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Nature Genetics, ISSN 1061-4036, 08/2017, Volume 49, Issue 8, pp. 1167 - 1173
Journal Article
by Turcot, Valérie and Lu, Yingchang and Highland, Heather M and Schurmann, Claudia and Justice, Anne E and Fine, Rebecca S and Bradfield, Jonathan P and Esko, Tõnu and Giri, Ayush and Graff, Mariaelisa and Guo, Xiuqing and Hendricks, Audrey E and Karaderi, Tugce and Lempradl, Adelheid and Locke, Adam E and Mahajan, Anubha and Marouli, Eirini and Sivapalaratnam, Suthesh and Young, Kristin L and Alfred, Tamuno and Feitosa, Mary F and Masca, Nicholas G. D and Manning, Alisa K and Medina-Gomez, Carolina and Mudgal, Poorva and Ng, Maggie C. Y and Reiner, Alex P and Vedantam, Sailaja and Willems, Sara M and Winkler, Thomas W and Abecasis, Gonçalo and Aben, Katja K and Alam, Dewan S and Alharthi, Sameer E and Allison, Matthew and Amouyel, Philippe and Asselbergs, Folkert W and Auer, Paul L and Balkau, Beverley and Bang, Lia E and Barroso, Inês and Bastarache, Lisa and Benn, Marianne and Bergmann, Sven and Bielak, Lawrence F and Blüher, Matthias and Boehnke, Michael and Boeing, Heiner and Boerwinkle, Eric and Böger, Carsten A and Bork-Jensen, Jette and Bots, Michiel L and Bottinger, Erwin P and Bowden, Donald W and Brandslund, Ivan and Breen, Gerome and Brilliant, Murray H and Broer, Linda and Brumat, Marco and Burt, Amber A and Butterworth, Adam S and Campbell, Peter T and Cappellani, Stefania and Carey, David J and Catamo, Eulalia and Caulfield, Mark J and Chambers, John C and Chasman, Daniel I and Chen, Yii-Der I and Chowdhury, Rajiv and Christensen, Cramer and Chu, Audrey Y and Cocca, Massimiliano and Cook, James P and Corley, Janie and Corominas Galbany, Jordi and Cox, Amanda J and Crosslin, David S and Cuellar-Partida, Gabriel and D'Eustacchio, Angela and Danesh, John and Davies, Gail and Bakker, Paul I. W and Groot, Mark C. H and Mutsert, Renée and Deary, Ian J and Dedoussis, George and Demerath, Ellen W and Heijer, Martin and Hollander, Anneke I and Ruijter, Hester M and Dennis, Joe G and Denny, Josh C and Angelantonio, Emanuele and Drenos, Fotios and Du, Mengmeng and Dubé, Marie-Pierre and Dunning, Alison M and Easton, Douglas F and Edwards, Todd L and ... and Chd Exome Consortium and EPIC InterAct Consortium and Global Lipids Genetic Consortium and GoT2D Genes Consortium and MAGIC Investigators and Understanding Soc Sci Grp and ReproGen Consortium and Interval Study and Epic-Cvd Consortium and ExomeBP Consortium and T2D-Genes Consortium and INTERVAL Study and EPIC-CVD Consortium and EPIC InterAct Consortium and CHD Exome+ Consortium and Understanding Society Scientific Group and The MAGIC Investigators and Medicinska fakulteten and Institutionen för folkhälsa och klinisk medicin and Enheten för biobanksforskning and Allmänmedicin and Umeå universitet and Medicin
Nature Genetics, ISSN 1061-4036, 01/2018, Volume 50, Issue 1, pp. 26 - 35
Journal Article
by Sifrim, Alejandro and Hitz, Marc-Phillip and Wilsdon, Anna and Breckpot, Jeroen and Turki, Saeed H Al and Thienpont, Bernard and McRae, Jeremy and Fitzgerald, Tomas W and Singh, Tarjinder and Swaminathan, Ganesh Jawahar and Prigmore, Elena and Rajan, Diana and Abdul-Khaliq, Hashim and Banka, Siddharth and Bauer, Ulrike M M and Bentham, Jamie and Berger, Felix and Bhattacharya, Shoumo and Bu'Lock, Frances and Canham, Natalie and Colgiu, Irina-Gabriela and Cosgrove, Catherine and Cox, Helen and Daehnert, Ingo and Daly, Allan and Danesh, John and Fryer, Alan and Gewillig, Marc and Hobson, Emma and Hoff, Kirstin and Homfray, Tessa and Kahlert, Anne-Karin and Ketley, Ami and Kramer, Hans-Heiner and Lachlan, Katherine and Lampe, Anne Katrin and Louw, Jacoba J and Manickara, Ashok Kumar and Manase, Dorin and McCarthy, Karen P and Metcalfe, Kay and Moore, Carmel