Business Daily (Nairobi)
Mwaura Kimani
6 April 2008
Pharmaceutical giant GlaxoSmithKline has moved to allay fears that a drug many HIV patients use may also raise the risk of heart attacks over time, as suggested by a group of European researchers.
Researchers from the University of Copenhagen in Denmark said last week two well-known HIV drugs - abacavir which is manufactured by GSK and didanosine sold by Bristol-Myers Squibb - appeared to increase the risk of heart attacks.
GSK officials in Kenya said although the drug is hardly used in the country - as it is on the second line therapy - the concerns were being seriously considered.
"There is no cause to worry. GSK is committed to understanding this data more fully," said Dr William Mwatu, GSK's medical and regulatory affairs director in East Africa.
According to Dr Mwatu, the company sells an estimated 24,000 doses of the drugs in Kenya annually.
However, it has been tough for scientists to pinpoint the source of the excess cardiovascular risk noted in HIV patients.
"Physicians must take into consideration the risk factors of the patients before administering treatment because factors such as lifestyle could also come to play in accelerating heart attacks," said Dr Mwatu. Researchers, however, stressed that the danger is minimal compared to the life-extending effects of these medications, called protease inhibitors.
Based on that data, the European Medicines Agency and US Food and Drug Administration are now conducting a safety review of the potential risks of both drugs.
But GSK said its research on the same showed no link of the drug to cases of heart attack.
"We did not find a result consistent with that of the study," said GSK spokesman, Dr Didier Lapierre in a statement on GSK's website.
The controversy over the findings could throw a spanner into the works in the fight against HIV/Aids, especially in the Sub-Saharan Africa where the scourge has taken a heavy toll.
Abacavir is sold by GSK under the brand name Ziagen, which had global sales of $218 million (Sh13.7 billion) in 2007.
The drug is also a component of the firm's Trizivir, Epzicom and Kivexa Aids drugs, which had more than $1 billion (Sh62 billion) in combined 2007 sales.
Didanosine is manufactured by Bristol-Myers Squibb.
The concern arises from the study of more than 33,000 patients that found those taking medicines containing the active ingredient Abacavir had a greater chance of developing a heart attack.
Many people with HIV take a combination of antiretroviral drugs, which include a protease inhibitor and a nucleoside reverse transcriptase inhibitor such as abacavir or didanosine.
Concerns have been raised about the cardiovascular effects of long-term use of these drugs.
"We have investigated a number of drugs used to treat HIV patients for whether they are associated with an altered risk of having a heart attack," said lead researcher Dr Jens Lundgren in the study findings, published in the New England Journal of Medicine and in the online edition of The Lancet, the world's leading independent general medical journal.
"We have identified [that] two of those drugs were indeed associated with an increased risk of a heart attack."
A related study published last week in the Journal of Clinical Endocrinology and Metabolism by a team at Harvard Medical School, found that HIV infection- and possibly, treatment - boosted rates for heart attack nearly twofold.
Experts first noticed arise in heart trouble among HIV-infected people in the 1980s and early 1990s, before the advent of life-extending "highly active antiretroviral therapy" (HAART).
That suggested that HIV infection, on its own, might boost cardiovascular risks.
However, according to the researchers, the actual risk of having a heart attack when using these drugs varies with whether a patient already has underlying risk for heart attack.
For example, a patient who is at risk for having a heart attack will increase his or her risk by 38 per cent by using either abacavir or didanosine, he said.
"However, if you have a very small underlying risk of heart attack, the risk will only be slightly increased," Lundgren said.
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