European Medicines Agency Welcomes Continuation Of D:A:D Study

February 4, 2009 at 2:00 pm Leave a comment

The European Medicines Agency (EMEA) has welcomed the commitment of the
sponsors to continue the D:A:D study at least until 2012. This ensures
that the study, which was started on the initiative of the EMEA in 1999,
will remain one of the most powerful pharmacovigilance tools to monitor
the long-term safety of antiretroviral medicines.

D:A:D (Data Collection on Adverse Events of Anti-HIV Drugs) is a
prospective study based on multinational cohort collaboration, which
includes data from 33,308 patients in 11 ongoing HIV cohorts in Europe,
Australia and the United States of America.

The D:A:D study was started in response to a request from the EMEA to
all marketing authorisation holders of antiretroviral medicines. It set
out to conduct a collaborative review of the cardiovascular safety and
metabolic and body composition changes possibly associated with HIV
treatment. The scope of the study was extended in 2005 to also
investigate liver-related safety.

Although marketing authorisation holders of antiretroviral medicines
contribute to the funding of the study, it is run in scientific
independence. This is ensured by an independent scientific steering
committee, which takes all scientific and procedural decisions, and by
the so-called HAART Oversight Committee, which administers funds for
studies, follows their progress and ensures their completion and reports
regularly to the EMEA. The Oversight Committee includes also
representatives of academia, patient organisations, the EMEA and the USA
Food and Drug Administration (FDA).

Due to its large size and long follow-up, the D:A:D study has had a
pioneering role in drug safety, helping to address existing and new
emerging safety concerns, as well as to learn more about HIV infection
itself. This is likely to serve as a model for future collaborative
observational studies that will analyse the safety of whole therapeutic
classes of medicines.

During the January 2009 meeting of the EMEA’s Committee for Medicinal
Products for Human Use (CHMP) representatives of the HAART Oversight
Committee and the steering committee presented the achievements made
over the last ten years and the plans for the study’s continuation.

The study now monitors all authorised antiretroviral medicines. In
addition, the marketing authorisation holders for any new antiretroviral
medicines authorised in the future will be required to take part in the

D:A:D will continue to explore cardiovascular and liver-related safety.
An association between antiretroviral combination therapy and myocardial
infarction was identified in 2003. Further follow-up established that
this was mainly explained by cumulative exposure to protease inhibitors.
More recently an association with the recent use of abacavir and
didanosine was found and is being further investigated.

The study will also be expanded to consider whether antiretroviral
medicines affect the risk of contracting non-AIDS defining cancers and
endstage kidney disease, as well as to examine patterns of causes of
death over time and laboratory markers of liver and kidney function.

The results from the first ten years of the study have shown that the
benefit-risk balance of antiretroviral medicines remains strongly
positive and that the overall mortality of HIV-infected patients has
dramatically declined since the introduction of highly active
antiretroviral therapy (HAART).


1. More information about the D:A:D study is available at:

2. The EMEA published statements on results from the D:A:D study in
April 2003
August 2005.

3. In 2008, the EMEA issued a press release on abacavir and a
potential increase in the risk of heart disease as a follow-up to a
signal detected in the D:A:D study. The press release is available here.

4. This press release, together with other information on the work
of the EMEA, can be found on the EMEA website:




Entry filed under: Uncategorized.

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