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Efficacy, safety, and palatability of RACTAB(®) formulation amlodipine orally disintegrating tablets.

Fukui-Soubou M, Terashima H, Kawashima K, Utsunomiya O, Terada T - Drugs R D (2011)

Bottom Line: The aim of this study was to confirm the efficacy, safety, and expected palatability of amlodipine orally disintegrating tablets (ODT) [RACTAB(®) formulation (Towa, Osaka, Japan)].The results of this postmarketing surveillance study indicated that the efficacy, safety, and palatability of amlodipine ODT met our expectations (dissolves quickly in the mouth, tastes good, and is not rough on the tongue).Accordingly, amlodipine ODT are believed to be an easy-to-use formulation for prescribing doctors, dispensing pharmacists, and patients receiving treatment.

View Article: PubMed Central - PubMed

Affiliation: Towa Pharmaceutical Co., Ltd., Osaka, Japan.

ABSTRACT

Objective: The aim of this study was to confirm the efficacy, safety, and expected palatability of amlodipine orally disintegrating tablets (ODT) [RACTAB(®) formulation (Towa, Osaka, Japan)]. We report the re-analyzed results of 1687 cases in clinical settings obtained through postmarketing surveillance in Japan.

Method: Study subjects were patients receiving treatment for the first time with amlodipine ODT for hypertension under routine care. A multicenter central registration system was used for this prospective survey. The survey was conducted from October 2008 to October 2010. The observational period was 12 weeks, during which time surveys on outpatient blood pressure, adverse events, palatability, etc. were conducted.

Results: Blood pressure stabilized following treatment, and both systolic and diastolic blood pressures were favorably controlled. Adverse events observed were not significantly different from those observed during drug use trials of amlodipine formulations reported in 2003. Moreover, palatability of amlodipine ODT showed a 99.6% (227 of 228 cases) favorable patient acceptance, which is consistent with the initial design concept of RACTAB(®) formulation.

Conclusions: The results of this postmarketing surveillance study indicated that the efficacy, safety, and palatability of amlodipine ODT met our expectations (dissolves quickly in the mouth, tastes good, and is not rough on the tongue). Accordingly, amlodipine ODT are believed to be an easy-to-use formulation for prescribing doctors, dispensing pharmacists, and patients receiving treatment.

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Related in: MedlinePlus

Cases where systolic blood pressure (SBP) has been lowered by the antihypertensive from treatment initiation (treatment-naïve cases: single drug [5 mg] dose [non-substituted antihyperintensive]). Paired t-test (time of final observation vs time of treatment initiation). NS = no significant difference; *** p < 0.001.
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Fig2: Cases where systolic blood pressure (SBP) has been lowered by the antihypertensive from treatment initiation (treatment-naïve cases: single drug [5 mg] dose [non-substituted antihyperintensive]). Paired t-test (time of final observation vs time of treatment initiation). NS = no significant difference; *** p < 0.001.

Mentions: After treatment initiation, systolic and diastolic blood pressures of the 596 treatment-naïve cases dropped significantly within 2 weeks (p < 0.001) and then declined moderately until a favorably stabilized transition was confirmed within 12 weeks. The changes in systolic and diastolic blood pressures between treatment initiation and after 12 weeks varied from 163.9 mmHg (95% CI 162.4, 165.4) to 136.3 mmHg (95% CI 135.1, 137.4) and from 94.5 mmHg (95% CI 93.5, 95.5) to 80.2 mmHg (95% CI 79.4, 81.1), respectively. In addition, heart rates were stabilized within 12 weeks after treatment initiation. In figure 2, the antihypertensive effect on different original systolic blood pressures in the 329 cases (21.3%) in which a single drug dose of 5 mg was administered is shown as an average value from treatment initiation to the time of final evaluation. When systolic blood pressure was ≥140 mmHg at treatment initiation, a significant antihypertensive effect was observed relative to the blood pressure value before treatment.


