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JAMA, ISSN 0098-7484, 03/2013, Volume 309, Issue 11, pp. 1154 - 1162
Journal Article
Stroke, ISSN 0039-2499, 06/2008, Volume 39, Issue 6, pp. 1827 - 1833
Journal Article
Journal Article
Journal Article
The New England Journal of Medicine, ISSN 0028-4793, 05/1994, Volume 330, Issue 20, pp. 1426 - 1430
Journal Article
Journal Article
AIDS Care, ISSN 0954-0121, 10/2004, Volume 16, Issue 7, pp. 841 - 850
The Ryan White Comprehensive AIDS Resources Emergency Act 1990 (CARE Act) is one of the largest federal programmes funding medical and support services for... 
Journal Article
by Olga Lomakina and Ekaterina Alekseeva and Sania Valieva and Tatiana Bzarova and Irina Nikishina and Elena Zholobova and Svetlana Rodionovskaya and Maria Kaleda and Yasuo Nakagishi and Masaki Shimizu and Mao Mizuta and Akihiro Yachie and Yuko Sugita and Nami Okamoto and Kousuke Shabana and Takuji Murata and Hiroshi Tamai and Eve M. Smith and Peng Yin and Andrea L. Jorgensen and Michael W. Beresford and on behalf of On behalf of the UK JSLE Cohort Study and Eve M. Smith and Antonio Eleuteri and Beatrice Goilav and Laura Lewandowski and Angel Phuti and Dawn Wahezi and Tamar Rubinstein and Caroline Jones and Paul Newland and Stephen Marks and Rachel Corkhill and Diana Ekdawy and Clarissa Pilkington and Kjell Tullus and Chaim Putterman and Chris Scott and Antony C. Fisher and Michael W. Beresford and Eve M. Smith and Laura Lewandowski and Angel Phuti and Andrea Jorgensen and Chris Scott and Michael W. Beresford and Ezgi Deniz Batu and Can Kosukcu and Ekim Taskiran and Sema Akman and Kubra Ozturk and Betul Sozeri and Erbil Unsal and Zelal Ekinci and Yelda Bilginer and Mehmet Alikasifoglu and Seza Ozen and Hanna Lythgoe and Michael W. Beresford and Hermine I. Brunner and Gaurav Gulati and Jordan T. Jones and Mekibib Altaye and Jamie Eaton and Mark Difrancesco and Joo Guan Yeo and Jingyao Leong and Loshinidevi D/O Thana Bathi and Thaschawee Arkachaisri and Salvatore Albani and Nagla Abdelrahman and Michael W Beresford and Valentina Leone and UK JSLE study group supported by the National Institute of Health Research Clinical Research Network and Noortje Groot and D. Shaikhani and I. E. M. Bultink and M. Bijl and R. J. E. M. Dolhain and Y. K. O. Teng and E. Zirkzee and K. de Leeuw and R. Fritsch-Stork and S. S. M. Kamphuis and Rachael D. Wright and Eve M. Smith and Michael W. Beresford and Reem Abdawani and Laila Al Shaqshi and Ibrahim Al Zakwani and Natali W. Gormezano and David Kern and Oriany L. Pereira and Gladys C. C. Esteves and Adriana M. Sallum and Nadia E. Aikawa and Rosa M. Pereira and Clovis A. Silva and Eloisa Bonfa and Jessica Beckmann and ...
PEDIATRIC RHEUMATOLOGY, ISSN 1546-0096, 05/2017, Volume 15, Issue S1, pp. 105 - 201
Journal Article
FRONTIERS IN MICROBIOLOGY, ISSN 1664-302X, 05/2019, Volume 10, p. 973
This study aimed to evaluate how the feeding strategy of rabbit kits at the onset of solid feed intake could affect ecological diversity and co-occurrence... 
