STATIC - Statin Termination in Cancer

Summary

There are many guidelines on when to start drug treatment, but surprisingly few guidelines on how and when to stop drugs. For example, there are currently no clear guidelines on when to stop preventive medications such as statins in patients in palliative cancer care. According to previous studies, these drugs are often deprescribed far too late in the process, often close to death. This can lead to unwanted side effects, such as muscle weakness, increased fatigue, and also contribute to unnecessary drug costs and unnecessary environmental impact. In the STATIC I study the safety and effects of early deprescribing of statins in palliative cancer care is explored. The primary aim of the STATIC study is to study the change in LDL-levels (mmol/L) after statin termination. The secondary outcomes includes change in levels of other steroids (cholesterol, HDL, Q10, 25-hydroxyvitamin D, lanosterol), change in muscle strength, cardiovascular events, fatigue and quality of life after statin deprescribing. STATIC I is a pilot study to optimize the design for the randomized study STATIC II. The study aim at including 40 patients with advanced cancer within specialized palliative care with an expected survival time \>1 month to \<1 year (surprise question 1 year). At start of the study statins are deprescribed and the patients are followed for 12 weeks. Data collection is performed at baseline, 2, 4, 8 and 12 weeks. A control group (n=40) comprising patients with advanced cancer and no ongoing statin treatment, are included from the same specialized palliative care units. The control group is followed for 12 weeks regarding muscle strength and symptom burden. The current studies can provide important and valuable knowledge on the safety and effects of early describing.

Eligibility

Inclusion Criteria intervention arm:

* ≥ 18 years,
* "No"-answer to the "surprise question" 1 year: Would you be surprised if this patient died in the next year? (this is a common and validated prognostic tool in palliative care)
* advanced cancer
* ongoing palliative care at the the unit study units
* treatment with statins ≥ 3 months for primary or secondary prevention before study inclusion

Inclusion Criteria control-group:

* Same as above but no statin treamnet

Exclusion Criteria:h

* Cognitive impairment
* Does not understand the Swedish language
* Known homozygous or double heterozygous familial hypercholesterolemia
* Active cardiovascular disease or sufficient risk of active cardiovascular disease that requires ongoing medication with statins (assessed by a specialist in cardiology)
* myositis symptoms
* Other contraindications to deprescribe statins.

Conditions1

Interventions1

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