Trial Outcomes & Findings for A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors (NCT NCT02019264)

NCT ID: NCT02019264

Last Updated: 2019-07-16

Results Overview

The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14673 participants

Primary outcome timeframe

Baseline up to Month 42

Results posted on

2019-07-16

Participant Flow

Participants took part in the study at investigative sites in the United States, Bahamas, Canada, Mexico, Chile, New Zealand, Poland, and Australia from 24 Jan 2014 to 14 May 2018.

A total of 14,673 participants were screened and enrolled, of which 2673 participants were screen failures and 12,000 were randomized to receive lorcaserin hydrochloride (HCl) or placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg Participants received lorcaserin HCL 10 milligram (mg), tablets, orally, twice daily for up to 52 months.
Overall Study STARTED	6000	6000
Overall Study Safety Analysis Set	5992	5995
Overall Study COMPLETED	5752	5793
Overall Study NOT COMPLETED	248	207

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg Participants received lorcaserin HCL 10 milligram (mg), tablets, orally, twice daily for up to 52 months.
Overall Study Not treated	6	4
Overall Study Lost to Follow-up	50	47
Overall Study Withdrawal by Subject	142	117
Overall Study Administrative reason	36	28
Overall Study Missing	14	11

Baseline Characteristics

A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6000 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=6000 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.	Total n=12000 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 8.31 • n=5 Participants	63.5 years STANDARD_DEVIATION 8.33 • n=7 Participants	63.6 years STANDARD_DEVIATION 8.32 • n=5 Participants
Sex: Female, Male Female	2186 Participants n=5 Participants	2112 Participants n=7 Participants	4298 Participants n=5 Participants
Sex: Female, Male Male	3814 Participants n=5 Participants	3888 Participants n=7 Participants	7702 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	536 Participants n=5 Participants	502 Participants n=7 Participants	1038 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5464 Participants n=5 Participants	5498 Participants n=7 Participants	10962 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) Asian	74 Participants n=5 Participants	85 Participants n=7 Participants	159 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) Black or African American	466 Participants n=5 Participants	454 Participants n=7 Participants	920 Participants n=5 Participants
Race (NIH/OMB) White	5331 Participants n=5 Participants	5309 Participants n=7 Participants	10640 Participants n=5 Participants
Race (NIH/OMB) More than one race	85 Participants n=5 Participants	96 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Month 42

Population: The total time analysis set using the intent-to-treat (ITT) set, events were counted that occurred while participants were on and off treatment. Participants with no events were censored at their last study contact or at the visit following sponsor notification of study completion, whichever occurred first.

The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=6000 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=6000 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

PRIMARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The total time analysis set used the ITT set, events were counted that occurred while participants were on and off treatment. Participants with no events were censored at their last study contact or at the visit following Sponsor Notification of Study Completion, whichever occurred first.

The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=6000 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=6000 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to First Occurrence of MACE+	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: Prediabetes and total time analysis set used ITT set: without a history of any type of diabetes and who were prediabetic at baseline; events were counted that occurred while participants were on, off treatment; participants with no events were censored at last study contact/at visit after notification of study completion, whichever occurred first.

Time from randomization to conversion to T2DM was defined as first occurrence of any component of the 2013 American Diabetes Association (ADA) Diagnostic Criteria (ADA, 2013) in participants with prediabetes at baseline. The diagnostic criteria were met if a participant had unequivocal hyperglycemia (random plasma glucose greater than or equal to (\>=) 200 milligram per deciliter (mg/dL) (11.1 millimole per liter \[mmol/L\]) with classic symptoms of hyperglycemia or hyperglycemic crisis) or any of the following criteria were observed and subsequently confirmed on repeat laboratory testing such as: glycosylated hemoglobin (HbA1c) \>=to 6.5%; fasting plasma glucose (FPG) \>=126 mg/dL (7.0 mmol/L); 2-hour plasma glucose \>=200 mg/dL (11.1 mmol/L) by an oral glucose tolerance test (OGTT). The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=1976 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=2015 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The total time analysis set used the ITT set, events counted occurred while participants were on and off treatment. Participants with no events were censored at last study contact or at the visit following Sponsor Notification of Study Completion, whichever first.

