Trial Outcomes & Findings for Lipid Management in Clinical Practice (MK-0524A-115) (NCT NCT01071278)

Last Updated: 2015-08-11

Results Overview

Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (\<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).

Recruitment status

COMPLETED

Target enrollment

2390 participants

Primary outcome timeframe

From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)

Results posted on

2015-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	All Evaluable Participants Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
Overall Study STARTED	2390
Overall Study COMPLETED	1677
Overall Study NOT COMPLETED	713

Reasons for withdrawal

Reasons for withdrawal
Measure	All Evaluable Participants Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
Overall Study Premature Discontinuation	254
Overall Study Completion Status Unknown	459

Baseline Characteristics

Lipid Management in Clinical Practice (MK-0524A-115)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intent-to-Treat Population n=2359 Participants Baseline characteristics were reported for the 2359 participants in the Intent-to-Treat (ITT) Population, which included all participants from the Evaluable Population who began therapy at or after Visit 1. The ITT Population excluded 31 of the 2390 evaluable participants who began treatment prior to Visit 1.
Age, Continuous	61.1 years n=5 Participants
Sex/Gender, Customized Male	1572 participants n=5 Participants
Sex/Gender, Customized Female	776 participants n=5 Participants
Sex/Gender, Customized Not reported	11 participants n=5 Participants
Region of Enrollment Germany	2359 participants n=5 Participants

PRIMARY outcome

Timeframe: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)

Population: Results are for the Intent-to-Treat (ITT) Population. Information regarding the participation in a disease management program was not reported for 63 participants in the ITT Population.

Outcome measures

Outcome measures
Measure	Patients Treated Within a Disease Management Program n=1224 Participants Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.	Patients Treated Outside a Disease Management Program n=1072 Participants Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
Number of Participants With Lipid Panel Control 1 lipid parameter	249 participants	192 participants
Number of Participants With Lipid Panel Control 2 lipid parameters	245 participants	231 participants
Number of Participants With Lipid Panel Control 3 lipid parameters	232 participants	194 participants
Number of Participants With Lipid Panel Control No lipid parameter	70 participants	33 participants
Number of Participants With Lipid Panel Control Not Reported	428 participants	422 participants

