A survey of contraception in five West European countries

In 1984 and 1985, a survey was conducted of 7696 women aged 15-44 living in Italy, France, Great Britain, Spain and the Federal Republic of Germany. The aim of the study was to examine the use of contraceptive methods, the differences in contraceptive use, knowledge of fertility, communication about contraception, motives for choice and the perceptions held by women regarding contraceptive methods, particularly oral contraception. The results show important differences between the countries studie

Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening

BACKGROUND & AIMS: Elafibranor is an agonist of the peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-δ. Elafibranor improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. We assessed the safety and efficacy of elafibranor in an international, randomized, double-blind placebo-controlled trial of patients with nonalcoholic steatohepatitis (NASH). METHODS: Patients with NASH without cirrhosis were randomly assigned to groups given elafibranor 80 mg (n = 93), elafibranor 120 mg (n = 91), or placebo (n = 92) each day for 52 weeks at sites in Europe and the United States. Clinical and laboratory evaluations were performed every 2 months during this 1-year period. Liver biopsies were then collected and patients were assessed 3 months later. The primary outcome was resolution of NASH without fibrosis worsening, using protocol-defined and modified definitions. Data from the groups given the different doses of elafibranor were compared with those from the placebo group using step-down logistic regression, adjusting for baseline nonalcoholic fatty liver disease activity score. RESULTS: In intention-to-treat analysis, there was no significant difference between the elafibranor and placebo groups in the protocol-defined primary outcome. However, NASH resolved without fibrosis worsening in a higher proportion of patients in the 120-mg elafibranor group vs the placebo group (19% vs 12%; odds ratio = 2.31; 95% confidence interval: 1.02-5.24; P = .045), based on a post-hoc analysis for the modified definition. In post-hoc analyses of patients with nonalcoholic fatty liver disease activity score ≥4 (n = 234), elafibranor 120 mg resolved NASH in larger proportions of patients than placebo based on the protocol definition (20% vs 11%; odds ratio = 3.16; 95% confidence interval: 1.22-8.13; P = .018) and the modified definitions (19% vs 9%; odds ratio = 3.52; 95% confidence interval: 1.32-9.40; P = .013). Patients with NASH resolution after receiving elafibranor 120 mg had reduced liver fibrosis stages compared with those without NASH resolution (mean reduction of 0.65 ± 0.61 in responders for the primary outcome vs an increase of 0.10 ± 0.98 in nonresponders; P < .001). Liver enzymes, lipids, glucose profiles, and markers of systemic inflammation were significantly reduced in the elafibranor 120-mg group vs the placebo group. Elafibranor was well tolerated and did not cause weight gain or cardiac events, but did produce a mild, reversible increase in serum creatinine (effect size vs placebo: increase of 4.31 ± 1.19 μmol/L; P < .001). CONCLUSIONS: A post-hoc analysis of data from trial of patients with NASH showed that elafibranor (120 mg/d for 1 year) resolved NASH without fibrosis worsening, based on a modified definition, in the intention-to-treat analysis and in patients with moderate or severe NASH. However, the predefined end point was not met in the intention to treat population. Elafibranor was well tolerated and improved patients\u27 cardiometabolic risk profile. ClinicalTrials.gov number: NCT01694849

Human recombinant follicle stimulating hormone (rFSH) compared to urinary human menopausal gonadotropin (HMG) for ovarian stimulation in assisted reproduction: a literature review and cost evaluation

BACKGROUND: Gonadotropins are protein hormones which are central to the complex endocrine system that regulates normal growth, sexual development, and reproductive function. There is still a lively debate on which type of gonadotropin medication should be used, either human menopausal gonadotropin or recombinant follicle-stimulating hormone. The objective of the study was to perform a systematic review of the recent literature to compare recombinant follicle-stimulating hormone to human menopausal gonadotropin with the aim to assess any differences in terms of efficacy and to provide a cost evaluation based on findings of this systematic review. METHODS: The review was conducted selecting prospective, randomized, controlled trials comparing the two gonadotropin medications from a literature search of several databases. The outcome measure used to evaluate efficacy was the number of oocytes retrieved per cycle. In addition, a cost evaluation was performed based on retrieved efficacy data. RESULTS: The number of oocytes retrieved appeared to be higher for human menopausal gonadotropin in only 2 studies while 10 out of 13 studies showed a higher mean number of oocytes retrieved per cycle for recombinant follicle-stimulating hormone. The results of the cost evaluation provided a similar cost per oocyte for both hormones. CONCLUSIONS: Recombinant follicle-stimulating hormone treatment resulted in a higher oocytes yield per cycle than human menopausal gonadotropin at similar cost per oocyte

