Biomedical subjects

Giovannino Ciccone

Publications and source records attributed to Giovannino Ciccone.

At least 19 recordsLinked to original sources

PubMed2026

RENOIR phase 3 rituximab-lenalidomide vs rituximab as maintenance treatment in relapsed/refractory follicular lymphoma.

Maintenance treatment in older patients with relapsed or refractory (R/R) follicular lymphoma (FL) remains an area of investigation. RENOIR was a multicenter, phase 3, open-label randomized trial conducted by the Fondazione Italiana Linfomi (FIL) in older patients with R/R FL after 1 or 2 previous therapies. Patients achieving partial response or complete response (CR) after 4 to 6 cycles of standard rituximab (R)-based chemotherapy were randomized 1:1 to maintenance with R alone (standard arm) or R plus lenalidomide (R2; experimental arm). The primary end point was 2-year progression-free survival (PFS) from randomization, with an expected hazard ratio (HR) of 0.5. A total of 152 patients (median age, 71 years) were enrolled. After induction, 129 (85%) achieved an overall response (CR, 58%) and were randomized to R (n = 65) or R2 (n = 64). At a median follow-up of 68 months, the 2-year PFS was 73% in the R2 arm and 64% in the R arm. An unplanned hypothesis-generating subgroup analysis showed a greater 2-year PFS benefit with R2 in patients aged <70 years: R2, 96% vs R, 69%. Two-year overall survival rates were similar (R2, 80% vs R, 89%). Grade 3/4 adverse events were more frequent in R2, mainly neutropenia and gastrointestinal disorders. In conclusion, the primary end point of the study was not met, and R2 maintenance did not significantly improve 2-year PFS in older patients with R/R FL, although a numerical benefit was observed. R2 showed a more favorable benefit-risk profile in patients aged <70 years, whereas in older patients careful consideration of individual tolerability is warranted. This trial was registered at www.clinicaltrials.gov as NCT02390869.

Humans↗

PubMed2006

Maternal complications and procedures in pregnancy and at birth and wheezing phenotypes in children.

RATIONALE: There is increasing interest in the potential influence of fetal and early life conditions on childhood wheezing. OBJECTIVES: To investigate the associations between maternal complications and procedures in pregnancy and at birth and the risk of various wheezing phenotypes in young children. METHODS: We studied 15,609 children, aged 6-7 yr, enrolled in a population-based study. Standardized questionnaires were completed by the children's mothers. RESULTS: Of the children, 9.5% (1,478) had transient early wheezing, 5.4% (884) had persistent wheezing, and 6.1% (948) had late-onset wheezing. Maternal hypertension or preeclampsia was associated with an increased risk of all three wheezing phenotypes (for transient early wheezing: odds ratio [OR], 1.40; 95% confidence interval [95% CI], 1.08-1.82; for persistent wheezing: OR, 1.59; 95% CI, 1.15-2.19; and for late-onset wheezing: OR, 1.47; 95% CI, 1.06-2.01). Use of antibiotics for urinary tract infections was associated with transient early wheezing (OR, 1.52; 95% CI, 1.16-2.00), whereas antibiotic administration at delivery was associated with both transient early wheezing (OR, 1.21; 95% CI, 1.01-1.46) and persistent wheezing (OR, 1.39; 95% CI, 1.10-1.75). Children who had a mother with diabetes were also more likely to have persistent wheezing (OR, 1.72; 95% CI, 0.99-3.00). Neither amniocentesis/chorionic villus sampling, nor weight gain in pregnancy, nor cesarean section was associated with the subsequent development of wheezing. Maternal asthma or atopy was not an effect modifier of the associations found. CONCLUSIONS: Some maternal complications during pregnancy and at delivery may increase the risk of developing different phenotypes of wheezing in childhood.

Child↗

PubMed2006

Prevalence of undiagnosed metabolic syndrome in a population of adult asymptomatic subjects.