The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or HF, or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=6000 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=6000 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to First Occurrence of the Individual Components of MACE+ MI	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.
Time From Randomization to First Occurrence of the Individual Components of MACE+ Stroke	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.
Time From Randomization to First Occurrence of the Individual Components of MACE+ CV death	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.
Time From Randomization to First Occurrence of the Individual Components of MACE+ Hospitalization for unstable angina	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.
Time From Randomization to First Occurrence of the Individual Components of MACE+ HF	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.
Time From Randomization to First Occurrence of the Individual Components of MACE+ Coronary revascularization	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=6000 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=6000 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Event of All-cause Mortality	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The prediabetes analysis set included all participants in the ITT set without a history of any type of diabetes and who were prediabetic at baseline.

Normal glucose homeostasis was defined as HbA1c less than or equal to (\<=) 5.6% and FPG \< 100 mg/dL without any antidiabetic treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=1976 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=2015 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The nondiabetes analysis set included all participants in the ITT set without a history of any type of diabetes at baseline.

The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=2569 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=2615 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline, and Month 6

Population: The T2DM analysis set included all participants in the ITT set who had T2DM at baseline. The T2DM analysis set where data was available at specified time points.

Outcome measures

Outcome measures
Measure	Placebo n=3403 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=3362 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline Baseline	6.99 percentage of HbA1c Standard Deviation 1.066	7.01 percentage of HbA1c Standard Deviation 1.082
Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline Change at Month 6	0.06 percentage of HbA1c Standard Deviation 0.777	-0.33 percentage of HbA1c Standard Deviation 0.785

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The ITT set included all randomized participants regardless of whether they took study drug or not. This set was the same as the full analysis set.

New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (albumin-to-creatinine ratio \[ACR\] \>=30mcg/mg and ACR\>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased \>=30% from Baseline during treatment), newly developed chronic kidney disease (CKD) (eGFR \>=90 milliliter per minute per 1.73 \[mL/min/1.73\]body surface area (BSA) and without kidney damage at Baseline changed to CKD Stage 1/higher as per National Kidney Foundation \[NKF\] Guidelines \[2002\]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines \[2002\] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times Baseline value and \>=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=6000 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=6000 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The prediabetes analysis set included all participants in the ITT set without a history of any type of diabetes and who were prediabetic at baseline.

New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR \>=30mcg/mg and ACR \>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased \>=30% from baseline during treatment), CKD (eGFR \>=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines \[2002\]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines \[2002\] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and \>=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=1976 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=2015 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The T2DM analysis set included all participants in the ITT set who had T2DM at baseline.

New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR \>=30 mcg/mg and ACR \>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased \>=30% from baseline during treatment), CKD (eGFR \>=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines \[2002\]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines \[2002\] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and \>=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=3403 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=3362 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Baseline up to end of study (Month 56)

Population: The T2DM analysis set included all participants in the ITT set who had T2DM at baseline.

Improvement in renal function was defined as first occurrence of regression of albuminuria or regression of CKD. Regression of albuminuria was defined as when participants with macroalbuminuria at baseline developed microalbuminuria or nonalbuminuria (ACR \<30 mcg/mg in spot urine), or participants with microalbuminuria at baseline became nonalbuminuric, and ACR value decreased \>= 30% from previous assessment during treatment. Regression of CKD defined as when participants with CKD Stage 1 or higher at baseline improved to normal or lower stages by NKF guidelines (eGFR \>=90 with albuminuria at baseline improved to eGFR \>=90 without albuminuria, or eGFR 60 to 89 at baseline became eGFR \>=90 with or without albuminuria, or eGFR between 30 to 59 at baseline improved to \>60 mL/min/1.73 BSA) during treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Outcome measures

Outcome measures
Measure	Placebo n=3403 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=3362 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.	NA days Median time and 95% confidence interval could not be calculated since quartile was not estimable due to higher number of censored participants.

SECONDARY outcome

Timeframe: Months 6 and 12

Population: The FDA-defined valvulopathy analysis set included all participants in the ITT set without FDA-defined valvulopathy at baseline. The FDA-defined valvulopathy analysis set where data was available at specified time point.

