Conference on Functional Genomics and Disease
The 3rd Conference on Functional Genomics and Disease will be held in Innsbruck, Austria next autumn. On 1 to 4 October 2008, over 50 speakers will present papers and conduct workshops on the topics ranging from molecular biology to epigenetics to personalized medicine. Of particular interest are the cutting-edge applications of genomics and proteomics in the field of cancer research (oncogenomics), neurology (neurogenomics), and vascular medicine (angiogenomics). Other topics of medical significance are lipidogenomics, inflammatory diseases and ageing. The conference is sponsored by the European Science Foundation. The first two conferences were held in Prague in 2003 and Oslo in 2005.
More details are to be found at:
Avandia Remains on Market but with Additional Warning
The US FDA has recommended that Avandia (rosiglitazone) be allowed to remain on market. However, additional warning has been inserted in the existing boxed warning in the product’s labeling. The new warning highlights the potential increased risk for cardiovascular events, especially myocardial infarction [1].
Avandia, manufactured by GlaxoSmithKline (GSK), was approved for marketing in 1999 in the US as oral treatment for type-2 diabetes mellitus. It has the advantage that it can be used as a stand-alone therapy or as co-therapy with other oral anti-diabetes treatments.
An article in NEJM early this year reported a meta-analysis of 42 randomized controlled clinical trials on rosaglitazone. The results show that “rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance.” [2]
The FDA has requested GSK to conduct a new long-term postmarketing study to evaluate the potential cardiovascular risk of Avandia and the manufacturer agreed to comply [1]. The study is expected to be concluded by 2014.
Sources:
Baby’s First Solid Food: Later is Not Necessarily Better
More and more mothers are putting off the introduction of first solid food to infants out of fear of food allergies and celiac disease. Two recent reports indicate that this delay is actually unwarranted and can lead to health problems. In a recent review, Guandalini reports that not only early but also “late (7 months or after) first explosure to gluten may favor the onset of celiac disease in predisposed individuals” [1]. Too early and too late gluten introduction can also result “in a significantly higher risk of the appearance of islet cell immunity,” a condition that can lead to type-1 diabetes.
In another study, German researchers did not find any association between the time of solid food introduction, the type of food, and the incidence of eczema in a cohort of 4753 infants. The results of the study indicate that „neither a delayed introduction of solids beyond the fourth month nor a delayed introduction of the most potentially allergenic solids beyond the sixth month of life“ can prevent eczema in infants [2].
Based on recent evidence, introduction of solid foods to babies should occur between 4 and 6 months and only as complementary food to breast milk. Breasfeeding during the introduction of gluten can delay the onset of celiac disease [1].
Sources:
[1] Issues in Complementary Feeding (2007). Nestle Nutr Workshop Ser Pediatr Program 60: 139-155.
[2] Journal of Pediatrics 151:352-358 (October 2007)
Limits on MRI Use in the EU postponed
The EU decided to postpone introducing a law regulating workers’ exposure to electromagnetic fields [1]. The decision is based on the fact that such as legislation would place serious limits on the use of magnetic resonance imaging (MRIs).
Directive 2004/40/EC was aimed to protect workers against the occupational hazard of electromagnetic field exposure and was to take effect in April 2008 [2]. However, the high occupational limit values set by the directive would inadvertently put a ban on the use of MRI in diagnostic medicine.
“MRI is currently the leading technique for detecting brain tumours and many other serious conditions. It allows doctors to help 8 million patients each year…[the EC] is well aware of the enormous benefits of MRI and of its immense value for public health.” [1]
Other international agencies such as the International Commission on Non-Ionising Radiation Protection (ICNIRP) and the World Health Organisation (WHO) are looking into revising the current occupational limit values for electromagnetic fields [1]. The EU will probably introduce a revised directive based on similar limits in 2012.
In the meantime, the EU is pushing for more research in this field. It is funding projects under the 7th Framework Programme for Research to explore hybrid imaging systems such as MRI/PET and MRI/Ultrasound [1].
Sources:
[1] EU Press Release 26/10/2007. Commission to postpone and amend electromagnetic fields legislation to protect MRI Reference: IP/07/1610.
