Korean Diabetes J.  2010 Dec;34(6):359-367. 10.4093/kdj.2010.34.6.359.

A Retrospective Study on the Efficacy of a Ten-Milligram Dosage of Atorvastatin for Treatment of Hypercholesterolemia in Type 2 Diabetes Mellitus Patients

• Kim DK
• Lee SR
• Kim MS
• Bae SH
• Hwang JY
• Kim JM
• Suh SH
• Lee HJ
• Park MK
• Kim DK

• KMID: 2222363
• DOI: http://doi.org/10.4093/kdj.2010.34.6.359

Abstract

BACKGROUND
There have been few clinical studies on 10 mg atorvastatin as a starting dosage for treatment of hypercholesterolemia in type 2 diabetes mellitus (T2DM) patients. This retrospective study aims to evaluate the efficacy of 10 mg dosage of atorvastatin in clinical setting.
METHODS
One hundred five enrolled patients with high levels of low density lipoprotein cholesterol (LDL-C, > 100 mg/dL) took 10 mg atorvastatin. After 6 months, they were divided into 'Responder group' (LDL-C < 100 mg/dL) and 'Non-responder group' (LDL-C > or = 100 mg/dL), and the response rate was calculated. Thereafter, we subdivided the 'Responder group' into Maintenance (10 mg), Reduced dosage (5 mg), and Discontinuance group (0 mg). The 'Non-Responder group' was subdivided into Maintenance (10 mg) and Double dosage group (20 mg). After consecutive 6 months, the response rates of each 10 mg Maintenance groups were compared to those of the other groups, respectively.
RESULTS
Following the first 6 months, the response rate of 10 mg fixed dosage was 74.3%. In the 'Responder group', response rates of 10 mg, 5 mg and Discontinuance groups following 6 months were 52.6%, 53.1%, and 12.5%, respectively. In the 'Non-responder group', response rates of 10 mg and 20 mg groups were 28.6% and 50.0%. Baseline LDL-C levels and body mass index (BMI) of 'Responder group' were significantly lower than those of 'Non-responder group' (P = 0.004, respectively).
CONCLUSION
Hypercholesterolemia treatment with 10 mg, fixed dosage of atorvastatin was effective in three quarters of the subjects during the first 6-month treatment; however, a significant number of patients with high LDL-C levels and/or BMI require higher starting and maintenance dosage.

Keyword

Atorvastatin; Diabetes mellitus, type 2; Hypercholesterolemia

MeSH Terms

Body Mass Index
Cholesterol
Cholesterol, LDL
Diabetes Mellitus, Type 2
Heptanoic Acids
Humans
Hypercholesterolemia
Lipoproteins
Pyrroles
Retrospective Studies
Atorvastatin Calcium
Cholesterol
Cholesterol, LDL
Heptanoic Acids
Lipoproteins
Pyrroles

Figure

• 

  Fig. 1 Schematic flow diagram of study setting: 105 patients with type 2 diabetes mellitus (T2DM) underwent atorvastatin 10 mg therapy as starting dose for reducing high low density lipoprotein cholesterol (LDL-C) levels (> 100 mg/dL) were enrolled for the study. After 6 months of treatment, the subjects were divided into a responder group (LDL-C < 100 mg/dL) or Non-Responder group (LDL-C ≥ 100 mg/dL). Thereafter, the Responder group was subdivided into a Remission maintenance group and Remission maintenance failure group. The Non-responder group was subdivided into a Delayed remission group and Remission failure group. Dosage modifications were made following a response to each dosage of atorvastatin.

• 

  Fig. 2 Low density lipoprotein cholesterol (LDL-C) profiles during the 5 years following initial therapy with atorvastatin 10 mg. Among 28 patients, 8 patients (A-H) used atorvastatin 10 mg as a starting and maintenance dosage without any change in dosage for the entire 5 year period. Of those 8 patients, 7 had final LDL-C levels below 100 mg/dL. Therefore, for this group, the 5-year response rate to an atorvastatin 10 mg fixed dosage was 87.5%.

• 

  Fig. 3 Correlation between baseline low density lipoprotein cholesterol (LDL-C) levels and body mass index (BMI) (two significant risk factors for short-term non-response).There was significant correlation between these two risk factors. The correlation coefficient was 0.251 (P = 0.01).

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