Follow me on twitter @drportnay for daily thoughts, comments on recent news items and retweets

Wednesday, September 9, 2009

Safety vs Efficacy?

I have always been intrigued by this simple yet very complex conundrum. What's more important: safety or efficacy.

Safety: Is the treatment/drug safe? = does it cause harm?

Efficacy: Does the treatment/drug work? = Does the it do what you want it to do?

I've been thinking about this question for the past two day, ever since I read a recent report from JACC regarding the new medication dronedarone. Dronedarone is a new treatment for suppression of atrial fibrillation (AF). Its major selling points are that is has a short half life and less toxicity. Amiodarone is the drug that it is trying to compete with. Amiodarone does a great job of suppressing atrial fibrillation but is toxic. Amiodarone is iodine based and can be toxic to the thyroid, lungs, liver and skin.

The recent trial was a meta-analysis comparing 4 trials which looked at amiodarone vs placebo and 4 trials which looked at dronedarone vs placebo. "Compared to placebo, amiodarone reduced the odds of recurrent AF by 88% and dronedarone reduced the odds of recurrent AF by 21%. Compared to dronedarone, amiodarone reduced the odds of recurrent AF by 51%, but increased the odds of all-cause mortality by 61% and increased the odds of drug discontinuation because of an adverse drug effect by 81%."

Therefore: the authors concluded that "For every 100 patients treated with dronedarone instead of amiodarone, one may expect that 23 more patients will have recurrent AF and that there will be one less death and six fewer patients with adverse events requiring drug discontinuation."

  1. Amiodarone works better than donedarone for suppression of AF
  2. Donedarone is safer than amiodarone

Question I have:

  1. How do I decide which drug to give?
  2. Should it be my decision or my patients decision?
  3. Which patients will I give which drug to?
  4. Should all physicians be required to discuss both medications with the patient?

What do you think?

J Am Coll Cardiol 2009;54:1089-1095.


  1. From what I hear from atrial fibrillation patients who are weighing that same decision, it's really not such a difficult decision initially.

    Most feel that it should be a joint decision between patient and doctor, with the patient knowing the risks of each alternative. Most afib patients that I hear from would much rather try the safer drug first, even if it's less effective. For many of them, the safest drug, dronedarone, will do the job and not subject them to the horrible side effects of amiodarone.

    The decision is much harder if the dronedarone doesn't work. Most patients will do just about anything to avoid amiodarone because of the risk of damaging their lungs, livers, kidneys, vision, etc. That's when it's a much harder decision, and many will opt for ablation or surgery so they can avoid amiodarone at all costs.

    Mellanie True Hills

  2. Angioplasty Side effects
    Angioplasty has provided to be boon for heart patient. They found ray of hope after coming this technology into existence. This has been one of the best technologies used. Stent, is used in this technology. There are also few side effects for this. But in spite of angioplasty side affects this s still very good for heart patient.