Efficacy of Generic Atorvastatin in a Real-World Setting

Figures & data

Figure 1 Study flow.

Table 1 Clinical Parameters of Dyslipidemia Patients Who Switched Treatment from Brand-Name Atorvastatin to Generic Atorvastatin

Factors	Mean (SD) or Number (%)
Age	60.97 (12.26)
Male sex	236 (48.36)
Education
Primary school	7 (1.43)
Secondary school	4 (0.82)
College	3 (0.61)
Unknown	475 (97.34)
Insurance
Basic	206 (42.21)
Social security	95 (19.47)
Government	161 (32.99)
Self-pay	25 (5.12)
Occupation
Government officer	11 (2.25)
Private company	45 (9.22)
Farmer	31 (6.35)
Unemployed	84 (17.21)
Unknown	313 (64.14)
Co-morbid disease
Hypertension	272 (55.74)
Atrial fibrillation	17 (3.48)
Diabetes	222 (45.49)
Chronic kidney disease	56 (11.48)
Heart failure	16 (3.28)
Coronary artery disease	62 (12.70)
Stroke	31 (6.35)
Dose of atorvastatin, mg
10	3 (0.61)
20	207 (42.42)
40	270 (46.13)
60	7 (1.43)
80	1 (0.20)

Table 4 Lipid Parameters of Dyslipidemia Patients Before Switching Treatment from Brand-Name to Generic Atorvastatin and 6 Months After Stratified by Sex

Factors	Baseline	6th Month	Mean Differences	95% CI	p value
Sex
Female (n = 252)
Chol	178.30 (47.79)	171.17 (45.08)	−7.12	−12.88, −1.37	0.015
Tg	140.98 (65.84)	141.07 (71.80)	0.08	−9.36, 9.53	0.985
HDL	53.74 (13.92)	52.05 (13.05)	−1.68	−3.07, −0.30	0.017
LDL	111.78 (42.38)	102.30 (36.98)	−9.48	−13.89, −5.07	< 0.001
Male (n = 236)
Chol	170.76 (51.08)	161.37 (43.03)	−9.38	−15.24, −3.53	0.001
Tg	147.53 (73.51)	150.21 (82.91)	2.67	−7.31, 12.65	0.598
HDL	49.52 (12.59)	46.94 (12.56)	−2.58	−3.90, −1.25	< 0.001
LDL	108.27 (47.11)	99.16 (48.69)	−9.10	−15.16, −3.03	0.003

Abbreviations: CI, confidence interval; Chol, cholesterol (mg/dL); Tg, triglyceride (mg/dL); HDL, high-density lipoprotein-cholesterol (mg/dL); LDL, low-density lipoprotein-cholesterol (mg/dL).

Table 5 Lipid Parameters of Dyslipidemia Patients Before Switching Treatment from Brand-Name to Generic Atorvastatin and 6 Months After Stratified by Co-Morbid Disease

Factors	Baseline	6th Month	Mean Differences	95% CI	p value
Hypertension
No (n = 216)
Chol	174.82 (49.83)	165.58 (46.57)	−9.23	−14.97, −3.49	0.001
Tg	142.48 (69.98)	141.24 (76.05)	−1.24	−10.98, 8.50	0.801
HDL	51.84 (13.74)	49.57 (13.29)	−2.27	−3.58, −0.95	< 0.001
LDL	111.14 (46.48)	103.88 (52.05)	−7.25	−13.44, −1.06	0.021
Yes (n = 272)
Chol	174.12 (49.50)	166.62 (42.32)	−7.49	−13.31, −1.67	0.011
Tg	145.62 (69.61)	149.12 (78.66)	3.50	−6.10, 13.10	0.473
HDL	51.48 (13.20)	49.47 (12.87)	−2.01	−3.38, −0.63	0.004
LDL	109.24 (43.34)	98.32 (34.12)	−10.91	−15.40, −6.43	< 0.001

Abbreviations: CI, confidence interval; Chol, cholesterol (mg/dL); Tg, triglyceride (mg/dL); HDL, high-density lipoprotein-cholesterol (mg/dL); LDL, low-density lipoprotein-cholesterol (mg/dL).

Table 6 Lipid Parameters of Dyslipidemia Patients Before Switching Treatment from Brand-Name to Generic Atorvastatin and 6 Months After Stratified by Dose

Factors	Baseline	6th Month	Mean Differences	95% CI	p value
Dose
10–20 mg (n = 210)
Chol	169.71 (45.68)	163.64 (35.88)	−6.07	−12.34, 0.19	0.057
Tg	134.33 (62.48)	136.70 (61.71)	2.37	−66.55, 11.29	0.600
HDL	53.33 (12.49)	50.85 (12.64)	−2.48	−3.64, −1.31	< 0.001
LDL	105.69 (41.71)	97.50 (31.88)	−8.18	−13.20, −3.15	0.001
40–80 mg (n = 278)
Chol	178.14 (52.25)	168.11 (49.84)	−10.02	−15.45, −4.59	< 0.001
Tg	152.58 (74.42)	153.08 (88.17)	0.49	−9.69, 10.68	0.923
HDL	50.24 (14.04)	48.40 (13.30)	−1.83	−3.30, −0.37	0.014
LDL	113.40 (46.67)	103.26 (49.74)	−10.14	−15.43, −4.84	< 0.001

Abbreviations: CI, confidence interval; Chol, cholesterol (mg/dL); Tg, triglyceride (mg/dL); HDL, high-density lipoprotein-cholesterol (mg/dL); LDL, low-density lipoprotein-cholesterol (mg/dL).

