Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention : A Randomized Trial
Authors' conclusion
Metabolic risk factors, including prediabetes and obesity, contributed to new-onset DM in statin- and placebo-treated participants. A clinically significant effect of pitavastatin on DM was seen primarily among those with multiple risk factors for DM at entry. Strategies targeting key metabolic risk factors, like obesity and prediabetes, may help protect against DM among PWH.
Study context
- Population
- People with HIV aged 40 to 75 years with low to moderate atherosclerotic cardiovascular disease (ASCVD) risk, without diabetes mellitus (DM) at entryrandomized 1:1
- Participants
- 7,731 people
- Comparison
- Pitavastatin 4 mg daily vs placebo
- Primary endpoint
- New-onset DM (clinical diagnosis requiring medication) in relation to predefined demographic and metabolic risk factors, by treatment group
- Follow-up
- Median 5.6 years
Methodological detailsphase 3, multicenter, global, placebo-controlled, primary ASCVD prevention
- Phase 3
- Multicenter
- Global
- Placebo-controlled
- Primary ASCVD prevention
Primary result
As reported in the abstract
DM incidence, ≥3 DM risk factors vs no risk factors
Pitavastatin: ≥3 risk factors vs none
3.24 per 100 PY vs. 0.34 per 100 PY
Placebo: ≥3 risk factors vs none
2.66 per 100 PY vs. 0.27 per 100 PY
Further findings
DM incidence by region
- Incidence of DM was highest in South Asia
Factors associated with new-onset DM
- High BMI, prediabetes and metabolic syndrome components strongly associated with new-onset DM
- all P < 0.005
- Adjusted analyses
Original publication
Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention : A Randomized Trial. Ann Intern Med. Published 8 October 2024. doi:10.
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