Lipid Metabolism Disorder
Conditions
Keywords
Lipid metabolism disorder
Brief summary
The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are 18 years of age or older with lipid disorder treated with nicotinic acid/laropiprant
Exclusion criteria
* Patient is currently participating in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Lipid Panel Control | From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22) | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Reported Adverse Events | Up to 22 weeks |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intent-to-Treat Population 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. | 2,359 |
| Total | 2,359 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Completion Status Unknown | 459 |
| Overall Study | Premature Discontinuation | 254 |
Baseline characteristics
| Characteristic | Intent-to-Treat Population |
|---|---|
| Age, Continuous | 61.1 years |
| Region of Enrollment Germany | 2359 participants |
| Sex/Gender, Customized Female | 776 participants |
| Sex/Gender, Customized Male | 1572 participants |
| Sex/Gender, Customized Not reported | 11 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,390 |
| serious Total, serious adverse events | 20 / 2,390 |
Outcome results
Primary
Number of Participants With Lipid Panel Control
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated Within a Disease Management Program | Number of Participants With Lipid Panel Control | No lipid parameter | 70 participants |
| Patients Treated Within a Disease Management Program | Number of Participants With Lipid Panel Control | 1 lipid parameter | 249 participants |
| Patients Treated Within a Disease Management Program | Number of Participants With Lipid Panel Control | Not Reported | 428 participants |
| Patients Treated Within a Disease Management Program | Number of Participants With Lipid Panel Control | 2 lipid parameters | 245 participants |
| Patients Treated Within a Disease Management Program | Number of Participants With Lipid Panel Control | 3 lipid parameters | 232 participants |
| Patients Treated Outside a Disease Management Program | Number of Participants With Lipid Panel Control | 2 lipid parameters | 231 participants |
| Patients Treated Outside a Disease Management Program | Number of Participants With Lipid Panel Control | 3 lipid parameters | 194 participants |
| Patients Treated Outside a Disease Management Program | Number of Participants With Lipid Panel Control | No lipid parameter | 33 participants |
| Patients Treated Outside a Disease Management Program | Number of Participants With Lipid Panel Control | Not Reported | 422 participants |
| Patients Treated Outside a Disease Management Program | Number of Participants With Lipid Panel Control | 1 lipid parameter | 192 participants |
Secondary
Number of Participants Who Reported Adverse Events
Time frame: Up to 22 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Dyspepsia | 4 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Eructation | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Leukocytosis | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Acute Myocardial Infarction | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Angina Pectoris | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Cardiovascular Disorder | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Coronary Artery Insufficiency | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Tachycardia | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Eyelid Oedema | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Visual Impairment | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Abdominal Discomfort | 7 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Abdominal Distension | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Abdominal Pain | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Abdominal Pain Upper | 9 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Constipation | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Diarrhoea | 13 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Flatulence | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Gastrointestinal Disorder | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Irritable Bowel Syndrome | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Lip Swelling | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Nausea | 30 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Pancreatic Cyst | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Pancreatitis Chronic | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Vomiting | 9 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Adverse Event | 4 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Asthenia | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Chills | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Condition Aggravated | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Drug Ineffective | 6 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Drug Intolerance | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Face Oedema | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Fatigue | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Feeling Abnormal | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Feeling Hot | 9 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Hyperthermia | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Malaise | 4 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Oedema | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Oedema Peripheral | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Pain | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Swelling | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Cholelithiasis | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Hypersensitivity | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Diverticulitis | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Gastroenteritis | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Rash Pustular | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Splenic Abscess | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Accident | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Alanine Aminotransferase Increased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Cholesterol Abnormal | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Cholesterol Increased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Creatine Phosphokinase Increased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Creatinine Increased | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Glucose Abnormal | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Glucose Fluctuation | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Glucose Increased | 5 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Pressure Decreased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Triglycerides Abnormal | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Triglycerides Increased | 5 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Blood Uric Acid Increased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Gamma-Glutamyltransferase Increased | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Lipids Abnormal | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Lipids Increased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Lipoprotein (A) Increased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Weight Increased | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Diabetes Mellitus | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Diabetes Mellitus Inadequate Control | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Gout | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Hyperglycaemia | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Lactose Intolerance | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Lipid Metabolism Disorder | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Arthralgia | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Muscular Weakness | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Musculoskeletal Discomfort | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Musculoskeletal Stiffness | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Myalgia | 6 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Pain In Extremity | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Spondylitis | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Multiple Myeloma | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Burning Sensation | 4 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Dizziness | 10 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Dysaesthesia | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Headache | 9 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Hypotonia | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Paraesthesia | 10 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Anxiety | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Depressed Mood | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Depression | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Fear | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Insomnia | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Loss of Libido | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Restlessness | 7 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Sleep Disorder | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Asthma | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Dyspnoea | 4 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Increased Upper Airway Secretion | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Cold Sweat | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Dermatitis Allergic | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Eczema | 4 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Erythema | 17 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Hyperhidrosis | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Petechiae | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Pruritus | 31 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Pruritus Generalised | 7 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Rash | 9 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Skin Burning Sensation | 3 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Skin Disorder | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Skin Reaction | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Skin Swelling | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Swelling Face | 2 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Urticaria | 4 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Appendicectomy | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Pain Management | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Vascular Graft | 1 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Flushing | 54 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Hot Flush | 8 participants |
| Patients Treated Within a Disease Management Program | Number of Participants Who Reported Adverse Events | Hypertension | 1 participants |