Prognostic Factors for Patients with Congestive Heart Failure – An Extended Evaluation of the SPICE-Study.
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Date
2013-10
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Abstract
Aims: Controlled clinical trials collect huge amounts of high quality data. It is a waste of
information to evaluate these data only for the efficacy and safety of the investigational
medication. We propose extended evaluations of large trials for scientific purposes,
especially to find the most important risk factors of the disease or variables which are
associated with risk to have the disease.
Methodology: The SPICE study is a controlled, randomised, completely masked trial
that has investigated the efficacy of the Crataegus product WSÒ 1442 in 2681
randomised patients with congestive heart failure (CHF). It was initiated and sponsored
by Dr. Willmar Schwabe Pharmaceuticals. Results have already been published. We
asked the sponsor to send us the data for an extended evaluation which was performed
with a multivariate Cox regression model to find risk factors for the composite endpoint
cardiac death, non-fatal myocardial infarction or hospitalisation due to progressive heart failure.
Results: Most important risk factors are lower New York Heart Association (NYHA)
function class, younger age and higher left ventricular ejection fraction. Patients had less
cardiac events when taking glycosides, antiarrhythmics, nitrates, diuretics, beta blockers
and calcium antagonists, so patients with a high number of cardiovascular medication
have a poorer prognosis. Three scenarios for the interpretation of cardioactive
medications as “risk” are presented. We assume that symptoms leading to the indication
of a specific cardioactive medication are the risk. This risk is only partly balanced by
medication intake. In general, the intake of cardioactive medication is associated with the
risk to have the disease.
Conclusion: An extended evaluation of large clinical studies finds out what is important
for the outcome besides specific efficacy of the investigational drug. This is usually not
the scope of pharmaceutical companies, but useful for science, doctors and patients.
Description
Keywords
Congestive heart failure, Prognostic factors, cox regression model, crataegus extract
Citation
Mayer Benjamin, Holubarsch Christian, Muche Rainer, Gaus Wilhelm. Prognostic Factors for Patients with Congestive Heart Failure – An Extended Evaluation of the SPICE-Study. British Journal of Medicine and Medical Research. 2013 Oct-Dec; 3(4): 1952-1964.