterone in hypogonadal men and instruction in the use of a vacuum device and intracavernosal alprostadil (Caverject) in all men was offered. All men were followed up by telephone and/or questionnaire about erection outcome three to twelve months later. RESULTS: Nineteen diabetic men, aged 53.1+/-8.2 years and forty non-diabetic men, aged 54.8+/-11.6 years were seen. Follow-up information beyond three months was complete in fifty-three (90%). Eighteen eugonadal men chose no further therapy and four of these men had spontaneous return of erections. Eight men were hypogonadal and potency returned in two of six men treated with replacement testosterone. Nine men used the vacuum device, which was effective in three of them. Forty-one men had a trial of Caverject injection, which was effective in twenty-eight. Only twelve of these men used Caverject for longer than six months. CONCLUSIONS: Return of erections with therapy beyond three months in unselected men with impotence is successful in only about one-third. Unexpected hypogonadism is relatively common in impotent men, but testosterone replacement therapy has a low rate of improving erections. New therapies for impotence need careful follow-up studies to assess their effectiveness in clinical practice.

Alprostadil↗
PubMed1999

Newer pharmacologic alternatives for erectile dysfunction.

With the introduction of effective pharmacologic therapies for erectile dysfunction, more men are seeking treatment. The underlying cause of erectile dysfunction is usually a chronic medical illness or a side effect of certain drugs. Less commonly, the problem is psychogenic. Even after optimal treatment of common medical disorders such as diabetes mellitus and hypertension, erectile dysfunction may persist. Pharmacologic treatments, such as the intracavernosal or transurethral administration of alprostadil or the use of the new oral medication sildenafil, may offer patients substantial benefit. Before any of these drugs are prescribed, consideration should be given to existing medical illnesses and medications, partner satisfaction, comfort with the method of administration and the side effect profile.

Alprostadil↗
PubMed2000

Rationale for the combination of PGE(1) and S-nitroso-glutathione to induce relaxation of human penile smooth muscle.

Many men with erectile dysfunction have been successfully treated with intracavernosal injection of prostaglandin E(1) (PGE(1)) but this treatment is ineffective in 30 to 40% of patients. The goals of this study were to characterize PGE(1)-induced relaxation of isolated human penile smooth muscle (penile arteries and trabecular strips), correlating this in vitro response with the clinical response to this drug, and to evaluate the effects of the combination of PGE(1) with S-nitrosoglutathione (SNO-Glu) on relaxation of isolated human penile smooth muscle. Large variability in the EC(50) and maximal relaxation induced by PGE(1) was observed between tissues of different patients. Patients with poor clinical response to intracavernosal alprostadil (PGE(1)) had significantly larger EC(50) values and smaller maximal relaxation compared with patients with partial or complete clinical response to this drug. SNO-Glu consistently produced complete or near complete relaxation of human corpus cavernosum strips and penile arteries, even when the tissue responded poorly to PGE(1). In trabecular strips, the combination of PGE(1) and SNO-Glu in a 1:100 ratio demonstrated a synergistic relaxation effect. The combination of PGE(1) and SNO-Glu simultaneously increased the levels of both cAMP and cGMP in human corpus cavernosum tissue. Our results suggest that the clinical effectiveness of intracavernosal administration of PGE(1) is related to the variability of the relaxation responses of human trabecular tissue and penile arteries to this drug. The synergistic interaction of PGE(1) and SNO-Glu makes this combination an effective method to cause penile smooth muscle relaxation, a necessary step to initiate and maintain penile erection.

Alprostadil↗
PubMed2000

Intraoperative pharmacological erection as an aid to pediatric hypospadias repair.