BACKGROUND: To evaluate in the general population the prevalence of undiagnosed metabolic syndrome (MS), defined according to the National Cholesterol Education Program (NCEP) and International Diabetes Federation (IDF) criteria. METHODS: A population-based cross-sectional study of 1175 asymptomatic adults in North-Western Italy. RESULTS: The prevalence of undiagnosed MS was 16.4% (95% CI=14.4-18.6) (NCEP) and 28.0% (25.4-30.6) (IDF), respectively, 5.2% (3.6-7.3) and 8.9% (6.6-11.3) in normal-BMI and 26.6% (23.3-30.2) and 45.3% (41.3-49.2) in overweight/obese individuals. Of the total cohort, 52% were overweight/obese and they accounted for 85% of the cases of MS; a further 19% were normal weight with light physical activity and accounted, respectively, for 12% (NCEP) and 13% (IDF) of the cases. Only 25% (NCEP) and 14% (IDF) of participants showed no component of the MS (respectively, 40 and 26% of those not-overweight and 11 and 3% of those overweight/obese). CONCLUSIONS: More than 97% of unknown MS cases would be identified among apparently healthy individuals when overweight/obese, and normal-BMI subjects with low physical activity were screened. These two criteria might, therefore, be used to prioritise screening programmes in asymptomatic subjects, since even apparently healthy individuals, who are not-overweight, frequently show one or more metabolic abnormalities, whose co-existence has been demonstrated to be hazardous.

Cross-Sectional Studies↗

PubMed2006

Long-term follow-up of previous hepatitis C virus positive nonresponders to interferon monotherapy successfully retreated with combination therapy: are they really cured?

OBJECTIVES: To evaluate whether in chronic hepatitis C-positive patients who failed to respond to interferon (IFN) monotherapy a sustained response obtained with retreatment using the combination therapy of IFN + ribavirin can be safely considered to reflect eradication of the infection. METHODS: Prospective follow-up of a cohort of 97 patients who responded to retreatment with different regimens of IFN + ribavirin after failing to respond to a first IFN monotherapy course. The patients were followed throughout 7 yr of follow-up with determinations of HCV viremia every 6 months. RESULTS: At the end of the follow-up, 11 patients (11.3%) showed a viremic reappearance. HCV late relapse rates were 0%, 13%, 20%, and 12% in patients retreated, respectively, with 3 MU IFN + ribavirin for 12 months (Group 1), 5 MU IFN + ribavirin for 12 months (Group 2), 3 MU IFN + ribavirin for 6 months (Group 3), and 5 MU IFN + ribavirin for 6 months (Group 4) (Group 2 vs Group 3, p= 0.005). The virologic relapses occurred within 2 yr from therapy withdrawal. Among patients with genotype 1 and 4, the long-term response was significantly higher in Group 2 than in Group 3 (15%vs 3%, p= 0.03). In patients with genotype 2 and 3, the long-term virological response was not affected by the different regimens. CONCLUSIONS: Nonresponders to IFN monotherapy who achieve a sustained virologic response after retreatment with IFN + ribavirin stand a discrete risk of HCV reactivation within 2 yr after therapy.

Adult↗

PubMed2006

Accessibility as a major determinant of radiotherapy underutilization: a population based study.

BACKGROUND AND PURPOSE: A survey was conducted of radiotherapy (RT) resources and utilization in a northwestern Italian Region in order to assess geographical variations in radiotherapy utilization rates, and the effects of infrastructure supply on accessibility. MATERIALS AND METHODS: The survey was conducted by analysing standardized utilization rates based on administrative records. The data were analysed at both Regional and Local Health Unit (LHU) level. RESULTS: Wide variation was found among LHUs RT utilization rates--the sex- and age-standardized rates varied from 1.8/1000 inhabitants to more than 3/1000 inhabitants. Patients resident in LHUs with no RT service showed a lower probability of accessing RT (standardized rate ratio (SRR), 0.82; 95%IC, 0.80-0.85). The utilization rate decreased in relation to the distance between a patient's residence and the nearest RT service; the reduction was greater for patients > or =70 years of age. CONCLUSION: The wide geographic variation implies lack of equity in access to services. Utilization levels decreased significantly with increasing distance from the nearest RT service, distance being a barrier to access particularly for older persons. The heterogeneous distribution of services on the Regional territory seems a relevant explanation of differences in utilization rates.

