
People living with HIV (PWH) on statin therapy who have certain metabolic risk factors, such as obesity and prediabetes, are at greater risk of developing diabetes mellitus (DM), reports a study. This association is also present in those treated with placebo.
This multicentre, phase III trial included 7,731 PWH aged 40 to 75 years with low-to-moderate risk for atherosclerotic cardiovascular disease (ASCVD) without DM at study entry. Participants were randomly allocated to receive either pitavastatin 4 mg daily or placebo.
The researchers determined new-onset DM at each visit via clinical diagnosis requiring initiation of medication treatment for DM. They also assessed DM with regard to predefined demographic and metabolic risk factors, stratified by treatment group. Finally, the effects of pitavastatin on progression to new DM were also examined.
Compared with participants with no metabolic risk factors, those with three or more DM risk factors were at greater risk for DM in each treatment group: pitavastatin (incidence rate [IR], 3.24 vs 0.34 per 100 person-years [PY]) and placebo (IR, 2.66 vs 0.27 per 100 PY).
Of note, South Asia had the highest incidence of DM. Adjusted analyses further revealed that high BMI, prediabetes, and metabolic syndrome components strongly correlated with new-onset DM (p<0.005 for all).
“A clinically significant effect of pitavastatin on DM was seen primarily among those with multiple risk factors for DM at entry,” the researchers said. “Strategies targeting key metabolic risk factors, like obesity and prediabetes, may help protect against DM among PWH.”
This study was limited by pitavastatin as the only statin assessed and by DM assessed clinically.