UPDATE 3-Abbott drug, statin combo may hurt women-US study

* Women on fibrate and statin had more adverse events

* FDA panel to discuss trial findings on May 19

* Abbott shares close down 1 percent (Changes headline)

By Esha Dey

WASHINGTON, April 25 (Reuters) - A study of Abbott Laboratories' (ABT.N) Trilipix showed female patients who took the drug along with a statin experienced more heart problems than those on a statin alone, U.S. health regulators said.

However, the clinical significance of the finding was unclear, the U.S. Food and Drug Administration said.

About 30 percent of the patients were women.

An FDA advisory committee will discuss the findings of the trial, named ACCORD Lipid, on May 19.

Abbott Labs shares closed down 48 cents to $51.32 on Monday.

Trilipix is approved to lower a type of blood fats called triglycerides in combination with a statin -- a widely used class of drugs that lower bad LDL cholesterol. Trilipix belongs to the fibrate class and is an active form of fenofibrate.

"Based on ACCORD, it appears that adding a fibrate to a statin does not provide benefit in women and may in fact be harmful," Wells Fargo analyst Larry Biegelsen said.

Overall, patients on Trilipix and a statin did not experience any statistically significant difference in the number of major adverse events, compared with those receiving statin and a placebo, the FDA said on its website.

Abbott spokeswoman Elizabeth Hoff said the gender-specific results of ACCORD Lipid were not consistent with previous fibrate outcomes studies.

In another study named FIELD, which had two times more women than ACCORD, fenofibrate showed a strong cardiovascular benefit in women, Hoff said.

The FIELD trial was done in diabetic patients, aged 50 to 75, to see if fenofibrate can reduce the risk of heart diseases. The main analysis of the trial had shown that fenofibrate did not reduce cardiac events.

An analysis of part of the ACCORD study reported at a major heart meeting last year had found adding fibrates to statins provided no additional protection from heart disease in patients suffering from Type 2 diabetes. [ID:nN14199420]

Biegelsen said he expects the finding related to female patients to be an important topic of discussion for the FDA panel and sees some risk of a change to the drug's label to reflect the risk profile.

"Abbott's position remains firm that the body of evidence supports combination therapy in appropriate patients, consistent with current labeling of Trilipix," Abbott's Hoff said. (Reporting by Esha Dey, editing by Matthew Lewis and Carol Bishopric)