Limitations of real-world treatment with atorvastatin monotherapy for lowering LDL-C in high-risk cardiovascular patients in the US

Figures & data

Figure 1 Study design.

Notes: *For Humana Medicare analysis, there was an additional requirement of one atorvastatin Rx within 45 days of LDL-C measure.
Abbreviations: LDL-C, low-density lipoprotein cholesterol; Rx, prescription.

Figure 2 Patient accrual.

Abbreviations: Atorva, atorvastatin; AVD, atherosclerotic vascular disease; CHD, coronary heart disease; EMR, electronic medical record; FU, follow-up; LDL-C, low-density lipoprotein cholesterol; Rx, prescription.

Table 1 Patient characteristics

Characteristics	GE Centricity EMR N=10,693^†	Humana Medicare N=16,798^‡
Age	68.0±10.2	73.7±8.4
Male	6,275 (58.7)	8,750 (52.1)
Diabetes	2,170 (20.3)	3,159 (18.8)
Baseline LDL-C mmol/L ± SD(mg/dL ± SD)*	2.1±0.8 (82.2±29.7)	2.5±0.9 (98.2±35.3)
AVD or CHD diagnosis
CHD	7,879 (73.7)	11,690 (69.6)
Ischemic stroke	1,033 (9.7)	864 (5.1)
PAD	521 (4.9)	617 (3.7)
Atherosclerosis	2,338 (21.9)	3,976 (23.7)
Atorvastatin dose before LDL-C measure**
10 mg	2,326 (21.8)	4,262 (25.3)
20 mg	3,170 (29.7)	5,520 (32.9)
40 mg	3,198 (29.9)	4,672 (27.8)
80 mg	1,999 (18.7)	2,344 (14.0)

Notes: Values are expressed as mean ± SD or N (%).

* The last LDL-C measure taken in 12 month baseline period closest to the index date;

** dose based on last prescription before the follow-up LDL-C measure; ^†3,649 (34.1%) and ^‡13,568 (80.8%) of these patients had received some type of lipid-lowering therapy during the 12-month baseline period, and of these, ^†2,362 (22.0%) and ^‡11,744 (69.9%) were on atorvastatin therapy.

Abbreviations: AVD, atherosclerotic vascular disease; CHD, coronary heart disease; EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol; PAD, peripheral arterial disease; SD, standard deviation.

Table 2 Follow-up LDL-C levels by atorvastatin dose

Atorvastatin dose	GE Centricity EMR N=10,693 LDL-C mmol/L (mg/dL)	Humana Medicare N=16,798 LDL-C mmol/L (mg/dL)
10 mg	2.2±0.8 (83.5±29.6)	2.3±0.8 (88.7±29.4)
20 mg	2.1±0.8 (82.7±29.6)	2.3±0.8 (88.8±31.1)
40 mg	2.2±0.8 (83.1±30.6)	2.3±0.8 (86.9±31.3)
80 mg	2.1±0.8 (82.4±31.6)	2.2±0.9 (85.9±33.9)
All doses combined	2.2±0.8 (82.9±30.3)	2.3±0.8 (87.9±31.2)

Notes: Values are expressed as mean ± SD.

Abbreviations: EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol; SD, standard deviation.

Figure 3 Distribution of LDL-C levels around <1.8 mmol/L (<70 mg/dL) and <2.6 mmol/L (<100 mg/dL) cut points.

Abbreviations: EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol.

Figure 4 Proportion of patients with LDL-C <1.8 mmol/L (<70 mg/dL) and <2.6 mmol/L (<100 mg/dL) by atorvastatin dose.

Abbreviations: EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol.