Outcome measures

Outcome measures
Measure	Placebo n=1935 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=1925 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes Month 6	1.4 percentage of participants	2.1 percentage of participants
Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes Month 12	1.5 percentage of participants	1.8 percentage of participants

SECONDARY outcome

Timeframe: Months 6 and 12

Population: The ITT analysis set in participants with FDA-defined valvulopathy at baseline was used. The ITT analysis set in participants with FDA-defined valvulopathy at baseline where data was available at specified time point.

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=225 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy Month 6	2.1 percentage of participants	3.5 percentage of participants
Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy Month 12	1.7 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: The ITT analysis set-participants in ECHO substudy included all randomized participants regardless of whether they took study drug or not. The ITT analysis set-participants in the ECHO substudy, where data was available at specified time points.

Outcome measures

Outcome measures
Measure	Placebo n=2167 Participants Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=2151 Participants Participants received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.
Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure Baseline	26.4354 Millimeter of mercury (mmHg) Standard Deviation 7.66312	26.2029 Millimeter of mercury (mmHg) Standard Deviation 7.54123
Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure Change at Month 12	-0.6418 Millimeter of mercury (mmHg) Standard Deviation 6.81716	-0.8223 Millimeter of mercury (mmHg) Standard Deviation 7.23770

Adverse Events

Placebo

Serious events: 2021 serious events

Other events: 4788 other events

Deaths: 202 deaths

Lorcaserin 10 mg

Serious events: 1974 serious events

Other events: 4946 other events

Deaths: 219 deaths

Serious adverse events

Other adverse events

Additional Information

Eisai Medical Information

Eisai Ltd

Phone: +1-888-274-2378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=5992 participants at risk Participants received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.	Lorcaserin 10 mg n=5995 participants at risk Participants received lorcaserin HCL 10 milligram (mg), tablets, orally, twice daily for up to 52 months.
Gastrointestinal disorders Constipation	4.1% 248/5992 • Number of events 268 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	5.6% 336/5995 • Number of events 362 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Gastrointestinal disorders Diarrhoea	5.4% 324/5992 • Number of events 362 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	7.0% 419/5995 • Number of events 478 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Gastrointestinal disorders Nausea	4.8% 286/5992 • Number of events 329 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	5.9% 356/5995 • Number of events 398 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
General disorders Fatigue	5.0% 302/5992 • Number of events 329 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	8.3% 496/5995 • Number of events 548 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
General disorders Oedema peripheral	5.7% 340/5992 • Number of events 385 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	4.5% 267/5995 • Number of events 294 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Infections and infestations Bronchitis	7.8% 468/5992 • Number of events 584 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	7.6% 455/5995 • Number of events 536 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Infections and infestations Nasopharyngitis	5.6% 338/5992 • Number of events 418 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	5.9% 353/5995 • Number of events 426 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Infections and infestations Upper respiratory tract infection	9.5% 567/5992 • Number of events 690 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	8.8% 528/5995 • Number of events 659 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Infections and infestations Urinary tract infection	6.7% 400/5992 • Number of events 575 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	7.3% 440/5995 • Number of events 593 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 452/5992 • Number of events 542 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	7.6% 457/5995 • Number of events 544 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Musculoskeletal and connective tissue disorders Back pain	7.5% 452/5992 • Number of events 496 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	7.6% 457/5995 • Number of events 496 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Nervous system disorders Dizziness	5.7% 340/5992 • Number of events 407 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	9.0% 537/5995 • Number of events 640 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Nervous system disorders Headache	4.6% 274/5992 • Number of events 316 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	6.4% 383/5995 • Number of events 445 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Respiratory, thoracic and mediastinal disorders Cough	5.1% 303/5992 • Number of events 351 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	6.3% 376/5995 • Number of events 431 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.2% 310/5992 • Number of events 347 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).	4.8% 285/5995 • Number of events 312 • From baseline up to 30 days after last dose of study drug (approximately 56 months) Adverse events were collected for the participants who were in the safety analysis set (all participants who received at least 1 dose of study drug and had at least one post dose safety assessment).