Science & Research

Completed OWH-funded Research Projects on Cardiovascular Disease

Women often experience heart disease differently than men. The FDA Office of Women's Health (OWH) supports research to help the FDA learn more about sex differences in the safety and efficacy of FDA-regulated medical products for the diagnosis and treatment of heart disease. The projects listed on this page have been completed. Publications highlighting the projects results are listed after the name of the project.

Completed OWH-funded Research on Cardiovascular Disease

Current OWH-funded Research on Cardiovascular Disease

Learn about other OWH-funded Research


 

Completed Projects listed by Funding Year
 

Women often experience heart disease differently than men. The FDA Office of Women's Health (OWH) supports research to help the FDA learn more about sex differences in the safety and efficacy of FDA-regulated medical products for the diagnosis and treatment of heart disease. The projects listed on this page have been completed. Publications highlighting the projects results are listed after the name of the project.

Completed OWH-funded Research on Cardiovascular Disease

Current OWH-funded Research on Cardiovascular Disease

Learn about other OWH-funded Research


 

Completed Projects listed by Funding Year
 

2015

Preclinical test methods for percutaneously implanted heart valves - effect of non-circular valve configuration after implantation on valve leaflet dynamics – Terry Woods, PhD, CDRH

  • Duraiswamy N, Weaver J, Ekrami Y, Retta S, Wu C. A Parametric Computational Study of the Impact of Non-circular Configurations on Bioprosthetic Heart Valve Leaflet Deformations and Stresses: Possible Implications for Transcatheter Heart Valves. Cardiovasc Eng Technol. Jun 2016; 7: 126-138.

Sex-specific outcomes with cardiac resynchronization therapy– Daniel Canos, PhD, CDRH (Supplementary funds)

  • Zusterzeel R, Spatz E, Curtis J, Sanders WE, Selzman KA, Pina IL Bao H, Ponirakis A, Varosy PD, Masoudi FA, Canos DA, Strauss DG. Cardiac Resynchronization Therapy in Women Versus Men: Observational Comparative Effectiveness Study from the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes Mar 2015; 8: S4-11.
  • Zusterzeel R, Selzman KA, Sanders WE, O’Callaghan KM, Canos DA, Vernooy K, Prinzen FW, Gorgels APM, Strauss DG. Toward Sex-Specific Guidelines for Cardiac Resynchronization Therapy. J Cardiovasc Trans Res Feb 2016; 9: 12-22.
  • Zusterzeel R, O’Callaghan KM, Canos DA, Sanders WE, Marinac-Dabic D, Strauss DG. Report from the FDA: Improving the Safety and Effectiveness of Medical Device Therapy in Women. J Womens Health. May 2016; 25: 428-430.

A pilot study for evaluating genetic influences on sex differences of drug-induced – proarrhythmia – Li Pang, MD, NCTR

  • Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, Zamora V, Smith G, Crumb WJ, Pang L, Lyn-Cook B, Ross J, Brock M, Chvatal S, Millard D, Galeotti L, Stockbridge N, Strauss DG. Comprehensive Translational Assessment of Human Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias. Toxicol Sci Oct 2016: pii kfw200 (Epub ahead of print).

2014

Develop animal and cellular models to investigate the mechanisms of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine to support post-marketing surveillance of these antibody-based HER2-targeted therapies, and characterize novel serum biomarker of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine – Wen Jin Wu, MD, PhD, CDER

  • Mohan N, Shen Y, Endo Y, et al. Trastuzumab, but Not Pertuzumab, Dysregulates HER2 Signaling to Mediate Inhibition of Autophagy and Increase in Reactive Oxygen Species Production in Human Cardiomyocytes. Mol Cancer Ther Jun 2016; 15: 1321-1331.
  • Yan H, Endo Y, Shen Y, et al. Ado-Trastuzumab Emtansine Targets Hepatocytes via Human Epidermal Growth Factor Receptor 2 to induce Hepatotoxicity. Mol Cancer Ther Mar 2016; 15: 480-490.
  • Mohan N, Wu WJ. Tastuzumab is not a tyrosine kinase inhibitor. Nat Rev Cardiology Nov 2015; 12: 669.
  • Dokmanovic M, Wu WJ. Monitoring Trastuzumab Resistance and Cardiotoxicity: A Tale of Personalized Medicine. Adv Clin Chem; 70: 95-130.