Table 2 Clinical Parameters of Dyslipidemia Patients Before Switching Treatment from Brand-Name to Generic Atorvastatin and 6 Months After

Factors	Baseline	6th Month	Mean Differences	95% CI	p value
BMI	26.57 (5.36)	26.48 (5.33)	−0.09	−0.25, 0.07	0.285
Chol	174.43 (49.58)	166.15 (44.25)	−8.28	−12.38, −4.19	<0.001
Tg	144.20 (69.71)	145.55 (77.50)	1.35	−5.48, 8.19	0.696
HDL	51.64 (13.43)	49.51 (13.04)	−2.13	−3.08, −1.17	<0.001
LDL	110.08 (44.72)	100.78 (43.03)	−9.30	−12.99, −5.59	<0.001
BUN	17.32 (10.57)	17.82 (12.32)	0.50	−0.49, 1.50	0.323
Cr	1.22 (1.14)	1.23 (1.12)	0.01	−0.02, 0.05	0.496
eGFR	72.93 (26.44)	72.84 (26.97)	−0.09	−0.93, 0.74	0.828
AST	30.85 (28.27)	30.07 (21.08)	−0.78	−7.29, 5.74	0.841
ALT	30.30 (17.00)	34.67 (37.73)	4.37	−2.34, 11.10	0.199
CK	235.30 (107.31)	205.84 (90.82)	−29.46	−79.70, 20.78	0.225

Abbreviations: CI, confidence interval; BMI, body mass index (kg/m²); Chol, cholesterol (mg/dL); Tg, triglyceride (mg/dL); HDL, high-density lipoprotein-cholesterol (mg/dL); LDL, low-density lipoprotein-cholesterol (mg/dL); BUN, blood urea nitrogen (mg/dL); Cr, creatinine (mg/dL); eGFR, estimated glomerular filtration rate (mL/min/1.73m²); ALT, alanine aminotransferase (U/L); AST, aspartate aminotransferase (U/L); CK, creatinine kinase (U/L).

Table 3 Lipid Parameters of Dyslipidemia Patients Before Switching Treatment from Brand-Name to Generic Atorvastatin and 6 Months After Stratified by Age

Factors	Baseline	6th Month	Mean Differences	95% CI	p value
Age
< 60 (n = 216)
Chol	180.85 (54.92)	170.04 (46.24)	−9.58	−15.38, −3.78	0.001
Tg	149.82 (75.60)	157.17 (91.39)	4.10	−7.11, 15.31	0.471
HDL	52.08 (13.71)	49.21 (12.75)	−2.39	−3.74, −1.04	< 0.001
LDL	115.66 (49.73)	103.76 (40.51)	−11.90	−16.76, −7.04	< 0.001
≥ 60 (n = 272)
Chol	169.43 (43.30)	162.00 (40.07)	−7.18	−12.96, −1.39	0.015
Tg	137.95 (63.12)	137.44 (63.86)	−1.01	−9.37, 7.33	0.810
HDL	51.38 (13.47)	49.24 (13.21)	−1.89	−3.24, −0.54	0.006
LDL	105.65 (39.85)	98.42 (44.87)	−7.23	−12.64, −1.81	0.009

Abbreviations: CI, confidence interval; Chol, cholesterol (mg/dL); Tg, triglyceride (mg/dL); HDL, high-density lipoprotein-cholesterol (mg/dL); LDL, low-density lipoprotein-cholesterol (mg/dL).

Table 7 Lipid Parameters of Dyslipidemia Patients Before Switching Treatment from Brand-Name to Generic Atorvastatin and 6 Months After Stratified by Indications for Dyslipidemia Treatment

Factors	Baseline	6th Month	Mean Differences	95% CI	p value
Indications
Primary (n = 398)
Chol	176.08 (48.27)	167.08 (44.26)	−9.00	−13.53, −4.46	< 0.001
Tg	142.37 (68.81)	143.76 (78.56)	1.38	−6.32, 9.10	0.723
HDL	52.04 (13.36)	50.04 (13.14)	−2.00	−3.04, −0.96	< 0.001
LDL	111.61 (44.32)	101.75 (44.48)	−9.85	−14.05, −5.64	< 0.001
Secondary (n = 90)
Chol	166.15 (55.43)	161.46 (44.25)	−4.69	−14.30, 4.91	0.332
Tg	153.93 (74.10)	155.14 (71.40)	1.20	−12.78, 15.18	0.864
HDL	49.48 (13.72)	46.67 (12.25)	−2.80	−5.28, −0.32)	0.027
LDL	103.33 (46.11)	96.48 (35.81)	−6.84	−14.51, 0.83	0.079

Abbreviations: CI, confidence interval; Chol, cholesterol (mg/dL); Tg, triglyceride (mg/dL); HDL, high-density lipoprotein-cholesterol (mg/dL); LDL, low-density lipoprotein-cholesterol (mg/dL).