SAMSON Trial: 90% of statin complaints are nosebo effects

The SAMSON trial was demonstrated with a clever design by allowing patients to be half-confident that most of the side effects caused by statins will return to placebo.

In the N-of-1 trial, 60 patients were randomly randomized with 20 mg atorvastatin, placebo, and empty bottles for one month, blindly for one year, and their symptoms were checked in daily using the smartphone app.

Average symptom intensity on a 100-point scale was higher when people were taking pills-8.0 during the pillless month compared to 15.4 on placebo and 16.3 on statins (both) P<0.001)-However, there is no significant difference between placebo and statins (P= 0.39).

Comparing individual patients with their own results, placebo actually appeared to be more than twice as ill as statins due to some outliers between patients, said Dr. James Howard of Imperial College London. Virtually reported American Heart Association (AHA) Virtual Conference and Online New England Journal of Medicine..

Pooling patient-wide results, 90% of symptoms may be due to the so-called nosebo effect (0.90 ratio of untreated placebo to untreated statin).

When the data were provided, 30 of the 60 patients (who had previously stopped taking statins due to side effects that appeared within 2 weeks of initiation) succeeded in resuming statins for chronic use. Did.

The fact that statin-related complaints are a perceptual problem will not come as news to clinicians, commented Stephen Nissen, MD, MD, Cleveland Clinic.In front of him GAUSS-3 trial In 2016, 60% of intolerable muscular symptoms reported with multiple statins were shown to be not actually due to statins in about 60% of patients based on the blinded placebo challenge for enrollment.

“It gives a fairly consistent message that many statin intolerant patients can, in fact, tolerate statins if you work hard enough,” he said. Today’s MedPage..

At the clinic N-of-1 Challenge It may be useful for individual patients, but it is rewarding, Nissen said.

“It’s very encouraging, it shows that it’s a strategy we can potentially adopt,” he said. “Of course the problem is that you have to agree with people to do this. That’s the problem. How many doctors give informed consent to get patients to do this? How easy is atorvastatin placebo? Is it available to? Practical Problems with doing this in clinical practice. “

“Very elegant,” said Salim Vilani, MD, of Baylor College of Medicine in Houston and the American College of Cardiology, but the results could have been invalidated because the trial did not use a washout period between treatments. He commented that he had sex. Of the Chairman of the Cardiovascular Disease Council.

“In reality, many patients develop symptoms after two weeks, so these findings cannot be generalized,” said Francine Welty, AHA session debater at the Beth Israel Dicones Medical Center in Boston. MD, PhD warned. she is, Search trial, Almost all people with a genetic predisposition to statin-induced toxicity who developed muscle pain did so beyond the first month of treatment.

“The side effects of non-drug-related drugs are often greatest in the first few weeks of treatment and tend to diminish over time,” she said.

Samsung The findings argued that doctors should not deny complaints of statin-related muscles and other symptoms.

“These results also show 10% of the effects associated with statin therapy,” he said. Today’s MedPage.. Accept the patient’s symptoms, And talking about what to do now, he suggested from his experience running a dyslipidemia clinic. “Almost all of these reassure patients Side effects It’s reversible, [explain] What are the benefits of receiving statin therapy, working with patients, and having a positive attitude? “

These discussions take time, but are worth it. He noted the potentially life-saving effects of high-risk individuals and the fact that so many participants are happy to return to statins.