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Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial.

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dc.contributor.authorNa, SH-
dc.contributor.authorLee, HY-
dc.contributor.authorHong Baek, S-
dc.contributor.authorJeon, HK-
dc.contributor.authorKang, JH-
dc.contributor.authorKim, YN-
dc.contributor.authorPark, CG-
dc.contributor.authorRyu, JK-
dc.contributor.authorRhee, MY-
dc.contributor.authorKim, MH-
dc.contributor.authorHong, TJ-
dc.contributor.authorChoi, DJ-
dc.contributor.authorCho, SW-
dc.contributor.authorCha, DH-
dc.contributor.authorJeon, ES-
dc.contributor.authorKim, JJ-
dc.contributor.authorShin, JH-
dc.contributor.authorPark, SH-
dc.contributor.authorLee, SH-
dc.contributor.authorJohn, SH-
dc.contributor.authorShin, ES-
dc.contributor.authorKim, NH-
dc.contributor.authorLee, SY-
dc.contributor.authorKwan, J-
dc.contributor.authorJeong, MH-
dc.contributor.authorKim, SW-
dc.contributor.authorJeong, JO-
dc.contributor.authorKim, DW-
dc.contributor.authorLee, NH-
dc.contributor.authorPark, WJ-
dc.contributor.authorAhn, JC-
dc.contributor.authorWon, KH-
dc.contributor.authorUk Lee, S-
dc.contributor.authorCho, JH-
dc.contributor.authorKim, SK-
dc.contributor.authorAhn, T-
dc.contributor.authorHong, S-
dc.contributor.authorYoo, SY-
dc.contributor.authorKim, SY-
dc.contributor.authorKim, BS-
dc.contributor.authorJuhn, JH-
dc.contributor.authorLee, YJ-
dc.contributor.authorOh, BH-
dc.date.accessioned2017-03-27T06:05:18Z-
dc.date.available2017-03-27T06:05:18Z-
dc.date.issued2015-
dc.identifier.issn0149-2918-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/13647-
dc.description.abstractPURPOSE: The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension.

METHODS: Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2).

FINDINGS: Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were -2.0 (8.8) mm Hg in the L10 group, -6.7 (8.5) mm Hg in L10/V80 group, and -8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was -4.6 mm Hg (95% CI, -6.5 to -2.6; P < 0.001) in the L10/V80 group and -5.9 mm Hg (95% CI, -7.9 to -4.0, P < 0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were -5.6 (7.9)/-8.0 (12.0) mm Hg and -5.5 (7.0)/-8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups.

IMPLICATIONS: Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.
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dc.language.isoen-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAntihypertensive Agents-
dc.subject.MESHBlood Pressure-
dc.subject.MESHDihydropyridines-
dc.subject.MESHDizziness-
dc.subject.MESHDose-Response Relationship, Drug-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Combinations-
dc.subject.MESHFemale-
dc.subject.MESHHeadache-
dc.subject.MESHHumans-
dc.subject.MESHHypertension-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHValsartan-
dc.subject.MESHYoung Adult-
dc.titleEvaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial.-
dc.typeArticle-
dc.identifier.pmid26164786-
dc.identifier.urlhttps://linkinghub.elsevier.com/retrieve/pii/S0149-2918(15)00854-1-
dc.contributor.affiliatedAuthor신, 준한-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.clinthera.2015.05.512-
dc.citation.titleClinical therapeutics-
dc.citation.volume37-
dc.citation.number8-
dc.citation.date2015-
dc.citation.startPage1726-
dc.citation.endPage1739-
dc.identifier.bibliographicCitationClinical therapeutics, 37(8). : 1726-1739, 2015-
dc.identifier.eissn1879-114X-
dc.relation.journalidJ001492918-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
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