Thursday 29 January 2009

‘JUPITER’ and the risk of heart disease

Statins are blockbuster drugs taken by millions around the world. Results from the ‘JUPITER’ clinical trial[1] indicate that these cholesterol-lowering agents could decrease the risk of heart disease even for persons with low cholesterol levels; meaning that millions more could benefit from popping a statin pill…

But could they really? What indicators and risk factors dictate the prescription of statins? How should vascular risk be measured? And what are the factors that count towards this risk? An Editorial in the January 2009 issue of CMRO discusses the JUPITER study and explores these interesting themes.

The trial suggests that hsCRP, a protein associated with inflammation, can be used to identify subjects without vascular disease who should receive statins despite a low or intermediate calculated risk. The CMRO editorial highlights the fact that risk assessment needs to be re-examined, and discusses the role of hsCRP-testing in what the authors call risk stratification. The authors also feel that guidelines (and clinical practice) may need changing if indeed statins do have a much wider role in preventing vascular disease than was previously thought.

Of course, if relatively healthy persons (‘low or intermediate risk’) are to be prescribed statins, then there are terrific cost implications too. The authors of the editorial remark that this is all the more so if the benefits observed from taking Crestor (used in the JUPITER trial) can not be reproduced by cheaper, generic statins.

At the heart of the ongoing scientific debate, the fundamental question remains: do statins have a convincing role in primary prevention of heart disease? Read the editorial (an open access article) here find out what the authors think.

[1] JUPITER: Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin

Wednesday 7 January 2009

Impact of predictive pharmacokinetics

The implementation of studies aiming at predicting ADME properties at preclinical drug discovery stages has been central in the effort to reduce attrition rates.
In a clear and authoritative article reviewing the development, over the past three decades, of Discovery Metabolism and Pharmacokinetics research, Dr Summerfield analyses the key elements which moved the field forward and anticipates how new paradigms, such as translational medicine and systems thinking, will push it further.
He concludes that, although the predictive metabolism and pharmacokinetics approach already proved successful, a strong impact on drug pipelines will only be achieved when pharmacodynamics and toxicology are integrated in a similar way to drug discovery programmes.
The article will be available in the March issue of Expert Opinion on Drug Discovery