Community Health Planning↗

PubMed2006

Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial.

BACKGROUND: Since 1960, oral melphalan and prednisone (MP) has been regarded as the standard of care in elderly multiple myeloma patients. This multicentre randomised trial compared oral MP plus thalidomide (MPT) with MP alone in patients aged 60-85 years. METHODS: Patients with newly diagnosed multiple myeloma were randomly assigned to receive oral MP for six 4-week cycles plus thalidomide (n=129; 100 mg per day continuously until any sign of relapse or progressive disease) or MP alone (n=126). Analysis was intention-to-treat. This study is registered at , number NCT00232934. RESULTS: Patients treated with thalidomide had higher response rates and longer event-free survival (primary endpoints) than patients who were not. Combined complete or partial response rates were 76.0% for MPT and 47.6% for MP alone (absolute difference 28.3%, 95% CI 16.5-39.1), and the near-complete or complete response rates were 27.9% and 7.2%, respectively. 2-year event-free survival rates were 54% for MPT and 27% for MP (hazard ratio [HR] for MPT 0.51, 95% CI 0.35-0.75, p=0.0006). 3-year survival rates were 80% for MPT and 64% for MP (HR for MPT 0.68, 95% CI 0.38-1.22, p=0.19). Rates of grade 3 or 4 adverse events were 48% in MPT patients and 25% in MP patients (p=0.0002). Introduction of enoxaparin prophylaxis reduced rate of thromboembolism from 20% to 3% (p=0.005). CONCLUSION: Oral MPT is an effective first-line treatment for elderly patients with multiple myeloma. Anticoagulant prophylaxis reduces frequency of thrombosis. Longer follow-up is needed to assess effect on overall survival.

Aged↗

PubMed2006

Changes in prevalence of asthma and allergies among children and adolescents in Italy: 1994-2002.

BACKGROUND: Several studies conducted during the 1990s indicated an increase in the prevalence of symptoms of asthma; more recent investigations suggest that the trend is stabilizing or may even be reversing. OBJECTIVE: We compared 2 cross-sectional surveys conducted in 1994 and 2002 in 8 areas in northern and central Italy, to evaluate prevalence changes for asthma, allergic rhinitis, and eczema. METHODS: The International Study of Asthma and Allergies in Childhood methods and questionnaires were used to investigate 6- to 7-year-old children (16,115 and 11,287 questionnaires completed by parents in 1994-1995 and 2002, respectively) and 13- to 14-year-old adolescents (19,723 and 10,267 questionnaires completed by adolescents in 1994-1995 and 2002, respectively). In each phase, the overall response rate was >90%. Prevalence changes were calculated as the absolute difference between the prevalence recorded on the 2 occasions. RESULTS: The prevalence of wheeze (past 12 months) increased slightly among children (change: 0.8%; 95% confidence interval [CI]: 0.0% to 1.6%) and was rather stable among adolescents. Symptoms of allergic rhinitis (children: change: 5.2%; 95% CI: 4.0% to 6.4%; adolescents: change: 4.1%; 95% CI: 1.9% to 6.3%) and symptoms of atopic eczema (children: change: 4.4%; 95% CI: 3.6% to 5.2%; adolescents: change: 2.1%; 95% CI: 1.2% to 3.0%) increased clearly in both age groups. There was some heterogeneity across the centers among adolescents, especially for allergic rhinitis, with larger increases seen in the 3 metropolitan areas. The changes observed paralleled profound family changes, ie, better parental education, higher rates of maternal employment, and lower rates of exposure to parental smoke. These factors, however, do not explain all of the observed changes in prevalence. CONCLUSIONS: The results indicate that the epidemiologic features of asthma and allergies in Italy are changing rapidly, although the causes are still uncertain.