Efficacy, safety, and palatability of RACTAB(®) formulation amlodipine orally disintegrating tablets.

Fukui-Soubou M, Terashima H, Kawashima K, Utsunomiya O, Terada T - Drugs R D (2011)

Cases where systolic blood pressure (SBP) has been lowered by the antihypertensive from treatment initiation (treatment-naïve cases: single drug [5 mg] dose [non-substituted antihyperintensive]). Paired t-test (time of final observation vs time of treatment initiation). NS = no significant difference; *** p < 0.001.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585955&req=5

Fig2: Cases where systolic blood pressure (SBP) has been lowered by the antihypertensive from treatment initiation (treatment-naïve cases: single drug [5 mg] dose [non-substituted antihyperintensive]). Paired t-test (time of final observation vs time of treatment initiation). NS = no significant difference; *** p < 0.001.
Mentions: After treatment initiation, systolic and diastolic blood pressures of the 596 treatment-naïve cases dropped significantly within 2 weeks (p < 0.001) and then declined moderately until a favorably stabilized transition was confirmed within 12 weeks. The changes in systolic and diastolic blood pressures between treatment initiation and after 12 weeks varied from 163.9 mmHg (95% CI 162.4, 165.4) to 136.3 mmHg (95% CI 135.1, 137.4) and from 94.5 mmHg (95% CI 93.5, 95.5) to 80.2 mmHg (95% CI 79.4, 81.1), respectively. In addition, heart rates were stabilized within 12 weeks after treatment initiation. In figure 2, the antihypertensive effect on different original systolic blood pressures in the 329 cases (21.3%) in which a single drug dose of 5 mg was administered is shown as an average value from treatment initiation to the time of final evaluation. When systolic blood pressure was ≥140 mmHg at treatment initiation, a significant antihypertensive effect was observed relative to the blood pressure value before treatment.

Bottom Line: The aim of this study was to confirm the efficacy, safety, and expected palatability of amlodipine orally disintegrating tablets (ODT) [RACTAB(®) formulation (Towa, Osaka, Japan)].The results of this postmarketing surveillance study indicated that the efficacy, safety, and palatability of amlodipine ODT met our expectations (dissolves quickly in the mouth, tastes good, and is not rough on the tongue).Accordingly, amlodipine ODT are believed to be an easy-to-use formulation for prescribing doctors, dispensing pharmacists, and patients receiving treatment.

View Article: PubMed Central - PubMed

Affiliation: Towa Pharmaceutical Co., Ltd., Osaka, Japan.

ABSTRACT

Objective: The aim of this study was to confirm the efficacy, safety, and expected palatability of amlodipine orally disintegrating tablets (ODT) [RACTAB(®) formulation (Towa, Osaka, Japan)]. We report the re-analyzed results of 1687 cases in clinical settings obtained through postmarketing surveillance in Japan.

Method: Study subjects were patients receiving treatment for the first time with amlodipine ODT for hypertension under routine care. A multicenter central registration system was used for this prospective survey. The survey was conducted from October 2008 to October 2010. The observational period was 12 weeks, during which time surveys on outpatient blood pressure, adverse events, palatability, etc. were conducted.

Results: Blood pressure stabilized following treatment, and both systolic and diastolic blood pressures were favorably controlled. Adverse events observed were not significantly different from those observed during drug use trials of amlodipine formulations reported in 2003. Moreover, palatability of amlodipine ODT showed a 99.6% (227 of 228 cases) favorable patient acceptance, which is consistent with the initial design concept of RACTAB(®) formulation.

Conclusions: The results of this postmarketing surveillance study indicated that the efficacy, safety, and palatability of amlodipine ODT met our expectations (dissolves quickly in the mouth, tastes good, and is not rough on the tongue). Accordingly, amlodipine ODT are believed to be an easy-to-use formulation for prescribing doctors, dispensing pharmacists, and patients receiving treatment.

Show MeSH
Related in: MedlinePlus