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Phase 3 GAUSS-3 Trial Of Repatha (Evolocumab) In Statin-Intolerant Patients With High Cholesterol Meets Co-Primary Endpoints of LDL Cholesterol Reduction

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Additional Information

Additional Relevant Details The study met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24. The mean percent reductions in LDL-C, or "bad" cholesterol, compared to ezetimibe, were consistent with results observed in the 12-week Phase 2 GAUSS-1 and Phase 3 GAUSS-2 trials.

In the GAUSS-3 trial there were no new safety findings. The most common adverse events that occurred in greater than 5 percent of patients in the Repatha group were myalgia, nasopharyngitis, muscle spasms, arthralgia, pain in extremity, fatigue, headache and back pain.
http://www.amgen.com...
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Catalyst Date
Occurred on:
Feb 04, 2016
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Related Keywords Phase 3 Trial, Gauss-3, Evolocumab, Statin-intolerant Patients, High Cholesterol, Ldl Cholesterol Reduction, Primary Endpoints, Repatha, Low-density Lipoprotein Cholesterol, Statins