PURPOSE: The intraoperative evaluation of erection is a major advance in hypospadias surgery. We determined the advantages of erections induced pharmacologically over those induced by intracorporeal saline injection for evaluating chordee during hypospadias surgery. MATERIALS AND METHODS: During the repair of hypospadias or chordee without hypospadias 56 boys 6 months to 13 years old underwent pharmacological erection induced by 14 microg. alprostadil administered intracavernously. Phenylephrine (40 microg. ) was given for detumescence. We monitored the adequacy of erection and detumescence, changes in blood pressure and pulse, and in 3 cases intracorporeal pressure. Intraoperative artificial erection was also induced in 30 patients. RESULTS: Erection occurred within 1 minute of injection. It was judged to be excellent in 47 cases and adequate in 6, while it failed in 3 probably due to injection outside of the corpora. Erection involved the whole penis, in contrast to artificial erection when tourniquet placement altered the erection and left the penile base flaccid. The degree of chordee remained stable during evaluation compared to artificial erection when curvature varied with the force of the saline injection. Erection persisted during chordee repair as long as the corpora were not opened. Detumescence occurred within seconds in all cases in which phenylephrine was given. There were no cases of priapism, and systemic blood pressure and pulse did not change. Intracorporeal pressure during pharmacological erection was 47 to 70 mm. Hg, whereas during artificial erection pressure was 50 to 250 mm. Hg depending on how much saline was injected and how rapidly fluid drained through the tourniquet. Chordee was induced by over injection. CONCLUSIONS: Pharmacological erection in hypospadias repair is effective and reliable with no significant complications. It is especially valuable in severe hypospadias and in patients with a large suprapubic fat pad. Artificial erection with saline injection should be performed with only moderate force since over filling is unphysiological and may falsely induce chordee.

Adolescent↗
PubMed2000

[Effect of vazaprostan on microcirculation in patients with scleroderma systematic].

AIM: To investigate the effect of vazaprostan (alprostadil) on skin blood flow in patients with sclerodermia systematica (SS). MATERIAL AND METHODS: A total of 51 patients with SS aged 33-70 years were included in the study. 33 of them received a 3-hour infusion of vazaprostan at the standard dose for 20 consecutive days. The rest 18 patients received low molecular dextran solution. Before and at the end of the treatment digital skin microcirculation was measured with a laser Doppler flowmeter. The laser probe was attached to the distal pad of the ring finger on the left hand. Baseline blood flow and vascular reactivity in the tests with sympathetic stimulation, local heating and during orthostasis were evaluated. RESULTS: Baseline blood flow and vascular response to functional tests were significantly reduced in all the patients. At the end of the treatment the flow increased only in patients treated with vazaprostan. Vascular reactivity was not changed after the treatment in both groups of patients. CONCLUSION: Vazaprostan increases baseline blood flow and contributes to the improvement of microcirculation in patients with SS.

Adult↗
PubMedDate not supplied

[Ischemic ulcer in Madelung disease].

We describe a 50 years old man with multiple symmetric lipomatosis (Madelung disease) and two years history of intermittent claudication who was hospitalized because of persistent ulcer of left foot. Lipomata were located on the neck, shoulders and chest; they enlarged gradually over a few years, becoming huge in size. Ulceration of the foot appeared a few weeks before hospitalization and its ischaemic origin was uncertain because of atypical character (painless, ankle/brachial index > 0.5). After angiographic examination patient was assigned for conservative treatment. Intravenous infusions of alprostadil were given with poor effect. Because of gradual enlargement of the ulceration, pain intensification and relatively favourable angiographic picture aorto-bifemoral prosthesis implantation was performed with satisfactory short-therm effect. In addition, patient required vitamin B12 supplementation due to megalocytic anemia.

Alprostadil↗
PubMed2001

[Clinical efficacy of alprostan in treatment of obliterating multifocal atherosclerotic affection of arteries in patients with critical ischemia of lower extremities].

Experience of application of alprostan (PGE1, alprostadil) in 19 patients with atherosclerotic affection of vessels, chronic and acute ischemia of lower extremities in III-IV stage in combination with affection of other vascular basins was summarized. In 10 patients, to whom operative vascular reconstruction was contraindicated and/or technically unrealizable, the conservative treatment was conducted using alprostan during 12-25 days up to the clinical effect achievement (total dose up to 1.6 mg). In 9 patients after performance of conservative treatment using alprostan the vascular bed reconstruction was done. Daily infusion of alprostan in 0.1 mg dose diluted in 250-400 ml of isotonic solution of sodium chloride during 2.5-3 h with duration of course not less than 15 days and 1.2-2.2 mg total dose of preparation constitutes an optimal scheme of treatment. Good result was noted in treatment of patients in stage II of ischemia, application of alprostan in stage IV of ischemia had permitted to reduce the extremity amputation volume or to escape it on the whole, and to restore more rapidly the cutaneous integrity in the trophic disorders regions. The alprostan usage is trustworthy in patients with multifocal atherosclerosis with the cardiac coronary vessels affection in an ischemic heart disease.

