ORLANDO, FL — While some guidelines recommend statin use to achieve low-density lipoprotein cholesterol (LDL-C) goal under 70 mg/dL for primary prevention of atherosclerotic cardiovascular disease (ASCVD) in patients at higher risk, others recommend against a target LDL-C level.
The authors of a new study published in the journal Drug Safety pointed 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.1
The study team from the University of Central Florida and the Orlando VA Healthcare System sought to assess the association of strict (≤ 70 mg/dL) versus lenient (> 70 to100 mg/dL) LDL-C lowering on major adverse cardiovascular events (MACE), diabetes progression, diabetes microvascular complications, and total mortality in patients with diabetes.
The retrospective propensity score (PS)-matched study used a national cohort of, predominantly male, veterans diagnosed with diabetes without prior cardiovascular disease from fiscal years 2003-2015. All were initiated on a statin. The researchers focused on the difference between strict and lenient LDL-C lowering, taking into account. 65 baseline characteristics, including comorbidities, risk scores, medication classes usage, vital signs and laboratory data.
Defined as the key outcomes were 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 veterans’ mean (SD) age was 64 (9.5) years, and 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 vs lenient group (66.7% in strict versus 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 versus 15% in lenient; OR 0.97; 95% CI 0.92-1.02, P = 0.20).
“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.”
- Odeleye V, Masarweh O, Restrepo J, Alvarez CA, Mansi IA. Association of Strict Versus Lenient Cholesterol Lowering with Cardiac Outcomes, Diabetes Progression and Complications, and Mortality in Patients with Diabetes Treated with Statins: Is Less More? Drug Saf. 2023 Oct 2. doi: 10.1007/s40264-023-01347-8. Epub ahead of print. PMID: 37782373.