microbiota | MICROFLORA | BEHAVIOR | co-occurrence pattern | MICROBIOLOGY | onset of solid feeding | weaning | FIBER | diversity | COMMUNITY | rabbit | FERMENTATION | POSTNATAL-DEVELOPMENT | cecum | PROTEINS | age | DIGESTIVE HEALTH | MILK | Rabbits | Microbiota (Symbiotic organisms) | Costs (Law) | Analysis | Life Sciences
Journal Article
by Jeffrey T Jensen Leon Speroff Professor and Vice Chair for Research of Obstetrics and Gynecology Health & Science University Dr Jensen reports he is a consultant for and receives grant/research support from HRA Pharma Healthcare Pharm Council and ContraMed and is a consultant for Teva Pharmaceuticals and Microchips Synopsis: the third attempt FDA approved the mixed serotonin agonist/antagonist flibanserin for the treatment of generalized hypoactive sexual desire disorder in premenopausal women Sources: Food and Drug Administration FDA Briefing Document: Joint Meeting of the Bone and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee Available at wwwfdagov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088pdf Accessed August 24 Katz M al Efficacy of flibanserin in women with hypoactive sexual desire disorder: Results from the BEGONIA trial J Sex Med 2013 and 10:1807-1815 Thorp J al Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the DAISY study J Sex Med 2012 and 9:793-804 On August 18 FDA approved flibanserin to treat acquired hypoactive sexual desire disorder (HSDD) in premenopausal women The dose of flibanserin is 100 mg orally daily taken at bedtime A total of 3548 patients were randomized to treatment (flibanserin n = 2310 and placebo n = 1238) in the combined data from the three pivotal trials submitted in the new drug application (NDA) (the two published trials are referenced above) In the combined evaluation group mean age of participants was 36 years and most (~89%) were white and reported being in a relationship with a mean length of 11 years The overall completion rate was 78% for placebo and 70% for flibanserin (24 weeks of treatment) The two co-primary endpoints in the published studies were: 1) change in the number of satisfying sexual events (SSEs) from baseline (28-day interval) to end of study (28-day interval and 2) change in the eDiary sexual desire score from baseline to end of study (sum of daily sexual desire scores over 28 days) In these studies used a personal handheld electronic device (eDiary) to record on a daily basis information about sexual activity sexual encounters and desire The third (unpublished) study referenced in the NDA did not use the eDiary to capture data for sexual desire Instead Female Sexual Function Index (FSFI) sexual desire domain questions were assessed every 4 weeks at clinic visits and the baseline and final clinical visit data were used for the co-primary efficacy endpoint (the FSFI was a secondary endpoint in the other studies) Key secondary endpoints included: 1) how often subjects reported being bothered by low sexual desire (“never” “rarely” “occasionally” “frequently” or “always” and 2) the number of “satisfying sexual episodes (SSE)” each assessed for the 28-day baseline and end-of-study intervals The FDA review panel concluded that flibanserin’s treatment effects were consistent across the three trials with respect to increasing overall satisfying sexual events (statistically significant P < 005 and median increase of 05 to 10 episodes in 28 days and reducing distress (mean treatment difference [95% confidence interval]: -03 [-04 to -01] -04 [-05 to -02] and 03 [-04 to -01] in the three studies) Although treatment benefit was also consistently demonstrated for sexual desire became statistically significant only when measured using the FSFI-desire domain questions (mean treatment difference [95% CI]: 03 [02-04]4 [02-05] and 03 [02-05]) but not with the eDiary Descriptive data presented suggest that the clinical effect takes about 4 weeks to develop Side effects occurred significantly more frequently in the treatment group twice as many (128% vs 59%) discontinuations for adverse events (AEs) The most common AEs included dizziness (114% vs 22%) (112% vs 31%) (104% vs 37%) (92% vs 5 and insomnia (49% vs 24%) There was no difference with respect to depression In a small substudy where subjects consumed moderate (2-4 drinks) amounts of ethanol with and without flibanserin combination precipitated hypotension and presyncope/syncope in some participants Due to these findings FDA approved flibanserin with a risk evaluation and mitigation strategy (REMS) to assure safe use The REMS requires that prescribers and pharmacies complete training and be certified with the REMS Certified prescribers must counsel patients using a Patient-Provider Agreement form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment The labeling for flibanserin (Addyi™) will include a black box warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment those who use moderate or strong CYP3A4 inhibitors and in those who have liver impairment COMMENTARY What would you pay for a drug that must be taken daily to have (at best) a marginal impact on female sexual desire and is associated with serious side effects particularly when coadministered with moderate amounts of alcohol? How about $1 billion? That’s the amount of money that Valient Pharmaceuticals paid to acquire Sprout Pharmaceuticals company that successfully received FDA approval for flibanserin The approval came on the third round and was controversial1 It took three pivotal studies and a patient advocacy campaign to gain approval The initial NDA was submitted by Boehringer Ingelheim (BI) in 2010 At that time committee voted unanimously that the risks exceeded potential benefits and BI discontinued development of the drug Rights were sold to Sprout Pharmaceuticals company with no other products Sprout filed a second NDA in 2013 and the application was again rejected After the second NDA was denied advocacy group called Even the Score was formed to advocate for what it called “gender equality” in access to treatments for sexual dysfunction The group promoted the claim that there are 26 approved medications for male sexual dysfunction but none for women and however failed to mention that none of these treatments were approved for low sexual desire1 The male products include forms of testosterone and the phosphodiesterase (PDE)-5 inhibitors used to treat erectile dysfunction Although the claim may have been inaccurate advocacy appeared to work and Addyi is now approved Flibanserin is classified as a mixed post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist2 It initially was studied for activity as an antidepressant While the drug was no more effective than placebo in treating depression was more effective than placebo in terms of study participants’ responses to the question “How strong is your sex drive?” This led BI to the clinical development program for treatment of sexual desire The Diagnostic and Statistical Manual of Mental Disorders (DSMD) edition HSDD as “persistently or recurrently deficient or absent sexual fantasies and desire for sexual activity” accompanied by “marked distress and interpersonal difficulty” that is not accounted for by a nonsexual mental disorder relationship stress general medical condition In 2013 DSMD edition HSDD with female sexual arousal disorder into female sexual interest/arousal disorder (FSIAD) The FDA has recognized that there are no approved treatments for these disorders3 But is flibanserin the answer? First is not like treating an arousal disorder with a PDE5 inhibitor dosed a few times per month Daily treatment is required and it appears to take about a month to show any benefit at all That with serious side effects like hypotension and syncope in some individuals (particularly with alcohol use) and annoying less serious adverse events like headache and nausea in others’t make this a dream drug Still allure of a drug to treat desire is intoxicating Imagine the conversation that ends with “if you loved me would get that medicine that makes you more interested in sex” While women are generally motivated to improve relationships is important to recognize that the diagnosis of FSIAD requires that the lack of desire is accompanied by “marked distress and interpersonal difficulty” Guilt and desire to please a partner should not be deciding factors The FDA did a good thing requiring that providers receive training to become certified to prescribe flibanserin I hope that goes far enough While it is important not to dismiss a therapeutic opportunity is critical that you make an accurate diagnosis In my practice refer patients with sexual desire disorders to a qualified sexual therapist for counseling and treatment I suspect a minority may benefit from flibanserin However imagine that Valient Pharmaceuticals is banking on widespread over-prescription of this product That’s the $1 billion dollar answer REFERENCES 1 Gellad WF al Evaluation of flibanserin: Science and advocacy at the FDA JAMA 2015 and July 6 [Epub ahead of print] 2 Stahl SM Mechanism of action of flibanserin multifunctional serotonin agonist and antagonist (MSAA) hypoactive sexual desire disorder CNS Spectr 2015 and 20:1-6 3 Nappi RE Why are there no FDA-approved treatments for female sexual dysfunction? Expert Opin Pharmacother 2015 and 16:1735-1738
OB GYN Clinical Alert, ISSN 0743-8354, 10/2015, Volume 32, Issue 6
Leon Speroff Professor and Vice Chair for Research, Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland Dr. Jensen reports he... 
Studies | Advocacy | Mental disorders | Committees | Alcohol | FDA approval | Patients | Pharmaceuticals
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