Examination of the safety and use of apomorphine prescribed in general practice in England as a treatment for erectile dysfunction

BJU International

Volumn 98, Issue 1, 2006, Pages 125-131

  MacLennan, Karyn M ^a   Boshier, Andrew ^a,b   Wilton, Lynda V ^a,b   Shakir, Saad A W ^a,b  

^a DRUG SAFETY RESEARCH UNIT   (United Kingdom)

^b UNIVERSITY OF PORTSMOUTH   (United Kingdom)

Author keywords

Apomorphine (Uprima ); Drug safety; Erectile dysfunction; Prescription event monitoring

Indexed keywords

APOMORPHINE; NITRATE; SILDENAFIL;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ARTHRALGIA; ARTICLE; BLISTER; BURNING SENSATION; CARCINOMATOSIS; CENTRAL NERVOUS SYSTEM; CEREBROVASCULAR ACCIDENT; COHORT ANALYSIS; CONFUSION; CONTROLLED STUDY; COUGHING; DIABETES MELLITUS; DRUG EFFICACY; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG INDUCED CANCER; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; DRUG USE; DYSPNEA; EPISTAXIS; ERECTILE DYSFUNCTION; FACE EDEMA; FALLING; FEMALE; FLUSHING; GENERAL PRACTICE; GENERAL PRACTITIONER; GLOSSITIS; HEART INFARCTION; HEART PALPITATION; HUMAN; HYPERGLYCEMIA; HYPERHIDROSIS; HYPOTENSION; INJURY; ISCHEMIC HEART DISEASE; LOWER RESPIRATORY TRACT INFECTION; LUNG CARCINOMA; MAJOR CLINICAL STUDY; MALAISE; MALE; MOUTH PAIN; MYALGIA; NAUSEA; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PARESTHESIA; PATIENT SAFETY; PHARYNGITIS; PREMATURE EJACULATION; PRESCRIPTION; PRIORITY JOURNAL; QUESTIONNAIRE; SIDE EFFECT; SYNCOPE; THORAX PAIN; UNITED KINGDOM; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URETHRITIS; VERTIGO; VOMITING; WHEEZING; XEROSTOMIA;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; APOMORPHINE; COHORT STUDIES; DOPAMINE AGONISTS; ENGLAND; FAMILY PRACTICE; HUMANS; IMPOTENCE; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 33745112680     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2006.06253.x     Document Type: Article

References (21)

1. Fazio L Brock G. Erectile dysfunction: management update. CMAJ 2004 170: 1429 37
2. Korenman SG. Epidemiology of erectile dysfunction. Endocrine 2004 23: 87 91
3. Fine SR. Erectile dysfunction and comorbid diseases, androgen deficiency, and diminished libido in men. J Am Osteopath Assoc 2004 104 ( Suppl. 1 S9 15
4. Seftel AD Sun P Swindle R. The prevalence of hypertension, hyperlipidemia, diabetes mellitus and depression in men with erectile dysfunction. J Urol 2004 171: 2341 5
5. El-Sakka AI Morsy AM Fagih BI Nassar AH. Coronary artery risk factors in patients with erectile dysfunction. J Urol 2004 172: 251 4
6. Kloner RA Speakman M. Erectile dysfunction and atherosclerosis. Curr Atheroscler Rep 2002 4: 397 401
7. Jackson G. Sexual dysfunction and diabetes. Int J Clin Pract 2004 58: 358 62
8. No Authors listed. New oral drugs for erectile dysfunction. Drug Ther Bull 2004 42: 49 52
9. Giuliano F Allard J. Apomorphine SL (Uprima®): preclinical and clinical experiences learned from the first central nervous system-acting ED drug. Int J Impot Res 2002 14 ( Suppl. 1 S53 6
10. Abbott Laboratories Ltd. UK summary of product characteristics: Uprima®. September 2004
11. Altwein JE Keuler FU. Oral treatment of erectile dysfunction with apomorphine SL. Urol Int 2001 67: 257 63
12. Mulhall JP Bukofzer S Edmonds AL George M Apomorphine SL Study Group. An open-label, uncontrolled dose-optimization study of sublingual apomorphine in erectile dysfunction. Clin Ther 2001 23: 1260 71
13. Montorsi F. Tolerability and safety of apomorphine SL (IxenseTM). Int J Impot Res 2003 15 ( Suppl. 2 S7 9
14. Von Keitz AT Stroberg P Bukofzer S Mallard N Hibberd M. A European multicentre study to evaluate the tolerability of apomorphine sublingual administered in a forced dose-escalation regimen in patients with erectile dysfunction. BJU Int 2002 89: 409 15
15. Heaton JP. Key issues from the clinical trials of apomorphine SL. World J Urol 2001 19: 25 31
16. Shakir S. Prescription-event monitoring. In Mann RD Andrews E, Pharmacovigilance. Chichester: John Wiley & Sons Ltd, UK, 2002: 333 44
17. Strom BL. Sample size considerations for pharmacoepidemiology studies. In Strom B, Pharmacoepidemiology, 2nd edn. Chichester: John Wiley & Sons Ltd, 1994: 29 38
18. Machin D Campbell MJ Fayers PM et al. Sample Size Tables for Clinical Studies. Oxford: Blackwell Science Ltd, 1997: 143 50
19. CIOMS/WHO. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva WHO, 2002
20. Royal College of Physicians. Guidelines on the practice of Ethics Committees in Medical Research involving Human Subjects. Third Edition. Report of the College Committee on Ethical Issues in Medicine. London: RCP, 1996
21. Multi-Centre Research Ethics Committees Guidance Notes. Examples of enquiries and surveys in the public interest where no reference to a research ethics committee is necessary. Appendix C, 2000. http://www.corec.org.uk/recs/ guidance/guidance.htm. Accessed February 2006