This study estimates the cost-effectiveness and budget impact of introducing ferric carboxymaltose (FCM) for the treatment of iron deficiency (ID) in patients with left ejection fraction (LVEF) <50%, stabilised after an episode of acute heart failure (AHF), from the perspective of healthcare payers in 5 European countries.

ObjectiveTo explore maintenance of effect with OROS MPH in adults with ADHD.MethodsMulticenter study randomizing adult subjects with ADHD who completed open-label (OL) treatment with OROS MPH (18-90mg/day) for at least 52-week and consented to a 4-week, randomized, double-blind (DB), placebo-controlled (PLC) withdrawal period. Efficacy measures included total CAARS score, CAARS-S:S, GAE, CGI-S and CGI-C. Endpoint analyses were performed using LOCF.Results99/155 patients completed the OL OROS MPH treatment phase, only 45/99 patients consented to double-blind randomization. At DB baseline, mean ± SD TCS was 12.1±5.34 (n=23) in the continued OROS MPH group and 16.5±7.49 (n=22) in the placebo group. CAARS changed from DB baseline to DB endpoint by 4.0±7.61 and 6.5±7.82, respectively (p = 0.2586 between groups). CGI-C scores indicated more worsening of symptoms in the placebo group compared to the continued PR OROS MPH (p = 0.0422). Median (range) GAE scores at endpoint were 2.0 (0-3) and 0.5 (0-3), respectively (p=0.0254). Other efficacy endpoints were numerically in favor of OROS MPH. The randomized withdrawal phase may have been underpowered to show statistical significance between treatment groups for the primary outcome. The incidence of treatment-emergent AEs during the DB phase was comparable between groups.ConclusionsThe results indicate that treatment discontinuation after long-term exposure of adults with ADHD to OROS MPH is associated with worsening of clinical symptoms. Statistical significance for several outcomes was not reached, possibly due to study limitations.

The Reversed-phase (RP) gradient elution chromatography of nociceptin/orphanin FQ (N/OFQ), a neuropeptide with many biological effects, has been modeled under linear and non-linear conditions. In order to do this, the chromatographic behavior has been studied under both linear and nonliner conditions under isocratic mode at different mobile phase compositions—ranging from 16 to 19% (v/v) acetonitrile (ACN) in aqueous trifluoracetic acid (TFA) 0.1% (v/v)—on a C-8 column. Although the range of mobile phase compositions investigated was quite narrow, the retention factor of this relatively small polypeptide (N/OFQ is a heptadecapeptide) has been found to change by more than 400%. In these conditions, gradient operation resulted thus to be the optimum approach for non-linear elution. As the available amount of N/OFQ was extremely reduced (only a few milligrams), the adsorption isotherms of the peptide, at the different mobile phase compositions examined, have been measured through the so-called inverse method (IM) on a 5 cm long column. The adsorption data at different mobile phase compositions have been fitted to several models of adsorption. The dependence of the isotherm parameters on the mobile phase composition was modeled by using the linear solvent strength (LSS) model and a generalized Langmuir isotherm that includes the mobile phase composition dependence. The overloaded gradient separation of N/OFQ has been modeled by numerically solving the equilibrium-dispersive (ED) model of chromatography under a selected gradient elution mode, on the basis of the previously determined generalized Langmuir isotherm. The agreement between theoretical calculations and experimental overloaded band profiles appeared reasonably accurate.

European Journal of PainVolume 10, Issue S1 p. S185d-S186 711 DOUBLE-BLIND, PLACEBO-CONTROLLED, REPEAT-DOSE ASSESSMENT OF ONCE-DAILY OROS® HYDROMORPHONE IN PATIENTS WITH MODERATE TO SEVERE CHRONIC OSTEOARTHRITIS PAIN S. Waechter, Medical Affairs, Janssen-Cilag Europe, Baar, SwitzerlandSearch for more papers by this authorR.R. Eckardt, Private Practice: Richard R. Eckardt, MD, Roanoke VASearch for more papers by this authorS. Khanna, ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorJ. Thipphawong, ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorR. Skowronski, ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorJ.C. Tudor, ALZA Corporation, Mountain View, CA, USASearch for more papers by this author S. Waechter, Medical Affairs, Janssen-Cilag Europe, Baar, SwitzerlandSearch for more papers by this authorR.R. Eckardt, Private Practice: Richard R. Eckardt, MD, Roanoke VASearch for more papers by this authorS. Khanna, ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorJ. Thipphawong, ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorR. Skowronski, ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorJ.C. Tudor, ALZA Corporation, Mountain View, CA, USASearch for more papers by this author First published: 13 January 2012 https://doi.org/10.1016/S1090-3801(06)60714-3Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume10, IssueS1September 2006Pages S185d-S186 RelatedInformation

European Journal of PainVolume 10, Issue S1 p. S173-S173 661 LONG-TERM ASSESSMENT OF THE CLINICAL EFFICACY AND SAFETY OF ONCE-DAILY OROS® HYDROMORPHONE IN PATIENTS WITH SEVERE CHRONIC PAIN M. Ates, M. Ates Janssen-Cilag Turkey, Istanbul, TurkeySearch for more papers by this authorU. Richarz, U. Richarz Medical Affairs, Janssen-Cilag Europe, Baar, SwitzerlandSearch for more papers by this authorS. Waechter, S. Waechter Medical Affairs, Janssen-Cilag Europe, Baar, SwitzerlandSearch for more papers by this authorJ. Thipphawong, J. Thipphawong ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorJ.C. Tudor, J.C. Tudor ALZA Corporation, Mountain View, CA, USASearch for more papers by this author M. Ates, M. Ates Janssen-Cilag Turkey, Istanbul, TurkeySearch for more papers by this authorU. Richarz, U. Richarz Medical Affairs, Janssen-Cilag Europe, Baar, SwitzerlandSearch for more papers by this authorS. Waechter, S. Waechter Medical Affairs, Janssen-Cilag Europe, Baar, SwitzerlandSearch for more papers by this authorJ. Thipphawong, J. Thipphawong ALZA Corporation, Mountain View, CA, USASearch for more papers by this authorJ.C. Tudor, J.C. Tudor ALZA Corporation, Mountain View, CA, USASearch for more papers by this author First published: 13 January 2012 https://doi.org/10.1016/S1090-3801(06)60664-2Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume10, IssueS1September 2006Pages S173-S173 RelatedInformation