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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

Onset of adverse drug reactions (ADRs) at different periods (excluding substituted cases).
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Fig4: Onset of adverse drug reactions (ADRs) at different periods (excluding substituted cases).

Mentions: In an analysis of the onset period of ‘ADRs occurring early in treatment’ in the 1243 cases other than the substituted cases in which amlodipine besylate was first administered as the active component, 32 ADR events were categorized as ‘ADRs occurring early in treatment’. Of them, 81% (n = 26) were ADRs occurring in <4 weeks of treatment initiation. Furthermore, of the 26 ADRs, 65% (n = 17) occurred in <2 weeks after treatment initiation (figure 4).


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)

Onset of adverse drug reactions (ADRs) at different periods (excluding substituted cases).
© Copyright Policy
Related In: Results  -  Collection

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

Fig4: Onset of adverse drug reactions (ADRs) at different periods (excluding substituted cases).
Mentions: In an analysis of the onset period of ‘ADRs occurring early in treatment’ in the 1243 cases other than the substituted cases in which amlodipine besylate was first administered as the active component, 32 ADR events were categorized as ‘ADRs occurring early in treatment’. Of them, 81% (n = 26) were ADRs occurring in <4 weeks of treatment initiation. Furthermore, of the 26 ADRs, 65% (n = 17) occurred in <2 weeks after treatment initiation (figure 4).

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