[2] Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004. Official Journal of the European Union L 159.
A Promising Vaccine against Hypertension: Results from a Phase II Trial
An investigational vaccine against angiotensin II being tested by Cytos Biotechnology is showing promise. Results from an exploratory Phase IIa trial were presented at the American Heart Association Scientific Sessions 2007 [1] this month. CYT006-AngQb is a virus-like particle-based conjugate vaccine and is indicated for patients with mild to moderate hypertension. Preliminary results show “a significant reduction of daytime ambulatory blood pressure (BP) and a marked reduction in the early morning hours, when most adverse cardiovascular events occur.” [2]
Currently available antihypertensive drugs have a short half-life and must be taken on a daily basis. CYT006-AngQb has the advantage of producing extended antibody response with a half-life of about 4 months [2, 3].
In addition to a good efficacy profile, CYT006-AngQb was reported to be well-tolerated. The most common adverse events reported were pain, erythema, or edema at the injection site, and headache. All events were transient and no drug-related adverse events were reported during the 12-month follow-up period [3].
If approved, the vaccine would be a major breakthrough in the long-term management of hypertension.
Sources:
2 Medscape
GRACE: Combating Antimicrobial Resistance
The use of antibiotics “are not justified to reduce the risk of serious complications for upper RTI, sore throat, or otitis media.” This was one of the main conclusions of a retrospective cohort study in the UK as reported recently in BMJ. The study looked into more than 3 million cases of RTI found in the UK General Practice Research Database [1].
There have always been concerns about the indiscriminate use of antibiotics, especially as preemptive measure to reduce complications of upper RTI. The emergence of multidrug-resistant bacterial strains indicates that these concerns are justified.
In Europe, a one of a kind consortium is tackling the problem of antimicrobial resistance in community-acquired lower RTI. The Network of Excellence GRACE consists of “17 academic groups with a wide spectrum of expertise, spread widely across the EU Member States.” Among these are two leading European scientific societies, the European Society of Clinical Microbiology and Infectious Diseases and European Respiratory Society. GRACE integrates clinical research with genomics as well as education and training of medical professionals [2].
Abbreviations:
GRACE = Genomics to Combat Resistance against Antibiotics in Community-acquired lower respiratory tract infection in
Europe
RTI = respiratory tract infection
Sources:
Safety issues with prasugrel: the latest from TRITON-TIMI 38
TRITON-TIMI 38 is one of the biggest phase III clinical trials on prasugrel, a new thienopyridine from Lilly/Daiichi Sankyo. The trial was designed as multicenter, randomized, double-blind, and parallel-group. Over 13000 patients from different countries were enrolled based on the main inclusion criterion of having moderate- to high-risk ACS and undergoing PCI. Of these, about 73% had unstable angina/non-ST-segment elevation MI and 37% ST-segment elevation MI [1, 2].
The participants were randomized to either prasugrel or the comparator clopidogrel. Clopidogrel combined with aspirin is the first line antiplatelet therapy for the prevention of thrombotic complications of PCI. Prasugrel is said to be less variable and achieves a higher level of platelet inhibition than the comparator. The primary end point of the trial is the time of the first event of cardiovascular death, MI, or stroke [1, 2].
The latest results from the trial as reported in the latest issue of NEJM [3] show good efficacy profile but fall short in terms of safety. Prasugrel significantly reduced cardiovascular events compared to clopidogrel. However, the incidence of bleeding in prasugrel patients was significantly higher. The risk of bleeding is especially elevated in patients who have had CABG or cerebrovascular problems [3]. Safety concerns in terms of bleeding were actually reported already last year at the World Congress of Cardiology in Barcelona, Spain [4].
Abbreviations:
TRITON_TIMI 38: TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38.
ACS: acute coronray syndrome
PCI: percutaneous coronary intervention
MI: myocardial infarction
CABG: coronary artery bypass graft
Sources:
- TIMI homepage
- American Heart Journal 152(4):627-635, October 2006
- NEJM 357:2001-2015 November 2007.
- Heartwire 21 September 2006