Adolescent↗

PubMed2005

Digestive endoscopy is not a major risk factor for transmitting hepatitis C virus.

BACKGROUND: The potential role of digestive endoscopy as a mode for transmission of hepatitis C virus (HCV) is controversial. OBJECTIVE: To evaluate the role of digestive endoscopy in transmitting HCV by comparing the incidence of HCV infection in a cohort of patients undergoing endoscopy and in a cohort of blood donors. DESIGN: Prospective cohort study. SETTING: 3 endoscopic units and 2 blood banks in northwestern Italy. PATIENTS: The potentially exposed cohort consisted of 9188 outpatients consecutively recruited from 3 endoscopic units. Of 9008 patients negative for antibody to HCV (anti-HCV), 8260 (92%) were retested for anti-HCV 6 months after endoscopy. The unexposed cohort consisted of 51,230 healthy, anti-HCV-negative persons who donated blood at 2 blood banks in the same area and during the same time period; 38,280 of them (75%) were tested again for anti-HCV 6 to 48 months after the first blood donation (95,317 person-years of observation). MEASUREMENTS: Differences in the anti-HCV seroconversion rate between the exposed cohort (patients undergoing endoscopy) and the unexposed cohort (blood donors). Seroconversion was evaluated by a third-generation enzyme immunoassay for anti-HCV; persons positive for anti-HCV were tested for HCV RNA by polymerase chain reaction. RESULTS: All 8260 persons undergoing endoscopy remained negative for anti-HCV 6 months after the procedure (risk per 1000 persons, 0 [95% CI, 0 to 0.465]); in particular, none of the 912 patients who underwent endoscopy with the same instrument previously used on HCV carriers showed anti-HCV seroconversion (risk per 1000 persons, 0 [CI, 0 to 4.195]). Four blood donors became positive for anti-HCV and HCV RNA (mean follow-up, 2.49 years; 0.042 case per 1000 person-years [CI, 0.011 to 0.107 case per 1000 person-years]); each had undergone minor surgery before the second test. LIMITATIONS: In the endoscopy cohort, 8.3% of patients were lost to follow-up. CONCLUSIONS: These findings support the hypothesis that properly performed digestive endoscopy is not a major risk factor for the transmission of HCV.

Adult↗

PubMed2005

Guidelines for preoperative assessment: impact on clinical practice and costs.

OBJECTIVE: To describe preoperative evaluation in the San Giovanni Battista Hospital in Turin and to forecast the economic impact when preoperative assessment guidelines are implemented. DESIGN: We enrolled, in a month, 702 consecutive patients, excluding cardiac, thoracic, neuro- and vascular surgery, as well as emergency operations. Preoperative assessment data were collected individually, followed by simulating various applications of guidelines based on: (i) preoperative tests relying on full medical history and physical examination to discriminate preoperative risk patients; (ii) organization of a preoperative evaluation unit and tests before patient hospitalization. MAIN MEASURES: Mean number of tests prescribed, preoperative assessment cost per patient. RESULTS: The application of preoperative guidelines would decrease the mean number of tests prescribed from 20 laboratory and 1.9 instrumental to, respectively, 3 and 1.4 per patient. Tests deemed inappropriate by guidelines did not add any relevant clinical information to our study. Economic analysis estimates a reduction of 63% in cost per patient for preoperative tests by introducing guideline criteria (from 69 euros to 26 euros). As regards the cost per patient for preoperative evaluation and hospital stay (115 euros considering only variable costs, 580 euros including all costs), the application of the guidelines would reduce costs by 41-52% according to different cost evaluation approaches for hospital stay. CONCLUSION: Preoperative guidelines fully introduced in practice could notably increase efficiency without affecting the quality of care.

Adolescent↗

PubMed2005

Side-to-side stapled anastomosis strongly reduces anastomotic leak rates in Crohn's disease surgery.

