Should patients be given an initial low test dose of sildenafil?

Authors
Citation
Js. Cohen, Should patients be given an initial low test dose of sildenafil?, DRUG SAFETY, 23(1), 2000, pp. 1-9
Citations number
41
Categorie Soggetti
Pharmacology
Journal title
DRUG SAFETY
ISSN journal
01145916 → ACNP
Volume
23
Issue
1
Year of publication
2000
Pages
1 - 9
Database
ISI
SICI code
0114-5916(200007)23:1<1:SPBGAI>2.0.ZU;2-F
Abstract
Sildenafil is highly effective for treating erectile dysfunction (ED). Howe ver, its use has been associated with serious adverse events including myoc ardial infarctions and strokes, and 130 verifiable plus 112 unverified deat hs reported to the US Food and Drug Administration during the 8 months afte r sildenafil was introduced in the US, and 522 reported deaths during the 1 3.5 months after its introduction. Moreover, some events have occurred in m en taking their first dose of the agent, suggesting that sildenafil, like s ome drugs that affect blood pressure, may provoke a first-dose reaction. Th is possibility warrants extra caution to be used when initiating treatment with sildenafil. Such caution is not currently provided by the current dosa ge guidelines that, for example, recommend the use of sildenafil 50mg initi ally for most men between the ages of 18 and 65 years, despite wide differe nces in bodyweight, age, drug metabolism, health status and usage of other medications. It can be difficult to identify the patient who may be unusually sensitive to the effects of sildenafil. Exercise stress tests have been recommended, but serious adverse events have occurred in men with normal stress tests fo llowing the ingestion of sildenafil. Blood pressure monitoring following si ldenafil administration will not prevent a serious adverse drug event alrea dy in progress. This article discusses the advantages and disadvantages of initiating treatment with a low test dose of sildenafil, performed at home or in the doctor's office. The advantages of this approach include: (i) ide ntifying patients who are highly sensitive to the effects of sildenafil and who may need no higher dose; (ii) minimising adverse effects such as flush ing and dizziness that often frighten patients and may affect adherence; (i ii) avoidance of major adverse events; and (iv) reassuring patients with ED who remain wary about trying sildenafil therapy.