Trial-based cost-effectiveness of abatacept for rheumatoid arthritis patients in Italy.

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic, inflammatory disorder leading to disability and reduced quality of life. Effective treatment is a significant economic burden on the Italian healthcare system. Economic models in RA are commonly based on indirect treatment comparisons. METHODS: This study assessed the cost-effectiveness of abatacept relative to adalimumab for RA in Italy based on a head-to-head trial by means of a cost-consequence analysis. RESULTS: Health benefits based on the most stringent efficacy criteria were in favor of abatacept compared to adalimumab. Rates for more costly adverse events were higher for adalimumab compared to abatacept, which was reflected in the lower costs for abatacept (-€237,246 or -€237per patient). CONCLUSION: The health economic value of abatacept compared with adalimumab from the perspective of the Italian NHS depends on the choice of health outcome. Health gains with abatacept were generally based on more stringent criteria and lower total costs.

Probing transport mechanisms of BaFe2As2 superconducting films and grain boundary junctions by noise spectroscopy.

An important step forward for the understanding of high-temperature superconductivity has been the discovery of iron-based superconductors. Among these compounds, iron pnictides could be used for high-field magnet applications, resulting more advantageous over conventional superconductors, due to a high upper critical field as well as its low anisotropy at low temperatures. However, the principal obstacle in fabricating high quality superconducting wires and tapes is given by grain boundaries. In order to study these effects, the dc transport and voltage-noise properties of Co-doped BaFe2As2 superconducting films with artificial grain boundary junctions have been investigated. A specific procedure allows the separation of the film noise from that of the junction. While the former shows a standard 1/f behaviour, the latter is characterized by an unconventional temperature-dependent multi-Lorentzian voltage-spectral density. Moreover, below the film superconducting critical temperature, a peculiar noise spectrum is found for the grain boundary junction. Possible theoretical interpretation of these phenomena is proposed.

Efficacy on menopausal neurovegetative symptoms and some plasma lipids blood levels of an herbal product containing isoflavones and other plant extracts.

OBJECTIVES: To assess the efficacy of a product containing isoflavones and other plant extracts (BIO) on whole menopausal symptomatology and plasma lipids profile. METHODS: Multicentre, randomized, double blind, placebo controlled clinical investigation on 125 menopausal women randomly assigned to two groups treated for 6 months with placebo or one tablet daily of an herbal product containing 72 mg/dose of isoflavones of different plants origin and other plant extracts (BIO). Primary end-point: Kupperman Menopause Index (KI) variations; secondary end-point: activity on plasma lipids profile and clinical global impression (CGI) on efficacy and tolerability by investigators and patients. The usual parametric test (paired Student t test) was performed to evaluate the significance. In case of non-applicability of parametric tests, the non-parametric Mann-Whitney U test was used. The differences where considered significant at p<0.05 level. RESULTS: At the end of treatment in both groups KI showed a significant decrease (p<0.001). However, in the BIO group the KI reduction was significantly higher (p=0.0265) than in the placebo group after 4 and 6 months of treatment. In the BIO treated patients the LDL cholesterol showed a borderline but not significant reduction compared to placebo (p=0.0608) and triglyceride (TG) a significant (p=0.0151) decrease compared to placebo. The investigator's and patient's CGI on BIO group where superior as compared to placebo. Clinical tolerability was good in booth groups. CONCLUSION: On the basis of positive effects on KI and lipids profile as well as of good clinical tolerability, BIO can be considered one of the possible alternative therapy for conventional HRT.

Effects of neridronate treatment in elderly women with osteoporosis.

