Statins for High Cholesterol in Children
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Children's Mercy Hospital Kansas City
Must be taking: Rosuvastatin
Must not be taking: OATP1B1 inducers/inhibitors
Disqualifiers: Pregnancy, Cardiovascular defects, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?
Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin
Will I have to stop taking my current medications?
If you are currently taking statins, you will need to stop them for at least 4 weeks before starting the trial and throughout its duration. The protocol does not specify about other medications, but if they interact with statins, you may need to stop them as well.
What data supports the effectiveness of the drug Rosuvastatin for high cholesterol in children?
Research shows that Rosuvastatin, a type of statin, is effective in lowering bad cholesterol (LDL-C) levels in both adults and children. Studies have demonstrated that it can significantly reduce cholesterol levels, making it a potentially beneficial treatment for children with high cholesterol.12345
Is rosuvastatin safe for use in humans?
Rosuvastatin is generally considered safe with mostly acceptable side effects, but rare serious side effects like ischaemic colitis (inflammation of the colon due to reduced blood flow) have been reported. It is well tolerated with no evidence of liver or muscle toxicity in preliminary studies.13567
How is the drug Rosuvastatin different from other treatments for high cholesterol in children?
Rosuvastatin is unique because it is a statin, which works by blocking a specific enzyme in the liver to reduce cholesterol production, making it effective in lowering 'bad' cholesterol (LDL) levels. Unlike some other treatments, it is specifically designed to target cholesterol production, which can be particularly beneficial for children with high cholesterol.89101112
Research Team
Eligibility Criteria
This trial is for obese and non-obese children and adolescents aged 8-21 with high LDL cholesterol levels who have a specific genotype (SLCO1B1 c.521TT). They must not be on statin therapy, can't be pregnant, should not have significant heart defects or unsafe metal implants for MRI, and must be able to swallow tablets.Inclusion Criteria
LDL cholesterol >130mg/dl (>95% percentile)
Provide informed permission-assent (<18 yrs.) or consent (≥18 yrs.)
I am between 8 and 21 years old.
See 3 more
Exclusion Criteria
I cannot swallow pills.
Pregnancy
Non-fasting
See 8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline Mevalonate and MRI Imaging to assess liver adiposity
1-2 weeks
Treatment
Participants receive rosuvastatin to evaluate the effect of liver fat percentage on statin disposition and response
2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Rosuvastatin (HMG-CoA Reductase Inhibitor)
Trial OverviewThe study tests the effects of Rosuvastatin (10mg) on liver fat in kids with high cholesterol. It's an open-label trial meaning everyone knows what treatment they're getting. The focus is on how body fat influences the drug's transport and effectiveness in the liver.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Mevalonate Change After RosuvastatinExperimental Treatment1 Intervention
Group II: Baseline Mevalonate and MRI ImagingActive Control1 Intervention
Rosuvastatin is already approved in Canada, Japan for the following indications:
Approved in Canada as Crestor for:
- Hypercholesterolemia
- Mixed dyslipidemia
- Prevention of cardiovascular disease
Approved in Japan as Crestor for:
- Hypercholesterolemia
- Familial hypercholesterolemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Mercy HospitalKansas City, MO
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Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor
Trials
261
Patients Recruited
941,000+
Findings from Research
In the JUPITER trial, rosuvastatin significantly reduced the occurrence of major cardiovascular events in healthy individuals aged ≥60 years (women) or ≥50 years (men) with normal LDL-C levels but elevated hsCRP levels, demonstrating its efficacy in primary prevention of cardiovascular disease.
Rosuvastatin was well tolerated, with most side effects being mild to moderate, and it effectively lowered both LDL-C and hsCRP levels, although the exact mechanism of its benefits remains unclear.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Rosuvastatin: a review of its use in the prevention of cardiovascular disease in apparently healthy women or men with normal LDL-C levels and elevated hsCRP levels.Carter, NJ.[2015]
Statins, which inhibit the enzyme HMG-CoA reductase, have been proven to be both safe and effective in treating hyperlipidemia in adults and may also benefit children with hypercholesterolemia.
In studies lasting up to three years, six different statins (lovastatin, fluvastatin, pravastatin, simvastatin, atorvastatin, and rosuvastatin) have shown significant reductions in total cholesterol and LDL cholesterol levels in children.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Use of statins in children].Tapia Ceballos, L., Picazo Angelín, B., Ruiz García, C.[2019]
In a study of 502 patients with primary hypercholesterolemia, rosuvastatin (5 mg and 10 mg) significantly reduced LDL cholesterol levels by 42% and 49%, respectively, outperforming pravastatin and simvastatin, which reduced LDL-C by 28% and 37%.