Adult↗
PubMed2000

Pharmacotherapy for erectile dysfunction.

OBJECTIVE: To review current pharmacologic treatment options for erectile dysfunction. METHODS: Relevant literatures from the past two decades regarding the following treatments were reviewed: intracavemous injection, topical therapy, transurethral therapy and oral drugs. STUDY SELECTION: More than 125 originally identified articles were reviewed, and 45 were selected that especially addressed the stated purpose. RESULTS: Among the pharmacologic treatment options available, intracavemous injection therapy remains the most effective although the drop-out rate is high. Topical creams and gels have not been very successful. Transurethral alprostadil can be more effective if a constriction device is applied at the base of the penis. Oral sildenafil has the highest patient acceptance rate although systemic side effects can be a major drawback. CONCLUSIONS: Effective pharmacotherapies for ED of various etiologies are now available. However, proper evaluation of every patient should be performed before giving treatment so that a number of potentially life-threatening causes of erectile dysfunction would not be missed.

Alprostadil↗
PubMed2002

Topiglan MacroChem.

MacroChem is developing Topiglan, a topical gel containing prostaglandin E1 (PGE1 or alprostadil) and its patented through-the-skin absorption enhancer excipient (SEPA), for the potential treatment of erectile dysfunction. By September 2000, it was in phase III clinical trials [382682]. By October 2000, MacroChem expected to file an NDA for Topiglan in late 2002 [387433]. In January 2002, at the JP Morgan Hambrecht & Quist 20th Annual Healthcare Conference in San Francisco, CA, MacroChem stated that further phase III studies were planned, including a reformulation that could reduce initation and increase dosage, as well as providing new packaging that improves dose consistency These studies should be underway by the third quarter of 2002, with a potential launch in late 2003 or early 2004 [436390]. The company's patented SEPA technology used in Topiglan is an absorption enhancer for transdermal delivery that has the potential to effectively increase the passage of therapeutic agents through the skin. The application of SEPA alone to the skin of carcinogenic-sensitive rats did not cause the development of tumors attributable to the SEPA [357621]. The company received a US notice of allowance of all patent claims covering Topiglan in February 1999. The patent (US-05942545) was issued in August 1999 [316028], [337720]. Further patent applications are pending in Canada, Europe and Japan [337720]. In February 2000, MacroChem filed further patent applications in 13 countries in Europe, Asia and Latin America and with the EPO [355947].

Adjuvants, Pharmaceutic↗
PubMed2003

[The therapeutic efficacy for ED patients treated with low dosage of PGE1].

OBJECTIVES: To evaluate the efficacy of intrameatal application of low dosage alprostadil (PGE1) cream (300 mcg) for the treatment of erectile dysfunction (ED). METHODS: A total of 43 ED patients were selected in the study based on the inclusion criteria. All of the patients signed informed consent forms and entered a 4-week open-label clinical study. A dosage of 300 mg PGE1 in 75 mg cream was applied intrameatally. RESULTS: The results showed that the primary efficacy (IIEF Q3 + Q4) reached 70.73% after application of the cream. The successful intercourse rate was 86.41%. Based on the GAQ (global assessment Question); 73.17% of the patients were satisfied with their sexual life. At the same time, all of the secondary criteria supported the primary efficacy results. Two patients withdrew during the study period. Six patients (14.63%) had urethral pain or penile redness, which were mostly mild and transient. CONCLUSIONS: With intrameatal low dosage (300 mcg PGE1) of the PGE1 cream can achieve an equivalent efficacy as that with the full dosage.

Adult↗
PubMed2002

[New aspects of prostaglandin E1 therapeutic influence in thrombo-angiitis obliterans].