PURPOSE: Anastomotic configuration may influence anastomotic leak rates. The aim of this study was to determine whether a side-to-side stapled ileocolonic anastomosis produces lower anastomotic leak rates than those with a handsewn end-to-end ileocolonic anastomosis after ileocecal or ileocolonic resection for Crohn's disease. METHODS: A series of 122 consecutive patients underwent elective ileocecal or ileocolonic resection with ileocolonic anastomosis for Crohn's disease from January 1998 to June 2003: 71 had handsewn end-to-end anastomosis and 51 had side-to-side stapled anastomosis. The choice between the two anastomoses was left to the surgeon's preference. A retrospective analysis was performed to assess if there was any difference in anastomotic leak rates. RESULTS: The two groups were comparable in terms of age, gender, preoperative presence of abscess or fistula, history of smoking, and albumin levels. More patients were taking steroids in the handsewn group than in the stapled group. In the handsewn group there were 10 anastomotic leaks (14.1 percent) and in the stapled group there was 1 anastomotic leak (2.0 percent) (risk difference, +12.1 percent; 95 percent confidence interval, 1.7-22.2; P = 0.02). Anastomotic configuration was the sole variable that influenced anastomotic leak rates at univariate analysis. Mortality was 1.4 percent in the handsewn group and 0 percent in the stapled group. Complications other than anastomotic leak developed in 11 patients in the hand-sewn group and in 6 patients in the stapled group. Mean postoperative hospital stay was 12.3 days in the handsewn group and 9.7 days in the stapled group (P = 0.03). Excluding those patients who had an anastomotic leak, the difference was still present (handsewn group, 10.1 days; stapled group, 9.1 days; P = 0.04). CONCLUSION: Although confirmation from randomized, controlled trials is required, side-to-side stapled anastomosis seems to substantially decrease anastomotic leak rates in surgical patients with Crohn's disease, compared with handsewn end-to-end anastomosis. Postoperative hospital stay decreased in the stapled anastomosis group, and this was not entirely a result of decreased anastomotic leak rates.

Adult↗

PubMed2005

Thalidomide plus dexamethasone is an effective salvage regimen for myeloma patients relapsing after autologous transplant.

OBJECTIVES: High-dose therapy followed by autologous transplant (AT) is the effective induction treatment for newly diagnosed multiple myeloma (MM) patients. The best salvage therapy has not been defined; treatment options include thalidomide plus dexamethasone (TD), AT and conventional chemotherapy (CC). The aim of the study was to define the best treatment option for patients relapsing after AT. PATIENTS AND METHODS: We compared the outcome of 90 MM patients treated at diagnosis with AT and then salvaged with TD (43 patients), AT (28 patients) or CC (19 patients). The major prognostic factors, the median times between diagnosis and start of salvage treatment and the progression-free survival (PFS) from diagnosis were similar among the three groups. RESULTS: The response rate was higher after salvage AT and after TD, and lower after CC (P < 0.001). TD significantly prolonged PFS from first relapse (P < 0.0001). Median PFS was 20.3 months after TD, 9 months after AT, and 4.5 months after CC. Overall survival (OS) from first relapse was significantly improved by TD (median OS 55.5 months) but not by AT (15 months) or CC (27.5 months) (P = 0.008). Multivariate analysis indicated that TD and age were the only independent risk factors associated with improved outcome. CONCLUSION: TD improved PFS and OS in myeloma patients relapsing after AT.

Adult↗

PubMed2005

Histopathological findings in 851 autopsies of drug addicts, with toxicologic and virologic correlations.