Novel therapeutic approaches to prevent drug-induced torsade de pointes – Norman Stockbridge, MD, CDER

  • Vicente J, Johannsen L, Mason JW, et al. Sex Differences in Drug-Induced Changes in Ventricular Repolarization. J Electrocardiol Nov 2015; 48: 1081-1987.
  • Johannsen L, Vicente J, Mason JW, et al. Late sodium current block for drug-induced Long QT syndrome: Results from a prospective clinical trial. Clin pharmacol Ther Feb 2016; 99: 214-223.
  • Galeotti L, Van Dam P, Johannesen L, et al. Computer Simulations to Investigate Causes of T-wave Notching. J Electrocardiol Nov 2015; 48: 927-932.
  • Vicente J, Johannesen L, Mason JW, et al. Comprehensive T wave Morphology Assessment in a Randomized Clinical Study of Dofetillide, Quinidine, Ranolazine and Verapamil. J Am Heart Assoc Apr 2015; 4: e001615.
  • Vicente J, Johannesen L, Hosseini M, et al. (2016) Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block. PLoS ONE 11(12): e0163619. doi:10.1371/journal.pone.0163619.
  • Johannesen L, Vicente J, Hosseini M, Strauss DG (2016) Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk. PLoS ONE 11(12): e0166925. doi:10.1371/journal.pone.0166925.

Blood pressure threshold for cardiovascular risk: an assessment of sex-based criterion – Chang-Wei Chang, PhD / Nysia George, PhD, NCTR

Sex differences in drug-induced QT prolongation and torsade de pointes: establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs – Li Pang, MD, NCTR

  • Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, Zamora V, Smith G, Crumb WJ, Pang L, Lyn-Cook B, Ross J, Brock M, Chvatal S, Millard D, Galeotti L, Stockbridge N, Strauss DG. Comprehensive Translational Assessment of Human Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias. Toxicol Sci Oct 2016: pii kfw200 (Epub ahead of print).

2013

PK analysis of the samples for a study funded by CDER Critical Pathways titled, “A double-blind, randomized, placebo-controlled single-dose, five-period crossover study of the electrocardiographic effects of ranolazine, dofetilide, verapamil and quinidine in healthy subjects” – David Strauss, MD, PhD, CDRH and Norman Stockbridge, MD, PhD, CDER

  • Johannesen L, Vicente J, Mason J, et al. Differentiating drug-induced multi-channel block on the electrocardiogram: Randomized study of dofetilide, quinidine, ranolazine, and verapamil. Clin Pharmacol Ther 2014 Nov;96(5):549-58.
  • Vicente J, Johannesen L, Mason JW, et al. Comprehensive T wave morphology assessment in a randomized clinical study of dofetilide, quinidine, ranolazine, and verapamil. J Am Heart Assoc. 2015 Apr 13;4(4).
  • Vicente J, Johannesen L, Mason JW, et al. Sex differences in drug-induced changes in ventricular repolarization. Journal of Electrocardiology 2015;48, Issue 6, 1081–1087. http://dx.doi.org/10.1016/j.jelectrocard.2015.08.004

2012

Novel Electrocardiogaphic Device Algroithms to Assess Cardiac Safety of Investigational Drugs – David Strauss, MD, PhD, CDRH

