Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus
Table 1
(a) Baseline demographics, laboratory, and vital measures of study population. (b) Baseline antihyperglycemic and antihypertensive/cardioprotective medications of study populationa.
(a)
Variable
All patients with incoming HbA1c ≤7.0
Patients with incoming A1c ≤7.0 that completed 52 study weeks
Bromocriptine-QR (,219)
Placebo ()
Bromocriptine-QR ()
Placebo ()
Age (years)
60.4 ± 10.1
60.4 ± 10.1
60.9 ± 9.6
60.8 ± 9.9
Duration of diabetes (years)
6.8 ± 6.9
6.6 ± 6.5
6.7 ± 6.5
6.7 ± 6.8
Male sex
673 (55)
335 (54)
454 (61)
262 (58)
Race:
White
869 (71)
431 (70)
546 (73)
327 (72)
Black
183 (15)
110 (18)
113 (15)
76 (17)
Hispanic
142 (12)
63 (10)
74 (10)
41 (9)
Asian
10 (1)
6 (1)
7 (1)
5 (1)
Other
15 (1)
5 (1)
10 (1)
4 (1)
Comorbid conditions
Hypertension
908 (74)
457 (74)
558 (74)
348 (77)
Angina pectoris
119 (10)
57 (9)
79 (11)
45 (10)
Myocardial infarction
98 (8)
52 (8)
62 (8)
44 (10)
Revascularization
111 (9)
69 (11)
69 (9)
57 (13)
Stroke
43 (4)
29 (5)
29 (4)
21 (5)
Hypercholesterolemia
914 (75)
458 (74)
574 (77)
351 (77)
Hypertriglyceridemia
470 (39)
241 (39)
297 (40)
181 (40)
Current smoker
161 (13)
73 (12)
98 (13)
48 (11)
Former smoker
495 (41)
258 (42)
321 (43)
193 (43)
HbA1c (%)
6.3 ± 0.49
6.3 ± 0.48
6.3 ± 0.48
6.3 ± 0.47
Fasting glucose (mmol/L)
7.00 ± 1.56
6.89 ± 1.44
7.06 ± 1.56
6.83 ± 1.44
Total cholesterol (mmol/L)
4.58 ± 1.03
4.53 ± 0.93
4.47 ± 0.96
4.53 ± 0.93
LDL cholesterol (mmol/L)
2.51 ± 0.83
2.48 ± 0.75
2.43 ± 0.78
2.48 ± 0.75
HDL cholesterol (mmol/L)
1.19 ± 0.31
1.22 ± 0.31
1.19 ± 0.31
1.19 ± 0.28
Triglycerides (mmol/L)
1.94 ± 1.33
1.86 ± 1.22
1.93 ± 1.23
1.91 ± 1.32
Systolic BP (mmHg)
130 ± 14
129 ± 13
130 ± 14
129 ± 13
Diastolic BP (mmHg),
77 ± 9
77 ± 9
77 ± 9
76 ± 9
Creatinine (mol/L)
97.24 ± 17.68
97.24 ± 17.68
97.24 ± 17.68
97.24 ± 17.68
Body mass index (kg/m2)
32.2 ± 5.0
32.3 ± 5.1
32.3 ± 5.0
32.2 ± 5.0
Data are shown as means ± SD for continuous variables and number (%) for categorical variables. Based on history as assessed by study site investigator.
(b)
Variable
All patients with incoming HbA1c ≤7.0
Patients with incoming HbA1c ≤7.0 that completed 52 weeks of study
Bromocriptine-QR (,219)
Placebo ()
Bromocriptine-QR ()
Placebo ()
Diabetes Treatment Regimen
Diet only
194 (16)
93 (15)
115 (15)
67 (15)
One oral hypoglycemic agent
570 (47)
304 (49)
365 (49)
221 (49)
Two oral hypoglycemic agents
350 (29)
154 (25)
203 (27)
117 (26)
Oral agent plus insulin
59 (5)
30 (5)
43 (6)
24 (5)
Insulin only
45 (4)
34 (6)
24 (3)
24 (5)
Not reported
1
0
0
0
Anti-diabetes Medications by Agent—no. (%)
Insulin
104 (9)
64 (10)
67 (9)
48 (11)
Metformin
698 (57)
347 (56)
412 (55)
262 (58)
Thiazolidinediones
238 (20)
116 (19)
148 (20)
83 (18)
Sulfonylureas
406 (33)
187 (30)
260 (35)
141 (31)
Other
16 (1)
10 (2)
11 (1)
7 (2)
Cardio-protective Medications by Class—no. (%)
ACE Inhibitors
578 (47)
275 (45)
370 (49)
216 (48)
Angiotensin II Receptor Inhibitors
215 (18)
123 (20)
127 (17)
92 (20)
Beta Blockers
278 (23)
156 (25)
180 (24)
125 (28)
Diuretics
411 (34)
215 (35)
255 (34)
158 (35)
Calcium Channel Blockersb
198 (16)
120 (20)
119 (16)
89 (20)
HMG CoA Reductase Inhibitor
711 (58)
360 (59)
452 (60)
274 (60)
Fibrate
86 (7)
42 (7)
59 (8)
36 (8)
Platelet Aggregation Inhibitors
554 (45)
288 (47)
363 (48)
221 (49)
Cardio-protective Medications by Number—no. (%)
Taking 1 cardioprotective agent
218 (18)
101 (16)
127 (17)
78 (17)
Taking 2 cardioprotective agents
266 (22)
148 (24)
169 (23)
106 (23)
Taking 3 cardioprotective agents
238 (20)
113 (18)
157 (21)
88 (19)
Taking ≥4 cardioprotective agents
369 (30)
186 (30)
233 (31)
143 (32)
Includes fixed dose combinations. bCalcium channel blockers include dihydropryidine, pheny-alkylamine, benozothiazepine.