Table S1 Diagnosis and procedure codes used to identify patients

Comorbid disease	ICD9 diagnosis codes	CPT codes	ICD-9 procedure codes
Diabetes	250.xx
CHD/AVD
Acute myocardial infarction	410.xx
Previous myocardial infarction	412.xx, 429.7x
Ischemic stroke	362.34, 433.x1, 434.x1
Peripheral arterial disease	441.3x, 441.4x, 441.6x, 441.7x, 444.2x, 444.8x, 444.9x, 445.0x	34201, 34203, 35131, 35141, 35142, 35151, 35152, 35226, 35302, 35303, 35304, 35305, 35306, 35355, 35363, 35371, 35372, 35400, 35456, 35459, 35470, 35474, 35483, 35485, 35493, 35495, 35621, 35623, 35646, 35647, 35651, 35654, 35656, 35661, 35665, 35666, 35671, 35686, 35700, 35721, 35741, 35761, 35879, 35881, 35883, 35884	00.03, 00.55, 00.61–00.64, 38.02–38.06, 38.08, 38.18, 38.38, 38.48
Angina pectoris	413.xx
Other acute, subacute ischemic heart disease (eg, unstable angina, acute coronary syndrome)	411.xx
Revascularization		33140–33141, 33510, 33511, 33512, 33513, 33514, 33515, 33516, 33517, 33518, 33519, 33521, 33522, 33523, 33533, 33534, 33535–33536, 33572, 92973, 92980, 92981, 92982, 92984, 92995, 92996, 93540	00.66, 36.01–36.02, 36.05, 36.1x–36.3x
Acute carotid artery procedures		34001, 35001, 35002, 35201, 35231, 35261, 35286, 35301, 35390, 35501, 35506, 35508, 35509, 35510, 35526, 35601, 35606, 35626, 35642, 35691, 35694, 35701, 35901	00.61–00.65, 38.01–38.02, 38.11–38.12, 38.31–38.32, 38.41–38.42, 39.28, 39.7
Other forms of chronic ischemic heart disease	414.xx, v45.8, v45.81, v45.82
Atherosclerosis	429.2x, 433.x0, 434.x0, 437.0x, 437.1x, 440.xx, 444.0x, 444.1x, 445.8x		36.0x–36.3x, 38.12–38.16, 38.18, 38.34, 38.44, 39.22–39.26, 39.28, 39.29, 39.50, 39.71, 39.73, 39.90, 99.10

Abbreviations: AVD, atherosclerotic vascular disease; CHD, coronary heart disease; CPT, current procedural terminology; ICD-9, International Classification of Diseases, 9th revision.

Table S2 GE Centricity EMR: proportion of patients with LDL-C <1.8 mmol/L (<70 mg/dL) and proportion with levels >1.8 mmol/L (>70 mg/dL), categorized by distance from goal

Atorvastatin dose	% (95% CI)
	LDL-C <1.8 mmol/L (<70 mg/dL)	LDL-C ≥1.8 to <2.1 mmol/L (≥70 to <80 mg/dL)	LDL-C ≥2.1 to <2.3 mmol/L (≥80 to <90 mg/dL)	LDL-C ≥2.3 mmol/L (≥90 mg/dL)
10 mg	32.5 (31.6–33.4)	16.9 (16.2–17.6)	17.5 (16.8–18.2)	33.2 (32.3–34.1)
20 mg	35.3 (34.4–36.2)	24.3 (23.5–25.1)	13.9 (13.2–14.6)	33.0 (32.1–33.9)
40 mg	34.6 (33.7–35.5)	24.4 (23.6–25.2)	16.5 (15.8–17.2)	31.5 (30.6–32.4)
80 mg	37.3 (36.4–38.2)	14.0 (13.3–14.7)	14.3 (13.6–15.0)	32.1 (31.2–33.0)
All doses combined	34.8 (33.9–35.7)	17.3 (16.6–18.0)	15.5 (14.8–16.2)	32.4 (31.5–33.3)

Abbreviations: CI, confidence interval; EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol.

