Effects of antihypertensive drugs on SBP variability are dose-dependent and persist when used in combinations .
Use of a high dose of a calcium channel blocker alone or in combination with other agents is therefore likely to be particularly effective in prevention of stroke
BACKGROUND AND PURPOSE Recent studies have shown that visit-to-visit blood pressure variability is a powerful risk factor for stroke , is reduced by calcium channel blockers and diuretics , and increased by β-blockers .
However , it is unknown whether these effects are dose-dependent and persist in combination with other drugs .
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.
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 , prospect i ve , r and omized , 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
Effects of antihypertensive drugs on SBP variability are dose-dependent and persist when used in combinations .
Use of a high dose of a calcium channel blocker alone or in combination with other agents is therefore likely to be particularly effective in prevention of stroke
BACKGROUND AND PURPOSE Recent studies have shown that visit-to-visit blood pressure variability is a powerful risk factor for stroke , is reduced by calcium channel blockers and diuretics , and increased by β-blockers .
However , it is unknown whether these effects are dose-dependent and persist in combination with other drugs .