Trial Outcomes & Findings for Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia (NCT NCT00889226)

NCT ID: NCT00889226

Last Updated: 2019-09-17

Results Overview

compare the proportion of patients achieving LDL- C\<100mg/dL

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 161 participants
• Primary outcome timeframe: After 16wk drug administration
• Results posted on: 2019-09-17

Participant Flow

Participant milestones

Measure	Pitavastatin Group Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks	Atorvastatin Group Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Overall Study STARTED	83	78
Overall Study COMPLETED	58	43
Overall Study NOT COMPLETED	25	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pitavastatin Group n=83 Participants Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks	Atorvastatin Group n=78 Participants Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks	Total n=161 Participants Total of all reporting groups
Age, Continuous	59.6 years n=83 Participants	59.1 years n=78 Participants	59.3 years n=161 Participants
Sex: Female, Male Female	55 Participants n=83 Participants	54 Participants n=78 Participants	109 Participants n=161 Participants
Sex: Female, Male Male	28 Participants n=83 Participants	24 Participants n=78 Participants	52 Participants n=161 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	83 participants n=83 Participants	78 participants n=78 Participants	161 participants n=161 Participants

PRIMARY outcome

Timeframe: After 16wk drug administration

compare the proportion of patients achieving LDL- C<100mg/dL

Outcome measures

Measure	Pitavastatin Group n=80 Participants Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks	Atorvastatin Group n=68 Participants Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Proportion of Patients Achieving LDL- C<100mg/dL	61 Participants	54 Participants

SECONDARY outcome

Timeframe: After 16wk drug administration

The change of LDL-C between at 16-week and baseline

Outcome measures

Measure	Pitavastatin Group n=80 Participants Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks	Atorvastatin Group n=68 Participants Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
The Change of LDL-C	-69.8 mg/dl Standard Deviation 22.5	-70.9 mg/dl Standard Deviation 28.2

Adverse Events

Pitavastatin Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Atorvastatin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pitavastatin Group n=81 participants at risk Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks	Atorvastatin Group n=70 participants at risk Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Respiratory, thoracic and mediastinal disorders coughing	3.7% 3/81 • Number of events 3 • 16 weeks	0.00% 0/70 • 16 weeks

Additional Information

Dr. Hoyoung Sohn

CMC

Phone: 82-2-222-2222

Email: abc@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place