SECONDARY outcome

Timeframe: Up to 22 weeks

Outcome measures

Outcome measures
Measure	Patients Treated Within a Disease Management Program n=2390 Participants Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.	Patients Treated Outside a Disease Management Program Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
Number of Participants Who Reported Adverse Events Leukocytosis	1 participants	—
Number of Participants Who Reported Adverse Events Acute Myocardial Infarction	1 participants	—
Number of Participants Who Reported Adverse Events Angina Pectoris	1 participants	—
Number of Participants Who Reported Adverse Events Cardiovascular Disorder	1 participants	—
Number of Participants Who Reported Adverse Events Coronary Artery Insufficiency	1 participants	—
Number of Participants Who Reported Adverse Events Tachycardia	3 participants	—
Number of Participants Who Reported Adverse Events Eyelid Oedema	1 participants	—
Number of Participants Who Reported Adverse Events Visual Impairment	2 participants	—
Number of Participants Who Reported Adverse Events Abdominal Discomfort	7 participants	—
Number of Participants Who Reported Adverse Events Abdominal Distension	1 participants	—
Number of Participants Who Reported Adverse Events Abdominal Pain	3 participants	—
Number of Participants Who Reported Adverse Events Abdominal Pain Upper	9 participants	—
Number of Participants Who Reported Adverse Events Constipation	1 participants	—
Number of Participants Who Reported Adverse Events Diarrhoea	13 participants	—
Number of Participants Who Reported Adverse Events Dyspepsia	4 participants	—
Number of Participants Who Reported Adverse Events Eructation	1 participants	—
Number of Participants Who Reported Adverse Events Flatulence	3 participants	—
Number of Participants Who Reported Adverse Events Gastrointestinal Disorder	1 participants	—
Number of Participants Who Reported Adverse Events Irritable Bowel Syndrome	1 participants	—
Number of Participants Who Reported Adverse Events Lip Swelling	1 participants	—
Number of Participants Who Reported Adverse Events Nausea	30 participants	—
Number of Participants Who Reported Adverse Events Pancreatic Cyst	1 participants	—
Number of Participants Who Reported Adverse Events Pancreatitis Chronic	1 participants	—
Number of Participants Who Reported Adverse Events Vomiting	9 participants	—
Number of Participants Who Reported Adverse Events Adverse Event	4 participants	—
Number of Participants Who Reported Adverse Events Asthenia	1 participants	—
Number of Participants Who Reported Adverse Events Chills	2 participants	—
Number of Participants Who Reported Adverse Events Condition Aggravated	1 participants	—
Number of Participants Who Reported Adverse Events Drug Ineffective	6 participants	—
Number of Participants Who Reported Adverse Events Drug Intolerance	1 participants	—
Number of Participants Who Reported Adverse Events Face Oedema	1 participants	—
Number of Participants Who Reported Adverse Events Fatigue	2 participants	—
Number of Participants Who Reported Adverse Events Feeling Abnormal	1 participants	—
Number of Participants Who Reported Adverse Events Feeling Hot	9 participants	—
Number of Participants Who Reported Adverse Events Hyperthermia	1 participants	—
Number of Participants Who Reported Adverse Events Malaise	4 participants	—
Number of Participants Who Reported Adverse Events Oedema	1 participants	—
Number of Participants Who Reported Adverse Events Oedema Peripheral	2 participants	—
Number of Participants Who Reported Adverse Events Pain	2 participants	—
Number of Participants Who Reported Adverse Events Swelling	1 participants	—
Number of Participants Who Reported Adverse Events Cholelithiasis	1 participants	—
Number of Participants Who Reported Adverse Events Hypersensitivity	3 participants	—
Number of Participants Who Reported Adverse Events Diverticulitis	1 participants	—
Number of Participants Who Reported Adverse Events Gastroenteritis	1 participants	—
Number of Participants Who Reported Adverse Events Rash Pustular	1 participants	—
Number of Participants Who Reported Adverse Events Splenic Abscess	1 participants	—
Number of Participants Who Reported Adverse Events Accident	1 participants	—
Number of Participants Who Reported Adverse Events Alanine Aminotransferase Increased	1 participants	—
Number of Participants Who Reported Adverse Events Blood Cholesterol Abnormal	2 participants	—
Number of Participants Who Reported Adverse Events Blood Cholesterol Increased	1 participants	—
Number of Participants Who Reported Adverse Events Blood Creatine Phosphokinase Increased	1 participants	—
Number of Participants Who Reported Adverse Events Blood Creatinine Increased	3 participants	—
Number of Participants Who Reported Adverse Events Blood Glucose Abnormal	1 participants	—
Number of Participants Who Reported Adverse Events Blood Glucose Fluctuation	1 participants	—
Number of Participants Who Reported Adverse Events Blood Glucose Increased	5 participants	—
Number of Participants Who Reported Adverse Events Blood Pressure Decreased	1 participants	—
Number of Participants Who Reported Adverse Events Blood Triglycerides Abnormal	2 participants	—
Number of Participants Who Reported Adverse Events Blood Triglycerides Increased	5 participants	—
Number of Participants Who Reported Adverse Events Blood Uric Acid Increased	1 participants	—
Number of Participants Who Reported Adverse Events Gamma-Glutamyltransferase Increased	2 participants	—
Number of Participants Who Reported Adverse Events Lipids Abnormal	1 participants	—
Number of Participants Who Reported Adverse Events Lipids Increased	1 participants	—
Number of Participants Who Reported Adverse Events Lipoprotein (A) Increased	1 participants	—
Number of Participants Who Reported Adverse Events Weight Increased	1 participants	—
Number of Participants Who Reported Adverse Events Diabetes Mellitus	2 participants	—
Number of Participants Who Reported Adverse Events Diabetes Mellitus Inadequate Control	1 participants	—
Number of Participants Who Reported Adverse Events Gout	2 participants	—
Number of Participants Who Reported Adverse Events Hyperglycaemia	1 participants	—
Number of Participants Who Reported Adverse Events Lactose Intolerance	1 participants	—
Number of Participants Who Reported Adverse Events Lipid Metabolism Disorder	1 participants	—
Number of Participants Who Reported Adverse Events Arthralgia	1 participants	—
Number of Participants Who Reported Adverse Events Muscular Weakness	1 participants	—
Number of Participants Who Reported Adverse Events Musculoskeletal Discomfort	1 participants	—
Number of Participants Who Reported Adverse Events Musculoskeletal Stiffness	1 participants	—
Number of Participants Who Reported Adverse Events Myalgia	6 participants	—
Number of Participants Who Reported Adverse Events Pain In Extremity	1 participants	—
Number of Participants Who Reported Adverse Events Spondylitis	1 participants	—
Number of Participants Who Reported Adverse Events Multiple Myeloma	1 participants	—
Number of Participants Who Reported Adverse Events Burning Sensation	4 participants	—
Number of Participants Who Reported Adverse Events Dizziness	10 participants	—
Number of Participants Who Reported Adverse Events Dysaesthesia	1 participants	—
Number of Participants Who Reported Adverse Events Headache	9 participants	—
Number of Participants Who Reported Adverse Events Hypotonia	1 participants	—
Number of Participants Who Reported Adverse Events Paraesthesia	10 participants	—
Number of Participants Who Reported Adverse Events Anxiety	3 participants	—
Number of Participants Who Reported Adverse Events Depressed Mood	1 participants	—
Number of Participants Who Reported Adverse Events Depression	1 participants	—
Number of Participants Who Reported Adverse Events Fear	1 participants	—
Number of Participants Who Reported Adverse Events Insomnia	1 participants	—
Number of Participants Who Reported Adverse Events Loss of Libido	1 participants	—
Number of Participants Who Reported Adverse Events Restlessness	7 participants	—
Number of Participants Who Reported Adverse Events Sleep Disorder	1 participants	—
Number of Participants Who Reported Adverse Events Asthma	1 participants	—
Number of Participants Who Reported Adverse Events Dyspnoea	4 participants	—
Number of Participants Who Reported Adverse Events Increased Upper Airway Secretion	1 participants	—
Number of Participants Who Reported Adverse Events Cold Sweat	1 participants	—
Number of Participants Who Reported Adverse Events Dermatitis Allergic	1 participants	—
Number of Participants Who Reported Adverse Events Eczema	4 participants	—
Number of Participants Who Reported Adverse Events Erythema	17 participants	—
Number of Participants Who Reported Adverse Events Hyperhidrosis	3 participants	—
Number of Participants Who Reported Adverse Events Petechiae	1 participants	—
Number of Participants Who Reported Adverse Events Pruritus	31 participants	—
Number of Participants Who Reported Adverse Events Pruritus Generalised	7 participants	—
Number of Participants Who Reported Adverse Events Rash	9 participants	—
Number of Participants Who Reported Adverse Events Skin Burning Sensation	3 participants	—
Number of Participants Who Reported Adverse Events Skin Disorder	1 participants	—
Number of Participants Who Reported Adverse Events Skin Reaction	1 participants	—
Number of Participants Who Reported Adverse Events Skin Swelling	1 participants	—
Number of Participants Who Reported Adverse Events Swelling Face	2 participants	—
Number of Participants Who Reported Adverse Events Urticaria	4 participants	—
Number of Participants Who Reported Adverse Events Appendicectomy	1 participants	—
Number of Participants Who Reported Adverse Events Pain Management	1 participants	—
Number of Participants Who Reported Adverse Events Vascular Graft	1 participants	—
Number of Participants Who Reported Adverse Events Flushing	54 participants	—
Number of Participants Who Reported Adverse Events Hot Flush	8 participants	—
Number of Participants Who Reported Adverse Events Hypertension	1 participants	—

