Connecting Communities for Drug Safety Collaboration
Literature Review References
Statin Use Case
Andrade, S.E., Graham, et al. (2005). "Health Plan Administrative Databases can Efficiently Identify serious Myopathy and Rhabdomyolosis." J Clin Epidemiol 58 (2):171-4.
Alsheikh, A.; Maddukuri, P; Han,H., et al (2007). "Effects of the Magnitude of Lipid Lowering on Risk of Elevated Enzymes, Rhabdomyolysis, and Cancer." J American College of Cardiology 50 (5): 409-418.
Avis, H; Vissers, ?et al (2007). "A Systematic Review and Meta-Analysis of Statin Therapy in Children With Familial Hypercholesterolemia." J American Heart Association, Arteriosclerosis, Thrombosis and Vascular Biology (27): 1803-1810.
Benichou, C, Danan, G, Flanhault, A (1997). "Causality Assessment of Adverse Reactions to Drugs- II. An Original? Model for Validation of Drug Causality Assessment Methods: Case Reports with Positive Rechallenge." J Clinical Epidemiology 46 (11): 1331-1336.
Cheng, J (2004). "Rosuvastatin in the management of hyperlipidemia." Clinical Therapeutics 26 (9) 1368-87.
Cziraky, M.., Wiley, et al (2006). "Statin Safety: An Assessment Using an Administrative Claims Database."American Journal of Cardiology ?97 (8): 61-67.
De Abajo, FJ., Montero, et al (2004). "Acute and Clinically Relevant Drug-induced Liver Injury: a Population based Case-Control Study." British Journal of Clinical Pharmacology. 58(1):71-80.
De Denus, S., Spinler, et al (2004). "Statins and Liver Toxicity: A Meta- Analysis." Pharmacotherapy ?24 (5) 584-590.
Einarson, T, Metge, ?et al (2002). ?"An Examination of the Effect of cytochrome P450 Drug Interactions of hydroxymetthylglutaryl-coenzyme a reductase inhibitors on Health Care Utilization: A Canadian Population-based study." Clinical Therapeutics ?24 (12) 2126-2136.
Famularo, G.F., Miele, et al (2007). "Case Report: Liver Toxicity and Rosuvastatin Therapy." World Journal of Gastroenterology 13 (8) 1286-1288.
Goettsch, W.G; Heintjes, et al (2006). "Results from a rosuvastatin historical cohort study in more than 45000 Dutch statin users, a PHARMO Study" Pharmacoepidemiology and Drug Safety 15 (5) 435-443.
Graham, D., Staffa, et al (2004). ?"Incidence of Hospitalized Rhabdomyolysis in Patients Treated with Lipid Lowering Drugs"? JAMA? (21)? NEED MONTH 292; 2585-2590.
Guallar, R; Rodriquez, (2007). "Efficacy and Safety of Statins in Older Adults: A Meta-analysis" Journal of Gerontology, Series A Biological Sciences & Medical Sciences ?62 (8): 879-87.
Famularo G.; Miele, et al (2007). "Liver Toxicity or Rosuvastatin Therapy" World Journal of Gastroenterology 13 (8) 1286-1288.
Hennekens, CH. Holar, et al (2007). ?"Update for Primary Healthcare Providers: Recent Statin Trials and Revised National Cholesterol Education Program III Guidelines"? Medscape General Medicine. 8 (1) 54.
Hildemann, SK; Barho et al (2007). ?"Dual Cholesterol Inhibition with ezetimibe/simvastatin in Pre-treated Hypercholesterolaemic Patients with Coronary Heart Disease or Diabetes Mellitus: Prospective Observational Cohort Studies in Clinical Practice". Current Medical Research and Opinion. 23 (4) 713-9.
Insull, W.; Ghalli, et al (2007)." Achieving Low Density Lipoprotein Cholesterol Goal; Patients in Managed Care: Comparison of Rosuvastatin and Simvastatin in the SOLAR? Trial." Mayo Clinic Proc. 82 (5)543-550.
Kashani, A, Phillips et al (2006). "Risks Associated with Statin Therapy: A Systematic Overview of Randomized Clinical Trials". Circulation, American Heart Association. 114 (25) 2788-2797.
McAfee, A. T., E. E. Ming, et al. (2006). "The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy." Pharmacoepidemiol Drug Saf 15(7): 444-53.