Table S3 GE Centricity EMR: proportion of patients with LDL-C <2.6 mmol/L (<100 mg/dL) and proportion with levels >2.6 mmol/L (>100 mg/dL), categorized by distance from goal

Atorvastatin dose	% (95% CI)
	LDL-C <2.6 mmol/L (<100 mg/dL)	LDL-C ≥2.6 to <2.9 mmol/L (≥100 to <110 mg/dL)	LDL-C ≥2.9 to <3.1 mmol/L (≥110 to <120 mg/dL)	LDL-C ≥3.1 mmol/L (≥120 mg/dL)
10 mg	77.9 (77.1–78.7)	7.6 (7.1–8.1)	4.1 (3.7–4.5)	10.3 (9.7–10.9)
20 mg	77.7 (76.9–78.5)	8.0 (7.5–8.5)	4.8 (4.4–5.2)	9.5 (8.9–10.1)
40 mg	78.4 (77.6–79.2)	7.0 (6.5–7.5)	4.4 (4.0–4.8)	10.2 (9.6–10.8)
80 mg	77.9 (77.1–78.7)	6.4 (5.9–6.9)	5.4 (5.0–5.8)	10.3 (9.7–10.9)
All doses combined	78.0 (77.2–78.8)	7.3 (6.8–7.8)	4.6 (4.2–5.0)	10.0 (9.4–10.6)

Abbreviations: CI, confidence interval; EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol.

Table S4 Humana Medicare: proportion of patients with LDL-C <1.8 mmol/L (<70 100 mg/dL) and proportion with levels >1.8 mmol/L (>70 mg/dL) categorized by distance from goal

Atorvastatin dose	% (95% CI)
	LDL-C <1.8 mmol/L (<70 mg/dL)	LDL-C ≥1.8 to <2.1 mmol/L (≥70 to <80 mg/dL)	LDL-C ≥2.1 to <2.3 mmol/L (≥80 to <90 mg/dL)	LDL-C ≥2.3 mmol/L (≥90 mg/dL)
10 mg	25.7 (25.0–26.4)	15.4 (14.9–16.0)	16.5 (15.9–17.1)	42.4 (41.7–43.2)
20 mg	27.3 (26.6–27.8)	15.3 (14.8–15.8)	15.1 (14.6–15.6)	42.3 (41.6–43.1)
40 mg	29.7 (29.0–30.9)	16.1 (15.5–16.7)	15.6 (15.1–16.2)	38.6 (37.9–39.3)
80 mg	33.0 (32.3–33.7)	14.9 (14.4–15.4)	14.7 (14.2–15.2)	37.4 (36.7–38.1)
All doses combined	28.3 (27.6–29.0)	15.5 (15.0–16.1)	15.5 (15.0–16.1)	40.7 (40.0–41.4)

Abbreviations: CI, confidence interval; EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol.

Table S5 Humana Medicare: proportion of patients with LDL-C <2.6 mmol/L (<100 mg/dL) and proportion with levels >2.6 mmol/L (>100 mg/dL), categorized by distance from goal

Atorvastatin dose	% (95% CI)
	LDL-C <2.6 mmol/L (<100 mg/dL)	LDL-C ≥2.6 to <2.9 mmol/L (≥100 to <110 mg/dL)	LDL-C ≥2.9 to <3.1 mmol/L (≥110 to <120 mg/dL)	LDL-C ≥3.1 mmol/L (≥120 mg/dL)
10 mg	71.5 (70.8–72.2)	9.1 (8.7–9.5)	6.8 (6.4–7.2)	12.6 (12.2–13.1)
20 mg	70.6 (69.9–71.3)	9.2 (8.8–9.6)	6.2 (5.8–6.6)	14.0 (13.5–14.5)
40 mg	73.3 (72.6–74.0)	8.5 (8.1–8.9)	5.6 (5.3–6.0)	12.6 (12.1–13.1)
80 mg	73.8 (73.1–74.5)	8.5 (8.1–8.9)	5.3 (5.0–5.6)	12.4 (11.9–12.9)
All doses combined	72.0 (71.3–72.7)	8.8 (8.4–9.2)	6.0 (5.6–6.4)	13.2 (12.7–13.7)

Abbreviations: CI, confidence interval; EMR, electronic medical record; LDL-C, low-density lipoprotein cholesterol.