Search

Background. To compare the efficacy and tolerability of single doses of diclofenac dispersible and naproxen granular in patients with acute, painful, minor sports injuries. Methods. Forty-eight adult outpatients with moderate-to-severe pain on movement, following a traumatic event

Provides information on a study conducted to compare the effects of single doses of diclofenac dispersible and naproxen granular in patients with acute, painful, minor sports injuries. Description of diclofenac dispersible drug; Methodology used to conduct study; Results of study.

Sarcopenia has been recognized as a muscle disease, with adverse consequences on health. Updated recommendations, aimed at increasing awareness of sarcopenia and its accompanying risks, have been produced to urge the early detection and treatment of this disease. Recommended treatment is based on an individually tailored resistance exercise training program, the optimization of protein intake using high-quality protein sources (i.e., whey protein) in order to provide a high amount of essential amino acids-particularly leucine-and addressing vitamin D deficiency/insufficiency. The purpose of this review is to collate and describe all of the relevant efficacy studies carried out with a muscle-targeted oral nutritional supplementation (MT-ONS)-namely a whey-protein-based, leucine- and vitamin D-enriched formula aimed at optimizing their intake and satisfying their requirements-in different patient populations and clinical settings in order to determine if there is enough evidence to recommend prescription for the treatment of sarcopenia or its prevention in high-risk patient populations. Trials using a MT-ONS with or without a concomitant physical exercise program were systematically searched (up to June 2021), and those addressing relevant endpoints (muscle mass, physical performance and function) were critically reviewed. In total, 10 articles providing efficacy data from eight trials were identified and narratively reviewed. As far as older patients with sarcopenia are concerned, MT-ONS has been pertinently tested in six clinical trials (duration 4-52 weeks), mostly using a high-quality randomized controlled trial design and demonstrating efficacy in increasing the muscle mass and strength, as well as the physical performance versus iso-caloric placebo or standard practice. Consistent results have been observed in various clinical settings (community, rehabilitation centers, care homes), with or without adjunctive physical exercise programs. A positive effect on markers of inflammation has also been shown. A muscle-protein-sparing effect, with benefits on physical performance and function, has also been demonstrated in patients at risk of losing skeletal muscle mass (three trials), such as older patients undergoing weight loss or intensive rehabilitation programs associated with neurological disability (Parkinson's disease). MT-ONS has demonstrated not only a significant efficacy in clinical variables, but also a positive impact on healthcare resource consumption in the rehabilitation setting (length of stay and duration of rehabilitation). In summary, MT-ONS, alone or in association with an appropriate exercise program, is an effective therapy for older patients with sarcopenia and should be offered as a first-line treatment, not only to improve clinical outcomes but also to reduce healthcare resource consumption, particularly in patients admitted to a rehabilitation center.

Background: Hepatitis C virus (HCV) recurrence in HCV+ liver transplant recipients is almost inevitable and may be promoted by immunosuppression. We compared the amount of liver damage with regard to usage of steroids and basiliximab., Methods: A total of 140 HCV+ adult liver transplant recipients were randomly allocated to basiliximab + steroids or basiliximab + placebo (plus cyclosporine and azathioprine). Primary endpoint: hepatitis C histological recurrence (liver damage as for Ishak grading score >or=8 by biopsy at 12 months); secondary endpoints: treatment failure (death, graft loss, patient withdrawal), biopsy proven acute rejection (BPAR), treated acute rejection (tAR), allograft and patient survival rates at 12 months., Results: Any significant difference has been observed in the 12-month hepatitis C histological recurrence rate (41.2% basiliximab + steroids, 37.5% basiliximab + placebo, P = 0.354). The treatment failure rate was significantly higher in basiliximab + steroids (28.8%) than in basiliximab + placebo (15.6%), P = 0.03; the combination test for the evaluation of the joint hypothesis resulted in a borderline nonsignificant overall result (P = 0.059). BPAR rate was significantly lower in the group treated with steroids (24.3% basiliximab + steroids, 39.4% basiliximab + placebo, P = 0.04), while the tAR rate was similar (29.7% basiliximab + steroids and 37.9% basiliximab + placebo). Any significant differences in 1-year graft and patient survival rates have been observed (72.9% and 84.8% basiliximab+steroids; 81.5% and 89.0% basiliximab + placebo)., Conclusions: Results suggest that steroid-free therapy is associated with a significantly lower treatment failure rate, although histological recurrence rate of hepatitis C is similar in the two groups. This benefit is not offset by an evident increase in graft rejection rate requiring treatment.