This investigation was carried out on 851 consecutive judicial autopsies of drug addicts who died mostly of heroin overdose from 1977 to 1996. Research of anti-HIV/HBV/HCV antibodies was performed, and histologic sections were retrospectively reviewed. More than 65% were HBV/HCV-positive and about 17% HIV-positive; females were HIV-positive more often than males. Intracranial microhemorrhages were frequently found; cerebral infectious diseases were rare. Inflammatory heart lesions, myocardial fibrosis, and acute ischemia were common. Interstitial nephritis (found in about 8%) was more frequent in females, in older patients, and in those carrying HIV infection; glomerular sclerosis was detected in about 12%. Acute bronchitis and/or pneumonia was demonstrated in 12%, without significant association with HIV infection; pulmonary hemorrhages, foreign body granulomas, and food aspiration were also commonly seen; hyperplasia of pulmonary perivascular lymphatic tissue was rather characteristic. Liver was carrying steatosis in 66.3% and/or hepatitis in 64.5%; acute hepatitis was more frequent in females, chronic hepatitis in older subjects and in those proven positive for hepatotropic viruses; cirrhosis occurred more often in older patients, in those carrying virus infection, and in consumers of nonnarcotics drugs such as ethanol. No pathologic finding was clearly related to drug abuse; therefore, during autopsy, drug addiction can be suspected, but anamnestic and circumstantial data are needed to lead pathologists to request toxicologic analysis to ascertain the cause of death. The present investigation emphasizes that, in addition to the risk of death by overdose, the high incidence of acute and chronic diseases could seriously undermine the health status of heroin and/or other drug consumers.

Adult↗

PubMed2005

Implementing guidelines for venous thromboembolism prophylaxis in a large Italian teaching hospital: lights and shadows.

BACKGROUND AND OBJECTIVES: Venous thromboembolism (VTE) remains a serious complication in hospitalized patients, in spite of several published guidelines (GL) on its prevention. The objective of this study (part of the TRiPSS-2 project) was to evaluate the impact of a locally adapted GL, supported by a multifaceted implementation strategy, in improving VTE prophylaxis in a large teaching hospital. DESIGN AND METHODS: A before and after controlled study was used to evaluate the impact of the recommendations on the appropriateness of prophylaxis. We evaluated the medical charts of two random samples, each of 250 patients, discharged in the first semester of the years 2000 and 2002. The hospital incidence of VTE (1996-2004) was also monitored, through the discharge summaries. RESULTS: Among high risk patients, appropriateness of prophylaxis increased both in medical (from 25% to 41.7%, p=0.0075) and in surgical patients (from 63.7% to 97.1%, p=0.0004). A parallel sharp increase (by 6-8 times) of consumption of elastic stockings was documented. In both medical and surgical patients the incidence of VTE decreased markedly and sustainedly in 2002-2004, with an adjusted odds ratio of 0.68 (95% confidence interval: 0.62-0.75). However, the use of lower than recommended doses of heparins and the increased use of prophylaxis in low risk patients represent unsolved problems. INTERPRETATION AND CONCLUSIONS: Implementing locally adapted GL may be highly effective in improving appropriateness of prophylaxis and in reducing the incidence of VTE; however a careful evaluation of changes is recommended in order to identify unsolved problems or undesired effects.

Adult↗

PubMed2005

High dose sequential chemotherapy with autologous transplantation versus dose-dense chemotherapy MegaCEOP as first line treatment in poor-prognosis diffuse large cell lymphoma: an "Intergruppo Italiano Linfomi" randomized trial.