and Newbury-Ecob, Ruth and Omer, Seham Osman and Ouwehand, Willem H and Park, Soo-Mi and Parker, Michael J and Pickardt, Thomas and Pollard, Martin O and Robert, Leema and Roberts, David J and Sambrook, Jennifer and Setchfield, Kerry and Stiller, Brigitte and Thornborough, Chris and Toka, Okan and Watkins, Hugh and Williams, Denise and Wright, Michael and Mital, Seema and Daubeney, Piers E F and Keavney, Bernard and Goodship, Judith and Abu-Sulaiman, Riyadh Mahdi and Klaassen, Sabine and Wright, Caroline F and Firth, Helen V and Barrett, Jeffrey C and Devriendt, Koenraad and FitzPatrick, David R and Brook, J David and Hurles, Matthew E and INTERVAL Study and Deciphering Developmental Disorders Study and UK10K Consortium
Nature genetics, ISSN 1061-4036, 09/2016, Volume 48, Issue 9, p. 1060
Journal Article
by Turcot, Valérie and Lu, Yingchang and Highland, Heather M and Schurmann, Claudia and Justice, Anne E and Fine, Rebecca S and Bradfield, Jonathan P and Esko, Tõnu and Giri, Ayush and Graff, Mariaelisa and Guo, Xiuqing and Hendricks, Audrey E and Karaderi, Tugce and Lempradl, Adelheid and Locke, Adam E and Mahajan, Anubha and Marouli, Eirini and Sivapalaratnam, Suthesh and Young, Kristin L and Alfred, Tamuno and Feitosa, Mary F and Masca, Nicholas GD and Manning, Alisa K and Medina-Gomez, Carolina and Mudgal, Poorva and Ng, Maggie CY and Reiner, Alex P and Vedantam, Sailaja and Willems, Sara M and Winkler, Thomas W and Abecasis, Gonçalo and Aben, Katja K and Alam, Dewan S and Alharthi, Sameer E and Allison, Matthew and Amouyel, Philippe and Asselbergs, Folkert W and Auer, Paul L and Balkau, Beverley and Bang, Lia E and Barroso, Ines and Bastarache, Lisa and Benn, Marianne and Bergmann, Sven and Bielak, Lawrence F and Blüher, Matthias and Boehnke, Michael and Boeing, Heiner and Boerwinkle, Eric and Böger, Carsten A and Bork-Jensen, Jette and Bots, Michiel L and Bottinger, Erwin P and Bowden, Donald W and Brandslund, Ivan and Breen, Gerome and Brilliant, Murray H and Broer, Linda and Brumat, Marco and Burt, Amber A and Butterworth, Adam Stuart and Campbell, Peter T and Cappellani, Stefania and Carey, David J and Catamo, Eulalia and Caulfield, Mark J and Chambers, John C and Chasman, Daniel I and Chen, Yii-Der I and Chowdhury, Rajiv and Christensen, Cramer and Chu, Audrey Y and Cocca, Massimiliano and Collins, Francis S and Cook, James P and Corley, Janie and Corominas Galbany, Jordi and Cox, Amanda J and Crosslin, David S and Cuellar-Partida, Gabriel and D'Eustacchio, Angela and Danesh, John and Davies, Gail and Bakker, Paul IW and Groot, Mark CH and Mutsert, Renée and Deary, Ian J and Dedoussis, George and Demerath, Ellen W and Heijer, Martin and Hollander, Anneke I and Ruijter, Hester M and Dennis, Joe G and Denny, Josh C and Di Angelantonio, Emanuele and Drenos, Fotios and Du, Mengmeng and Dubé, Marie-Pierre and Dunning, Alison Margaret and Easton, Douglas Frederick and ... and Medicinska fakulteten and Science for Life Laboratory, SciLifeLab and Medicinska och farmaceutiska vetenskapsområdet and Kardiologi and Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm and Geriatrik and Kardiovaskulär epidemiologi and Uppsala universitet and Institutionen för medicinska vetenskaper and Molekylär epidemiologi and Institutionen för folkhälso- och vårdvetenskap and Uppsala kliniska forskningscentrum (UCR)
Nature Genetics, ISSN 1061-4036, 2018, Volume 50, Issue 1, p. 26
Journal Article
PLoS ONE, ISSN 1932-6203, 02/2014, Volume 9, Issue 2, p. e86858
Journal Article
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
Journal Article
FRONTIERS IN PHYSIOLOGY, ISSN 1664-042X, 08/2019, Volume 10, p. 994
Accurate evaluation of the appearance of QTc sex differences during childhood and adolescence is intricate. Inter-subject differences of individual QT/RR... 
