CardioExchange Archive

June 27th, 2011

Asprin Dosage in U.S. May Explain Disparity in Ticagrelor Results in PLATO

Larry Husten, PHD

Although the PLATO trial demonstrated the overall superiority of ticagrelor (Brilinta, AstraZeneca) to clopidogrel in more than 18,000 acute coronary syndrome patients worldwide, approval of the drug in the U.S. has been delayed because of ticagrelor’s lack of effect in the prespecified subgroup of patients from North America. Now, two analyses of the trial, presented […]

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January 3rd, 2011

PLATO CABG Substudy Raises Hope and Questions

Larry Husten, PHD

The much-anticipated CABG substudy from the PLATO (Platelet Inhibition and Patient Outcomes) trial comparing ticagrelor to clopidogrel in ACS patients has been published online in JACC. About 10% of the 18,624 patients enrolled in  PLATO underwent CABG. The substudy reports on the 1,261 who received the study drug within 7 days prior to their surgery. […]

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December 17th, 2010

FDA Delays Approval of Ticagrelor

Larry Husten, PHD

Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of data from the pivotal PLATO trial, but did not request any additional studies. AstraZeneca said it is evaluating the […]

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December 6th, 2010

Ticagrelor Gets European Approval

Larry Husten, PHD

Ticagrelor has received approval for marketing in Europe, according to AstraZeneca. The drug, which will go under the brand name of Brilique in Europe, will not be available in most European countries until the second half of 2011, the company said. A decision about the approval of ticagrelor in the U.S., where it will be […]

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September 15th, 2010

FDA: Ticagrelor Deadline Extended; No Clear Signal on Sibutramine

Larry Husten, PHD

FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the FDA […]

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August 29th, 2010

Genetic Substudies of Large Trials Question Value of Clopidogrel Genotyping

Larry Husten, PHD

Genetic substudies across a broad range of large clinical trials that used clopidogrel raise questions about the clinical utility of clopidogrel genotyping. The substudies come from large and important trials like PLATO, TRITON-TIMI 38, CURE, and ACTIVE A. A genetic substudy of PLATO finds that ticagrelor is superior to clopidogrel irrespective of genetic subtype. Therefore, according […]

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August 6th, 2010

Three Questions about Ticagrelor: Part 4 — Bob Harrington

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used in the […]

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August 5th, 2010

Three Questions about Ticagrelor: Part 3 — Jonathan Halperin

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used in the […]

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August 4th, 2010

Three Questions about Ticagrelor: Part 2 — Mori Krantz

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US were found to have no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses […]

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August 3rd, 2010

Three Questions about Ticagrelor: Part 1 — Sanjay Kaul

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used […]

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