Multiple treatment comparison in narcolepsy: a network meta-analysis

Study Objectives: Randomized controlled trials (RCTs) that compared the safety and efficacy of medical treatments for narcolepsy were analyzed using network meta-analysis. Methods: The RCTs in narcolepsy were searched. Network meta-analysis compared efficacy and safety of multiple treatments, multi-arm studies, and multi-criteria treatment decisions, based on a random model that assumed heterogeneity between studies, with corrections for multi-arm studies. Results: Fourteen RCTs, three drug treatments, and six doses were identified: sodium oxybate (6 and 9 g/d), modafinil (between 200 and 400 mg/d), and pitolisant (up to 20 and up to 40 mg/d). Significant heterogeneity (>50%) between studies was found in 12/14 studies for almost all endpoints, but between-design consistency was present. For ESS and MWT, sodium oxybate 9 g/d, modafinil, and pitolisant up to 40 mg/d had similar efficacy. Pitolisant 40 mg/d and sodium oxybate 9 g/d in two nightly doses had similar efficacy in reducing cataplexy. A good safety profile characterized by a TEAE incidence risk ratio (IRR) <1.5 was found for all the compared treatments, except for sodium oxybate 9 g/d. Although no significant difference was found, Pitolisant 40 mg was shown with the best P scores for the benefit/risk (BR) ratio. Conclusions: Modafinil (200-400 mg/d), sodium oxybate 9 g/d, and pitolisant up to 40 mg/d had similar efficacy in reducing excessive day time sleepiness. Only sodium oxybate 9 g/d and pitolisant up to 40 mg/d were shown with a comparable beneficial effect on cataplexy. Overall, Pitolisant was found with the best P score on the BR ratio. Clinical Trial Registration: PROSPERO 2017 CRD42017054686. Efficacy, safety, and benefit-risk comparison of alternative treatments in narcolepsy: a network multiple comparisons of treatment meta-analysis. http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017054686

Comparison of modafinil and pitolisant in narcolepsy: a non-inferiority meta-analytical approach.

Aim: To assess the non-inferiority of pitolisant, a new compound for the relief of excessive daytime sleepiness (EDS) and cataplexy in narcolepsy, compared with modafinil. Methods: Randomized controlled trials (RCTs) in narcolepsy were searched systematically. Network meta-analysis (NMA) compared the efficacy and safety of pitolisant and modafinil. The main endpoints are Epworth Sleepiness Scale (ESS), Maintenance of Wakefulness Test (MWT), the number of cataplexies, and overall safety. Results: Of 312 articles after removing duplicates, 10 RCTs were eligible for NMA. For ESS, a non-significant superior beneficial decrease (-0.69, [-2.18, 0.79]) showed non-inferiority of pitolisant (non-inferiority margin [NIM]=1, p=0.015). An MWT beneficial increase (2.12 minutes [-0.95, 5.19]; p=0.18) showed non-inferiority of pitolisant (NIM=-1). For cataplexy, the mean beneficial effect of pitolisant was significant, providing evidence of pitolisant superiority in addition to non-inferiority. The risk ratio (RR) of treatment-suspected adverse events for pitolisant/modafinil was 0.86 [0.44, 1.24] favoring pitolisant, confirming non-inferiority considering a safety margin of RR=1.25 (tolerance of 25%). Conclusions: Pitolisant is non-inferior to modafinil in relieving EDS, but superior to modafinil in reducing cataplexy, outranking modafinil in narcolepsy type-1 patients. Despite a slight superiority of pitolisant in EDS relief, both drugs perform equally in narcolepsy type-2 patients

Natfidrofuryl in the treatment of subacute stroke

In a placebo-controlled, double-blind study, 82 patients in the subacute stage of a disabling stroke were studied to assess the effect on clinical improvement of 600 mg naftidrofuryl against placebo. Forty-two patients were treated with the drug and 40 with placebo, in each case administered for 60 days. All patients received 100 mg aspirin and 300 mg dipyridamole daily and entered a similar program of rehabilitation therapy. At the start and the end of the study, the motor functions of the upper and lower limbs, the ability to walk and to perform daily activities, the comprehension and expression of speech, and the mental progress were assessed with quantitative linear scales. In the group treated with active drug, a greater overall tendency of improvement was observed, reaching statistically significant levels for walking and activities of daily life when compared to placebo-treated patients. Overall improvement was negatively influenced by advancing age, but the statistically significant effect of treatment on walking and daily activities was not interfered with by age. Right-sided lesions showed better improvement under active drug than left-sided lesions. This may be due to a correctional effect of naftidrofuryl on hemispatial neglect.SCOPUS: cp.jinfo:eu-repo/semantics/publishe