Evaluation of vardenafil for the treatment of subjective tinnitus: A controlled pilot study

Journal of Negative Results in BioMedicine

Volumn 8, Issue 1, 2009, Pages

  Mazurek, Birgit ^a   Haupt, Heidemarie ^a   Szczepek, Agnieszka J ^a   Sandmann, Jörg ^a   Gross, Johann ^a   Klapp, Burghard F ^a   Kiesewetter, Holger ^a   Kalus, Ulrich ^a   Stöver, Timo ^b   Caffier, Philipp P ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; PLACEBO; VARDENAFIL; IMIDAZOLE DERIVATIVE; PHOSPHODIESTERASE INHIBITOR; PIPERAZINE DERIVATIVE; SULFONE; TRIAZINE DERIVATIVE;

ARTICLE; AUDIOMETRY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFECT; DRUG SAFETY; DRUG SCREENING; ERECTILE DYSFUNCTION; FEMALE; HEADACHE; HUMAN; MALE; NOSE CONGESTION; OXIDATIVE STRESS; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; QUESTIONNAIRE; TINNITUS; DOUBLE BLIND PROCEDURE; METABOLISM; MIDDLE AGED; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL;

AUDIOMETRY; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMIDAZOLES; MALE; MIDDLE AGED; OXIDATIVE STRESS; PHOSPHODIESTERASE INHIBITORS; PIPERAZINES; PROSPECTIVE STUDIES; SULFONES; TINNITUS; TRIAZINES;

EID: 61649084758     PISSN: None     EISSN: 14775751     Source Type: Journal    
DOI: 10.1186/1477-5751-8-3     Document Type: Article

References (56)