  • Johannesen L, Vicente J, Galeotti L and Strauss DG. “ECGlib: Library for Processing Electrocardiograms”. In: Comput Cardiol; 2013: IEEE; 2013. p. 951-954.
  • Vincente J, Johannesen L, Galeotti L, Strauss DG. ECGlab: User friendly ECG/VCG analysis tool for research environments. In: Comput Cardiol; 2013: IEEE; Sept 2013. p. 775-778.
  • Johannesen L, Vicente J, Gray RA, et al. Improving the Assessment of Heart Toxicity for all New Drugs Through Translational Regulatory Science. Clin Pharmacol Ther 2014; May; 95(5):501-8.
  • Vicente J, Johannesen L, Galeotti L, Strauss DG. Mechanisms of sex and age differences in ventricular repolarization in humans. American Heart Journal 2014 Nov;168(5):749-56.
  • Vicente J, Johannesen L, Strauss DG. Gender Differences in the Evolution of Spatial QRS-T Angle and Ventricular Gradient with Age. 38th Annual International Society of Computerized Electrocardiology Conference, San Jose, California, US. April 2013. Journal of electrocardiology 2013;46(6):619-620.

Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy - David Strauss, MD, PhD, CDRH

  • D Strauss. Filling Information Gaps for Women in Medical Device Trials. FDA Voice Blog: June 2014.
  • Zusterzeel R, Spatz ES, Curtis JP, et al. Cardiac resynchronization therapy in women versus men: Observational comparative effectiveness study from the national cardiovascular data registry. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2 Suppl 1):S4-11.
  • Zusterzeel R, Curtis JP, Canos DA, et al. Sex-specific mortality risk by QRS morphology and duration in patients receiving CRT: Results from the NCDR. Journal of the American College of Cardiology 2014; 64 (9):887-894. With accompanying editorial: Dec GW. Learning Toward a Better Understanding of CRT in Women. J Am Coll Cardiol. 2014;64(9):895-897.
  • Zusterzeel R., Selzman KA., Sanders WE. et al. Cardiac resynchronization therapy in women: US Food and Drug Administration meta-analysis of patient-level data. JAMA Intern Med 2014;174(8):1340-1348. With accompanying editorial: Bairey Merz CN, Vera Regitz-Zagrosek V. The Case for Sex- and Gender-Specific Medicine. JAMA Intern Med. 2014; 174(8):1348-1349.
  • Z Loring, D Strauss, G Gerstenblith, et al. Cardiac MRI scar patterns differ by gender in an implantable cardioverter defibrillator and cardiac resynchronization cohort, Heart Rhythm 2013; 10(5):659–665.
  • Loring Z, Caños DA, Selzman K, et al. Left Bundle Branch Block Predicts Better Survival in Women than Men Receiving Cardiac Resynchronization Therapy: Long Term Follow-Up of 145,000 Patients. J Am Coll Cardiol HF 2013; 1:237-44

Investigate the mechanisms of trastuzumab-induced cardiotoxicity and cardiotoxicity and cardio protective role of antioxidants in trastuzumab-mediated cardiac dysfunction - Wen Jin Wu, MD, PhD, CDER

  • ElZarrad MK, Mukhopadhyay P, Mohan N, et al. Trastuzumab alters the expression of genes essential for cardiac function and induces ultrastructural changes of cardiomyocytes in mice. PLoS One Nov 2013; 8:e79543. doi:10.1371/journal.pone.0079543 
  • Wu W, Dokmanovic M. (2012) Trastuzumab. In Schwab M. (Ed.) Encyclopedia of Cancer(pp.3776). Springer-Verlag Berlin Heidelberg. http://link.springer.com/referenceworkentry/10.1007/978-3-642-16483-5_5962

2011

Preclinical Test Methods for Percutaneously Implanted Heart Valves: Effect of Non-Circular Valve Configuration After Implantation On Valve Leaflet Dynamics – Terry Woods, NCTR

Genetic and epigenetic mechanisms for sex differences in the kidney of a rat model system: developing safety biomarkers for FDA regulated products – James Fuscoe, PhD, NCTR

