Clinical Briefs in Primary Care
August 1, 2005 6 minutes read
Statin Therapy and LDL Cholesterol Goal Attainment
Source: Schultz JS, et al. Am J Manag Care. 2005;11:306-312.
The appropriateness of statin therapy for persons with hyperlipidemia is well established. Although clinical trial data showing reductions in cardiovascular events with statin therapy are consistent and impressive, patients treated outside of clinical trial settings may have obstacles to enjoying the same benefits. Hence, it is critical to identify which factors are indicative of non-compliance with statin therapy.
Regression analysis indicated that older men were the most compliant population, especially if they experienced more outpatient visits specifically addressing hyperlipidemia. Also, persons who underwent a cardiovascular procedure were more adherent to statin regimens. Approximately 50% of all treated individuals reached the NCEP LDL goal, and again it was older, high-risk males and persons who underwent a cardiovascular procedure who were most likely to achieve their LDL goal. Finally, as prescription co-pay increased, compliance decreased.
Younger high-risk patients, women, and those with fewer outpatient visits specifically directed towards hyperlipidemia showed the lowest adherence. The authors suggest that managed care populations would be well served by specifically targeting these at-risk groups to enhance adherence to statin therapy, and that the barrier of higher co-pays impacts compliance in a meaningful way, even in this population of employed individuals.
Clinical Validity of a Negative CT Scan in PE Patients
Source: Quiroz R, et al. JAMA. 2005;293:2012-2017.
The optimum diagnostic tool for acute pulmonary embolism (PE) is currently a matter of debate. Although pulmonary angiography is often considered the gold standard for diagnosis of pulmonary embolism (PE), inter-observer agreement about subsegmental PE diagnosed by pulmonary angiography may be as low as 45-66%. Rather than do a direct comparative trial, it might be equally effective to maximize the negative predictive value of an investigative tool instead; for instance, one could establish the frequency of thromboembolic events subsequent to withholding anticoagulation in the face of a negative test: subsequent thromboembolic events would be indicative of a false-negative test.
The composite data from fifteen studies included 3,500 patients. For subjects to be included in the analysis, after CT (a variety of CT methodologies were used, including single-slice spiral CT and multidetector-row CT) there had to be at least a 3-month followup, and each study had to have at least 30 patients.
The overall negative predictive value of CT scan was 99.4%. These numbers compare favorably with the negative predictive value of pulmonary angiography. Hence, after a negative CT scan, anticoagulation may be withheld with a similar degree of confidence as after a negative pulmonary angiogram. Utilization of CT techniques instead of angiography would reduce radiation, health care costs, and patient risk, without compromising diagnostic accuracy.
Prostatectomy vs Watchful Waiting in Prostate Cancer
Source: Bill-Axelson A, et al. N Engl J Med. 2005;352:1977-1984.
Public awareness, clinician interest, and PSA screening have uncovered a burgeoning population of men with early prostate cancer (EPC). Because prostate cancer is diverse in its gradations of virulence, and most men who harbor silent prostate cancer in their later years are not destined to die of prostate cancer (ie, they die with prostate cancer’ not from prostate cancer’), the value of invasive treatment of EPC has been a matter of some controversy.
In 2003, early data (6.2 years followup) on a population of 695 men with EPC from Sweden, Finland, and Iceland found improved prostate cancer-related mortality (50% reduction) from radical prostatectomy compared to watchful waiting. At that point, however, there was no measurable reduction in overall mortality. The following commentary is pertinent to the longer-term data accrued at 10-years followup.
Similar to the data at first followup, 10 year data indicate a relative risk reduction of 44% for prostate cancer death in favor of radical prostatectomy over watchful waiting. Additionally, at the 10-year mark, there was a statistically significant 26% relative risk reduction in all-cause mortality. Clinicians who were doubtful about the benefits of surgical management for EPC now have supportive data reflecting favorable endpoints relative to prostate cancer death, as well as all-cause mortality.
White-Coat HTN
Source: Neumann SA, et al. Am J Hypertens. 2005;18(5 pt. 1):584-588.
