CHF And Arrhtyhmias
At study start, 21% of the more than 7,000 EMPA-REG OUTCOME trial participants had existing peripheral artery disease.
The FDA's final approval is pending the period of patent and/or exclusivity protection, and may not be made effective until the period has expired.
"The risks of ventricular arrhythmias and sudden cardiac death vary in specific populations with different underlying cardiac conditions and with specific family history and genetic variants, and this variation has important implications for studying and applying therapies," a guideline co-author said in a statement.
Compared with women who did not consume caffeine, women who consumed caffeine had an adjusted hazard ratio for death of 0.49 for <100 mg caffeine/day, 0.43 for 100 to <200mg/day, and 0.34 for ≥200 mg caffeine/day (P=0.007).
Traditional methods of measuring weight or body mass index are ineffective in assessing whether a person is overfat, the study authors said.