  • Kwekel JC, Desai VG, Moland CL, et al. Life cycle analysis of kidney gene expression in male F344 rats. PloS One 2013; 8(10):e75305
  • Kwekel JC, Desai VG, Moland CL, et al. Sex differences in kidney gene expression during the life cycle of F344 rats. Biol of Sex Differ 2013; 4(14)
  • Marti HP, Fuscoe JC, Kwekel JC, Anagnostopoulu A, Scherer A. Metzincins and related genes in experimental renal ageing: towards a unifying fibrosis classifier across species. Nephrol Dial Transplant 2014; doi: 10.1093/ndt/gfu027.
  • Yu Y, Fuscoe JC, Zhao C, et al. A rat RNA-Seq transcriptomic BodyMap across 11 organs and 4 developmental stages. Nat Commun 2014; 5:3230.
  • Kwekel JC, Vijay V, Desai VG, et al. Age and sex differences in kidney microRNA expression during the life span of F344 rats. Biol Sex Differ. 2015 Jan;6(1):1.

Prospective assessment of clinical and patients-reported outcomes for female patients undergoing Percutaneous Coronary Intervention (PCI) procedures via femoral and radial access - Katie O’Callaghan, CDRH

  • Hess CN, Krucoff MW, Sheng S, et al. Comparison of quality-of-life measures after radial versus femoral artery access for cardiac catheterization in women: Results of the Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women quality-of-life substudy. Am Heart J. 2015 Aug;170(2):371-9.
  • Hess CN, Rao SV, MD, Kong DF et al. Embedding a randomized clinical trial into an ongoing registry infrastructure: Unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J 2013;166:421-428. http://dx.doi.org/10.1016/j.ahj.2013.06.013.

Addressing the unmet medical needs for cardioproctection in women receiving chemotherapy – Rao, Ashutosh, CDER

  • Gonzalez Y, Pokrzywinski KL , Rosen ET, et al. Reproductive hormone levels and differential mitochondria-related oxidative gene expression as potential mechanisms for gender differences in cardiosensitivity to Doxorubicin in tumor-bearing spontaneously hypertensive rats. Cancer Chemother Pharmacol (2015) 76:447–459. DOI 10.1007/s00280-015-2786-8.

Sex-based differences in the molecular mechanisms of polymer degradation in drug eluting stents (DES) - Patwardhan, Dinesh, PhD, CDRH

  • J Guo, D Saylor, E Glaser, D Patwardhan. Impact of artificial plaque composition on drug transport. J Pharm Sci, 2013 Jun;102(6):1905-14.
  • McDermott MK, Kim CS, Saylor DM, et al. Impact of copolymer ratio on drug distribution in styrene-isobutylene-styrene block copolymers. J Biomed Mater Res B Appl Biomater. 2013 Oct;101(7):1191-9

Sex-Specific Left Bundle Branch Block Criteria and ECG Scar Quantification to Predict Benefit from Cardiac Resynchronization Therapy (CRT) – David Strauss MD, PhD, CDRH

  • Loring Z, Chelliah S, Selvester R, et al.  A detailed guide for quantification of myocardial scar with the Selvester QRS score in the presence of electrocardiogram confounders. Journal of Electrocardiology 2011; 44:544–554.
  • • Loring Z, Caños DA, Selzman K, et al. Left Bundle Branch Block Predicts Better Survival in Women Than Men Receiving Cardiac Resynchronization Therapy Long-Term Follow-Up of ~45,000 Patients. JACC: Heart Failure 2013; 1, No. 3: 237-244.

2010

Atrial Fibrillation Ablation Registry Study (SAFARI) - Ellen Pinnow, MPH, CDRH

Assessment of outcomes and bleeding complications following implantation of drug eluting stents (DES) and dual anti-platelet therapy (DAPT) - Hesha Duggirala, Ph.D, CDRH

  • Hess CN, McCoy LA, Duggirala HJ, et al. Sex-based differences in outcomes after percutaneous coronary intervention for acute myocardial infarction: A report from TRANSLATE-ACS. J Am Heart Assoc 2014; 3(1):e000523.

