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Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.

Choi MG, Rhee PL, Park H, Lee OY, Lee KJ, Choi SC, Seol SY, Chun HJ, Rew JS, Lee DH, Song GA, Jung HY, Jeong HY, Sung IK, Lee JS, Lee ST, Kim SK, Shin YW - J Neurogastroenterol Motil (2015)

Bottom Line: The safety profile of both drugs was comparable.DA-9701 significantly improves symptoms in patients with FD.DA-9701 showed non-inferior efficacy to itopride with com-parable safety.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea.

ABSTRACT

Background/aims: Therapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients.

Methods: Patients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspep-tic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire.

Results: We randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as ≥ 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable.

Conclusions: DA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with com-parable safety.

No MeSH data available.


Related in: MedlinePlus

Summary of patient flow. Subjects who discontinued intervention or had a major violation were excluded from per protocol analysis. Some subjects had overlapping exclusion factors.
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f1-jnm-21-414: Summary of patient flow. Subjects who discontinued intervention or had a major violation were excluded from per protocol analysis. Some subjects had overlapping exclusion factors.

Mentions: A total of 545 patients were screened, and finally 464 patients were randomly allocated (Figure). The most frequent reasons for exclusion prior to randomization were organic diseases, co-morbidity and dyspepsia symptoms that did not meet the severity criteria during the baseline period. Nine percent of patients in the DA-9701 (21/231) and itopride (22/233) groups did not complete the study. Four hundred and fifty-five patients were available for the FA analysis: 228 for DA-9701 versus 227 for itopride. Data on 375 patients were available for the per protocol analysis: 185 for DA-9701 versus 190 for itopride. Patients randomized to DA-9701 or itopride had similar demography, body mass index, and symptom scores at the baseline (Table 1).


Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.

Choi MG, Rhee PL, Park H, Lee OY, Lee KJ, Choi SC, Seol SY, Chun HJ, Rew JS, Lee DH, Song GA, Jung HY, Jeong HY, Sung IK, Lee JS, Lee ST, Kim SK, Shin YW - J Neurogastroenterol Motil (2015)

Summary of patient flow. Subjects who discontinued intervention or had a major violation were excluded from per protocol analysis. Some subjects had overlapping exclusion factors.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4496904&req=5

f1-jnm-21-414: Summary of patient flow. Subjects who discontinued intervention or had a major violation were excluded from per protocol analysis. Some subjects had overlapping exclusion factors.
Mentions: A total of 545 patients were screened, and finally 464 patients were randomly allocated (Figure). The most frequent reasons for exclusion prior to randomization were organic diseases, co-morbidity and dyspepsia symptoms that did not meet the severity criteria during the baseline period. Nine percent of patients in the DA-9701 (21/231) and itopride (22/233) groups did not complete the study. Four hundred and fifty-five patients were available for the FA analysis: 228 for DA-9701 versus 227 for itopride. Data on 375 patients were available for the per protocol analysis: 185 for DA-9701 versus 190 for itopride. Patients randomized to DA-9701 or itopride had similar demography, body mass index, and symptom scores at the baseline (Table 1).

Bottom Line: The safety profile of both drugs was comparable.DA-9701 significantly improves symptoms in patients with FD.DA-9701 showed non-inferior efficacy to itopride with com-parable safety.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea.

ABSTRACT

Background/aims: Therapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients.

Methods: Patients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspep-tic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire.

Results: We randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as ≥ 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable.

Conclusions: DA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with com-parable safety.

No MeSH data available.


Related in: MedlinePlus