March 3rd, 2014

A New Approach for the Statin-Intolerant Patient?

We are all well familiar with the patient who reports muscle symptoms with statins.  But just how should we deal with this?  How do we know that symptoms are due to the statin rather than some other factor?  The reported incidence of myalgia in clinical trials has been criticized on many fronts as inaccurate, underestimating the “real world” experience.

Clearly, one of the challenges is determining whether a patient’s symptoms are attributable to statin or some other cause. To assess this, a unique study design — an “n-of-1 trial” — has been purported as an effective way to limit biases in individual patients as each patient serves as his or her own control.  N-of-1 trials are single-patient, randomized, multiple crossover, blinded comparisons of an active treatment versus placebo.

In a study published today in the Annals of Internal Medicine, researchers at Western University in London, Ontario conducted a proof-of-concept study to assess the feasibility and potential value of n-of-1 trials in patients with statin-related myalgia.

Eight patients who had discontinued statin use due to myalgia were randomly assigned to statin therapy or placebo, up to three times each, for up to three weeks. Treatment periods were separated by three-week washout intervals to minimize carryover effects.   Seven patients completed the entire trial (three treatment pairs), and one completed two treatment pairs. For each n-of-1 trial, there was no clinically significant difference in myalgia or other pain measures.   Five patients resumed open-label statin treatment at the end of the trial.

The authors suggested that this type of trial is a potentially useful tool to examine myalgia caused by statin use in selected patients.

What do you think of this type of trial design?

How do you approach the statin intolerant patient now?

Would the n-of-1 approach be successful in your practice?

4 Responses to “A New Approach for the Statin-Intolerant Patient?”

  1. Joel Wolkowicz, MDCM says:

    O Canada! N-of-1 trial is not new. It was proposed to us in training in the 1980’s by a physician from McMaster University in Hamilton, Ont.

  2. This type of trial is quite plausible in these patients and makes a lot sense. As for treating statin intolerant patients – I’ve noticed many of patients are not exactly clear what myalgia truly are and are often confounded by other medical processes – I usually employ an every other day or three times a week schedule with potent statins with known fewer side effects and tend to get great results – I think treatment in these patients in addition to education required a decent amount of encouragement any support to deal with problems of they arise…

  3. Matthew Carr, MD says:

    I agree that the best approach has been Lipitor or crestor once a week and gradual increase to several times a week so called pulse rx. Very successful with this approach

  4. Enrique Guadiana, Cardiology says:

    My approach to statin intolerant patients is first to lower the dose, second add CoQ10 and if necessary switching patients to pravastatin considering the fact that carriers of the SLCO1B1*5 allele do not have myalgias while on pravastatin, is a hydrophilic statin and is not metabolized by CYP3A4. I am evaluating the use of L carnitine.