Statins for Primary Prevention in Everyone 75 Years and Older? It Could Be Cost-Effective: Analysis

Marlene Busko

April 24, 2015

CORVALLIS, OR — If all 75- to 94-year-olds living in the US in 2014 received generic statins for 10 years for primary prevention of MIs and death from CHD, this would be cost-effective, but only when geriatric-specific side effects—that is, functional limitations (muscle pain and weakness) and mild cognitive impairment—were excluded, researchers conclude[1].

In an article published in the April 21, 2015 issue of the Annals of Internal Medicine, Dr Michelle C Odden (Oregon State University, Corvallis) and colleagues describe how they used a simulation model and the limited available evidence to estimate the cost-effectiveness of such a preventive strategy in very elderly people.

"At effectiveness similar to that in trials, statins are projected to be cost-effective for primary prevention [in these older adults]; however, even a small increase in geriatric-specific adverse effects could [result in net harm]," they report. "In our simulations, a 10% to 30% increased risk for these adverse effects would offset the cardiovascular benefit," according to Odden and colleagues.

Thus, more research is needed "to inform decision making in populations who are frail or have multiple chronic health complications."

"Key Take-Homes"

In the meantime, "the key take-home message from this study is that despite low cost and high potential benefit, even very modest adverse effects attributable to statins tip the balance in the direction of harm," Dr Michael W Rich (Washington University School of Medicine, Saint Louis, MO) writes in an accompanying editorial[2].

Although the investigators "conducted an elegant series of analyses showing that cost should not be an important consideration in the decision to prescribe statins in older adults, I believe that the findings strongly support the view that when it comes to prescribing statins for primary prevention in older adults, less is more," he writes.

Commenting for heartwire from Medscape, Dr Neil Stone (Northwestern University Feinberg School of Medicine, Chicago, IL), chair of the expert panel who wrote the ACC/AHA guidelines, agreed that this study emphasizes the need for physicians and elderly patients to discuss the pros and cons when considering whether or not to begin taking statins for primary prevention.

PROSPER looked at people aged 70 to 82 and the Heart Protection Study of cholesterol lowering with simvastatin looked at people aged 40 to 80, and neither found an increase in cognitive impairment with statins vs placebo, Stone noted, although there have been anecdotal reports of this, which would require further investigation. If a statin is prescribed and "if the patient experiences any difficulties [such as muscle pain or weakness], it is important to stop and reevaluate" their statin therapy.

"Tenuous Balance of Benefits and Harms"

Odden and colleagues used the Cardiovascular Disease Policy Model, with data from the National Health and Nutrition Examination Survey (NHANES) and findings from the Prospective Study of Pravastatin in the Elderly at Risk of Vascular Disease (PROSPER) study from 70- to 82-year-old men and women to estimate the potential benefits, harms, and costs of generic statin therapy for primary prevention in people who were 75 to 94 in 2014.

The model predicted that if everyone were treated with a statin, this would result in eight million additional users and prevent 105,000 (4.3%) incident MIs and 68,000 (2.3%) CHD deaths. It would add 197,000 disability-adjusted life-years (DALYs) at an incremental cost of $25,200 per additional DALY, which is below the $50,000 per DALY that is deemed acceptable, Rich notes.

The findings remained robust unless the price exceeded $30 per month or the effectiveness of the statins was less than estimated in PROSPER.

However, "an important caveat is that potential adverse effects and harms were not included in the primary models," Rich emphasizes.

When Odden et al looked at the effect of functional limitations and cognitive impairment, they found that an increased relative risk of 1.10 to 1.29 for these adverse effects could offset the cardiovascular benefits. "We focused on functional limitation due to muscle pain and weakness and mild cognitive impairment because these conditions are prevalent in older adults and can have an important and immediate effect on quality of life and independence," the researchers explain.

They acknowledge that projections that are based on a forecasting model should be viewed with caution, and there was limited available clinical-trial evidence in this age group.

Nevertheless, "our results underscore both the tremendous potential benefit of statin use and the tenuous balance of benefits and harms and highlight the need to quantify and adequately account for all health effects of the use of these medications for primary prevention in older adults," they write.

Rich notes that the ACC/AHA guidelines provide only two paragraphs addressing adults older than 75 (one each for primary prevention and for secondary prevention). Clinicians need to consider that older adults are at increased risk of myalgia, fatigue, and cognitive impairment and accumulate more comorbidities as they age, and high cholesterol has been associated with increased survival in people aged 85 and older.

"In this context, I fully agree with the view articulated in the 2013 ACC/AHA guideline," Rich concludes. The guidelines emphasize the need for a physician-patient discussion to decide whether or not a particular patient would benefit from starting preventive statin therapy and state that "accordingly, a discussion of the potential CVD risk reduction benefits, risk of adverse effects, drug-drug interactions, and consideration of patient preferences should precede the initiation of statin therapy for primary prevention in older individuals."

Odden has no relevant financial relationships. Disclosures for the coauthors are listed in the article. Rich and Stone have no relevant financial relationships.

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