Efficacy and Tolerability of Telmisartan Plus Amlodipine in Asian Patients Not Adequately Controlled on Either Monotherapy or on Low-Dose Combination Therapy

Table 3

Efficacy and safety results of individual studies.

	A5 nonresponder study 1		A5 nonresponder study 2		T40 nonresponder study		T80 nonresponder study		Nonresponder to; low-dose combination study
Trial identifier	NCT00558064		NCT01103960		NCT00550953		NCT01222520		NCT01286558
Reference	Data on file		Zhu et al., [28]		Data on file		Data on file		Data on file
Double-blind treatment groups	A5	T20 + A5 for 2 weeks; T40/A5 SPC for 6 weeks	A5	T80/A5 SPC	T40	T40/A5 SPC	T80	T80/A5 SPC	T40/A5 SPC	T80/A5 SPC
𝑁, randomized	262	269	164	160	158	156	87	87	113	112
Adjusted mean treatment difference in DBP*, 95% CI		5.1; (4.0–6.2)**		2.4; (0.7–4.1)^†		8.0; (6.4–9.6)**		9.1; (7.1–11.2)**		1.5; (−0.2, 3.4)
Overall incidence of adverse events, 𝑛 (%)	78; (29.8)	81; (30.1)	33; (20.1)	33; (20.6)	35; (22.2)	47; (30.1)	14; (16.1)	12; (13.8)	26; (23.0)	19; (17.0)
Incidence of peripheral edema, 𝑛 (%)	1; (0.4%)	0; (0.0)	1; (0.6%)	1; (0.6%)	0; (0.0)	0; (0.0)	0; (0.0)	0; (0.0)	2; (1.8)	2; (1.8)
Discontinuation due to adverse events, 𝑛 (%)	2; (0.8%)	3; (1.1%)	2; (1.2)	1; (0.6)	3; (1.9)	3; (1.9)	1; (1.1)	0; (0.0)	1; (0.9)	1; (0.9)

A5: amlodipine 5 mg; CI: confidence interval; DBP: diastolic blood pressure; NA: not applicable; NCT: National Clinical Trial; SE: standard error; SPC: single-pill combination; T20: telmisartan 20 mg; T40: telmisartan 40 mg; T80: telmisartan 80 mg.
∗The treatment effect (i.e., the difference between treatment groups in reduction from the reference baseline in mean seated DBP at trough after 8 weeks of double-blind treatment) was estimated by the least squares mean and its 95% CI.
^∗∗𝑃<0.0001, ^†𝑃<0.01.