Adherence to therapeutic and diagnostic recommendations in patients with femur fracture and at risk of re-fracture or death: results of an analysis of administrative databases.

The aim of the present study was to evaluate the application into clinical practice of therapeutic and diagnostic recommendations for the prevention of bone re-fracture in postmenopausal women after an hospitalization for hip fracture in clinical practice and to assess the relationship between the application of diagnostic recommendations and re-fracture or death risk. A retrospective cohort analysis was conducted. All female patients, at least 65 years old, and with an hospitalization with main or secondary diagnosis of hip fracture during the period 1 January 2006 - 31 December 2008, were included. Besides demographic characteristics and comorbidities, drug treatment prescriptions related to bone fracture or supplementary with calcium or vitamin D and prescriptions of recommended laboratory and instrumental diagnostic tests (e.g. spine radiography), were analysed. A total of 5,636 patients were included in the study. The prescription of a drug treatment aimed to reduce the risk of re-fracture was found in 16.3% of patients, among them 76.3% (699 patients) used bisphosphonates only, 17.1% (157 patients) strontium ranelate only and 4.9% (45 patients) used more than one treatment during the observation period. Among the patients who did not receive drug treatment, 17.5% made use of only supplemental calcium and vitamin D. The remaining part of patients (69.1%) received no treatment. The prescription of at least one laboratory test of first and second level was performed, respectively, on 53.7% and 43.1% of included patients, whereas the prescription of at least one instrumental test of first and second level was performed, respectively, on 5.9% and 0.8%. Although it is established that the prescription of the recommended tests and appropriate drug treatment are significantly associated with reduced risk of re-fracture and death, today the application of these recommendations is reduced.

Baseline characteristics of the population enrolled in the Italian Observational Study on Severe Osteoporosis (ISSO).

OBJECTIVES: Baseline characteristics of the population enrolled in the ISSO study, designed to evaluate the incidence of vertebral and non-vertebral fractures in Italian patients with severe osteoporosis treated according to clinical practice over 24 months observation. METHODS: Prospective observational study in 783 post-menopausal women and men entering 18-month treatment with teriparatide in a community setting at 57 centres in Italy. Characterisation included demographics, fracture risk factors, bone mineral density, fracture status, Health-Related Quality of Life (HRQoL) measured by the European Quality of Life Questionnaire, EQ-5D, and back pain assessed by VAS. RESULTS: Most patients were elderly women (90.5%), mean age±SD was 72.9±8.8 years. Nearly all (91.3%) had experienced ≥ 1 vertebral fracture (mean±SD, 3.6±2.2 per patient), 37.5% had ≥ 1 non-vertebral fracture (mean±SD, 1.4±0.7 per patient). Nearly all patients were suffering from back pain (94.9%), which had significantly restricted their daily activities (51.7%) and had likely or very likely been caused by vertebral fractures (29.2% and 55.8%, respectively). Mean EuroQoL EQ-5D index value was 0.58±0.25 and VAS score 49.2±23.6. Non-vertebral fractures, back pain and multiple vertebral fractures were associated with lower HRQoL (EuroQoL-5D Index both p<0.001, EQ-5D VAS score p=0.025 and p<0.016, respectively). Many patients were physically inactive (81.1%). One third (34.7%) of population had co-morbidities and 60.5% were on chronic concomitant treatments. Few subjects reported a maternal history of osteoporosis (15.5%), regular consumption of alcohol (13.3%) or were current smokers (11.5%). Nearly two-thirds (71.5%) had already been treated for osteoporosis, mainly with bisphosphonates. Calcium and vitamin D supplements were taken by 13% and 15.5% of the total population, respectively. CONCLUSIONS: At enrollment, the population of ISSO study mostly consisted in aging women, who had osteoporosis with high fracture risk, poor HRQoL and suffered from significant back pain. Most of them had already been treated by bisphosphonates but without calcium and vitamin D supplements. Back pain, as well as non-vertebral and multiple vertebral fractures, were associated with lower HRQoL.

[Effect of iron depletion on long-term response to interferon in patients with chronic hepatitis C with increased plasma iron without accumulation of liver iron]. / Effetto della ferrodeplezione sulla risposta a lungo termine all'interferone in pazienti affetti da epatite cronica C con aumentato ferro plasmatico senza accumulo di ferro epatico.

We studied the effect of iron depletion on the response to subsequent interferon therapy in a population of 83 patients affected by chronic hepatitis C who had not previously undergone any specific therapy and who had laboratory confirmation of iron overload (serum ferritin > 400 ng/mL in the males and > 300 ng/mL in the females). The population was divided into two homogeneous groups. Group A consisted of 43 patients who underwent phlebotomy (300 mL every 10-15 days for an average total of 8 sessions) until serum ferritin levels of < 100 ng/mL were obtained. The 40 patients in Group B were treated with interferon without prior iron depletion. Iron depletion alone, induced in Group A, brought about a highly significant (p < 0.01) reduction of alanine aminotransferase serum values: from 165 U/L (range 60-370 U/L) to 67 U/L (range 27-158 U/L). Seventy-six patients completed therapy and follow-up: a complete and sustained response was obtained in 12/39 cases in Group A and in 6/37 cases in Group B (p < 0.05). Iron depletion carried out in patients with chronic hepatitis C, who have elevated base values of serum ferritin, induces a significant reduction in necro-inflammatory activity (notable decrease in average alanine aminotransferase values) and improves the response to subsequent treatment with interferon, although it does not modify the viral load.