Adverse Events

All Evaluable Participants

Serious events: 20 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Evaluable Participants n=2390 participants at risk Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
Blood and lymphatic system disorders Leukocytosis	0.04% 1/2390 • Number of events 1
Cardiac disorders Acute Myocardial Infarction	0.04% 1/2390 • Number of events 1
Cardiac disorders Coronary Artery Insufficiency	0.04% 1/2390 • Number of events 1
Gastrointestinal disorders Lip Swelling	0.04% 1/2390 • Number of events 1
Gastrointestinal disorders Pancreatic Cyst	0.04% 1/2390 • Number of events 1
Gastrointestinal disorders Pancreatitis Chronic	0.04% 1/2390 • Number of events 1
General disorders Feeling Hot	0.04% 1/2390 • Number of events 1
General disorders Oedema Peripheral	0.04% 1/2390 • Number of events 1
Hepatobiliary disorders Cholelithiasis	0.04% 1/2390 • Number of events 1
Immune system disorders Hypersensitivity	0.04% 1/2390 • Number of events 1
Infections and infestations Diverticulitis	0.04% 1/2390 • Number of events 1
Infections and infestations Splenic Abscess	0.04% 1/2390 • Number of events 1
Injury, poisoning and procedural complications Accident	0.04% 1/2390 • Number of events 1
Investigations Blood Cholesterol Abnormal	0.04% 1/2390 • Number of events 1
Investigations Blood Creatinine Increased	0.08% 2/2390 • Number of events 2
Investigations Blood Triglycerides Abnormal	0.08% 2/2390 • Number of events 2
Investigations Blood Triglycerides Increased	0.04% 1/2390 • Number of events 1
Investigations Lipoprotein (A) Increased	0.04% 1/2390 • Number of events 1
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.04% 1/2390 • Number of events 1
Metabolism and nutrition disorders Lipid Metabolism Disorder	0.04% 1/2390 • Number of events 1
Musculoskeletal and connective tissue disorders Spondylitis	0.04% 1/2390 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple Myeloma	0.04% 1/2390 • Number of events 1
Psychiatric disorders Depression	0.04% 1/2390 • Number of events 1
Skin and subcutaneous tissue disorders Erythema	0.04% 1/2390 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus Generalised	0.04% 1/2390 • Number of events 1
Skin and subcutaneous tissue disorders Swelling Face	0.04% 1/2390 • Number of events 1
Surgical and medical procedures Appendicectomy	0.04% 1/2390 • Number of events 1
Surgical and medical procedures Pain Management	0.04% 1/2390 • Number of events 1
Skin and subcutaneous tissue disorders Skin Swelling	0.04% 1/2390 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MSD SHARP \& DOHME GmbH and its comarketing companies have exclusive rights to the use and evaluation of the data collected in this study.
Publication restrictions are in place

Restriction type: OTHER