Influence of pre-treatment blood pressure levels on antihypertensive drug benefits in diabetics: the roadmap experience

Figures & data

Table 1. Baseline characteristics of the study subjects at the screening and at the 1-year visit.

Total patients (n)	Screening visit	One-year visit
Gender (n)
Male	2054	1857
Female	2395	2156
Known duration of diabetes (yrs)	6.05 (5.96) / 4.3	6.00 (5.91) / 4.2
Insulin treatment (n; %)	821 (18.5%)	717 (17.9%)
Oral hypoglycaemic agents (n; %)	3752 (84.3%)	3414 (85.1%)
HbA1c (% )	7.7 (1.62) / 7.3	7.7 (1.61) / 7.3
Fasting blood glucose (mg/dL)	9.1 (3.10) / 8.4	9.1 (3.09) / 8.4
Systolic BP (mmHg)	140.8 (16.26) /140.0	141.0 (16.17) / 140.0
Diastolic BP (mmHg)	84.0 (9.78) / 84.0	84.1 (9.72) / 84.0
Antihypertensive treatment (n; %)	3314 (74.5%)	3020 (75.3%)
Use of amlodipine (n; %)	718 (16.1%)	662 (16.5%)
BMI (kg/m^2 )	31.0 (4.91) / 30.5	31.0 (4.88) / 30.5
High waist circumference (>102 cm in men, >88 cm in women)	3181 (71.5%)	2861 (71.3%)
Metabolic Syndrome (NCEP-ATPIII criteria)	3528 (79.3%)	3178 (79.2%)
Current smokers (n;%)	831 (18.7%)	743 (18.5%)
Ex-smokers (n; %)	897 (20.2%)	815 (20.3%)
Non-smokers (n; %)	2706 (60.6%)	2436 (60.7%)
eGFR (ml/min/1.73m^2) [MDRD equation]	84.5 (16.76) /84.0	84.4 (16.71) / 83.7
Hb (g/dL)	14.2 (1.26) / 14.2	14.2 (1.26) / 14.2
Triglycerides (mmol/L)*	2.1 ( 1.25) / 1.8	2.1 (1.26) / 1.8
Cholesterol (mmol/L)†	5.3 (1.12) / 5.2	5.3 (1.11) / 5.2
LDL cholesterol (mmol/L)‡	3.2 (0.92) / 3.1	3.2 (0.91) / 3.1
Uric acid (mg/dL)	5.5 (1.41) / 5.4	5.5 (1.41) / 5.4
Known family history of diabetes	2194 (49.3%)	1978 (49.3%)
Known family history of CV events	1678 (37.7%)	1507 (37.6%)

OM: Olmesartan; PL: Placebo.

Mean (standard deviation) for continuous variables, n (percentages) for categorical variables * Mean =185.8 mg/dL; †Mean = 204.6 mg/dL; ‡Mean = 123.6 mg/dL.

Figure 1. BP frequency distribution for systolic BP (A) and diastolic BP (B) at baseline and 1 year of follow-up. Actual (bars) and modelled (lines) blood pressure (BP) frequency distributions are shown. Upper panels represent distributions at randomisation (Visit 1) and lower panels after 1-year. BP stages are indicated by dotted lines and shading. Cell widths are 2 mmHg.

Figure 2. Effect of pre-treatment BP on systolic (A) and diastolic BP response on the first year of therapy.

Table 2. Change in the prevalence of BP stages between randomisation and follow-up visits in the olmesartan and placebo groups (analysis restricted to patients with documented BP measurements).

	Baseline		1-year^a		2-years		3-years		4-years
	OM	PL	OM	PL	OM	PL	OM	PL	OM	PL
Patients^c	2232	2214	2020	1998	1842	1800	1629	1590	422	400
C-I (%)^b	10.9	11.9	27.6	18.3	27.1	17.9	28.5	18.8	28.3	21.3
C-II (%)	47.4	49.1	61.9	67.1	64.9	70.6	65.2	72.4	64.4	71.2
C-III (%)	32.1	32	9.4	12.2	7.0	9.9	5.5	7.2	6.3	6.4
C-IV (%)	9.6	7.0	1.1	2.5	0.9	1.5	0.9	1.6	0.9	1.1
Total	100	100	100	100	100	100	100	100	100	100

OM: Olmesartan; PL: Placebo.

^aAll changes between randomisation and visit 1 are significant (p < .001). ^bThe definitions of BP categories are described in the material and methods section.

^cPatients with documented BP measurements are counted.

Table 3. Antihypertensive therapy at baseline and during follow-up in the olmesartan and placebo groups (analysis restricted to patients with documented medications).

	Baseline		1-year		2-years		3-years		4-years
	OM	PL	OM	PL	OM	PL	OM	PL	OM	PL
Patients	2232	2215	2090	2075	1947	1920	1771	1750	751	728
Total non-Omlesartan Antihypertensive Drugs/subject
Patients^a (mean ± SD)	1.50 (1.24)	1.50 (1.29)	1.80 (1.38)	2.0 (1.39)	2.0 (1.45)	2.2 (1.46)	2.0 (1.44)	2.4 (1.51)	2.2 (1.44)	2.60 (1.56)
Total antihypertensive Drugs/subject
	2.5	1.5	2.8	2.0	3.0	2.2	3.0	2.4	3.2	2.60
Backgrund antihypertensive drug therapy by drug class (% of subjects)
BB	40.8	42.0	47.1	51.8	48.2	53.5	48.6	55.3	50.7	59.3
CCB	40.8	42.0	44.2	50.7	51.3	59.4	53.5	63.0	55.1	64.3
D	31.6	31.9	38.4	46.0	39.2	48.1	39.2	48.1	42.6	53.6
Vasodilators	2.4	1.6	2.9	2.1	3.2	2.1	3.6	2.1	4.0	3.0
CAA	7.6	8.0	9.7	12.0	10.4	13.9	11.1	15.4	10.9	14.3
ACEI/ARB	0.1	0.1	0.6	0.8	1.2	1.8	3.7	4.5	16.1	17.4

OM: Olmesartan; PL: Placebo; BB: Beta Blocker; CCA: Calcium Channel Antagonist; ACEI; Angiotensin Converting Enzyme Inhibitor; ARB: Angiotensin Receptor Blocker.

^aPatients with blood documented pressure medications are shown (the patient data used for the analysis of BP shown in Table 2 and the patient number used for the analysis of BP medications shown here are overlapping but not identical).

Figure 3. Classification of patients according to BP categories and treatment group at baseline visit and during follow-up.