Locally-tested drugs to hit market this month
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MULTAQ
A decrease in the risk of cardiovascular death by 29 percent in patients with Atrial Fibrillation.
Reduced the risk of an arhythmic death by 45 percent.
EFFIENT
A decrease in the risk of a cardiovascular death, myocardial infarction ...
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MULTAQ
A decrease in the risk of cardiovascular death by 29 percent in patients with Atrial Fibrillation.
Reduced the risk of an arhythmic death by 45 percent.
EFFIENT
A decrease in the risk of a cardiovascular death, myocardial infarction and stroke by 19 percent.
After Mabel Mazoch had a heart attack in December 1995, she decided she wanted to help others.
She agreed to participate in a clinical drug trial for a new blood thinner.
"It was very interesting, that's all I can say," said the 71-year-old Yorktown native. "It was very simple, not at all difficult."
Two new heart-related drugs that have been part of local clinical tests have been approved by the Food and Drug Administration and will be on the pharmaceutical market this month.
The Victoria Heart and Vascular Center was among many places across the world to hold clinical trials for Prasrugel, an anti-platelet drug and Dronedarone, an anti-fibrillation drug, said Dr. Harish Chandna, a local interventional cardiologist.
Prasugrel, which will be marketed as Effient, serves as a successor to Plavix, a drug which is also blood thinner, Chandna said.
The newer drug, which was approved by the FDA in February, proves stronger in its prevention but does have an increased chance of bleeding and can interact with ulcer medication like Nexium, he said.
The anti-heart flutter medication Dronedarone, will be marketed as Multaq and was approved in July and will be the first drug on the market in the past 36 years for anti-fibrillation, he said.
Side effects of the new drug could include lung, eye and thyroid toxicity, he said.
Mazoch was on the trial for Effient for 18 months. She has never known whether she was on Plavix or Prasugrel.
"I just wanted to help other people," she said. "I've lived a very good life and I'm very conscientious about medicine."
The only effect Mazoch had with the pill was that she had thinned blood.
Mazoch would stop the pill days before any type of dental work, she said.
"I feel like I have accomplished something for the future," she said
Chandna and his office has held numerous clinical trials in the past 10 years.
The experience of helping approve a drug is the first for the Victoria site.
"It gives you more professional satisfaction and keeps you up-to-date," Chandna said.
Chandna and his team of cardiologists have already attended training seminars and sessions for both drugs.
"You get to meet with other doctors and interact and get their experiences," said Chandna, who got back in late July from the Multaq seminar.
The site is blinded from whether the patient took the new or older drug, Dolores Holly, Chandna's research coordinator said.
Henry Estrada also participated in the clinical trial for Multaq about a year and a half ago.
"My heartbeat was at a high rate," said the 56-year-old Victoria native. "Normally it is in the low 40s and it was in the 70s."
The trial worked well for Estrada, he said.
"They would see me about once a month and I had blood work done," he said. "After six months they would check me every two months."
In May 2008, Estrada had to get off the pill because of an operation. His heart rhythm was at a high level again at his final visit.
Estrada hopes to be back on Multaq once the pill hits the market.
"Right now he took me off of some medicines and he's going to see if the heart rhythm stays the same," Estrada said about his doctor. "If it goes up, he will have to put me back on it."
The large number of diabetics in South Texas and the large demographic of people over 50 in Victoria, make the city a good place to study and perform medical studies, Chandna said.
"It's a small city with big possibilities," Chandna said.
