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001-es BibID:BIBFORM027664
Első szerző:Poole-Wilson, Philip A.
Cím:Safety of Nifedipine GITS in Stable Angina : the ACTION Trial / Poole-Wilson Philip A., Kirwan Bridget-Anne, Vokó Zoltán, de Brouwer Sophie, van Dalen Fred J., Lubsen Jacobus
Dátum:2006
ISSN:0920-3206
Megjegyzések:We describe the safety profile of nifedipine GITS as assessed from adverse events reported in the ACTION trial in which 7,665 patients with stable, symptomatic coronary artery disease were randomly assigned nifedipine GITS or placebo and followed for a mean of 4.9 years. METHODS: All adverse events were coded using the COSTART coding dictionary. The incidence rate for each event was calculated as the number of patients with the event concerned divided by the total time 'at risk'. Hazard ratios comparing nifedipine with placebo and their 95% confidence intervals were obtained by Cox proportional-hazards analysis. RESULTS: As reported previously, nifedipine significantly reduced the incidence of cardiovascular events and procedures [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.83-0.95]. Apart from the known side effects of nifedipine, which include peripheral oedema, vasodilatation, hypotension, asthenia, constipation, leg cramps, non-specific respiratory complaints, impotence and polyuria, and which were reported more frequently in patients assigned nifedipine, the incidence rates of most other adverse events were similar. There were no differences in the occurrence of gastrointestinal haemorrhage, myocardial infarction and suicide. The rate of occurrence of death or new cancer excluding non-melanoma skin cancer for patients with no history of cancer at baseline was 2.53/100 patient years for patients assigned nifedipine and 2.37/100 patient years for patients assigned placebo (HR 1.06, 95% CI 0.93-1.22). CONCLUSION: Overall nifedipine GITS was well tolerated by patients with stable symptomatic angina.
Tárgyszavak:Orvostudományok Egészségtudományok idegen nyelvű folyóiratközlemény külföldi lapban
randomised controlled trial
angina pectoris
nifedipine GITS
adverse events
Megjelenés:Cardiovascular Drugs And Therapy. - 20 : 1 (2006), p. 45-54. -
További szerzők:Kirwan, Bridget-Anne Vokó Zoltán (1968-) (epidemiológus) de Brouwer, Sophie Dalen, Frederik J., van Lubsen, Jacobus
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001-es BibID:BIBFORM003600
Első szerző:Poole-Wilson, Philip A.
Cím:Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data / Poole-Wilson P. A., Kirwan B. A., Vokó Z., de Brouwer S., Dunselman P. H., van Dalen F.J., Lubsen J., ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators
Dátum:2007
Tárgyszavak:Orvostudományok Egészségtudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Journal of clinical epidemiology. - 60 : 7 (2007), p. 727-733. -
További szerzők:Kirwan, Bridget-Anne Vokó Zoltán (1968-) (epidemiológus) de Brouwer, Sophie Dunselman, Peter H.J.M. Dalen, Frederik J., van Lubsen, Jacobus ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators
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DOI
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