Assessment of Risk Factors Associated with Exposure to Proton Pump inhibitors and Fracture and CV outcomes in post-menopausal osteoporosis woman - Antonio Paredes, CDER

Risk of Adverse Events Following Cardiac Catheterization by Hemostasis Device Use – Phase III - Dale Tavris, MD, MPH, CDRH

  • Tavris DR, Wang Y, Jacobs S, et al. Bleeding and vascular complications at the femoral access site following percutaneous coronary intervention (PCI): an evaluation of hemostasis strategies. J Invasive Cardiol 2012 124: 328-34.

The swan-ganz balloon flotation pulmonary artery catheter: possible racial and sex discrepancies - Daniel Canos, Ph.D, CDRH

  • Iantorno M, Panza JA, Cook NL, et al. Gender-and race-based utilization and outcomes of pulmonary artery catheterization in the setting of full-time intensivist staffing. Acute Card Care 2012; 14:125-30.
  • Cooper HA, Najafi AH, Ghafourian K, et al. Diagnosis of cardiogenic shock without the use of a pulmonary artery catheter. Eur Heart J Acute Cardiovasc Care. 2015 Feb;4(1):88-95.

Sex- and age- related differences in baseline QT, QT prolongation, and TdP risk - Christine Garnett, Pharm D, CDRH


2009

Analysis of sex-differences in cardiac resynchronization therapy devices: inclusion, adverse events, and outcomes - Kathryn O’Callaghan, CDRH

Sex-based differences in the safety of drug-eluting stents containing bioresorbable materials - Dinesh Patwardhan, Ph.D., CDRH

  • McDermott MK, Saylor DM, Casas R, et al. Microstructure and elution of tetracycline from block copolymer coatings. J Pharm Sci. 2010 Jun;99(6):2777-85.

2008

Workshop: Guidance for the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Devices - Kathryn O’Callaghan, CDRH

Gender-Related Differences in QT Effects and Torsade de Pointes Potential of Drugs - Christine Garnett, PharmD/ Phillip Dinh, PhD, CDER

  • Dinh P, Sun J, Bai S, Kordzakhia G. Sex-Related Differences in QTc Effects Potential of Drugs. Rev Recent Clin Trials 2011; 6(3): 220-227.

2007

Factors Accelerating the Progression of Heart Failure (HF) in Women: Implications for Drug Interactions with Medical Devices - Soma Kalb, PhD, CDRH

Real-World Outcomes of Drug-Eluting Stents - Art Sedrakyan, MD, PhD, CDRH/AHRQ

  • Douglas PS, Brennan JM, Anstrom KA, et al., Clinical Effectiveness of Coronary Stents in Elderly Persons - Results From 262,700 Medicare Patients in the American College of Cardiology–National Cardiovascular Data Registry, J Am C Cardiol 2009; 53(18):1629-41.

Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes and Therapeutic Targets - Baitang Ning, Ph.D., NCTR

  • Guo L, Dial S, Shi L, et al. Similarities and Differences in the Expression of Drug Metabolizing Enzymes between Human Hepatic Cell Lines and Primary Human Hepatocytes. Drug Metab Dispos, 2011; 39(3):528-38.
  • Yang L, Yan L, Hong H, et al. Sex difference in the expression of drug metabolizing and transporter genes in human liver. J. Drug Metab. & Toxicol. 2012; 3:119. doi:10.4172/2157-7609.1000119.

The Impact of Sex-Based Differences in Atherosclerotic Plaque on the Response to Drug Eluting Stent Implantation - Dinesh Patwardhan, PhD, CDRH

  • Kim CS, Saylor DM, McDermott MK, et al. Modeling solvent evaporation during the manufacture of controlled drug-release coatings and the impact on release kinetics. J Biomed Mater Res B Appl Biomater. 2009 Aug;90(2):688-99.

2006

Evaluation of Availability and Quality of Information Available on Females Included in Mechanical device Implant Trials - Kathryn O’Callaghan, CDRH

ECG Warehouse - Mortara Instruments Inc., Justin Mortara, PhD, Mortara Instruments Inc.

