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Is all that intensive drug treatment worthwhile?
A paper published in 2006 demonstrated that laboratory findings do not constitute disease. And altering measurements such as blood pressure or cholesterol if you are elderly show little or no benefit (despite what the pharmaceutical industry and many doctors would have us believe).
One thing that seems to be forgotten is that we are not an immortal species; we all have to die eventually and if one thing doesn't get us, something else will. That is why it is so important, when evaluating treatments, not just to consider deaths due to the disorder being treated, but also to look at deaths from all causes. This is frequently not done - particularly in papers about diseases of the heart.
The Finnish researchers enrolled 400 home-dwelling people between the ages of 75 years and 90 years with CVD. These people were randomly selected from the population living in Helsinki and randomly assigned, using concealed allocation, to receive either usual care from their primary care physician or to receive specialized care based on current evidence-based European guidelines for chronic cardiovascular disease (CVD).
The strength of this study is that the researchers randomly invited patients from the general population to participate, making the results applicable to typical primary care.
The interventions included stopping smoking, changing their diets, being medicated for high blood pressure and cholesterol, taking beta-blockers following a heart attack, angiotensin-converting enzyme (ACE) inhibitors for heart failure, anticoagulant drugs in selected patients and aspirin.
Over an average 3.4 years, beta-blocker, ACE inhibitor, diuretic, and statin use was significantly higher in the intervention group. Was there any benefit? No! Blood pressure and cholesterol control were significantly better in the intervention group. However, patient-oriented outcomes, which were common, were not improved.
- The incidence of heart attacks, congestive heart failure, stroke, or cardiovascular death were similar between the two groups.
- Deaths due to any cause occurred at similar rates in both groups (18% vs 17%).
- The time until a first cardiovascular event did not differ between the two groups.
In other words, all that time spent by doctors, the inconvenience to patients of having tests, the drugs used and money spent, the side effects that the intervention group inevitably had to endure from the drugs they were prescribed, as well as the inconvenience of having to give up pleasures such as smoking and eating an enjoyable diet, probably made their quality of life worse without adding so much as a day to their life-expectancy.
The study and abstract is below.
Strandberg TE, Pitkala KH, Berglind S, et al. Multifactorial intervention to prevent recurrent cardiovascular events in patients 75 years or older: The Drugs and Evidence-Based Medicine in the Elderly (DEBATE) study: a randomized, controlled trial. Am Heart J 2006; 152: 585-592. Department of Public Health Science and General Practice, University of Oulu, University Hospital, Oulu, Finland. timo.strandberg@oulu.fi AbstractOBJECTIVE: We aimed to examine whether better use of preventive methods and treatments of cardiovascular disease would reduce recurrent events in home-dwelling patients 75 years or older. METHODS: This was a randomized, controlled trial (a practical clinical trial, the DEBATE), conducted in 2000 to 2003 in Helsinki, Finland. We recruited 400 vascular patients with mean age of 80 years from the community, and they were randomly assigned to the intervention group (n = 199) where both nonpharmacological and pharmacological cardiovascular treatments were optimized by a geriatrician according to current guidelines. The control group (n = 201) received the usual care. Main outcome measures were major cardiovascular disease events and total mortality and changes in risk factors and medications. RESULTS: The groups were balanced at baseline. Mean duration of follow-up was 3.4 years. At 3 years, drug treatments had become more evidence-based in the intervention group. Consequently, total and low-density lipoprotein cholesterol levels (P < .0001) and systolic (P = .005) and diastolic (P = .009) blood pressure were significantly improved in the intervention group. However, neither primary end points (52 and 53 events in the intervention and control groups, respectively) nor total mortality (36 and 35 deaths) were significantly different between the two groups. No special adverse effects were encountered. CONCLUSION: It was possible and safe to institute evidence-based cardiovascular treatments and improve risk factors in patients 75 years or older in a pragmatic setting. During 3.4 years, however, this was not converted to clinical benefits. |
Last updated 17 May 2009
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