DAL-GENE TRIAL

However:

• On fatal and non-fatal MI, the dalcetrapib treatment showed a relative risk reduction of 21% compared to placebo (5.9% vs. 7.3%; HR 0.79; 95% CI 0.65-0.96; p=0.02).
• For the seven months prior to the COVID-19 pandemic, the hazard ratio and p-value in the dal-GenE trial were consistently clinically meaningful (HR< 0.85) and statistically significant (p<0.05).
• Study results censored on January 2020, prior to the COVID-19 pandemic, showed a relative risk reduction of 18% (HR = 0.82, 95% CI, 0.68-0.98; p=0.03) in the occurrence of the primary endpoint in the dalcetrapib treated group compared to placebo indicating that dalcetrapib appeared to be associated with this benefit up to the emergence of COVID-19.
• COVID-19 occurred as early as January 2020 worldwide and had a global impact on cardiovascular care. In particular, the numbers of patients diagnosed and hospitalized with myocardial infarction decreased steeply, while deaths increased. The dal-GenE study endpoints appear to have been impacted by the last 17 months of follow-up that occurred during COVID- 19 pandemic. The ratio of non-fatal events to death dropped from 1.7 to 0.9 during this period, most likely due to a reduction of reporting in non-fatal events and an increase in CV and non-CV death during the pandemic compared to pre-COVID. This finding is consistent with the published impact of the pandemic on cardiovascular care.
• A pre-specified on-treatment sensitivity analysis of the primary endpoint showed a relative risk reduction of 17% with dalcetrapib treatment compared to placebo (7.8% vs. 9.3%; HR 0.83; 95% CI 0.70-0.98, p=0.03).
• Further pre-specified analyses demonstrated that patients at a higher risk had greater benefits on dalcetrapib treatment. In patients with type 2 diabetes, the observed relative risk reduction with dalcetrapib was 23% versus placebo (HR = 0.77; 95% CI, 0.60-0.99, p=0.04).
• In North America, where randomized patients were at a higher risk, they had a relative risk reduction of 41% in the primary composite endpoint (HR 0.59; 95% CI, 0.42-0.82, p=0.002). In contrast, countries with low-risk patients representing 20% of randomized patients had no significant benefit.