Management of patients with HCV infection poorly tolerant to recombinant interferon alpha.

BACKGROUND/AIMS: To evaluate leukocyte interferon-alpha tolerability and efficacy in the retreatment of patients poorly tolerant to recombinant interferon-alpha. METHODOLOGY: Patients with chronic hepatitis C, poorly tolerant to a previous interferon-alpha treatment (118 patients; 73 "relapsers": Group I; 45 "non-responders": Group II) were retreated with 6 MU tiw of leukocyte interferon-alpha for 6 months and then followed-up for 12-34 months. Only patients with complete regression of any previous interferon-related adverse event were included. RESULTS: Three patients dropped out due to recurrence of a severe depressive syndrome. In 86/115 patients (75%) no significant lifestyle changes versus baseline were observed during retreatment, while 29 subjects experienced a moderately negative interference on their living habits. The different influence on the patients' quality of life of leukocyte interferon in comparison with the previous treatment was significant (P < 0.001). In 98 patients the interferon-related adverse events significantly decreased. After 12 months of follow-up, a sustained biochemical response was observed in 40 patients (Group I:31; Group II:9), and a persistent virological response in 28 (Group I:23; Group II:5). CONCLUSIONS: The good compliance with leukocyte interferon administration shown by poorly tolerant patients, non-responders/relapsers to recombinant interferon, permitted a retreatment with full doses, so increasing the chance to obtain a larger number of sustained responses.

[The retreatment with natural leukocyte interferon alfa-n3 of chronic hepatitis C patients: the intolerant and nonresponsive results to prior treatment with recombinant alfa interferon]. / Ritrattamento con interferone naturale leucocitario alfa-n3 di pazienti con epatite cronica C: risultati intolleranti e non responsivi a precedente trattamento con interferone alfa ricombinante.

To evaluate leukocyte interferon alpha-n3 tolerability and efficacy in the retreatment of patients with chronic hepatitis C poorly tolerant to previous treatment with recombinant interferon alpha, 142 patients (73 "relapsers" and 69 "nonresponders") were retreated with leukocyte interferon alpha-n3 (6 MU thrice weekly for 6 months) and followed up for 12-42 months. Only patients with complete regression of any previous interferon-related adverse events were included. Three patients dropped out due to recurrence of a severe depressive syndrome. In 104/139 patients (75%) no significant life-style changes vs baseline were observed during retreatment, while 35 subjects experienced moderately negative interference with their living habits. The different influence on the patients' quality of life during leukocyte interferon alpha-n3 treatment in comparison with the previous treatment was significant. In 118 patients (85%) the interferon-related adverse events significantly decreased. After 12 months of follow-up, a sustained biochemical response was observed in 48 patients (35%), and a persistent biochemical and virological response was seen in 33 (23%). The good compliance with leukocyte interferon alpha-n3 administration shown by poorly tolerant patients, "relapsers/nonresponders" to recombinant interferon, permitted retreatment with full doses and thus increased the chance of obtaining a larger number of sustained responses.

Prolonged treatment with ursodeoxycholic acid for primary biliary cirrhosis.

Eighteen patients affected with biopsy-proved primary biliary cirrhosis (PBC) (histological stage III and IV) received ursodeoxicholic acid (UDCA) 600 mg for 1 year. Signs and symptoms and biochemical tests (glutamic and oxalcetic transaminase, glutamic and pyruvic transaminase, bilirubine, gamma-glutamyl transpeptidase, alkaline phosphatase, leucine aminopeptidase, bile acids, plasma proteins electrophoresis, immunoglubulins A, G and M) and antimitochondrial antibodies were evaluated before the treatment and every four months during the treatment. The results were compared with those obtained in 8 untreated patients affected PBC. The control group of patients were comparable (as far as age, histological stage, biochemical tests are concerned) to the group who received UDCA. Bilirubine, ALP, gamma-GT and LAP decreased during the treatment with UDCA and remained lower than baseline values until the end of the observation (12 months), while no changes occurred in the untreated patients. Both in the treated and untreated group plasma protein electrophoresis, serum immunoglubulins A, G and M remained unchanged, as well as anti-mitochondrial antibody. A moderate reduction of transaminases and bile acids was observed in the group of patients receiving UDCA but it did not reach statistical significance. In 16 out of the 18 treated patients pruritus disappeared and resulted diminished in the remaining 2 patients. No significant amelioration of pruritus was observed in the patients who did not receive UDCA. In conclusion, our data show that prolonged treatment with UDCA drastically reduces pruritus and improves cholestasis biochemical tests in patients affected with symptomatic PBC.(ABSTRACT TRUNCATED AT 250 WORDS)