The authors of a new study published in the journal Drug Safety point out that achieving a target level that low usually requires the use of high-intensity statins, which have been associated with a higher risk of diabetes progression.
The University of Central Florida–led study team sought to assess the association of strict (≤70 mg/dL) versus lenient (>70 mg/dL-100 mg/dL) LDL-C lowering on major adverse cardiovascular events (MACE), diabetes progression, diabetes microvascular complications, and total mortality in patients with diabetes.
Their retrospective propensity score (PS)–matched study used a national cohort of predominantly male veterans diagnosed with diabetes without prior cardiovascular disease from fiscal years 2003 through 2015. All had begun taking statins.
The researchers tracked the differences between strict and lenient LDL-C lowering, taking into account 65 baseline characteristics, including comorbidities, risk scores, medication class usage, vital signs, and laboratory data. They defined the key outcomes as MACE, diabetes progression, microvascular diabetes complications, and total mortality.
From 80,110 eligible patients, the study team propensity score–matched 21,294 pairs of statin initiators with strict or lenient LDL-C lowering. The participants’ mean (SD) age was 64 (9.5) years, and the mean (SD) duration of follow-up was 6 (3) years.
Results indicated that MACE was similar in the PS-matched groups [6.1% in strict versus 5.8% in lenient; odds ratio (OR): 1.06; 95% confidence interval (95% CI) 0.98-1.15, P = 0.17]. On the other hand, diabetes progression was higher among the strict versus lenient group (66.7% in strict vs. 64.1% in lenient; OR 1.12; 95% CI 1.08-1.17, P< 0.001). No difference was determined in microvascular diabetes complications (22.3%) in strict versus 21.9% in lenient; OR 1.02; 95% CI 0.98-1.07, P = 0.31) and no difference in total mortality (14.6% in strict vs. 15% in lenient; OR 0.97; 95% CI 0.92-1.02, P = 0.20) was found.
“Strict compared with lenient lowering of LDL-C with statins in men with diabetes without preexisting ASCVD did not decrease the risk of MACE but was associated with an increased diabetes progression,” the researchers concluded. “Clinicians should monitor their patients for diabetes progression upon escalating statins to achieve LDL-C levels ≤ 70 mg/dL.”
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