BACKGROUND AND OBJECTIVES: Poor prognosis diffuse large cell lymphoma (DLCL) responds poorly to standard chemotherapy. Randomized studies comparing high-dose chemotherapy with autologous stem-cell transplantation (ASCT) against standard chemotherapy have produced conflicting results. Dose-dense chemotherapy with granulocyte colony-stimulating factor (G-CSF) support seems to hold promise. The purpose of this multicenter, randomized trial was to compare failure-free and overall survival in patients with poor prognosis DLCL treated with high-dose sequential (HDS) chemotherapy followed by ASCT or an outpatient dose-dense chemotherapy regimen (MegaCEOP). DESIGN AND METHODS: Between 1996 and 2001, 130 DLCL patients, aged < or = 60 years, with intermediate-high or high-risk disease, according to the International Prognostic Index score, and/or bone marrow involvement were enrolled. Sixty were randomized to HDS chemotherapy plus high-dose mitoxantrone and melphalan with ASCT (arm A) and 66 to the MegaCEOP regimen (6-8 courses of an escalated dose of cyclophosphamide and epirubicin plus vincristine and prednisone with G-CSF every 2-weeks) (arm B); 4 patients were considered ineligible. RESULTS: The complete remission rate was 59% in arm A and 70% in arm B (p = 0.18). After a median follow-up of 78 months, the 6-year failure-free survival was 45% in arm A and 48% in arm B (hazard ratio = 1.15, 95% confidence intervals = 0.72-1.84, p = 0.56). The 5-year overall survival was 49% in arm A and 63% in arm B (hazard ratio = 1.67, 95% confidence interval = 0.98-2.85, p = 0.06). Two cases of secondary acute myeloid leukemia were observed after treatment in group A. INTERPRETATION AND CONCLUSIONS: HDS and ASCT as initial therapy for patients with poor-prognosis DLCL does not provide a benefit over that of outpatient dose-dense MegaCEOP chemotherapy.

Adolescent↗

PubMed2004

Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized controlled trial.

High-dose therapy is an effective standard treatment for multiple myeloma patients. Evidence that intermediate-dose therapy improves survival is limited. At diagnosis, about 70% of patients are older than 65. Intermediate-dose regimen is very well tolerated in older patients. In a multicenter study, 194 patients were randomized to receive at diagnosis either conventional chemotherapy (6 courses of oral melphalan and prednisone [MP]) or intermediate-dose therapy (2 courses of melphalan at 100 mg/m(2) [MEL100]) with stem cell support. Response rate was higher after MEL100. Near-complete remission (nCR) was 6% after MP and 25% after MEL100 (P = .0002). At 3 years, MEL100 increased event-free survival (EFS) from 16% to 37% and overall survival (OS) from 62% to 77% (P < .001). Similar results were observed in patients aged 65 to 70: nCR was 8% after MP and 25% after MEL100 (P = .05); at 3 years, MEL100 improved EFS from 18% to 31% (P = .01) and OS from 58% to 73% (P = .01). Patients aged 65 to 70 had a median OS of 37.2 months (MP) versus 58 months (MEL100). Intermediate-dose melphalan improves response rate, EFS, and OS in myeloma patients, specifically in those aged 65 to 70. It constitutes a more effective first-line regimen than standard treatment for elderly patients.

Aged↗

PubMed2004

Low-dose continuous iron therapy leads to a positive iron balance and decreased serum transferrin levels in chronic haemodialysis patients.

BACKGROUND: Iron balance is critical for adequate erythropoiesis, but its optimal therapeutic regimen remains to be defined. Continuous maintenance therapy with iron has been proposed for dialysis patients on recombinant human erythropoietin (rHuEpo) in the hope that the regimen is adequate and safe. METHODS: We determined serum ferritin, transferrin, transferrin saturation (TSAT), serum transferrin receptors, albumin and C-reactive protein (CRP) in a 3-year prospective study in 30 chronic haemodialysis patients on dialysis treatment for 132+/-111 months (18 males, 12 females; mean age 56+/-14 years). Beginning in the year 2000, they regularly received low-dose maintenance iron supplementation (i.v. iron gluconate 31.25 mg/week) for 12 months (Period 1 or first treatment phase), followed by a 6-month withdrawal (Period 2 or stop phase) and then by continuous maintenance iron therapy (i.v. iron gluconate 31.25 mg/week) for another 9 months (Period 3 or re-challenge phase). RESULTS: A significant increase in serum ferritin and TSAT was observed, with values exceeding 500 ng/ml and 50% in 10/30 (33%) and 7/30 (23%) of subjects, respectively, in Period 1, and in 11 and 5% in Period 3. A significant decrease in serum transferrin was documented during Period 1, followed by an increase in Period 2 and a decrease in Period 3. Serum albumin remained stable. Serum transferrin was always negatively correlated with ferritin (r = -0.41, P<0.001) and weakly correlated with serum transferrin receptors (r = 0.178, P<0.05), but was not correlated with serum albumin or CRP. Regression equations based on pre-treatment serum ferritin values were developed for predicting the value of serum ferritin at any time following the beginning of continuous iron supplementation. They fitted a linear relationship for males (y = 81 + 21.5 x time) and for females (y = 65 + 22 x time). Percentile charts for quantitative tracking of serum ferritin increases and decreases in patients have also been developed from values measured at different times. These charts show box-plot distributions of expected ferritin against time. CONCLUSIONS: Even continuous low-dose maintenance iron therapy, with only 31.25 mg weekly over 1 year, cannot prevent the risk of iron overload in patients with moderate anaemia. Furthermore, this treatment is responsible for decreases in serum transferrin, unrelated to changes in serum albumin, possibly of concern for hypo-transferrinaemia as an independent risk factor for iron toxicity.

