The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 3/28/2019 |
| Start Date: | April 15, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Gretchen Benson |
| Email: | gbenson@mhif.org |
| Phone: | 612-863-4222 |
This study will enroll patients who previously were not able to tolerate being on a statin
medication due to muscle-related side effects. Research has shown that many people who have
muscle symptoms on statin therapy do not experience the same side effects if they try it
again later. This study is part of a larger effort to:
- See how common it is for patients to still be intolerant of statin medication after
trying it a second time; and
- For those patients who do tolerate being on a statin after trying it a second time, see
how common it is for them to still be taking the statin 3 months after completing the
main part of the study.
Patients who agree to participate will be given a 5 month randomly allocated supply of statin
and placebo and track their symptoms weekly.
medication due to muscle-related side effects. Research has shown that many people who have
muscle symptoms on statin therapy do not experience the same side effects if they try it
again later. This study is part of a larger effort to:
- See how common it is for patients to still be intolerant of statin medication after
trying it a second time; and
- For those patients who do tolerate being on a statin after trying it a second time, see
how common it is for them to still be taking the statin 3 months after completing the
main part of the study.
Patients who agree to participate will be given a 5 month randomly allocated supply of statin
and placebo and track their symptoms weekly.
This study is a single center, double-blinded randomized controlled trial for patients
eligible for statin therapy by current guidelines, but not on statin therapy due to a history
of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly
allocated 4-week blister packs of capsules containing either 20mg of rosuvastatin or placebo.
While blinded to treatment, patients will document the severity of musculoskeletal symptoms
every week using a numerical scale. The primary endpoint will be the difference between the
mean musculoskeletal symptom score while randomized to statin therapy compared to the mean
score while on placebo. After completion of the study, the results will be unblinded and
reviewed at a 6 month follow-up visit with the patient and, for patients with symptoms found
to not correlate with statin therapy, a trial of non-blinded statin therapy over the next 3
months will be recommended. This study will serve as a pilot study to determine the
feasibility and potential benefits of a larger multicenter trial with similar aims.
eligible for statin therapy by current guidelines, but not on statin therapy due to a history
of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly
allocated 4-week blister packs of capsules containing either 20mg of rosuvastatin or placebo.
While blinded to treatment, patients will document the severity of musculoskeletal symptoms
every week using a numerical scale. The primary endpoint will be the difference between the
mean musculoskeletal symptom score while randomized to statin therapy compared to the mean
score while on placebo. After completion of the study, the results will be unblinded and
reviewed at a 6 month follow-up visit with the patient and, for patients with symptoms found
to not correlate with statin therapy, a trial of non-blinded statin therapy over the next 3
months will be recommended. This study will serve as a pilot study to determine the
feasibility and potential benefits of a larger multicenter trial with similar aims.
Inclusion Criteria:
- Adults age 21-75 years old
- Statin eligible according to the 2013 ACC/AHA cholesterol guidelines, including
individuals with:
- Known ASCVD
- Diabetes
- LDL-C > 190mg/dl
- 10-year ASCVD risk >7.5%
- Statin intolerant
- Defined by discontinuation of at least 2 separate statins due to potential
musculoskeletal side effects
Exclusion Criteria:
- Women who are pregnant, nursing or attempting to become pregnant.
- Individuals deemed to be at very high CVD risk and therefore appropriate for a PCSK9
inhibitor including:
- Individuals with familial hypercholesterolemia with markedly elevated LDL-C
levels
- Individuals with known ASCVD and recurrent events
- Individuals who are not otherwise clinically indicated to take 20mg rosuvastatin
- Individuals who experienced severe reactions in the past, including:
- Rhabdomyolysis
- Severe myositis
- Anaphylaxis
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