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Arch Iran Med. 2023;26(6): 290-299.
doi: 10.34172/aim.2023.45
PMID: 38310429
PMCID: PMC10685836
Scopus ID: 85175659329
  Abstract View: 1042
  PDF Download: 648

Original Article

Appropriateness of Intensive Statin Treatment in People with Type Two Diabetes and Mild Hypercholesterolemia: A Randomized Clinical Trial

Mohammad Taghi Gorji 1 ORCID logo, Fariba Alaei-Shahmiri 1, Gisoo Darban Hosseini Amirkhiz 2 ORCID logo, Seyed Hashem Sezavar 2, Mojtaba Malek 2* ORCID logo, Mohammad E Khamseh 1

1 Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran
2 Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran
*Corresponding Author: Mojtaba Malek, Email: malekmoj@gmail.com

Abstract

Background: The aim of this study was to compare moderate- versus high-intensity statin therapy in patients with type 2 diabetes and low-density lipoprotein (LDL) cholesterol less than 130 mg/dL.

Methods: This was a randomized, open-label, parallel design trial comprised of 79 patients randomly allocated into two groups receiving high-intensity [atorvastatin 40 mg (A40) or rosuvastatin 20 mg (R20) daily] or moderate-intensity [atorvastatin 20 mg (A20) or rosuvastatin 10 (R10) mg daily] statins for eight weeks. The variables investigated were lipid profile, high sensitivity C-reactive protein (hs-CRP), and interleukin-6 (IL-6).

Results: The percentage of decrease in LDL levels (±SD) for the high-intensity group (-35.5±25.5) was significantly greater than the moderate-intensity group (-24.6±23.5) (P=0.04). While 38.1% (n:8) of patients receiving A20 and 55% (n:11) of those being on R10 achieved the targets of≥30% reduction in the LDL level, these figures were 63.2% (n=12) and 73.8% (n=14) for A40 and R20 subgroups, respectively. Subsequently, the likelihood of achieving LDL reduction≥30%, was significantly greater with high-intensity statin therapy (OR: 3.1, 95% CI: 1.09, 8.90, P=0.03). Logistic regression analysis also showed that for every 1 mg/ dL increase in the baseline LDL level, the odds of achieving the LDL reduction≥30% increased by 1.04 times [95% CI: (1.01, 1.07), P=0.003].

Conclusion: Despite the general conception, moderate-intensity statins are not adequate for the majority of patients with T2DM and mild hyperlipidemia and greater numbers of patients could reach the LDL cholesterol target with high-intensity statin therapy.


Cite this article as: Gorji MT, Alaei-Shahmiri F, Darban Hosseini Amirkhiz G, Sezavar SH, Malek M, Khamseh ME. Appropriateness of intensive statin treatment in people with type two diabetes and mild hypercholesterolemia: a randomized clinical trial. Arch Iran Med. 2023;26(6):290-299. doi: 10.34172/aim.2023.42
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Submitted: 17 Feb 2022
Revision: 20 Apr 2022
Accepted: 06 Jun 2022
ePublished: 01 Jun 2023
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