Aged↗

PubMed2004

Patients with type 2 diabetes had higher rates of hospitalization than the general population.

OBJECTIVE: We describe the rate, causes, and predictors of hospitalization for all patients with type 2 diabetes in a diabetes clinic in Turin, Italy and compare their hospitalization rates with those of the general population. STUDY DESIGN AND SETTING: All patients were recruited and followed up for hospital admissions from January 1996 to June 2000. The role of risk factors was analyzed with a conditional proportional hazard model for repeated events. RESULTS: More than 50% of the patients had been admitted to hospital at least once for any cause, and 30% had had multiple admissions, accounting for nearly 90% of all days in hospital. For these patients, older age, high glycated hemoglobin level, obesity, insulin treatment, presence of nephropathy, coronary and peripheral artery disease and comorbidity were statistically independent predictors of hospital admission. The standardized hospital admission ratios were 158.8 for men <65 years of age and 113.3 for men > or = 65 years and 245.2 for women <65 years of age and 135.3 for women > or = 65 years of age. The highest ratios were for diabetes, vascular (cardiac and cerebral) diseases, and eye diseases in younger women. CONCLUSION: Patients with type 2 diabetes, and particularly younger women, had higher rates of hospitalization than the general population, with an excess risk of about 30%.

Aged↗

PubMed2004

Muscle tenderness in different headache types and its relation to anxiety and depression.

To assess in patients with migraine and tension type headache, both episodic and chronic, the extent to which muscle tenderness may relate to anxiety and depression, 459 patients with Episodic Migraine (EM, 125), Chronic Migraine (CM, 97), Episodic Tension Type Headache (ETTH, 82), Chronic Tension Type Headache (CTTH, 83), and EM+ETTH (72) were enrolled. For each patient, a psychological assessment on the Axis 1 of the DSM-IV and muscle palpation of pericranial and cervical muscles were carried out. A Pericranial Muscle Tenderness Score (PTS) and a Cervical Muscle Tenderness Score (CTS) were calculated (range 0-3). Logistic and linear regression analyses were employed to assess relations between muscle tenderness, the demographic variables and psychiatric disorders in the different patient groups. Odds ratio for 'male gender' was higher in groups with tension type headache. Only EM patients showed a positive association with increasing age. Anxiety and depression were significantly associated to CM. A significant negative correlation of PTS and CTS was observed in EM patients. In relation to male gender, the PTS was significantly lower in EM, ETTH and CTTH; CTS was significantly lower in EM, CM, and CTTH. Anxiety and, even more, anxiety and depression combined were positively associated to higher PTS and CTS in EM patients. Anxiety and depression were also positively associated to higher CTS in patients with EM+ETTH. In CTTH patients, PTS only was positively associated to anxiety and depression. We conclude that in patients with EM, the presence of anxiety or anxiety and depression combined considerably increases the level of muscle tenderness in the head and, even more, in the neck, and might facilitate the evolution into CM.

Adult↗