Uptitrating amlodipine significantly reduces blood pressure in diabetic patients with hypertension: a retrospective, pooled analysis

Figures & data

Table 1 Studies used in the pooled analysisa

Study	Design	Study number/NCT number (if applicable)	With diabetes (N=100)	Without diabetes (N=610)	Patient population	Total study durationb	Study dates
1	Randomized, multicenter, double-blind, parallel group	A0531004c	10	70	Washed out of antihypertensives or treatment naïve	18 weeks	6 March 2001–14 October 2003
2	Single arm, multicenter, open, non-interventional	A0531044c	38	134	Washed out of antihypertensives or treatment naïve	12 weeks	1 November 2001–31 March 2002
3	Randomized, multicenter, double-blind, parallel group	A0531085 NCT00415623	26	125	Uncontrolled on current antihypertensive at screening, doses stable throughout the study	16 weeks	6 January 2007–20 October 2007
4	Single arm, long-term extension for NCT00415623	A0531086 NCT00443456	12	57	Uncontrolled on current antihypertensive at screening, doses stable throughout the study	44 weeks	2 May 2007–11 June 2008
5	Randomized, multicenter, double- blind, parallel group	A053R0510c	12	121	Washed out of antihypertensives or treatment naïve	18 weeks	Study dates unavailable
6	Single arm, multicenter, open, non-interventional	AML-NY-93002c	2	103	Uncontrolled on current antihypertensive at screening, doses stable throughout the study, or treatment naïve	14 weeks	20 November 1993–30 April 1995

Notes:

a All Pfizer-sponsored studies of amlodipine treatment for mild to moderate hypertension for which there were patient-level data, diabetic status was known, and dose was titrated from 5 mg to 10 mg

b where applicable, total study duration included screening, baseline, and multiple study phases

c these trials started before September 2008, before clinical studies were registered at http://www.clinicaltrials.gov; NCT Number, ClinicalTrials.gov Identifier.

Table 2 Baseline characteristics of the study population stratified by diabetes status

Characteristic	With diabetes (N=100)	Without diabetes (N=610)
Male, n (%)	44 (44.9)a,*	350 (57.4)
Mean age, years (SD)	60.6 (9.64)	58.7 (11.08)
Mean SBP/DBP, mmHg (SE)	159.1 (1.40)/92.6 (0.94)*	160.0 (0.67)/96.2 (0.45)
Mean weight, kg (SD)	82.1 (16.80)*	75.4 (16.68)
Mean BMI, kg/m^2 (SD)	30.3 (4.60)*	27.0 (4.36)
History of CHD, n (%)	7 (7.0)	24 (3.9)
Prior antihypertensive use, n (%)	64 (64.0)	312 (51.1)
Prior antihypertensive use by class, n (%)b
ACEI	42 (42.0)	139 (22.8)
ARB	4 (4.0)	49 (8.0)
Alpha receptor agonist/antagonist	2 (2.0)	10 (1.6)
Alpha2-Adrenergic Agonist		1 (0.2)
BB	14 (14.0)	64 (10.5)
CCB	37 (37.0)	140 (23.0)
Centrally-acting antihypertensive	5 (5.0)	8 (1.3)
Diuretics	10 (10.0)	80 (13.1)
Ergot alkaloid		1 (0.2)
Vasodilator		1 (0.2)

Notes:

a N=98 (two patients with sex not specified)

b patients could have been taking more than one medication

* P<0.05.

Abbreviations: BMI, body mass index; CHD, coronary heart disease; DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation; SE, standard error; ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; BB, beta blocker; CCB, calcium channel blocker.

Figure 1 Sitting blood pressure at baseline and follow-up in (A) patients with diabetes and (B) patients without diabetes titrated from amlodipine 5 mg to 10 mg.

Notes: Analyses were conducted using the intent-to-treat population. Baseline was established while patients were on amlodipine 5-mg treatment; follow-up was determined using a last-observation-carried-forward analysis.
Abbreviations: BP, blood pressure; CI, confidence interval.

Table 3 Incidence of all-cause adverse events in patients with and without diabetes titrated from amlodipine 5 mg to 10 mg

Parameter	With diabetes (N=100)	Without diabetes (N=610)	Difference (%)b	95% CIb
Number of AEs	31	282
Patients with AEs, n (%)	22 (22.0)	176 (28.9)
Patients with serious AEs, n (%)	1 (1.0)	5 (0.8)
Patients withdrawn from treatment due to AEs, n (%)	3 (3.0)	20 (3.3)
Most common AEsa, n (%)
Back pain	0 (0.0)	8 (1.3)	−1.3	[−2.7, 2.1]
Nasopharyngitis	0 (0.0)	24 (3.9)	−3.9*	[−5.9, −0.5]
Peripheral edema	4 (4.0)	46 (7.5)	−3.5	[−7.3, 2.3]
Sinusitis	2 (2.0)	0 (0.0)	2.0*	[0.2, 7.0]
Upper respiratory tract infection	2 (2.0)	6 (1.0)	1.0	[−1.0, 5.6]

Notes: Analyses were conducted using the safety population. Baseline was established while patients were on amlodipine 5 mg treatment.

* P<0.05, null hypothesis is that the percentage of patients with the given AE is equal between the two subgroups, versus not equal

a those with an incidence >1.0% in either subgroup

b difference between the two subgroups in the percentage of most common AEs (those with diabetes minus those without), and associated 95% confidence interval.

Abbreviations: AEs, adverse events; CI, confidence interval.