A summary of safety of gadofosveset (MS-325) at 0.03 mmol/kg body weight dose: Phase II and phase III clinical trials data

Investigative Radiology

Volumn 41, Issue 11, 2006, Pages 822-830

  Shamsi, Kohkan ^a   Yucel, E Kent ^b   Chamberlin, Paul ^c  

^a Clinical Pharmacology Department   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c EPIX Pharmaceuticals Inc ^*  (United States)

Author keywords

Blood pool agent; Contrast agent; MR angiography; MR contrast media; Safety

Indexed keywords

GADOFOSVESET; IODINATED CONTRAST MEDIUM; IRON; PLACEBO;

ADULT; AGED; ARTICLE; BRADYCARDIA; BURNING SENSATION; CLINICAL LABORATORY; CLINICAL TRIAL; DOSE RESPONSE; DRUG MONITORING; DRUG SAFETY; DYSGEUSIA; ELECTROCARDIOGRAPHY; FACE EDEMA; FEMALE; HEADACHE; HEART INFARCTION; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPESTHESIA; HYPOTENSION; INJECTION SITE CONTUSION; INJURY; INSOMNIA; IRON BLOOD LEVEL; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; NAUSEA; NECROSIS; NERVOUSNESS; OXYGEN SATURATION; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PRURITUS; QT PROLONGATION; RASH; SIDE EFFECT; SKIN ATROPHY; SYNCOPE; THORAX PAIN; VASCULAR DISEASE; VASODILATATION; VITAL SIGN; VOMITING; X RAY;

EID: 33750011387     PISSN: 00209996     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.rli.0000242836.25299.8f     Document Type: Article

References (31)

1. Criqui MH, Fronek A, Barrett-Connor E, et al. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985;71:510-515.
2. Vogt MT, Wolfson SK, Kuller LH, Lower extremity arterial disease and the aging process: a review. J Clin Epidemiol. 1992;45:529-542.
3. Rieker O, Duber C, Neufang A, et al. CT angiography versus intraarterial digital subtraction angiography for assessment of aortoiliac occlusive disease. AJR Am J Roentgenol. 1997;169:1133-1138.
4. Tan KT, van Beek EJ, Brown PW, et al. Magnetic resonance angiography for the diagnosis of renal artery stenosis: a meta-analysis. Clin Radiol. 2002;57:617-624.
5. Grist T. MRA of the abdominal aorta and lower extremities. J Magn Reson Imaging. 2000;11:32-43.
6. Perreault P, Edelman MA, Baum RA, et al. MR angiography with gadofosveset trisodium for peripheral vascular disease: phase II trial. Radiology. 2003;229:811-820.
7. Deliganis AV, Maravilla KR, Heiman JR, et al. Female genitalia: dynamic MR imaging with use of gadofosveset - initial experiences evaluating female sexual response. Radiology. 2002;225:791-799.
8. Grist TM, Korosec FR, Peters DC, et al. Steady-state and dynamic MR angiography with MS-325: initial experience in humans. Radiology. 1998;207:539-544.
9. Rapp JH, Wolff SD, Quinn SF, et al. A multi-center, comparative, phase 3 study to determine the safety and efficacy of MS-325-enhanced MRA for evaluation of aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease. Radiology. 2005;236:71-78.
10. Goyen M, Edelman M, Parreault P, et al. MR angiography of aorto-iliac occlusive disease: a phase III study to determine the safety and efficacy of the blood-pool contrast agent MS-325. Radiology. 2005;236:825-833.
11. Bluemke D, Stillman AE, Bis KG, et al. Carotid MR angiography: Phase II study of safety and efficacy for MS-325. Radiology. 2001;219:114-122.
12. MedDRA®. Registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Available at: http://www.meddramsso.com/MSSOWeb/index.htm. Accessed August 22, 2006.
13. Food and Drug Administration. COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms. 3rd ed. Rockville, MD: Department of Health and Human Services, Food and Drug Administration, Center for Drugs and Biologics; 1989.
14. Eldredge HB, Spiller M, Chasse JM, et al. Species dependence on plasma protein binding and relaxivity of the gadolinium-based MRI contrast agent MS-325. Invest Radiol. 2006;41:229-243.
15. Lauffer RB, Parmelee DJ, Dunham SU, et al. MS-325: albumin-targeted contrast agent for MR angiography. Radiology. 1998;207:529-538.
16. Rohrer M, Bauer H, Mintorovitch J, et al. Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Invest Radiol. 2005;40:715-724.
17. Rubin DL, Desser TS, Semelka R, et al. A multicenter, randomized, double-blind study to evaluated the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentate dimeglumine) in patients with liver pathology: results of a Phase III clinical trial. J Magn Reson Imaging. 1999;9:240-250.
18. Murphy KJ, Brumberg JA, Cohan RH. Adverse reactions to gadolinium contrast media: a review of 36 cases. AJR Am J Roentgenol. 1996;167:847-849.
19. Parke-Davis. Cerebryx (Fosphenytoin Sodium Injection). Package Insert, 2002.
20. Baharav E, et al. Dexamethasone-induced perineal irritation. N Engl J Med. 1986;20:515-516.
21. Perron G, et al. Perineal pruritis after i. v. dexamethasone administration. Can J Anesth. 2003;50:749-750.
22. Prince MR, Choyke PL, Knopp MV. More on pseudohypocalcemia and gadolinium-enhanced MRI. N Engl J Med. 2004;350:87-88.
23. Choyke PL, Knopp MV. Pseudohypocalcemia with MR imaging contrast agents: a cautionary tale. Radiology. 2003;227:627-628.
24. Corot C, Idee M, Hentsch AM, et al. Structure-activity relationship of macrocyclic and linear gadolinium chelates: investigation of transmetallation effect on the zinc-dependent metallopeptidasc angiotensin-converting enzyme. J Magn Reson Imaging. 1998;8:695-702.
25. Caravan P, Cloutier NJ, Greenfield MT, et al. The interaction of MS-325 with human serum albumin and its effect on proton relaxation rates. J Am Chem Soc. 2002;27:3152-3162.
26. Fransson FG, Nylander E. Vascular injury following cardiac catheterization, coronary angiography, and coronary angioplasty. Eur Heart J. 1994;15:232-235.
27. Meyerson SI, Feldman T, Desai TR, et al. Angiographic access site complications in the era of arterial closure devices. Vasc Endovasc Surg. 36:137-144.
28. Egglin TK, O'Moore PV, Feinstein AR, et al. Complications of peripheral arteriography: a new system to identify patients at increased risk. J Vasc Surg. 1995;22:787-794.
29. U-King-Im JM, Hollingworth W, Trivedi RA, et al. Cost-effectiveness of diagnostic strategies prior to carotid endarterectomy. Ann Neurol. 2005;58:506-515.
30. Goyen M, Debatin JF. Gadopentate dimeglumine-enhanced three-dimensional MR-angiography: dosing, safety, and efficacy. J Magn Reson Imaging. 2004;19:261-273.
31. Shellock FG, Parker JR, Venetianer C, et al. Safety of gadobenate dimeglumine (MultiHance): summary of findings from clinical studies and postmarketing surveillance. Invest Radiol. 2006;41:500-509.