Stopping statins in the short-term is okay for stable patients

October 13, 2004

Wed, 13 Oct 2004 17:45:00

Manchester, NH - There is no increase in event risk associated with discontinuation of statin therapy for up to six weeks in stable cardiac patients, a new study has shown.

Dr Mary P McGowan (New England Heart Institute, Manchester, NH) and colleagues from the Treating to New Target (TNT) study group report their findings online October 11, 2004 in Circulation.

Some studies have shown an increase in events when statin therapy is discontinued, but these have been conducted in unstable patients admitted for acute coronary syndrome, the researchers explain.

McGowan told heartwire that reports of these studies made it into the lay press, and there was concern among her institutional review board because the protocol of many clinical trials requires a drug-washout period.

"I checked in the literature and I realized there were no data to refute this in stable cardiac patients, so I went to the TNT board and asked if I could look at this." This is the first study to examine this issue in stable patients, she believes.

Finding important as statins discontinued for a number of reasons

The sheer number of individuals with stable cardiac disease makes it imperative to determine whether the risk of cardiovascular outcomes increases after abrupt discontinuation of statin therapy, McGowan says. Many patients discontinue medications because of financial constraints, forgetfulness, or side effects. In addition, nearly all clinical trials involving statin therapy require a drug-washout period of six weeks or more.

TNT is testing two doses of atorvastatin (Lipitor®, Pfizer)10 and 80 mg dailyand requires a six-week dietary lead-in/drug-washout phase, where patients discontinue drug therapy. In the study, 16619 patients entered this washout period, 57% of whom were receiving prior statin therapy.

During the six-week phase, there were 24 primary events (defined as coronary heart disease death, nonfatal myocardial infarction, resuscitated cardiac arrest, and fatal or nonfatal stroke); throughout the subsequent open-label period there were 31 primary eventsthis equated to event rates of 0.20% during washout and 0.26% during the open-label phase. "Event rates were therefore similar during the two phases," the researchers note.

 

Short-term discontinuation of statin therapy in stable cardiac patients...does not lead to...increased risk of acute coronary syndromes.

 

"This study demonstrated that short-term discontinuation of statin therapy in stable cardiac patients apparently does not lead to a clinically important increased risk of acute coronary syndromes," they note.

"This finding is very important for a number of reasons. If abrupt withdrawal of statins resulted in an increase in cardiovascular events, this hazard would need to be weighed against proven long-term benefits."

But they stress that clinical-trial participants tend to be relatively healthy and stable and therefore have dramatic clinical differences from individuals who suffer an acute coronary event. "For this latter group, the degree of risk associated with abrupt statin discontinuation is still to be resolved," they conclude.



Related links

1. [HeartWire > Atherosclerosis; Jun 8, 2004]

2. [HeartWire > News; Apr 21, 2004]


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