White-coat hypertension (WC-HTN) is defined as elevated blood pressure (BP) when measured in the clinical office setting, which is not confirmed in other settings, eg, home BP monitoring or ambulatory BP monitoring (ABPM). To date, most evidence suggests that WC-HTN, unless associated with target-organ damage, does not require pharmacologic intervention. WC-HTN is perhaps simplistically attributed to the catecholamine impact some persons experience when visiting a clinician’s office, however this attribution is imperfect, since it is likely that many, if not most persons have some catechol exaggeration attendant to physician visits. It is poorly established whether WC-HTN patients actually differ from patients with essential HTN as far as activity of the autonomic nervous system goes. Autonomic regulation is commonly measured by assessment of heart rate variability (HRV). An earlier small study of HRV had discerned that WC-HTN does not share the same autonomic imbalance as HTN, supporting the hypothesis that WC-HTN may be more benign’ than HTN.
Neumann et al studied a population of untreated adult men (n = 120) who had undergone ABPM as well as clinic BP measurement and were then classified as either hypertensive, normotensive, or WC-HTN. HRV was used to assess cardiac autonomic status.
Calculating HRV requires a complex formula called spectral analysis, which can be used to assess sympathetic activity, parasympathetic activity, and the ratio of the two. HTN is characterized by increased sympathetic tone, decreased parasympathetic tone, and a corresponding increased sympathetic/parasympathetic ratio.
In this study, WC-HTN subjects demonstrated lowered parasympathetic tone and an increased sympathetic/parasympathetic ratio. These data will provide fuel for the continued controversy over whether WC-HTN is truly a benign disorder.
Make Diabetics Walk
Source: Di Loreto C, et al. Diabetes Care. 2005;28:1295-1302.
No clinician doubts that exercise is beneficial to patients, and that lack of exercise contributes directly to a diverse array of consequences. Amongst diabetics, vascular end points remain the most burdensome of all medical maladies. Despite the common wisdom of exercise’s benefits, there is insufficient data to confirm and quantify the impact of exercise upon outcomes in diabetic patients, and hence establish therapeutic exercise goals.
Di Loreto and colleagues studied a population of adult type 2 diabetics (DM2) in Italy. Subjects (n = 179) did not differ in weekly exercise energy expenditure at baseline, and all were given personal instruction about the importance of regular physical activity. The exercise target was at least 10 metabolic equivalents (METs)/h/week achieved through moderate intensity exercise (3-6 METS); this is approximately equivalent to current recommendations which suggest at least 30 minutes of moderate intensity activity most days of the week. At 2 years, subjects had varying levels of compliance with their encouragement to engage in exercise, allowing for their stratification into 6 levels, ranging from no increase from baseline in weekly activity to 37.5 METs/h/week increase.
As you probably anticipated, the 2 lowest tiers (minimum change in activity) enjoyed no favorable changes in BP, lipids, or Framingham CHD risk score, but the other groups did. There was a linear relationship between incremental increase in activity and favorable effects upon cardiovascular risk factors. Additionally, per capita health expenditures amongst those who became more physically active were substantially less than sedentary folks. Post-hoc analysis showed that the threshold for impacting cardiovascular risk factors was 10 METs/hr/week or greater. Maximum benefit was seen at 27 METs/hr/week, which corresponds to a 3-mile daily walk (either 1 hour/day at 3 mph or 45 minutes/day at 4 mph).
Treatment of Complicated Grief
Source: Shear K, et al. JAMA. 2005; 293:2601-2608.
Complicated grief is not a specific diagnosis listed in the DSM-IV. Nonetheless, clinicians are commonly faced with patients who suffer grief syndromes that do not follow a typical course of recovery, which might be termed complicated grief. When assessed 6 months or more after an important loss (eg, death of a spouse), it has four primary characteristics: disbelief that the death has actually occurred, anger/bitterness, recurrent episodes of painful emotions, and preoccupation by thoughts of the loved one’s death. Complicated grief is in some ways similar to post-traumatic stress disorder. The optimum therapeutic choice for persons who suffer complicated grief is not well described.
Complicated grief treatment (CGT) was compared to traditional interpersonal psychotherapy (IPT) in a study of 95 men and women. CGT consisted of cognitive-behavioral therapy-based techniques that are often used in management of PTSD trauma-related symptoms in combination with IPT, vs IPT alone.
Both interventions provided symptom improvement over a 19-week study period. CGT was superior to IPT both in number of responders (51% vs 28%) and time to response.
The appropriateness of statin therapy for persons with hyperlipidemia is well established. Although clinical trial data showing reductions in cardiovascular events with statin therapy are consistent and impressive, patients treated outside of clinical trial settings may have obstacles to enjoying the same benefits.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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