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Cognitive Function in a Randomized Trial of Evolocumab.

Robert P Giugliano1, François Mach1, Kenton Zavitz1

  • 1From the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital, Boston (R.P.G., K.I., E.K., M.S.S.); Hôpital Cantonal, Hopitaux Universitaires de Genève, Geneva (F.M.); Cambridge Cognition, Cambridge (K.Z.), and International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London (P.S.S.) - both in the United Kingdom; Amgen, Thousand Oaks, CA (C.K., J.S., H.W., N.H., S.M.W.); Sydney Medical School, NHMRC Clinical Trials Centre, University of Sydney, Sydney (A.K.); Oslo University Hospital, Ullevål, and Medical Faculty, University of Oslo - both in Oslo (T.R.P.); University of Iowa, Iowa City (J.G.R.); and Rhode Island Hospital, Department of Neurology, Alpert Medical School of Brown University, Providence (B.R.O.).

The New England Journal of Medicine
|August 17, 2017
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This study found that evolocumab, a PCSK9 inhibitor, did not negatively impact cognitive function in patients receiving statin therapy. Low LDL cholesterol levels associated with PCSK9 inhibitors were not linked to cognitive deficits.

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Area of Science:

  • Cardiovascular Medicine
  • Neuroscience
  • Pharmacology

Background:

  • Concerns exist regarding PCSK9 inhibitors and cognitive deficits due to associated low LDL cholesterol.
  • Clinical trials of PCSK9 inhibitors have prompted investigations into their neurological effects.

Purpose of the Study:

  • To assess the impact of evolocumab, a PCSK9 inhibitor, on cognitive function in patients undergoing statin therapy.
  • To determine if PCSK9 inhibition or resultant low LDL cholesterol levels affect executive function, memory, and psychomotor speed.

Main Methods:

  • A subgroup of 1204 patients from a randomized, placebo-controlled trial were prospectively evaluated.
  • Cognitive function was assessed using the Cambridge Neuropsychological Test Automated Battery, focusing on spatial working memory, episodic memory, and psychomotor speed.
  • The primary endpoint was the spatial working memory strategy index, with noninferiority analysis comparing evolocumab and placebo groups over a median of 19 months.

Main Results:

  • No significant between-group differences in cognitive function were observed between evolocumab and placebo groups.
  • The mean change in the spatial working memory strategy index was -0.21 in the evolocumab group and -0.29 in the placebo group (P=0.85 for superiority).
  • Secondary endpoints for working memory, episodic memory, and psychomotor speed also showed no significant differences between groups. Exploratory analysis found no association between LDL cholesterol levels and cognitive changes.

Conclusions:

  • Evolocumab, when added to statin therapy, does not result in significant cognitive deficits compared to placebo over a median of 19 months.
  • The study provides evidence that PCSK9 inhibition does not adversely affect cognitive function in this patient population.
  • Low LDL cholesterol levels achieved with evolocumab were not associated with cognitive impairment.