1. Phantom auditory perception (tinnitus): mechanisms of generation and perception. PJ Jastreboff, Neurosci Res 1990 8 221 254 10.1016/0168-0102(90) 90031-9 2175858
2. Hearing loss and tinnitus: 250 million people and a US$10 billion potential market. MM Vio RH Holme, Drug Discov Today 2005 10 1263 1265 10.1016/S1359-6446(05)03594-4 16214667
3. Classification and epidemiology of tinnitus. AJ Heller, Otolaryngol Clin North Am 2003 36 239 248 10.1016/S0030-6665(02)00160-3 12856294
4. Clinical management of tinnitus using a "progressive intervention" approach. JA Henry MA Schechter CL Loovis TL Zaugg C Kaelin M Montero, J Rehabil Res Dev 2005 42 95 116 10.1682/JRRD.2005.01.0005 16470467
5. Specific findings in distortion product otoacoustic emissions and growth functions with chronic tinnitus. G Hesse H Schaaf A Laubert, Int Tinnitus J 2005 11 6 13 16419682
6. Risk factors for tinnitus in a population of older adults: the blue mountains hearing study. D Sindhusake M Golding P Newall G Rubin K Jakobsen P Mitchell, Ear Hear 2003 24 501 507 10.1097/01.AUD.0000100204.08771.3D 14663349
7. Tinnitus and inferior colliculus activity in chinchillas related to three distinct patterns of cochlear trauma. CA Bauer JG Turner DM Caspary KS Myers TJ Brozoski, J Neurosci Res 2008 86 2564 2578 18438941 10.1002/jnr.21699
8. Cortical tonotopic map reorganization and its implications for treatment of tinnitus. JJ Eggermont, Acta Otolaryngol 2006 126 Suppl 556 9 12 10.1080/03655230600895259
9. The emotional ear in stress. KC Horner, Neurosci Biobehav Rev 2003 27 437 446 10.1016/S0149-7634(03)00071-X 14505685
10. Noise-induced cochlear hypoxia is intensity dependent, correlates with hearing loss and precedes reduction of cochlear blood flow. K Lamm W Arnold, Audiol Neurootol 1996 1 148 160 9390798
11. Intensity-dependent changes in oxygenation of cochlear perilymph during acoustic exposure. F Scheibe H Haupt C Ludwig, Hear Res 1992 63 19 25 10.1016/0378-5955(92)90069-Y 1464569
12. Intensity-related changes in cochlear blood flow in the guinea pig during and following acoustic exposure. F Scheibe H Haupt C Ludwig, Eur Arch Otorhinolaryngol 1993 250 281 285 10.1007/BF00186226 8217130
13. Sudden deafness in vertebrobasilar ischemia: clinical features, vascular topographical patterns and long-term outcome. H Lee RW Baloh, J Neurol Sci 2005 228 99 104 10.1016/j.jns.2004.10.016 15607217
14. A model of peripherally developing hearing loss and tinnitus based on the role of hypoxia and ischemia. B Mazurek H Haupt P Georgiewa BF Klapp A Reisshauer, Med Hypotheses 2006 67 892 899 10.1016/j.mehy.2006.03.040 16757123
15. Vascular inner ear partition: a concept for some forms of sensorineural hearing loss and vertigo. RA Tange, ORL J Otorhinolaryngol Relat Spec 1998 60 78 84 9553972
16. Cochlear blood flow during occlusion and reperfusion of the anterior inferior cerebellar artery - effect of topical application of dexamethasone to the round window. H Otake H Yamamoto M Teranishi M Sone T Nakashima, Acta Otolaryngol 2008 129 2 127 131 18607911 10.1080/00016480802078119
17. A reversible ischemia model in gerbil cochlea. T Ren NJ Brown M Zhang AL Nuttall JM Miller, Hear Res 1995 92 30 37 10.1016/0378-5955(95)00192-1 8647743
18. Expression of apoptosis-related genes in the organ of Corti, modiolus and stria vascularis of newborn rats. J Gross A Machulik N Amarjargal R Moller U Ungethum RJ Kuban, Brain Res 2007 1162 56 68 10.1016/j.brainres.2007.05.061 17612509
19. Influence of ischemia/hypoxia on the HIF-1 activity and expression of hypoxia-dependent genes in the cochlea of the newborn rat. B Mazurek C Rheinlander FU Fuchs N Amarjargal RJ Kuban U Ungethum, HNO 2006 54 689 697 10.1007/s00106-005-1371-6 16479386
20. Disorders of cochlear blood flow. T Nakashima S Naganawa M Sone M Tominaga H Hayashi H Yamamoto, Brain Res Brain Res Rev 2003 43 17 28 10.1016/S0165-0173(03)00189-9 14499459
21. Effects of nitric oxide synthase inhibitor on cochlear blood flow. H Hoshijima K Makimoto O Noi Y Ohinata H Takenaka, Hear Res 2002 171 32 42 10.1016/S0378-5955(02)00328-3 12204347
22. ATP-induced cochlear blood flow changes involve the nitric oxide pathway. T Ren AL Nuttall JM Miller, Hear Res 1997 112 87 94 10.1016/S0378-5955(97) 00109-3 9367231
23. Phosphodiesterase type 5 inhibitors: the day after. K Hatzimouratidis D Hatzichristou, Eur Urol 2007 51 75 88 10.1016/j.eururo.2006.07.020 16949200
24. PDE5 inhibitors beyond erectile dysfunction. P Sandner J Hutter H Tinel K Ziegelbauer E Bischoff, Int J Impot Res 2007 19 533 543 10.1038/sj.ijir.3901577 17625575
25. Novel phosphodiesterase-5 inhibitors: current indications and future directions. R Sharma, Indian J Med Sci 2007 61 667 679 18174638
26. Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): a randomized, double-blind, placebo-controlled trial in PDE5 inhibitor-naive men with ED and their partners. D Edwards G Hackett O Collins J Curram, J Sex Med 2006 3 1028 1036 10.1111/j.1743-6109.2006.00329.x 17100936
27. Synthesis and pharmacological evaluations of sildenafil analogues for treatment of erectile dysfunction. HA Flores Toque FB Priviero CE Teixeira E Perissutti F Fiorino B Severino, J Med Chem 2008 51 2807 2815 10.1021/jm701400r 18393409