Osteoporosis is a common disorder, especially among elderly post-menopausal women. Elderly women are often affected by co-morbidities, impaired gastrointestinal function and reduced mobility; therefore, the treatment strategy for their osteoporosis can be difficult. In this randomized pilot study, we have investigated the effects of a 12-month treatment with neridronate on bone mineral density (BMD), bone turnover markers and quality of life (QoL). The study included 40 women (age, 65-80 yr; post-menopausal period, >15yr) from a single osteoporosis centre. Twenty women received a monthly im injection of 25 mg of neridronate associated with a daily dose of 500 mg of calcium and 400 U of vitamin D. Twenty women received calcium plus vitamin D supplements alone. Changes in BMD at the lumbar spine and femoral neck were measured by dual energy X-ray absorptiometry. Serum type I collagen C-telopeptide (sCTX), urinary free-deoxypyridinoline (ufDPD), bone alkaline phosphatase (ALP) and serum osteocalcin levels were determined. For the QoL assessment, the Italian version of the SF-36 test was administrated. Spine and hip BMD rose by 6.6 +/- 3 and 4.2 +/- 2.3%, respectively (p < 0.05), after 12 months of neridronate treatment. Markers of skeletal turnover significantly fell already after 3 months of neridronate treatment and decreased progressively thereafter within 12 months. The mean decrease at 12 months ranged from 38 +/- 11% for sCTX to 25.2 +/- 15% for ufDPD (p < 0.001, all). The mean improvement in QoL in the treated group was 45.7% for bodily pain, 37.5% for general health perception, 23.1% for vitality, 18% for emotional role functioning and 12% for physical role functioning. The changes observed in BMD, turnover markers and QoL in the untreated group were ns. The intermittent neridronate administration was easily manageable and well tolerated. In conclusion, neridronate currently represents a valid option for the treatment of osteoporosis, since it helps just as much as oral BPs in the improvement of BMD and in particular conditions it can be even more effective.

Characterization of reproductive endocrine disorders in women with epilepsy.

An increased frequency of reproductive endocrine disorders has been reported in women with epilepsy. A possible role of the seizure disorder or, alternatively, of the use of antiepileptic drugs (AEDs) has been suggested as the pathogenic mechanism. The aim of the present study was to assess the frequency of reproductive endocrine disorders in a series of women with epilepsy, examining the possible relationships of these disturbances with different epilepsy syndromes and AED treatment. Fifty epileptic women, all of reproductive age and none pubertal, pregnant, or lactating, were submitted to clinical endocrinological evaluation, hormonal assessment, and ovarian ultrasonography. Subjects with abnormal findings in this preliminary study underwent additional evaluations. Reproductive endocrine disorders were diagnosed in 16 (32%), consisting of polycystic ovary syndrome in 13, hypothalamic amenorrhea in 2, and luteal phase deficiency in 1. There was no significant association of these disturbances with epilepsy type or AED treatment. Patients with reproductive endocrine disorders often showed delayed ovulation with shortened luteal phase. The results of this study suggest that the prevalence of disordered ovulation, in particular polycystic ovary syndrome, is increased in epilepsy, independent of antiepileptic medications or type of seizure disorder.

Minilaparoscopic ovarian drilling under local anesthesia in patients with polycystic ovary syndrome.

OBJECTIVE: To assess pain control in patients with polycystic ovary syndrome (PCOS) who are undergoing ovarian drilling during minilaparoscopy under local anesthesia and conscious sedation and to evaluate the efficacy of this protocol compared with the traditional approach in terms of operative and discharge times, subsequent ovulation, and pregnancy. DESIGN: Prospective randomized study. SETTING: University hospitals and private day-surgery unit. PATIENT(S): Sixty-two infertile women with PCOS. INTERVENTION(S): Group A underwent minilaparoscopic ovarian drilling under local anesthesia and conscious sedation. Group B (control group) was treated with traditional ovarian drilling by laparoscopy under general anesthesia. MAIN OUTCOME MEASURE(S): Intraoperative pain score in group A. Hormonal profile before and after surgery, operative and discharge times, postoperative analgesic requirements, and reproductive follow-up in both groups. RESULT(S): Group A showed a good intraoperative pain score. The hormonal profile after surgery did not differ between groups A and B. Operative times were also similar for both groups. The number of patients discharged within 2 hours after surgery was significantly higher in group A. The need for postoperative analgesics was significantly higher in group B. No statistically significant differences were noted between the groups in terms of pregnancy and ovulation rates. CONCLUSION(S): Intraoperative and postoperative local anesthesia plus conscious sedation allows outpatient bilateral ovarian drilling by minilaparoscopy to be performed without general anesthesia. The high pregnancy rates, the simplicity of the method, and the faster discharge time offer a new option for patients with PCOS who are resistant to clomiphene citrate. Moreover, ovarian cauterization can be performed simultaneously with a diagnostic minilaparoscopy and integrated into the infertility workup of these patients.