Prostaglandin E1 because of its unique protective and repaired endothelial action is used in the treatment of many diseases. The aim of the study was the investigation of prostaglandin E1 influence on some adhesive molecules profile in the patients with thrombangitis obliterans. 21 patients, aged 31-49 years (mean 40.3 +/- 5.3), with thrombangitis obliterans were observed. The control group consisted of 22 healthy patients, aged 18-50 years (mean 34.6 +/- 12.25 years). In both groups as well the number of circulated endothelial cells and selectin L, P, E and vWF factor concentration were measured. In patients suffered from thrombangitis obliterans these parameters were measured before and after 21 days intraarterial 10 mg PGE1 (Alprostadil) infusion. No PGE1 influence on selectin E concentration was observed, the mean values as well before as after the treatment were equal to 66.56 +/- 8.92 ng/ml. The decrease in selectin P concentration was observed but the difference was not statistically significant. The statistically significant reduction was observed in selectin L (decrease from 799.88 +/- 104.79 ng/ml to 764.83 +/- 116.04 ng/ml) and vWF concentration (decrease from 195.04% +/- 26.2% to 187.69% +/- 22.83%). The final PGE1 therapeutic result was the circulating endothelial cells decrease (from 2.47 +/- 1.01 before to 2.36 +/- 0.97 cells/ml after treatment). Intraarterial PGE1 infusion in patients with thrombangitis obliterans results in significant selectin L, vWF factor concentration decrease less; this decrease is less marked in selectin P concentration. As the inhibition of the adhesive molecules activation effect the number of exfoliated circulated endothelial cells decrease is observed.

Adolescent↗
PubMed1992

Effect of intravenous cimetidine, ranitidine and pentagastrin and intragastric prostaglandin E1 treatments on gastric transmucosal potential difference in the rat.

Effects of intravenous cimetidine, ranitidine and intragastric prostaglandin E1 (alprostadil) treatments on the transmucosal potential difference (PD) of the stomach were compared. It was also investigated whether the above-mentioned drugs influenced the decrease of PD which followed both intragastric administration of 30% alcohol or Ca++ solution in 5 Mm final concentration and intravenous administration of pentagastrin. Both cimetidine and ranitidine treatments led to significant (p < 0.05) increase of PD, the effect of ranitidine was dose dependent. Prostaglandin E1 in a dose of 40 micrograms/kg led to significant decrease of PD (< 0.05). Both intragastric administration of prostaglandin E1 in a dose of 40 micrograms/kg and intravenous administration of ranitidine in a dose of 10 mg/kg significantly diminish the effect of Ca++ and alcohol to decrease PD. Neither prostaglandin E1, nor ranitidine pretreatment had any effect on the rapid and highly significant (p < 0.01) decrease of PD following i.v. pentagastrin administration. It is hypothesized that transmucosal PD of the stomach provides information not only on the actual condition of the mucosal barrier but on the electrophysiology of gastric secretion as well.

Alprostadil↗
PubMed2004

[Administration of prostaglandin E1 in the treatment of patients with chronic lower limbs critical ischemia with concomitant ischemic heat disease].

Drug treatment of chronic lower limbs critical ischemia (CLLCI) remains an important problem, particularly in patients with concomitant ischemic heart disease treated with prostaglandins E1 (PGE1). Experience in treatment of these patients with alprostadil is presented. Symptoms of a high risk of coronary events are demonstrated, prophylactic measures are proposed.

Alprostadil↗
PubMed2005

[Anesthetic management for an infant with tetralogy of fallot with absent pulmonary valve].

Tetralogy of Fallot with absent pulmonary valve (TOF/APV) is a rare disease, and characterized by massive dilatation of pulmonary artery. Bronchial compression by the aneurysm-like dilated pulmonary artery sometimes results in severe respiratory compromise. Surgery including closure of VSD and right ventricular outflow construction is often needed in infancy. But, even after the surgical correction, patients often suffer from right ventricular failure due to right ventriculotomy and poor development of pulmonary capillaries. Therefore, preventing pulmonary hypertension is important during the perioperative period. We report an infant with TOF/APV. This 3 month-old boy developed respiratory distress suddenly. After the induction of anesthesia with sevoflurane, fentanyl, and vecuronium, continuous infusion of alprostadil and olprinone was started. Cardiopulmonary bypass (CPB) was instituted smoothly. VSD was closed and right ventricular outflow tract was reconstructed. Dilated pulmonary arteries were resected and plicated. Weaning from CPB was easy and postoperative course was uneventful with mild pulmonary hypertension. In the cases predisposed to right ventricular failure like TOF/APV, olprinone may be useful.

Alprostadil↗