PMID- 19592078
OWN - NLM
STAT- MEDLINE
DCOM- 20091023
LR  - 20181201
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 74
IP  - 4
DP  - 2009 Oct
TI  - Oral sildenafil citrate (viagra) for erectile dysfunction: a systematic review 
      and meta-analysis of harms.
PG  - 831-836.e8
LID - 10.1016/j.urology.2009.04.026 [doi]
AB  - OBJECTIVES: To summarize and compare evidence on harms in sildenafil- and 
      placebo-treated men with erectile dysfunction (ED) in a systematic review and 
      meta-analysis. METHODS: Randomized placebo-controlled trials (RCTs) were 
      identified using an electronic search in MEDLINE, EMBASE, PsycINFO, SCOPUS, and 
      Cochrane CENTRAL. The rates of any adverse events (AEs), most commonly reported 
      AEs, withdrawals because of adverse events, and serious adverse events were 
      ascertained and compared between sildenafil and placebo groups. The results of 
      men with ED were stratified by clinical condition(s). Statistical heterogeneity 
      was explored. Meta-analyses based on random-effects model were also performed. 
      RESULTS: A total of 49 RCTs were included. Sildenafil-treated men had a higher 
      risk for all-cause AEs (RR = 1.56, 95% CI: 1.38, 1.76), headache, flushing, 
      dyspepsia, and visual disturbances compared with placebo-treated men. The 
      magnitude of excess risk was greater in fixed- than in flexible-dose trials. The 
      rates of serious adverse events and withdrawals because of adverse events did not 
      differ in sildenafil vs placebo groups. A higher dose of sildenafil corresponded 
      to a greater risk of AEs. The increased risk of harms was observed within and 
      across clinically defined specific groups of patients. CONCLUSIONS: There was a 
      lack of RCTs reporting long-term (>6 months) harms data. In short-term trials, 
      men with ED randomized to sildenafil had an increased risk of all-cause any AEs, 
      headache, flushing, dyspepsia, and visual disturbances. The exploration of 
      different modes of dose optimization of sildenafil may be warranted.
FAU - Tsertsvadze, Alexander
AU  - Tsertsvadze A
AD  - Clinical Epidemiology Program, Ottawa Health Research Institute, Box 208, 501 
      Smyth Rd, Ottawa K1H 8L6, Ontario, Canada. atsertsvadze@ohri.ca
FAU - Yazdi, Fatemeh
AU  - Yazdi F
FAU - Fink, Howard A
AU  - Fink HA
FAU - MacDonald, Roderick
AU  - MacDonald R
FAU - Wilt, Timothy J
AU  - Wilt TJ
FAU - Bella, Anthony J
AU  - Bella AJ
FAU - Ansari, Mohammed T
AU  - Ansari MT
FAU - Garritty, Chantelle
AU  - Garritty C
FAU - Soares-Weiser, Karla
AU  - Soares-Weiser K
FAU - Daniel, Raymond
AU  - Daniel R
FAU - Sampson, Margaret
AU  - Sampson M
FAU - Moher, David
AU  - Moher D
LA  - eng
GR  - R01DK063300-01A2/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20090709
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
RN  - 0 (Phosphodiesterase Inhibitors)
RN  - 0 (Piperazines)
RN  - 0 (Purines)
RN  - 0 (Sulfones)
RN  - BW9B0ZE037 (Sildenafil Citrate)
SB  - IM
MH  - Administration, Oral
MH  - Clinical Trials as Topic
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Male
MH  - Phosphodiesterase Inhibitors/*administration & dosage/adverse effects
MH  - Piperazines/*administration & dosage/adverse effects
MH  - Purines/administration & dosage/adverse effects
MH  - Sildenafil Citrate
MH  - Sulfones/*administration & dosage/adverse effects
RF  - 67
EDAT- 2009/07/14 09:00
MHDA- 2009/10/24 06:00
CRDT- 2009/07/14 09:00
PHST- 2009/02/13 00:00 [received]
PHST- 2009/03/26 00:00 [revised]
PHST- 2009/04/05 00:00 [accepted]
PHST- 2009/07/14 09:00 [entrez]
PHST- 2009/07/14 09:00 [pubmed]
PHST- 2009/10/24 06:00 [medline]
AID - S0090-4295(09)00523-8 [pii]
AID - 10.1016/j.urology.2009.04.026 [doi]
PST - ppublish
SO  - Urology. 2009 Oct;74(4):831-836.e8. doi: 10.1016/j.urology.2009.04.026. Epub 2009 
      Jul 9.