Background: Liver transplantation has become established therapy for end-stage liver disease. Survival rates are satisfactory and the current challenge is the implementation of cost-optimization policies., Methods: This study was a cost-outcome and cost-determinant analyses in an Italian National Health Services liver transplantation unit. Collection of data related to survival and costs in 235 adult transplant recipients from 1997 to 2000. Costs included consumption-related costs (e.g., diagnostics, medication) and structure-related costs (e.g., staff, general costs, and overhead) allocated individually according to hospital patient days. The main variables were average cost per patient alive at the end of each year, average cost per month of patient alive, and average cost per transplantation., Results: Two hundred fifty-two transplantations were performed in 235 adults (mean follow-up, 16.5 months). Average cost per patient alive was constant (e107,014-e117,782), whereas average cost per month of patient alive progressively diminished to e7,098. Costs differed according to reason for transplantation, being lower in nonviral (mainly alcoholic) hepatitis and higher in fulminant hepatic failure and in rare liver diseases. Higher costs were also observed in patients with portal thrombosis and high pretransplant serum creatinine. The average cost per transplantation was fairly constant (e75,747-e83,846) and plateaued after 120 to 140 transplantations., Conclusions: The optimization of the cost-to-outcome ratio is linked to a reasonably high number of transplants per year, which allows early achievement of a cost-per-transplant plateau associated with a better survival rate, in addition to careful consideration of risk factors and diagnoses.

Objectives: To assess the efficacy and tolerability of a new matrix patch delivering 0.05 mg estradiol per day (Estraderm MX 50) in postmenopausal women with moderate to severe postmenopausal symptoms., Methods: A multicenter, double-blind, randomized, between-patient, placebo controlled trial in 109 postmenopausal women was carried out. Patches were applied twice weekly for 12 weeks. Patients were assessed at 4, 8 and 12 weeks of treatment. The primary efficacy variable was change from baseline in mean number of moderate to severe hot flushes (including night sweats) per 24 h during the last 2 weeks of treatment. Other variables included Kupperman Index, local and systemic tolerability. Plasma concentrations of estradiol (E2), estrone (E1) and estrone sulfate (E1S) were determined before and after treatment., Results: Estraderm MX was significantly superior to placebo (P < 0.001) in reducing mean number of moderate to severe hot flushes (including night sweats) per 24 h after 4, 8 and 12 weeks of treatment. The estimate of treatment group differences after 12 weeks was 4.2 hot flushes (95% confidence interval: 2.6-5.8). Estraderm MX also significantly reduced Kupperman Index at all time points compared to placebo (P < 0.001). Estraderm MX induced increases in mean E2, E1 and E1S plasma levels as expected (E2: baseline 2.7 pg/ml, 12 weeks 38.9 pg/ml; E1: baseline 18.8 pg/ml, 12 weeks 41.6 pg/ml; E1S: baseline 235.6 pg/ml, 12 weeks 765.1 pg/ml). Overall rates of adverse experiences were similar for Estraderm MX and placebo. The number of patients reporting skin irritation was low and similar in both groups., Conclusions: Estraderm MX 50, a new matrix patch, offers an effective and well tolerated dosage form for transdermal delivery of 0.05 mg E2 per day.