McClure, D, Valuck et al (2007). "Systematic review and meta-analysis of clinically relavant adverse events from HMG CoA reductase inhibitor trials worldwide from 1982-present." Pharmacoepidemiology and Drug Safety. 16 (2) 132-43.
McKenney, J.M (2006). ?"An Assessment of Statin Safety." The American Journal of Managed Care. 12 (11) 3110-317.
Murdock, D; Murdock, et al (1998). " Long-term safety and efficacy of combination gemfibrozil and HMG-CoA reductase inhibitors for the treatment of mixed lipid disorders." American Heart Journal. ?138 (1) 152-155.
Roberts, C.; Guallar, et al (2007)). "Efficacy and Safety of Statin Monotherapy in Older Adults: A Meta-Analysis". Journal of Gerontology. 62 (8) 879-887.
Stang, P, Morris, et al (2007). "The Co Prescription of Contraindicated Drugs with Statins: Continuing Potential for Increased risk of Adverse events." American Journal of Therapeutics. ?14 (1): 30-40
Warfarin Use Case
Aguilar, M, Hart, R., et al (2007). "Treatment of warfarin associated Intracerebral Hemorrhage: Literature Review and Expert Opinion." Mayo Clinic Proceedings ?82 (1) 82-92.
Aspinall, S, DeSanzo, et al (2005). "Bleeding Risk Index in an Anticoagulation Clinic," Journal General Internal Medicine 20 (7) 1008-1013.
Berwaerts, J, Dijkuizen, R., et al (2000). "Prediction of Functional Outcome and In-hospital Mortality after ?Admission with Oral Anti-coagulation related Intracerebral Hemorrhage." Stroke ?31 2558-62.
Delaney, J, Opatrny, L, et al (2007). "Drug Drug interactions between Antithrombotic Medications and the Risk of Gastrointestinal Bleeding." Canadian? Medical Association Journal 177 (4) 347-51.
Fang, M, Chang, Y, et al (2004).? "Advanced Age, Anticoagulation Intensity, and Risk for Intracranial Hemorrhage among Patients taking warfarin for Atrial Fibrillation." Annals of Internal Medicine 11 (10) 745-752.
Go, A., Hylek, et al (2001). "Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rythym Management and Stroke Prevention: The Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study." Journal of American Medical Association? 285 (18) 2370-2375.
Hart, R.,Benevento O, et al (1999). "Antithrombotic Therapy to Prevent Stroke in Patients with Atrial Fibrillation: A meta analysis." Annals of Internal Medicine 131 (9) 492-501.
Hart, R., Halperin, J (1999). "Atrial Fibrillation and Thromboembolism: A Decade of Progress in Stroke Prevention." Annal of Internal Medicine 131 (9) 688-694.
Hollowell, J., A. Ruigomez, et al. (2003). "The incidence of Bleeding Complications associated with Warfarin Treatment in General Practice in the United Kingdom." Br J Gen Pract 53(489): 312-4.
Hylek, E. Regan, S (2001). "Clinical Predictors of Prolonged Delay in Return of the International Normalized Ratio to within the Therapeutic Range after Excessive Anticoagulation with Warfarin." Annals of Internal Medicine 135 (6) 393-99.
Segal, J, McNamara, et al (2000). "Prevention of Thromboembolism in Atrial Fibrillation: A meta-analysis of trials of anticoagulants and antiplatelet drugs." Journal General Internal Medicine 15 (1) 56-67.
Shireman, T; Mahnken, ?et al (2006). "Development of a Contemporary Bleeding Risk Model for Elderly Warfarin Participants." CHEST 130 (5) 1390-1396.
Strong, S, Halperin (2007). "Confronting Atrial Fibrillation in the Elderly: Stroke Risk Stratification and emerging Antithrombotic Therapies." Geriatrics 62 (3) 22-7.
Wyowski, D., Nourjah, et al (2007). "Bleeding Complications with Warfarin Use: A Prevalent Adverse Effect Resulting in Regulatory Action." Archives of Internal Medicine 167 (13) 1414-1419.
Zhuang, K., Young, et al (2006). Administrative Claims Analysis of the Relationship Between warfarin Use and Risk of Hemorrhage Including Drug-Drug and Drug-Disease Interactions, Journal of Managed Care Pharmacy 12 (8) 640-648.
