At any given time Dr. Mahesh Krishnan is overseeing nine to 10 clinical trials, evaluating various medications and treatments for everything from diabetes to anemia, so it was not unexpected for Krishnan to be tapped to take part in a clinic trial investigating a new medication for lowering high cholesterol. The study is focusing on South Asians, specifically those of India, Pakistan, Bangladesh, Sri Lanka, Nepal or Bhutan heritage.
"Fairfax County has a large South-Asian population," said Krishnan, of the Virginia Nephrology Group in Fairfax and Arlington and a physician with the Clinical Research and Consulting Center. "I did a similar trial three or four years ago in younger people."
Problem is, after three months, no one has volunteered for the trial study, dubbed IRIS, for Investigation of Rosuvastatin In South-Asian subjects.
"THE STUDY looks at a statin drug, specifically targeting the South Asian population because it is a high-risk population for heart disease as a result of high cholesterol," Krishnan said.
Information provided by the drug's maker, AstraZeneca, claims that heart disease is the leading cause of death for South Asians and that the prevalence of the disease is higher in this population compared to Asians and non-Hispanic whites. The study is being conducted in areas with large South-Asian populations including California, Florida, New York, New Jersey and Virginia. According to the 2000 Census, more than 36,000 people of South-Asian descent call Fairfax home.
"As a whole, the South-Asian community is often underrepresented in clinical trials. A trial such as IRIS is a first step in equipping physicians with the knowledge they need to provide this community with the best treatment options available," said Dr. Prakash Deedwania, the study's lead investigator and a professor of medicine at the University of California at San Francisco School of Medicine.
The study, slated to take 12 weeks, includes a cholesterol screening, diet counseling, medication, physicals and follow up care. Participants are not paid for their services, but can receive a small stipend for their time.
SO FAR Krishnan is not discouraged by the lack of volunteers.
"It can take a while to educate the people," Krishnan said. "For South Asians, it's a genetic disposition to heart disease. If you look at it in terms of population, we have two-thirds of our population at risk of heart disease."
Krishnan said the study is for men and women, however, the risk of heart disease is greater in males. The doctor also does not think cultural differences are playing a part in the lack of volunteers.
"I think people are hesitant, in general, about trials," Krishnan said. "Nowadays, the way research is conducted, it's very rigorously overseen and there are a number of checks and balances.
"In some cases, trials provide medicines when none are available."
The drug being tested, Crestor, has already gone through two phases of testing — for clinical effectiveness and safety. The clinical trial represents phase three, testing for correct dosages and possible side effects. Krishnan said the class of drugs Crestor belongs to has the potential for muscle cramps as a side effect, otherwise, he does not expect any problems for volunteers.
Crestor was first approved in the Netherlands in 2002 and has since been granted approval in 17 other countries. It is still awaiting approval from the United States Food and Drug Administration.