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Multiple sclerosis, a demyelinating disease of the central nervous system, is the most common cause of neurological disability in young adults. Four types of disease have been defined: benign or stable, relapsing remitting, secondary progressive, and primary progressive multiple sclerosis.To evaluate the immunomodulant therapy in the treatment of multiple sclerosis from an economic point of view.In order to monitor immunomodulant drug prescriptions we utilized a specific database (FarmaDDSS), containing patient-linked data such as age, sex, prescriptions, diseases etc. In particular we estimated the Received Daily Dose (RDD) and the Prescribed Daily Dose (PDD) for each immunomodulant drug (interferon beta-1a, beta-1b, and glatiramer acetate). We also calculated the cost per RDD and patient’s and physician’s compliance.The average RDDs from 2007 to 2010 for Avonex®, Betaferon®, Copaxone®, Extavia®, Rebif22® and Rebif44® were 4,7 µg, 3,9 MU, 19,7 mg, 3,9 MU, 9,1 µg and 18,8 µg. The average costs per RDD were €29.62 for Avonex®, €28.80 for Betaferon®, €26.16 for Copaxone®, €26.59 for Extavia®, €27.54 for Rebif22® and €38,83 for Rebif44®.The study highlights the importance and validity of using RDDs to evaluate the actual consumption of immunomodulant therapy in the treatment of patients with multiple sclerosis. The study shows a difference between RDD and PDD for Rebif22® and Rebif44®. The use of pharmaceutical and clinical databases could allow to follow the patients throughout the care delivery pathway, improving compliance and reducing treatment costs.

Abstract: Objective: To assess the efficacy, safety and extent of perceived indications of acarbose, a new antidiabetic agent, under routine clinical practice conditions in an unselected Northern Italian population of type II diabetic patients. Methods: The study population was assigned to three different groups according to the physician's clinical judgement: group A (acarbose considered as an elective treatment); group B (acarbose considered to be of uncertain benefit); group C (acarbose deemed not to be appropriate). Group B patients were randomized either to continue their standard treatment or to add acarbose to it. Patients with type II diabetes mellitus were recruited from 17 diabetes outpatient clinics from one Italian region (Lombardy). A total of 1027 patients were recruited (group A: 283; group C: 494; group B: 250, of whom 124 were randomly assigned to standard treatment + acarbose and 126 to standard treatment alone). Acarbose was administered for 1 year at a median dose of 100 mg 3 times daily. Drug efficacy was evaluated in terms of mean HbA1c, pre- and post-prandial glycaemic values. Additional endpoints were the proportion of patients with HbA1c levels below 8% at the end of the study period and the proportion of subjects who needed a modification in the standard treatment. The safety and tolerability profiles of the drug were also investigated. Data on HbA1c, fasting and post-prandial blood glucose levels were analysed over time using repeated-measures analysis [Generalized Estimating Equation (GEE) models]. Results: The analysis of Group B showed that, after treatment for 1 year, the mean reduction in HbA1c levels in the acarbose group with respect to the control group was 0.30% (95% confidence limits −0.60 +0.02; P = 0.07), while the mean reduction in post-prandial glycaemia was 17 mg · dl−1 (95% c.l. −33.5 −0.8; P = 0.04). No difference resulted for fasting blood glucose levels. When looking at the baseline HbA1c levels, it emerged that the mean benefit associated with the use of acarbose was 0.14% (95% c.l. −0.6 +0.28; P = 0.5) in patients with HbA1c levels below 8%, 0.28% (95% c.l. −0.6 +0.05; P = 0.09) in those with values between 8% and 9.9% and 0.65% (95% c.l. −1.36 +0.06; P = 0.07) in those with values ≥10%. Only patients treated with diet ± oral anti-diabetic agents (OAA) benefited from acarbose treatment (mean benefit = 0.37%, 95% c.l. −0.65 −0.08), while no effect was shown for insulin-treated subjects. The proportion of patients with HbA1c below 8% increased from 31% to 44% in the acarbose group and from 40% to 45% in the control group (absolute difference between baseline and end-of-study values = 8.0% in favour of acarbose-treated patients; P = 0.058). Patients treated with acarbose were significantly more likely to undergo a dose reduction in concomitant diabetic treatments compared with the control group; they were also less likely to require an increase in the dose of standard treatment and to start insulin during the study period. One third of the patients could not assume the drug for the whole study period, mainly due to gastrointestinal side-effects. Conclusions: The design adopted in this study allowed an integrated evaluation of the overall effectiveness of acarbose in clinical practice. The benefits of the drug in an unselected population of non-insulin-dependent diabetes mellitus (NIDDM) patients are significant but of marginal clinical relevance. Only a better definition of the subgroups of patients who are more likely to benefit from long-term treatment, particularly through possible postponement of secondary OAA failure, will allow a reliable definition of the cost-effectiveness of this complementary component of anti-diabetic strategy.