28. Phosphodiesterase inhibitors for persistent pulmonary hypertension of the newborn: a review. JN Travadi SK Patole, Pediatr Pulmonol 2003 36 529 535 10.1002/ppul.10389 14618646
29. Pharmacology of phosphodiesterase-5 inhibitors. JD Corbin SH Francis, Int J Clin Pract 2002 56 453 459 12166544
30. Pharmacotherapy in acute tinnitis. The special role of hypoxia and ischemia in the pathogenesis of tinnitus. B Mazurek H Haupt J Gross, HNO 2006 54 9 15 10.1007/s00106-005-1292-4 16132881
31. The NO/ONOO-cycle as the etiological mechanism of tinnitus. ML Pall SA Bedient, Int Tinnitus J 2007 13 99 104 18229788
32. Plasma malondialdehyde as biomarker for oxidative stress: reference interval and effects of life-style factors. F Nielsen BB Mikkelsen JB Nielsen HR Andersen P Grandjean, Clin Chem 1997 43 1209 1214 9216458
33. Protein carbonyl groups as biomarkers of oxidative stress. I Dalle-Donne R Rossi D Giustarini A Milzani R Colombo, Clin Chim Acta 2003 329 23 38 10.1016/S0009-8981(03)00003-2 12589963
34. Total oxidative/anti-oxidative status and relation to bone mineral density in osteoporosis. O Altindag O Erel N Soran H Celik S Selek, Rheumatol Int 2008 28 317 321 10.1007/s00296-007-0452-0 17823800
35. Vascular oxidant stress and inflammation in hyperhomocysteinemia. L Papatheodorou N Weiss, Antioxid Redox Signal 2007 9 1941 1958 10.1089/ars.2007.1750 17822365
36. Quality management in the therapy of chronic tinnitus. G Goebel W Hiller, Proceedings of the 6th International Tinnitus Seminar London: The Tinnitus and Hyperacusis Centre, Hazell JW, 1999 357 363
37. Cognitive variables in tinnitus annoyance. RS Hallam SC Jakes R Hinchcliffe, Br J Clin Psychol 1988 27 Pt 3 213 222 3191301
38. The impact of tinnitus on quality of life in older adults. DM Nondahl KJ Cruickshanks DS Dalton BE Klein R Klein CR Schubert, J Am Acad Audiol 2007 18 257 266 10.3766/jaaa.18.3.7 17479618
39. Assessment tools for general health care settings: PRIME-MD, OARS, and SF-36. Primary Care Evaluation of Mental Health Disorders. Older Americans Resources and Services Questionnaire; Short Form-36. MP Van Hook B Berkman R Dunkle, Health Soc Work 1996 21 230 234 8854128
40. The SF-36 questionnaire and its usefulness in population studies: results of the German Health Interview and Examination Survey 1998. BM Kurth U Ellert, Soz Praventivmed 2002 47 266 277 10.1007/BF01326408 12415931
41. The determination of tinnitus loudness considering the effects of recruitment. RS Tyler D Conrad-Armes, J Speech Hear Res 1983 26 59 72 6865383
42. Biomarkers of oxidative damage in human disease. I Dalle-Donne R Rossi R Colombo D Giustarini A Milzani, Clin Chem 2006 52 601 623 10.1373/clinchem.2005. 061408 16484333
43. L Thomas, Labor und Diagnose Frankfurt/Main: TH-Books Verlagsgesellschaft 5 2000
44. New pharmacological strategies to restore hearing and treat tinnitus. MJ Guitton J Wang JL Puel, Acta Otolaryngol 2004 124 411 415 10.1080/ 00016480310000665 15224865
45. Cognitive neuroscience in tinnitus research: a current review. E Viirre, Int Tinnitus J 2007 13 110 117 18229790
46. Oxidative stress, nitric oxide, endothelial dysfunction and tinnitus. S Neri S Signorelli D Pulvirenti B Mauceri D Cilio F Bordonaro, Free Radic Res 2006 40 615 618 10.1080/10715760600623825 16753839
47. Guanylate cyclase and the.NO/cGMP signaling pathway. JW Denninger MA Marletta, Biochim Biophys Acta 1999 1411 334 350 10.1016/S0005-2728(99)00024-9 10320667
48. Systematics for mechanisms of tinnitus development. HP Zenner, HNO 1998 46 699 704 10.1007/s001060050299 9773325
49. Tinnitus sensitization: Sensory and psychophysiological aspects of a new pathway of acquired centralization of chronic tinnitus. HP Zenner M Pfister N Birbaumer, Otol Neurotol 2006 27 1054 1063 10.1097/01.mao.0000231604.64079.77 17130796
50. Summary of Medicinal Product Characteristics for Levitra®. http://www.emea.europa.eu/humandocs/PDFs/EPAR/levitra/H-475-PI-en.pdf
51. State-of-the-art mechanisms of intracochlear drug delivery. DA Borkholder, Curr Opin Otolaryngol Head Neck Surg 2008 16 472 477 10.1097/MOO.0b013e32830e20db 18797291
52. A novel controlled local drug delivery system for inner ear disease. DP Paulson W Abuzeid H Jiang T Oe BW O'Malley D Li, Laryngoscope 2008 118 706 711 10.1097/MLG.0b013e31815f8e41 18182968
53. In vivo and in vitro response of corpus cavernosum to phosphodiesterase-5 inhibition in the hypercholesterolaemic rabbit. F Firoozi PA Longhurst MD White, BJU Int 2005 96 164 168 10.1111/j.1464-410X.2005.05588.x 15963142
54. Indirect comparison of interventions using published randomised trials: systematic review of PDE-5 inhibitors for erectile dysfunction. RA Moore S Derry HJ McQuay, BMC Urol 2005 5 18 16354303 10.1186/1471-2490-5-18
55. US Food and Drug Administration. http://www.fda.gov/CDER/Drug/InfoSheets/ HCP/ED-HCP.htm
56. A case of sensorineural deafness following ingestion of sildenafil. B Mukherjee T Shivakumar, J Laryngol Otol 2007 121 395 397 10.1017/ S0022215106005512 17166328