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  • 1
    Electronic Resource
    Electronic Resource
    Clinical equivalence of two tablet formulations of felodipine (1995)
    Springer
    European journal of clinical pharmacology 49 (1995), S. 169-172 
    Details
    ISSN: 1432-1041
    Keywords: Felodipine ; Hypertension ; extended release formulation ; tolerability
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: This study was performed to assess whether a new formulation of felodipine extended release (FER) tablets with a 9 mm diameter is similar to the presently used 11 mm diameter FER formulation with respect to antihypertensive effect and tolerability in patients with essential hypertension. A randomised, double-blind, placebo controlled, three-way cross-over study design was used. Patients: Twenty-four patients with a supine diastolic blood pressure (DBP) of 95–115 mmHg after a 4-week placebo run-in period were given FER 5 mg 9 mm tablets, FER 5 mg 11 mm tablets and placebo in randomised order. The tablets were given once daily and each double-blind treatment period lasted for two weeks. Methods: Twenty-four hour ambulatory blood pressure monitoring was performed at the end of each treatment period. The primary effect variable was mean DBP over 24 hours. Nineteen patients had 24-hour blood pressure data valid for analysis using an analysis of variance with patient, treatment, period and carry-over as factors. Results: Both formulations of FER 5 mg tablets significantly reduced the mean 24-hour DBP compared to placebo. The 9 and 11 mm tablets resulted in, on average, 4.7 and 3.4 mmHg lower mean 24-hour DBP than placebo. There was, however, no significant difference between the two different FER formulations. Both FER formulations were well tolerated and similar to placebo in this respect. Conclusion: Both FER 5 mg tablet formulations (9 and 11 mm diameter), given once daily, were clinically equivalent with respect to antihypertensive effect and tolerability in patients with mild to moderate essential hypertension.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00192375
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Felodipine in the treatment of patients with severe hypertension and impaired renal function (1990)
    Springer
    Cardiovascular drugs and therapy 4 (1990), S. 253-259 
    Details
    ISSN: 1573-7241
    Keywords: felodipine ; hypertension ; impaired renal function
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Twenty-three patients with severe hypertension and impaired renal function were included in an open study of the efficacy and tolerance of felodipine treatment over 6 months. All patients were previously treated with a diuretic, a beta blocker, and a vasodilator, and eight of them also received an ACE inhibitor. At the start of felodipine treatment the previously used vasodilator was withdawn. In nine patients the concomitant antihypertensive treatment was reduced during the study. The glomerular filtration rate (GFR), as51Cr EDTA clearance, was determined before and at the end of the study. The blood pressure (BP) and heart rate (HR) were recorded at all clinical visits in the moring 12 hours after the evening dose of felodipine and 2 hours after the morning dose. Plasma concentrations of felodipine were measured at every visit before the morning dose and 2 hours after dose. The BP was reduced after felodipine was substituted for the previously used vasodilator. A significant additional antihypertensive effect was recorded 2 hours after the dose and amounted to −37±22/−15±12 mmHg (p=0.0001/p=0.0002) at 6 months. The effect measured 12 hours after the dose was less pronounced and was −11±28/−6±10 mmHg (p=0.15/p=0.03). Mean GFR was unchanged during the study, 38±19 versus 38±19 ml/min (n=16). There was a sixfold interindividual variation in the trough plasma concentrations at steady state at the same drug dosage. Higher plasma concentrations seemed to be required to achieve the same antihypertensive effects as in patients with less severe hypertension and normal renal function. The frequency of adverse effects and the number of patients withdrawn (n=5) were somewhat higher than reported in patients with normal renal function and may be related to the high doses (up to 80 mg daily) used. In conclusion our data suggest that felodipine, in addition to other antihypertensives, is effective and is usually well tolerated in the treatment of patients with severe hypertension and reduced renal function. In order to ensure a more even reduction of BP over the day, a tid dosage regimen of the plain-tablet formulation used in this study may be preferable.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01857641
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    Paper (German National Licenses)
    Fulltext
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