Peripheral neuropathy is one of the most common and disabling long‐term seque lae of diabetes mellitus. Aldose reductase inhibitors (ARIs) have been proposed and are increasingly used in many countries for the prevention and treatment of diabetic neuropathy. The aim of this study was to review existing evidence on the effectiveness of ARIs in the treatment of peripheral diabetic neuropathy, with particular reference to the type and clinical relevance of the end point used and to the consistency of results across studies. Thirteen randomized clinical trials (RTCs) comparing ARIs with placebo, published between 1981 and 1993 were included in the meta‐analysis. Nerve conduction velocity (NCV) was the only end point reported in all trials. Treatment effect was thus evaluated in terms of NCV mean difference in four different nerves: median motor, median sensory, peroneal motor, and sural sensory. A statistically significant reduction in decline of median motor NCV was present in the treated group as compared to the control group (mean 0.91 ms−1; 95 % CI 0.41–1.42 ms−1). For peroneal motor, median sensory, and sural sensory nerves results did not show any clear benefit for patients treated with ARIs. When the analysis was limited to trials with at least 1‐year treatment duration, a significant effect was present for peroneal motor NCV (mean 1.24 ms−1; 95 % CI 0.32–2.15 ms−1) and a benefit of borderline statistical significance was also present for median motor NCV (mean 0.69 ms−1; 95% CI −0.07−1.45 ms−1). A heterogeneous picture emerged when looking at the results of different studies and serious inconsistencies were also present in the direction of treatment effects among nerves in the same studies. Although the results of 1‐year treatment on motor NCV seem encouraging, the uncertainty about the reliability of the end‐point employed and the short treatment duration do not allow any clear conclusion about the efficacy of ARIs in the treatment of peripheral diabetic neuropathy.

We set out to describe patterns of care of an Italian diabetic population, with reference to the recommendations of the St Vincent Declaration. We investigated different aspects of care received by 2707 patients, of whom 2196 in the charge of 35 Diabetes Outpatient Clinics (DOCs) and 511 cared for by 49 General Practitioners (GPs). Data were collected by interviewing the patients, their physicians and by reviewing medical records. Our data show that diabetes care in Italy differs in many aspects from the recommendations of the St Vincent Declaration. Glycated haemoglobin measurement was lacking in 50 % of the patients in the charge of GPs and in 15 % of those attending DOCs. While the control of cardiovascular risk factors was satisfactory, information on albumin excretion was not available in one third of the patients. Overall, 79 % of the patients had had an eye examination in the previous 12 months. More than one‐third of the patients had not received adequate information on different aspects of care, with wide variations according to the setting of care. Forty‐two per cent of the patients attending DOCs and 14 % of those cared for by GPs practised blood glucose self‐monitoring; similarly, insulin therapy self‐management was performed by 50 % and 19 % of the patients attending DOCs and GPs, respectively. Our data call for vigorous efforts aimed at improving the awareness of the potential for reducing major diabetic complications. Therefore, it is essential to promote the incorporation of clearly defined clinical practice guidelines at each level of care. © 1997 by John Wiley & Sons, Ltd.

This pragmatic, large scale randomised trial was designed after considering the evidences emerged from the 1985 systematic overiew of all trials about adjuvant tamoxifen in women with early breast cancer, also confirmed in the 1990 systematic overview, that have demonstratad a highly significant improvement in 10-years survival. For the patients over the age of 50, the main question addressed in this protocol is whether the duration of tamoxifen therapy affects disease-free on overall survival. However, it is not yet known how long women with breast cancer should continue 10 take adjuvant tamoxifen. The obvious question, for this trial started in 1989, is whether a longer period, say 5 years, is more beneficial. For the protocol of this study all women 50 years and < 70 years with “operable” breast cancer, irrespective of nodal or menopausal status, where eligible. After primary therapy all patients were registered into the study through the coordinating center and received 20 mg tamoxifen daily for 2 years and, if they remained disease-free, were eligible for randomisation to stop or continue therapy for further 3 years. This protocol also permitted optional randomisation of patients to systemic chemotherapy or control, since there was little evidence, at that time, as to wheter additional benefits would be gained by using both chemotherapy and hormone therapy. This trial is the biggest trial about adjuvant treatments ever conducted in Italy, having recruited 2511 patients until January 1996 from 53 participating centers, of which 1722 were randomised to stop (862) or to continue (860) treatment. After 2 years of therapy, 16% of patients were not eligible for randomisation because they had relapsed and 4% had refused randomisation. Overall 1083 (47%) patients are N+ (139 of them with 3 nodes involved), 295 (12%) patients underwent adjuvant chemotherapy, 1277 (56%) patients are ER+, 374 (16%) ER-, 105 (5%) ER borderline and 524 (23%) did not perform the determination of the ER status (data not yet available for 231 patients). 10.5% of the patients has experienced side-effects attributable to tha hormone-therapy. After a median follow-up of 36 months, 1967 (78.4%) patients are disease-free, 147 (5.8%) have relapsed, 48 (1.9%) have developed a second tumour (7 endometrial cancer), 178(7.1%) have died and 171 (6.8%) have been lost to follow-up.