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REFLECTIONS
Dyslipidaemia
Dyslipidaemia Global Newsletter #6 2023

Pitavastatin to prevent cardiovascular disease in HIV infection. Dyslipidaemia
Grinspoon SK, et al. N Engl J Med. 2023 Aug 24;389(8):687-699.

The risk of ASCVD in persons with HIV is twice that in the
general population, therefore primary prevention strategies are
needed in this population.

This Phase 3, multinational, randomized, placebo-controlled
trial assessed the efficacy and safety of pitavastatin for the
prevention of CV events in persons with HIV infection and low-
to-moderate risk of ASCVD.

Participants between the ages of 40 and 75 years (median
screening LDL-C 108 mg/dL) receiving stable antiretroviral
therapy were assigned to receive oral pitavastatin calcium
(4 mg) (3888 participants) or placebo (3881 participants)
daily. The primary outcome was the occurrence of a major
adverse cardiovascular event (MACE), which was defined as a
composite of CV death, MI, hospitalization for unstable angina,
stroke, TIA, peripheral arterial ischaemia, revascularization, or
death from an undetermined cause.

During a median follow-up of 5.1 years, the incidence of MACE
was significantly lower in the pitavastatin group compared to the
placebo group (HR 0.65, 95% CI 0.48–0.90, p=0.002).

In terms of safety, non-fatal serious events were comparable between the two groups, while the incidence of diabetes mellitus and
grade ≥3 myalgia, muscle weakness, or myopathy, was more likely in the pitavastatin group.

The authors noted that although other statins that do not interact
with HIV medication may have similar protective effects, the
results reported are specific to pitavastatin. They also suggest
that other strategies that lower LDL-C may be useful in this
population and need to be compared with statin therapy with
respect to efficacy, safety, and cost.

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