QT/RR hysteresis | PHYSIOLOGY | THOROUGH | HEALTHY-SUBJECTS | SAFETY | QT/RR CURVATURES | LENGTH | PROLONGATION | SECONDARY SEX CHARACTERISTICS | QT/RR slope | QTc interval | individual QT/RR patterns | age | sex differences | CYCLE | Usage | Heart beat | Analysis | Electrocardiogram | Electrocardiography | Youth | Teenagers | Children | Health aspects
Journal Article
by Xu, J and Wang, L
FRONTIERS IN ENDOCRINOLOGY, ISSN 1664-2392, 08/2019, Volume 10, p. 541
Aim: There is an association between the low triiodothyronine (T3) state and the poor prognosis for severe acute conditions. However, the correlation between... 
low T3 syndrome | poor prognosis | pyogenic liver abscess | thyroid | MANIFESTATION | ENDOCRINOLOGY & METABOLISM | mortality | RISK | OUTCOMES | NONTHYROIDAL ILLNESS SYNDROME | LOW TRIIODOTHYRONINE | FAILURE | Medical research | Liver diseases | Prognosis | Analysis | Liver | Thyroid diseases | Medicine, Experimental | Thyroid hormones
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FRONTIERS IN PHYSIOLOGY, ISSN 1664-042X, 07/2019, Volume 10, p. 934
Electrocardiogram (ECG) studies of drug-induced prolongation of the interval between the J point and the peak of the T wave (JTp interval) distinguished QT... 
CARDIAC SAFETY | DESIGN | PHYSIOLOGY | THOROUGH | T wave peak measurement | HEALTHY-SUBJECTS | JTp interval prolongation | BLOCK | QT INTERVAL | ANGLE | PROARRHYTHMIC RISK-ASSESSMENT | normal healthy subjects | intra-subject stability of rate corrected ECG intervals | one-dimensional ECG representation | SAMPLE-SIZE | Electrocardiography | Electrocardiogram | Analysis
Journal Article
FRONTIERS IN PHYSIOLOGY, ISSN 1664-042X, 05/2019, Volume 10, p. 477
Closed-loop models of the interactions between blood pressure (BP) and heart rate variations allow for estimation of baroreflex sensitivity (feedback effects... 
SLEEP | PHYSIOLOGY | autonomic nervous system | blood pressure spectral analysis | ARTERIAL BLOOD-PRESSURE | HEART-RATE VARIABILITIES | MODEL | ambulatory blood pressure monitoring | SEQUENTIAL SPECTRAL-ANALYSIS | arterial baroreflex | REFLEX | hypertension | PULSE INTERVAL | Hypertension | Analysis | Heart beat
Journal Article
FRONTIERS IN PHYSIOLOGY, ISSN 1664-042X, 07/2019, Volume 10, p. 832
Background: An amount of cognition decline is normal with aging; however, intrinsic and extrinsic risk factors may exacerbate it, affecting social and... 
cognitive deficit | PHYSIOLOGY | DEMENTIA | QUALITY | PERFORMANCE | meta-analysis | ORAL-HEALTH | ADULTS | systematic review | tooth loss | IMPAIRMENT | masticatory dysfunction | COMMUNITY | PERIODONTITIS | INFLAMMATION | ASSOCIATION | Complications and side effects | Tooth loss | Cognition disorders | Temporomandibular joint disorders | Risk factors | Stress (Psychology)
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