Another Look at Bleeding Risk from Aspirin
Source: De Berardis G, et al. JAMA 2012; 307:2286-2294.
The role of aspirin (asa) for primary prevention of cardiovascular (CV) events has been a beleaguered topic for more than a decade. Although the risk reduction from ASA for secondary prevention of CV events clearly outweighs the bleeding risk, the balance for primary prevention of CV events is much less weighted toward the benefits side of the equation. Indeed, recent consensus groups have relied on the additional ASA benefits for prevention of colon cancer to make a case that when added to marginal CV event reduction, total risk reduction is sufficiently powerful to give primary prevention the green light.
De Berardis performed an analysis of bleeding risk among adults in Puglia, Italy, during the 2003-2008 interval. To qualify as a bleeding event, the study subject had to be hospitalized for either a gastrointestinal or intracerebral bleeding episode. A direct comparison between adults who received new prescriptions for low-dose (≤ 300 mg/d) ASA (n = 186,425) and matched controls who had not been prescribed ASA (n = 186,425) was done. A second question was whether the effects of ASA were different in diabetics than in others.
In the population as a whole (on ASA and control), diabetics had a higher risk of bleeding than non-diabetics, independent of ASA. Given that two recent randomized, controlled trials of ASA in diabetics have failed to show a CV benefit, the apparently inherently increased risk for bleeding in diabetics is concerning.
Can Aspirin Prevent Recurrence of Thromboembolism?
Source: Becattini C, et al. N Engl J Med 2012;366:1959-1967.
Current recommendations for management of proximal deep venous thrombosis or pulmonary embolus suggest a minimum of 6 months treatment with a vitamin K antagonist (warfarin). Although more prolonged use of warfarin does continue to reduce the risk of recurrent DVT, the cost, inconvenience, and bleeding risk of long-term warfarin is substantial. Since as many as 20% of persons with an unprovoked thromboembolic event will suffer a recurrence within 2 years of warfarin discontinuation, well-tolerated agents to reduce this risk would be very welcome.
Becattini et al randomized patients (n = 402) who had sustained unprovoked thromboembolism and completed a standard therapeutic course of warfarin (6-18 months) to either 100 mg/d ASA or placebo. Study participants were followed for 2 years, looking at the incidence of new thromboembolism (primary efficacy outcome) and major bleeding events (primary safety outcome).
Risk of thromboembolism was reduced by 42% in the ASA group compared to placebo (6.6% vs 11.2% new events/yr). Major bleeding was uncommon and not different between the groups (one event each group).
At the conclusion of an approved course of warfarin post-pulmonary embolus, clinicians and patients are presented with the difficult choice of whether to continue warfarin long-term. These results are encouraging that low-dose ASA has a meaningful potential role in long-term secondary prevention of thromboembolism, especially when warfarin continuation is not a desirable option.
A New Approach to Tinnitus
Source: Cima RFF, et al. Lancet 2012; 379:1951-1959.
I was surprised to learn that as many as 21% of adults will develop tinnitus (TIN) during their lifetime, as stated by Cima et al in the introduction to this clinical trial. Persons who develop TIN can experience a major decrement in quality of life. Despite thorough investigation, it is uncommon to find a correctible cause for TIN, which often persists indefinitely. Sufferers are left with sound-based therapies (e.g., a "masking" sound or neutral sound that distracts from the annoyance of the TIN sound) or cognitive behavioral treatment. Clinical trials to support either of these modalities are thus far somewhat insufficient.
Cima et al randomized TIN patients in the Netherlands to usual care vs specialized care (intervention). Components of specialized care included 8 weeks of intensive audiological diagnostics, audiological rehabilitation sessions, and individual cognitive behavioral therapy, followed by 12 weeks of group cognitive behavior therapy.
At 12 months, the intervention group enjoyed a significant improvement in quality of life compared to usual care. TIN can create TIN-related catastrophic thinking; this aspect of the disorder was also improved to a greater degree with the specialized care. The authors note that efficacy was not altered by TIN severity; hence, all TIN sufferers might benefit from consideration of this methodology.
Coffee Might be One Less Thing We Have to Worry About
Source: Freedman ND, et al. N Engl J Med 2012;366:1891-1904.
In the united states and europe, coffee is a staple of diet and social activities for most adults. Increased sympathetic tone — as generated by the autonomic nervous system, hyperthyroidism, cocaine, sympathetic amines, etc. — can be quite toxic. Caffeine also is a stimulant, albeit of short-lived duration. An association of coffee with higher LDL levels has also been noted. Could the commonplace life-long ingestion of coffee be toxic also?