Rosuvastatin 10 mg achieved National Cholesterol Education Program (NCEP) treatment goals in 87% of patients, demonstrating its superior efficacy compared to pravastatin (53%) and simvastatin (64%), while all treatments were well tolerated.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study.Paoletti, R., Fahmy, M., Mahla, G., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Rosuvastatin--a highly effective new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor: review of clinical trial data at 10-40 mg doses in dyslipidemic patients.Schuster, H.[2017]
Rosuvastatin is a powerful statin that effectively lowers total cholesterol, LDL cholesterol, triglycerides, and apolipoprotein B, potentially achieving better results than other statins, making it a promising option for treating hyperlipidaemia.
It is well tolerated with a low risk of liver or muscle toxicity, and its once-daily dosing and minimal drug interactions make it a convenient choice for patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical rationale for rosuvastatin, a potent new HMG-CoA reductase inhibitor.Hanefeld, M.[2015]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Rosuvastatin: do we need another statin?Ho, C.[2010]
Rosuvastatin, a commonly prescribed medication for high cholesterol, is generally safe but can lead to rare and serious side effects, such as ischaemic colitis.
In a case study of a 64-year-old woman, ischaemic colitis was diagnosed after starting rosuvastatin, and her symptoms resolved completely after discontinuing the drug, highlighting the need for awareness of this potential adverse reaction.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Adverse drug reaction: rosuvastatin as a cause for ischaemic colitis in a 64-year-old woman.Tan, J., Pretorius, CF., Flanagan, PV., et al.[2021]
In a study of 22 youths treated with risperidone for an average of 4.9 months, there was a significant average weight gain of 7.0 kg, indicating a notable side effect of this medication.
While no significant changes in triglyceride or cholesterol levels were observed overall, weight gain was strongly correlated with triglyceride level changes, suggesting the need for regular monitoring of these parameters in children and adolescents on risperidone.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Triglyceride, cholesterol and weight changes among risperidone-treated youths. A retrospective study.Martin, A., L'Ecuyer, S.[2019]
Antipsychotic medications, particularly second and third-generation types, have been shown to be effective in treating psychosis in children and adolescents, but they carry a risk of significant side effects, especially metabolic syndrome.
Clozapine is highlighted as the most effective antipsychotic for both adults and treatment-resistant children and adolescents, with specific guidance provided for managing its side effects.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Psychopharmacologic treatment of psychosis in children and adolescents: efficacy and management.Kranzler, HN., Cohen, SD.[2014]
In a study of 73 children with Tourette syndrome treated with antipsychotics over an average of 39.6 months, 45% developed lipid abnormalities, indicating a significant risk of metabolic side effects associated with these medications.
While neurologic complications were rare, occurring in only 3 out of 73 children, the findings highlight the importance of regular monitoring of growth and lipid profiles to manage the risks of antipsychotic treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Complications of antipsychotic therapy in children with tourette syndrome.Pringsheim, T., Pearce, M.[2010]
In a study of 13 adolescents with psychotic disorders, the prevalence of metabolic syndrome increased from 23% before starting clozapine to 46.2% after more than 6 months of treatment, indicating a significant risk associated with the medication.
Clozapine was effective in reducing symptoms of psychosis, as shown by a significant decrease in PANSS scores, particularly in those who developed metabolic syndrome during treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Metabolic Disturbances, Side Effect Profile and Effectiveness of Clozapine in Adolescents.Grover, S., Hazari, N., Chakrabarti, S., et al.[2020]
In a study of 82 children and adolescents treated with clozapine for severe psychiatric disorders, 95% were discharged on the medication, indicating its potential effectiveness in this population.
Common adverse events included sedation (26.8%) and sialorrhea (17.1%), highlighting the importance of careful monitoring for side effects during treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Retrospective Multicenter Evaluation of Clozapine Use in Pediatric Patients Admitted for Acute Psychiatric Hospitalization.Steinauer, LM., Leung, JG., Burkey, BW., et al.[2019]
References
Rosuvastatin: a review of its use in the prevention of cardiovascular disease in apparently healthy women or men with normal LDL-C levels and elevated hsCRP levels. [2015]
[Use of statins in children]. [2019]
Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. [2019]
Rosuvastatin--a highly effective new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor: review of clinical trial data at 10-40 mg doses in dyslipidemic patients. [2017]
Clinical rationale for rosuvastatin, a potent new HMG-CoA reductase inhibitor. [2015]
Rosuvastatin: do we need another statin? [2010]
Adverse drug reaction: rosuvastatin as a cause for ischaemic colitis in a 64-year-old woman. [2021]
Triglyceride, cholesterol and weight changes among risperidone-treated youths. A retrospective study. [2019]
Psychopharmacologic treatment of psychosis in children and adolescents: efficacy and management. [2014]
Complications of antipsychotic therapy in children with tourette syndrome. [2010]
Metabolic Disturbances, Side Effect Profile and Effectiveness of Clozapine in Adolescents. [2020]
A Retrospective Multicenter Evaluation of Clozapine Use in Pediatric Patients Admitted for Acute Psychiatric Hospitalization. [2019]