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`US study results on Gugulipid premature'

Vinson Kurian

Thiruvananthapuram , Aug. 23

SABINSA Corporation, the US-based sister concern of Sami Labs of Bangalore, has questioned what it described as the lack of balance in a Journal of the American Medical Association (JAMA) report giving results of research on the potential cardiovascular benefits of the company's branded gum guggal extract, Gugulipid.

Business Line had last week carried extracts of the JAMA study results, which, according to Dr Muhammed Majeed, founder and Chief Executive Officer of Sabinsa Corporation, "are an incomplete representation of the overall safety and efficacy of documented data". The JAMA study was co-funded by Sabinsa Corporation, which holds the IND (investigational new drug) licence No. 59, 712 relating to Gugulipid.

"This is an eight-week safety and preliminary efficacy study done for the first time with Gugulipid on the American population that we thought was of primary importance. Work on the same IND is continuing at Our Lady of Mercy Medical Centre, Bronx, New York, for a three-month duration to further evaluate efficacy," Dr Majeed said in a detailed communication.

Eight weeks is too short a period for some of Gugulipid's pharmacological effects to reveal themselves.

In general, all studies on products like this need to be done for three months or more. "We will continue our efforts in clinical documentation of this product as an efficacious cholesterol management nutraceutical," Dr Majeed said.

In 2002, Sabinsa obtained US Patent No. 6,436,991 for Gugulipid, which works towards the nutritional/nutraceutical improvement of cardiovascular disease.

The company has initiated a second IND study involving Gugulipid in the US, scheduled to begin in the fall of 2003.

According to Dr Vladimir Badmaev, Vice-President of Medical and Scientific Affairs, Sabinsa, cardiovascular disease is currently seen as a process where multiple lipid fractions, not just LDL, play an important role.

In fact, there are known cholesterol-lowering drugs which actually increase LDL, while lowering other important lipids, such as triglycerides.

The most recent considerations in therapy of high cholesterol include indices of inflammation, e.g. C-reactive protein, as well as levels of uric acid and lipoprotein (a).

The modern history of gum guggal started in the 1960s when the gum began to be systematically studied for its potential in the treatment of elevated blood cholesterol.

The safety profile, pre-clinical and clinical trials were done in the country during the 1980s at the Central Drug Research Institute (CDRI), Lucknow. There are nine published human clinical trials evaluating the hypolipidemic effect of guggal extracts.

However, only five studies used a standardised guggal extract, out of which only two were randomised and only one was placebo-controlled.

According to Dr Badmaev, the JAMA study did reaffirm the long history of safe use of Gugulipid.

Side-effects communicated to the Federal Drug Administration, in compliance with the IND study protocol, were in keeping with what has been previously documented — slight skin rash in a low number of participants.

Sabinsa is undertaking further clinical study evaluating fractions of Gugulipid to identify the potential skin sensitising components, the only side-effect reported.

According to Dr Majeed, the task of improving a worthy and safe nutraceutical such as Gugulipid was tedious, but ultimately rewarding.

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