The NIH-AARP Diet and Health Study solicited questionnaires from AARP members 50-71 years of age (n = 617,119) in 1995-96. Usable information for analysis was obtained from 402,263 of these. Many dietary aspects were addressed, but this communication was focused on coffee. Respondents grouped themselves into categories ranging from zero to more than six cups of coffee daily, subgrouped into caffeinated and decaffeinated.
By multivariate analysis (correcting for such confounders as smoking), there was an inverse relationship between coffee consumption and mortality for both men and women. For example, men who drank at least six cups of coffee daily had a 10% lower risk of death and women had a 15% lower risk. CV events, diabetes, and infectious disease causes of death were inversely associated with coffee drinking, and it did not appear to make a difference whether coffee was caffeinated or decaffeinated.
Given the observational nature of this trial, it is not possible to establish causation. Hence, while coffee consumption is associated with reduced mortality, we cannot yet say coffee consumption causes reduced mortality. Nonetheless, it is reassuring that a dietary habit so widespread among adults appears to be benign, and possibly even beneficial.
ED, Lower Urinary Tract Symptoms, and Ejaculatory Dysfunction
Source: Kwa JS, et al. Int J Impot Res 2012;24:101-105.
That erectile dysfunction (ed) in-creases with age is not the least bit surprising. Nor, with but a moment's consideration, is the correlation of age with lower urinary tract symptoms (LUTS) counterintuitive. After all, as men age, the prostate continues to enlarge, and nocturia, frequency, dribbling, difficulty starting/stopping stream commonly ensue. A curious observation within the last decade, however, is that there is an association between the presence of LUTS and ED that is independent of age. That is, at any age, men with LUTS have a higher frequency of ED, and the ED is correlated with the severity of LUTS. A mechanism interconnecting these two otherwise seemingly separate phenomenons has been elusive. However, a hypersensitivity to sympathetic tone has been noted both in ED and LUTS, and may be a central link. The common bond between ED and LUTS is further reflected by the recent approval of PDE5 inhibitors — which had heretofore been considered ED drugs — for management of benign prostatic hyperplasia (BPH).
In the data provided by Kwa et al on 250 mid-life men, it was again found that ED and LUTS increase with age. What they also note is that ejaculatory dysfunction (EjD) — which includes premature ejaculation, anejaculation, dry ejaculation, and decreased ejaculatory volume — also increases with age, although premature ejaculation alone was not associated with age.
EjD, ED, and LUTS have interrelatedness that is closely linked with age, but there may be other pathophysiologic correlates between them.
The Allure of Shared Medical Appointments in Diabetes Care
Sources: Ridge T. Diabetes Spectrum 2012;25:72-75. Miselli V, et al. Diabetes Spectrum 2012;25:79-84.
Two articles in the spring edition of the journal Diabetes Spectrum touch on the concept of shared medical appointments (e.g., group visits) to enhance management of type 2 diabetes. The appeal of group visits stems from several sources. First, in a busy clinical environment, the ability to share fundamental management concepts with multiple patients at the same time seems much more efficient. Second, group bonding and sharing experiences may foster team efforts that enhance knowledge, confidence, self-efficacy, and possibly even outcomes. The literature on this topic is generally favorable. The review article by Ridge describes various reports suggesting improved quality of life, knowledge, and (sometimes) diabetes control in persons who participate in group visits when compared with "usual care."
Miselli et al provide the details of their structured Group Care Model and the results of a 4-year study of their model. Patients with type 2 diabetes were randomized into group care or usual care. At the end of 4 years, BMI, fasting glycemia, A1c, total cholesterol, and blood pressure had improved in the group care cohort, whereas they had either stayed the same or worsened in the control group. Similarly, quality of life, diabetes knowledge, and healthy behaviors improved comparatively in the group care subjects.
The idea of group visits is not new, but it has been slow to take hold in clinical settings in the United States. The group visit model may make sense both from an economic and health outcomes perspective.
Another Look at Bleeding Risk from Aspirin; Can Aspirin Prevent Recurrence of Thromboembolism?; A New Approach to Tinnitus; Coffee Might be One Less Thing We Have to Worry About; ED, Lower Urinary Tract Symptoms, and Ejaculatory Dysfunction; The Allure of Shared Medical Appointments in Diabetes CareYou have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content