[Ovarian drilling in minilaroscopy and local anesthesia in the therapy of polycystic ovarian syndrome]. / Drilling ovarico in minilaparoscopia e anestesia locale nella terapia chirurgica della sindrome dell'ovaio policistico.

BACKGROUND: To evaluate the feasibility of ovarian drilling using minilaparoscopy under local anesthesia and to determine its efficacy in the surgical treatment of polycystic ovarian syndrome. METHODS: Prospective randomized study carried out in an out patient service on 62 women affected by PCOS divided into two groups: 32 patients (group A) underwent bilateral ovarian drilling by minilaparoscopy under local anesthesia and 30 patients (group B) underwent bilateral ovarian drilling by traditional laparoscopy under general anesthesia. RESULTS: Operation times were not different between the two groups. Discharge time was significantly lower in group A in comparison to group B. The rate of patients discharged after 2 hours was significantly higher in group A. The need for additional analgesia was lower in group A in comparison to group B. Serum LH, A and T levels were significantly reduced after surgery in both groups. Pregnancy rate after 1-year follow-up was higher, although not significantly in group A. Ovulation and abortion rates were not different between the two groups. CONCLUSIONS: Ovarian drilling in minilaparoscopy under local anesthesia is a new option for gynecologists, allowing similar therapeutical results to those achieved by traditional laparoscopy, but with the benefits of a less invasive technique that can be carried out in an outpatient service without the need for general anesthesia.

[Postmenopausal osteoporosis: therapeutic approaches]. / Osteoporosi postmenopausale. Approcci terapeutici.

The preventive and therapeutical measures to be implemented the post-menopausal osteoporosis are varied, although there is no clear, single protocol of intervention. ESTROGENS AND PROGESTOGENS: It si verify that the administration of estrogens and/or progestogens prevents bone loss with an action on mineral components of bone and on collagenic metabolism. BIPHOSPONATES: Operate inhibiting mineralization and, particularly, bone reabsorption. At present its use, in low dosages, is reserved to "fast bone loser" patients. CALCITONIN: It increases bone mass and significantly reduces the frequency of fractures in comparison with only calcium, but its use is limited by high costs. IPRIFLAVONE: Anti-reabsorption effects has on bone and stimulates osteoblastic activity; besides, it seems to developed the effect of estrogens on the bone. FLUORIDES: Fluorides also operate on both components of bone turnover, with a most important action on bone formation. An interesting approach is the association of low doses of monofluorophosphate with calcium. However, further confirmation of the "quality" of neoformed bone is necessary. CALCIUM: Calcium supplementation is obligatory where the alimentary supply of calcium is lower then 1 g/die or where an osteomalacic component coexists; only dosages higher than 15 g/die can produce/pharmacological effects on bone turnover. CALCITRIOL: The use is still disputed. The calcitriol-calcium association seems convincing haveved. ORG: OD 14. The efficacy of this synthetic steroid to prevent bone loss is probably superimposable on the efficacy of classic estrogen therapy.

Derangement of the hypothalamic GnRH pulse generator in women with epilepsy.

An increased frequency of reproductive endocrine diseases has been described in women with epilepsy and a subclinical reproductive dysfunction has been suggested in normally menstruating epileptic women. We assessed the reproductive endocrine function in 11 normally menstruating, drug-free epileptic women, evaluating the basal hormonal profile and LH pulsatile secretion during continuous EEG monitoring. A significant LH hyperpulsatility was observed in epileptic women compared with controls; moreover, a significant increase of gonadotropin basal secretions was observed when inter-ictal paroxysmal activity increased. The derangement of the hypothalamic GnRH pulse generator may represent a subclinical condition associated with epilepsy, not necessarily affecting the regularity of menstrual function. However, it is possible that the alteration of LH pulsatile pattern might eventually cause reproductive endocrine diseases. Paroxysmal activity seems to be an important additional factor in the derangement of gonadotropin secretion.