Phase 2
N=24
Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell Disease
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT01702246 ↗Enrolled (actual)
24
Serious AEs
26.3%
Results posted
Dec 2016
Primary outcome: Primary: Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin — 0.2365; 0.1311 proportion of pain days — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Simvastatin (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- UCSF Benioff Children's Hospital Oakland
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin |
0.2365; 0.1311 | 0.005 sig |
| SECONDARY Change in Plasma High Sensitivity C-reactive Protein |
7.2; 2.989 | 0.003 sig |
| SECONDARY Change From Baseline in Total Cholesterol Level After Treatment With Simvastatin |
124; 101 | 0.001 sig |
Summary
The purpose of this study is to determine whether simvastatin is effective in reducing the frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.
Eligibility Criteria
Inclusion Criteria
- Sickle cell disease (HbSS or S/β0 thalassemia)
- ≥ 3 vaso-occlusive pain episodes in the year prior to enrollment
- Age ≥ 10 years
- Weight > 30 kg
Exclusion Criteria
- Creatine kinase (CK) > UNL
- Total cholesterol 1.5-fold UNL)
- Hepatic dysfunction (ALT > 2-fold UNL)
- Treatment with drugs having known metabolic interactions with statins within the past 30 days
- Vaso-occlusive pain requiring hospitalization within past 30 days
- Red blood cell transfusion within the past 30 days
- Pregnancy/lactation
- Musculoskeletal disorder associated with an elevated CK level
- Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin)
- Chronic pain caused by avascular necrosis of the bone (AVN) or leg ulcers, and pain due to trauma or causes other than SCD.
- Major cognitive or neurological impairments that may hamper the ability to use the smartphone or complete the electronic pain diary in this study
Data sourced from ClinicalTrials.gov (NCT01702246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.