We evaluated bleeding pattern and endometrium following the administration of two of the most common types of progestogens used in hormone replacement therapy, medroxyprogesterone acetate (MPA) and medrogestone acetate. Twenty eight patients in spontaneous menopause were randomly allocated to two groups. Group 1 (n = 14) received 5 mg/day of of MPA and group 2 (n = 14) received 5 mg/day of medrogestone: both the progestogens were sequentially added for the last 12 days of a 21-day period of transdermal estradiol administration (50 micrograms per day). A 7-day treatment-free period completed the cycle. The study treatments were administered for 6 cycles. The endomtria were checked for their thickness by transvaginal ultrasound before starting treatment and at 6th treatment cycle (days 6-10 of the estrogen-only phase and during the period between days 8 and 12 of the progestogen addition). Endometrial biopsies were performed before starting treatment only in the patients with a positive progesterone challenge test and in all the patients at the end of the study during the addition of the progestogen. The bleeding pattern was closely monitored. MPA is accompanied by a thick endometrium with full secretory transformation in all cases. On the contrary, the same dose of medrogestone induced a consistent decrease of estrogen primed endometrium with only 4 cases of full secretory transformation. Four medrogestone-treated patients dropped out due to unscheduled bleeding. A low dose of medrogestone added to transdermal estradiol induced incomplete transformation of endometrium and oligo-amenorrhea more frequently than MPA, but it increased the chances of irregular bleeding. MPA fully transformed the endometrium: periods were thus heavier but regular. None of the patients in either group had endometrial hyperplasia.

The aim of this study was to evaluate the bronchodilating activity and the tolerability of broxaterol (B, CAS 76596-57-1) given as drops by inhalation after single administration at different doses and after repeated administrations for 1 month. Two groups of 12 patients each were treated in a double-blind fashion and according to a within-subject design: one group with B at the single doses of 1.25 mg and 2.50 mg and with placebo (P), and the other with B at the dose of 0.75 mg and with P. A further group of 12 patients was treated in open fashion for 1 month with B at the dose of 1.25 mg 3 times a day. On each study day for the single doses and on the 1st and 30th days for the repeated doses, forced vital capacity (FVC), forced expiratory volume (FEV1), maximal middle expiratory flow (MMEF), heart rate (HR) and systolic and diastolic blood pressure (BP) were measured immediately before and 15, 30, 60, 120 and 240 min after the conclusion of the treatment. At the beginning and at the end of the 1-month treatment period, haematology and biochemistry were checked. After B 0.75 mg, 1.25 mg and 2.50 mg the values of spirometric variables proved significantly and dose-dependently higher than the basal values. The changes from baseline in lung function test values with B (all doses) were significantly greater than with P.(ABSTRACT TRUNCATED AT 250 WORDS)

To investigate the beta 2-receptor selectivity of a new beta 2-adrenoceptor agonist, broxaterol, we compared the respiratory and cardiovascular effects of this compound with those of terbutaline and placebo. Twelve asthmatic patients were evaluated in a randomized, single blind, crossover study. A single dose of each study treatment (broxaterol 400 micrograms and terbutaline 500 micrograms was administered with metered dose inhalers. Measurements of lung function (vital capacity, forced expiratory volume in one second, airway resistance and specific airway conductance), heart rate and systolic/diastolic blood pressure were performed before and at 15, 30, 60, 120, 240 and 360 min after each study treatment. No significant difference was observed between broxaterol and terbutaline in VC, FEV1 and Raw changes, although a greater and significant increase in sGaw was found only with broxaterol. Significant increases in heart rate and systolic blood pressure were observed only with terbutaline. The results of this study suggest that broxaterol can promote a greater bronchodilator effect with less cardiovascular side effects than terbutaline, probably through a greater beta 2-receptor selectivity.

The bronchodilating activity and the ability of broxaterol transdermal patch to inhibit bronchial constriction in response to distilled water mist (UNH2O) inhalation were assessed. The study was performed in 10 asthmatic patients in clinical remission according to a placebo-controlled, double-blind, randomized crossover design. Test medications were broxaterol patch (size = 1.75 cm2; programmed delivery = 105 mcg/h) and a matched placebo patch. A spirometric examination was performed before patch application (at 8:30-9:00 a.m.) and 24 hours later. Immediately afterwards, the UNH2O inhalation test was made, consisting of 3 bronchial exposures lasting 30, 60 and 120 s respectively with 3-minute intervals between challenges. Immediately after each exposure, a spirometric examination and specific airway resistance measurements were made. The results obtained show that broxaterol patch exerts a statistically significant bronchodilating effect and has a better protective effect than placebo patch on UNH2O-induced bronchial constriction. The local tolerability of patches was very good. Slight tremors were observed in some subjects.