  • Sarapa N, Mortara JL, Brown BD, Isola L, Badilini F. Quantitative performance of e-scribe warehouse in detecting quality issues with digital annotated ECG data from healthy subjects. J Clin Pharmacol 2008; 48:538-546.

ECG Warehouse - Duke Clinical Research Institute and Duke University - Christopher Cabell, M.D., MHS, Duke Clinical Research Institute (DCRI)


2005

Assessment of the Accuracy of the Troponin Assay and the Diagnosis of Myocardial Infarction by Gender - Azadeh Shoaibi, PhD/ Dale Tavris, MD, MPh, CDRH

  • Shoaibi A, Tavris DR, McNulty S. Gender differences in correlates of troponin assay in diagnosis of myocardial infarction. Translational Research 2009; 154:250–256.
  • Tavris DR, Shoaibi A, Chen AY, Uchida T, Roe, Chen J. Gender differences in the treatment of non–ST-segment elevation myocardial infarction. Clin. Cardiol 2010; 33(2):99–103.

Systems Biology Approach to Evaluate Sex Differences in Heart of a Rat Model - James C. Fuscoe, Ph.D., NCTR

Implications of Gender-based Differences in Cardiovascular Disease on Imaging for Treatment and Diagnosis - Iacovos Kyprianou, Ph.D., CDRH

Use and Outcomes of Coronary Stents in Women: Use of a National Medicare Database - Karen Freund, MD, Boston Univ

Fruend KM, Jacobs AK, Pechacek JA, White HF, Ash AS. Disparities by Race, Ethnicity, and Sex in Treating Acute Coronary Syndromes. Journal of Women's Health 2012; 21(2): 126-131.


2004

Transmission Attenuation Correction for Female Patients Undergoing Myocardial Perfusion Imaging: Correction for Confounding Breast Tissue Artifact - Michelle Dew, MD, Univ. of Arizona

Pilot Study: Combined Beta1 Arg 389 and Alpha 2c Del 322-325 Adrenergic Receptor Polymorphisms and Heart Failure with Preserved Left Ventricular Ejection Fraction in African American Women - Thierry LeJemtel, MD, Tulane Univ


2003

Are Women at Higher risk from Proarrhythmic Drugs? - Jogarao Gobburu, PhD, CDER (03)

  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). E14 Guidance on Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythic Potential for Non-Antiarrthmic Drugs 2005. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129357.pdf

Discovery and Evaluation of Interspecies Biomarkers to Monitor the Early Onset and the Progression of Cardiovascular Toxicity Associated with Thiazolidinedione Compounds Used in the Treatment of Type 2 Diabetes - Eugene Herman, PhD, CDER

Cardiovascular Effects Of Ultrasound Contrast Agents in Intact and Ovariectomized Female Animals - Melvin Stratmeyer, PhD, CDRH

Electrophysiological Characterization of Several Torsadogenic Drugs in Isolated Rabbit Hearts - John Koerner, PhD, CDER

  • Katchman AN, Koerner J, Tosaka T, et al. Comparative evaluation of HERG currents and QT intervals following challenge with suspected torsadogenic and nontorsadogenic drugs. J Pharmacol Exp Ther. Epub 2006; 316:1098–1106.

2002

Pharmacokinetics and Pharmacodynamics (PK/PD) of Atenolol in Pregnancy - Mary Hebert, PharmD, University of Washington, Dept of Pharmacy

  • Hebert MF, Carr DB, Anderson GD, et al. Pharmacokinetics and pharmacodynamics of atenolol during pregnancy and postpartum. J Clin Pharmacol 2005; 45(1):25-33.
  • Eyal S, Kim JD, Anderson GD, et al. Atenolol Pharmacokinetics and Excretion in Breast Milk During the First 6 to 8 Months Postpartum. J Clin Pharmacol 2010; 50:1301-309

Incidence and attributable risk of serious adverse events and death associated with the use of homeostasis devices by gender – Dale Tavris MD, MPH, CDRH

