Results of a comparative, phase III, 12-week, multicenter, prospective,
randomized, double-blind assessment of the efficacy and tolerability of a
fixed-dose combination of telmisartan and amlodipine versus amlodipine
monotherapy in Indian adults with stage II hypertension.
Author(s): Sharma A(1), Bagchi A, Kinagi SB, Sharma YK, Baliga VP, Bollmall C.
Affiliation(s): Author information:
(1)Medical Services Department, Glenmark Pharmaceuticals Ltd., Glenmark House,
HDO Corporate Building, Chakala, Andheri (East), Mumbai 400099, India.
akhileshs@glenmarkpharma.com
Publication date & source: 2007, Clin Ther. , 29(12):2667-76
OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of
a new fixed-dose combination (FDC) of telmisartan 40 mg + amlodipine 5 mg (T+A)
compared with amlodipine 5-mg monotherapy (A) in adult Indian patients with stage
II hypertension.
METHODS: This comparative, Phase III, 12-week, multicenter, prospective,
randomized, double-blind study was conducted in Indian patients aged 18 to 65
years with established stage II hypertension. Patients were treated with oral FDC
of T+A or A QD before breakfast for 12 weeks; blood pressure (BP) and heart rate
were measured in the sitting position. Primary efficacy end points were reduction
in clinical systolic BP (SBP)/ diastolic BP (DBP) from baseline to study end and
number of responders (ie, patients who achieved target SBP/ DBP <130/<80 mm Hg)
at end of study. Tolerability was assessed by treatment-emergent adverse events,
identified using physical examination, laboratory analysis, and
electrocardiography.
RESULTS: A total of 210 patients were enrolled in the study; 203 patients (143
men, 60 women) completed the study while 7 were lost to follow-up (4 patients in
the T+A group and 3 in the A group) and considered with-drawn. At study end,
statistically significant percentage reductions from baseline within groups and
between groups were observed in SBP (T+A [-27.4%]; A [-16.6%]) and DBP (T+A
[-20.1%]; A [-13.3%]) (all, P < 0.05). Response rates were 87.3% (89/102) in the
T+A group and 69.3% (70/101) in the A group (P < 0.05). The prevalences of
adverse events were not significantly different between the 2 treatment groups
(T+A, 16.0% [17/106]; A, 15.4% [16/104]). Peripheral edema was reported in 8.5%
patients (9/106) in the T+A group compared with 13.5% (14/104) in the A group,
and cough was reported in 3.8% patients (4/106) in the T+A group and 1.0% (1/104)
patients in the A group; these differences did not reach statistical
significance. The incidences of headache, dizziness, and diarrhea were similar
between the 2 groups.
CONCLUSIONS: Among these Indian patients with stage II hypertension, the FDC of
T+A was found to be significantly more effective, with regard to BP reductions,
than A, and both treatments were well tolerated.
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