[Severe intermittent claudication: PGE1 treatment. A 40-week registry, efficacy and costs]. / Claudicatio intermittens severa: trattamento con PGE1. Registry, follow up (40 settimane), efficacia e costi.

AIM: Intermittent claudication (IC) in peripheral vascular disease is characterized by lower limb pain appearing on effort. Treatment with PGE1 has been successfully used to manage IC patients. This registry has evaluated safety and costs of PGE1 in the management of IC. METHODS: In this study a long-term treatment protocol (LTP), a short-term protocol (STP) and an outpatient (OP), "on-demand" treatment have been compared. A treadmill effort test has been used to evaluate walking distance. The follow up for these three protocols was 40 weeks. PGE1 treatment was associated to a risk reduction plan and to an exercise program. RESULTS: The final analysis has included 252 LTP patients, 223 STP patients and 284 OP patients (total 659 valid cases). A group of 171 comparable patients not treated with PGE1 was used for a parallel comparison. Cardiovascular mortality and morbidity has been evaluated in 731 PGE1 patients completing 24 months of follow up. All protocols have been well tolerated. No side effects were observed. The lower cost has been observed for OP patients. In the long term, mortality and morbidity were lower in patients treated with PGE1 in comparison with patients not treated with PGE1. CONCLUSION: Considering costs and results (increase in walking distance) and improvement in Karnofsky scale the STP plan appears to be better than LTP for IC patients. The OP, "on-demand" treatment offers further improvements. This last treatment plan is simpler; the plan allows better timing for exercise. The treatment can be used even in non-specialized centers.

Deep vein thrombosis and pulmonary embolism in a patient affected by uterine fibroids: clinical case.

A 51 year old woman was admitted for night dyspneic attacks and fainting. When hospitalised the patient reported in the previous 10 days dry cough, edema and pain (left leg). The woman's medical history did not show any risk factors for vein thromboembolism, d-dimer dosage appeared increased and arterial blood gas showed hypoxemia and hypocapnia. ECG and chest X-Rays were within normal limits; a chest CT diagnosed pulmonary embolism that was treated with thrombolytic therapy. Venous lower extremity ultrasound detected ilio-femoral and popliteal venous thrombosis and an abdominal CT showed a swollen and fibromatous uterus, obstructing the left iliac vein system. Thrombolytic therapy was effective to for pulmonary embolism and to begin recanalization of the iliac, femoral, and popliteal veins. The patients was sent home in good clinical conditions, with anticoagulant therapy; later the uterine fibroma was treated with hysterectomy.

Meriva®, a lecithinized curcumin delivery system, in the control of benign prostatic hyperplasia: a pilot, product evaluation registry study.

INTRODUCTION: The aim of this registry evaluation study was to compare, in symptomatic BPH patients, two management plans based on a currently validated standard treatment [defined as the best standard management (BSM)] including or not curcumin (administered as Meriva®) as a further complementary adjuvant element. Signs and symptoms were evaluated using the International Prostate Symptom Score (IPSS). SUBJECTS, METHODS: The study was carried out on a total of 61 subjects. 33 subjects (mean age 58.6;5.3) completed the survey with at least 24 weeks of treatment with Meriva® in association with the BSM. The BSM-alone control group consisted of 28 volunteers of similar age (58.4 years;3.4) and severity of the condition. The range of inclusion age was 55-65. No other clinical or metabolic problems were present. Meriva® was administered at the dosage of 2 tablets/day (2 x 500 mg of Meriva®/day, corresponding to 2 x 100 mg curcumin/day) with a compliance values > 95% as evaluated by the number of tablets used according to medical recommendation. No other drugs or food supplement were used during the study. RESULTS: All IPSS scores, with the exception of the stream weakness score in the BSM group, were improved (p<0.05 vs. inclusion) in both groups. The overall results in the Meriva® group were significantly better than in the BSM-only group (p<0.05). No side effects were recorded. The quality of life improved in both groups, but was significantly better in the Meriva® group (p<0.01). There was also a significantly more important decrease in clinical and subclinical episodes of urinary infections and urinary block in the Meriva® group (p<0.01). COMMENTS: In patients with BPH, the addition of Meriva® to the standard treatment contributed to the reduction of signs and symptoms of the disease without causing any significant additional side effect. This pilot experience suggests a potential novel clinical application of curcumin, and further studies aimed at selecting the most appropriate dosages and length of treatment as well as the possibility to including longer treatments will, undoubtedly, validate and optimize the role of Meriva® in the management of BPH.

