Abstract 208: Trends of Comorbidities in Clinical Trials of Lipid Lowering Therapies: A Systematic Review

Background: Prevalence of coexisting comorbidities in clinical trials of lipid lowering therapies remains uncertain.

Methods: We selected 61 trials (n = 485,678) with follow-up of ≥3 months from databases of MEDLINE and ClinicalTrials.gov through December 2018. Trends in the prevalence of comorbid conditions across study period were tested using simple linear regression.

Results: There was a downtrend in enrollment of patients with coronary artery disease (CAD) (57.1% [18,968 of 33,230] to 30.9% [59,078 of 190,930]) from 1993-1998 period to 2014-2018 and peripheral artery disease (PAD) (11.6% [9062 of 78,249] to 4.2% [7996 of 190,930]) from 1999-2003 period to 2014-2018; however, there was a significant increase in enrollment of hypertensives from 23.8% (7897 of 33,230) to 59.2% (112,978 of 190930) from 1993-1998 period to 2014-2018. Enrollment of cerebrovascular accident (CVA) improved from 2.1% (701 of 33,230) to 7.2% (13,836 of 190,930) during the same periods. Enrollment of patients with chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD) and cancer remained consistently low. The overall recruitment of patients with smoking (20.6% [55004 of 267631]) and heart failure (HF) (7.6% [20395 of 267631]) was higher among industry sponsored trials and PAD (10.2% [2279 of 22340) among university funded trials. The reporting on cancer, COPD and CKD was provided only by industry sponsored trials.

Conclusion: Overall reporting on comorbidity was consistently low across trials of lipid lowering therapy.