  • Tavris DR, Gallauresi B, Rich S, et al. Relative risks of reported serious injury and death associated with hemostasis devices by gender. Pharmacoepidemiology and Drug Safety 2003; 12(3):237-241
  • Tavris DR, Gallauresi BA, Lin B, Rich SE, Shaw RE, Weintraub WS, Brindis RG, Hewitt K. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 2004; 16(9):459-64.
  • Tavris DR, Dey S, Gallauresi BA, et al. Risk Of local adverse events following cardiac catheterization by hemostasis device use: phase II. J Invasive Cardiol 2005; 17(12):644-50
  • Tavris DR Md, Gallauresi BA, Dey S, et al. Risk of local adverse events by gender following cardiac catheterization. Pharmacoepidemiology And Drug Safety 2007; 16:125–131.

2001

Discovery and evaluation of interspecies biomarkers to identify and characterize the cardiotoxic effects of Transtuzumab (Herceptin), a novel antibody used in the treatment of breast cancer - Eugene Herman, PhD, CDER

Labetalol and Hypertension in Pregnancy: Pharmacokinetics and Pharmacodynamics - James Fischer, Ph.D. University of Illinois, Chicago

  • Fischer JH, Sarto GE, Hardman J, et al. Influence of gestational age and body weight on the pharmacokinetics of labetalol in pregnancy. Clin Pharmacokinet 2014 Apr;53(4):373-83

2000

Women's participation in clinical drug trials for unstable angina and myocardial infarction - Ann Farrell, MD, CDER

Surveillance of Sex-specific Utilization, Morbidity, and Mortality Associated with Transmyocardial Revascularization - Ronald Kaczmarek, MD, MPH, CDRH

  • Peterson ED, Kaul P, Kaczmarek RG, et al. From controlled trials to clinical practice: monitoring transmyocardial revascularization use and outcomes. J Am Coll Cardiol 2003; 42(9):1611-6.

1998

Flow studies and the use of a waveguide in cardiovascular devices - Harvey Rudolf, PhD, CDRH

Ovarian steroids and cardiovascular disease: The role of gender in the effectiveness of interventional medical devices - James Karanian, PhD, CDRH

Variations in the drug-induced QT interval prolongation during the menstrual cycle - Ana Szarfman, MD, PhD, Raymond L. Woosley, MD, PhD, CDER (co-funded by NIH ORWH, 98)

  • Rodriguez J, Kilborn MJ, Liu, XK, et al. Drug-Induced QT prolongation in women during the menstrual cycle. JAMA 2001; 285:1322-1326.

1994 -1997

Epidemiology of medical devices in women - Danica Marinac-Dabic, MD, CDRH (97)

A comparison of gender specific utilization of implantable cardioverter defibrillator therapy and post-implantation survivability - Steven Lascher, DVM, MPH, CDRH (97)

Administration of thrombolytic therapy to women with acute myocardial infarction. Is it too late? - Emily B. Shacter, PhD, CBER (96)

  • Rieves D, Wright G, Gupta G, Shacter E. Clinical Trial (GUSTO-1 and INJECT) Evidence of Earlier Death for Men than Women After Acute Myocardial Infarction. Am J Cardiol 2000; 85:147–153.

Gender differences in early and long-term results of coronary angioplasty with the Palmaz/Schatz stent - Danica Marinac-Dabic, MD, CDRH (95, 96, 97)

Comparison of the beta-adrenergic antagonist actions of propranolol in men and women - David Flockhart, MD, PhD, CDER (94)

Comparison of the potassium channel blocking actions of quinidine in men and women - Raymond L. Woosley, MD, PhD, CDER (94)

  • Benton RE, Sale M, Flockhart DA, et al. Greater quinidine-induced QTc interval prolongation in women. Clin Pharmacol Ther 2000; 67:413-8.

Terfenadine/Oral contraceptive study - Lou Cantillina, MD, CDER (94)

 

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