Product evaluation of Ureadin Rx Db (ISDIN) for prevention and treatment of mild-to-moderate xerosis of the foot in diabetic patients. Prevention of skin lesions due to microangiopathy.

UNLABELLED: The aim of this pilot, registry study was to evaluate a dermatological solution Ureadin Rx Db (ISDIN) including urea in a water-lipid-based foam delivery system in diabetic subjects with microangiopathy and with mild-to-moderate xerosis of the foot. The product was applied to the whole surface of the foot and particularly on the affected areas and pressure/contact zones, at least twice daily for 4 weeks. Skin breaks, ulcerations, infection, investigator and patients' questionnaire, microcirculatory measurements, skin thickness (ultrasound), laser Doppler flux and other parameters were observed and evaluated at inclusion and 4 weeks. RESULTS: The evaluation in skin breaks indicated a decrease in breaks in the Ureadin group vs controls (p<0.05) with the development of one ulcer in controls. There was a significant difference in favour of the Ureadin group in both the Investigator global assessment and in the subjects' assessment questionanire (p<0.05). At 4 weeks PO2 was improved in the Ureadin group (p<0.05) and PCO2 was significantly better (p<0.05) in the Ureadin group. Skin thickness was increased (p<0.05) in the Ureadin group (no change in controls) indicating a better hydration of the more superficial skin layers. Skin flux and the venoarteriolar response were better improved in the Ureadin group. Considering new skin lesions at 4 weeks there were no Class A lesions in the Ureadin group vs. 4 lesions in 26 patients (15.38%; p<0.05) in the control group. There was also a Class B lesion (3.84%; p<0.05) in controls. Diabetic control was good (as before inclusion and did not change at 4 weeks). Therefore the clinical and microcirculatory changes were very possibly due only to local management and not to a systemic improvement in the management of diabetes.

Meriva®, a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy.

BACKGROUND: In the present study, the improvement of diabetic microangiopathy and retinopathy was evaluated in 38 diabetic patients treated with a novel curcumin phospholipids delivery form (Meriva®). METHODS: Diabetes was diagnosed at least 5 years before inclusion and all patients had signs of retinal oedema and of peripheral microangiopathy. Meriva® was administered at the dosage of 2 tablets/day (each tablet containing 500 mg Meriva® corresponding to 100 mg curcumin) for a period of at least 4 weeks in addition to the standard management plan, while a comparable group of subjects (n = 39) followed the standard management plan alone. RESULTS: All subjects (treatment and controls) completed the follow-up period, there were no dropouts and Meriva® showed an optimal tolerability. At 4 weeks, microcirculatory and clinical evaluations indicated an improvement of microangiopathy. In terms of peripheral microangiopathy, in the Meriva® group, there was a significant improvement in the venoarteriolar response (p<0.05) and a decrease in the score of peripheral oedema (p<0.05), a sign typically associated with the failure of the venoarteriolar response. At the retinal level, high-resolution, duplex scanning, used to measure retinal flow, showed improvements in the Meriva® treated patients. The evaluation of retinal oedema (Steigerwalt's scale) showed an improvement associated with improved visual acuity (Snellen scale). There were no clinical or microcirculatory effects in controls. CONCLUSION: These preliminary observations, indicate the value of curcumin, when administered in a bioavailable form as with Meriva®, in the management of diabetic microangiopathy and retinopathy.