What are the primary limitations of studies exploring the safety of PCSK9 inhibitors for primary prevention?
The primary limitation of studies exploring the safety of PCSK9 inhibitors for primary prevention is their limited follow-up. Unlike the evidence evaluating the effects of statins, which include trials with longer term safety outcomes in secondary prevention, the PCSK9 literature is limited to safety outcomes of up to three years. The possibility of long-term reactions, adverse events, or consequences of prolonged levels of very low LDL-C with these agents are unknown.