Clinical Briefs
By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is a consultant for Sucampo Pharmaceuticals, Takeda, Boehringer Ingelheim; and is a consultant and on the speaker's bureau for Novo Nordisk, Lilly, Daiichi Sankyo, Forest Pharmaceuticals, Cephalon, Novartis, and Sanofi Aventis.
Intensive BP control in diabetes
Source: Accord Study Group. N Engl J Med 2010;362:1575-1585.
Because it is recognized that type 2 diabetics (DM2) incur greater risk of CV outcomes than the general population, consensus groups have advocated BP < 130/80 mmHg as a preferred goal, in contrast to 140/90 mmHg for the general hypertensive population. Despite enthusiasm for this posture, and essentially global advocacy for the concept that lower is better in diabetes, no prospective, randomized trial has been done that confirms such benefits. The ACCORD trial was designed to compare CV outcomes achieved with tight BP control (SBP < 120 mmHg) vs standard therapy (SBP < 140 mmHg). The ACCORD trial had several limbs, including a glucose control and a lipid control arm, which were not addressed in this publication.
Almost 5000 diabetics were randomly assigned to intensive BP vs standard BP treatment and followed for the primary endpoint of (composite) nonfatal MI and stroke, or CV death over a mean 4.7-year follow-up.
The tight control arm managed to achieve an SBP of 119.3 mmHg, compared to the standard treatment group SBP of 133.5 mmHg; of course, the number of medications required to attain control was substantially greater in the tight control group (3.4 drugs vs 2.3 drugs). Intensive BP lowering did not reduce the primary endpoint. Intensive BP control was associated with more adverse events.
No hypertension guidelines have been issued since the publication and promulgation of the ACCORD BP trial. Expert opinions vary in interpretation of this outcome. I have suggested that, in the absence of proven benefit by greater BP lowering, achievement of < 140/90 mmHg now represents a reasonable goal until further literature suggests otherwise.
Underrecognition of adverse effects
Source: Zimmerman M, et al. J Clin Psychiatry 2010;71:484-490.
The design of clinical trials sometimes allows for failed detection of adverse effects related to medication. Perhaps the most widely recognized disconnect is in relation to ACE inhibitors: Prescribing information suggests a very low incidence of cough (typically < 10%), yet clinical experience suggests twice that frequency. The primary reason for this incongruence is that most side effects are passively reported; for a variety of reasons, patients may fail to spontaneously report adversities that could be related to medication.
Zimmerman et al addressed this issue among depressed outpatients treated with a variety of antidepressants and anxio-lytics. Subjects were seen by board-certified psychiatrists, and after their office visits, filled out questionnaires addressing adverse effects possibly related to medication.
Over a 6-week interval, more than 25% of the 2233 reported side effects occurred at least daily, but fortunately, the majority were rated low on the severity scale. Only about 20% of individuals rated adverse effects as 4-5 on a 5-point scale.
Overall, 20 times more adverse effects were identified by questionnaire than in psychiatrists' records. Comparison limited to either highly frequent or bothersome adverse effects still found that questionnaires identified 2-3 times as many adversities as clinicians had recorded.
A number of explanations can clarify some of this discrepancy: Psychiatrists may not record all adverse effects they see, patients may not report all issues that bother them (or minimize the bother), and some adverse effects may be so anticipated that their presence does not merit specific notice. In any case, it appears that patients shoulder a much higher level of adverse effect burden when treated for depression than would be readily apparent from review of their clinical records.
Vitamin D from the sun or supplements?
Source: Terushkin V, et al. J Am Acad Dermatol 2010;62:929.e1-9.
While i cannot speak for you, my recent experience is that under every rock I overturn is a vitamin D-deficient patient. At least that's what checking 25-OH vitamin D levels (the currently recommended test for vitamin D status) suggests. Should we recommend sun exposure, supplements, or both to address hypovitaminosis D?
Terushkin et al compared the amount of sun exposure necessary to provide the same plasma vitamin D levels as a 400 IU/d vitamin D supplement. They chose to study individuals in Miami, FL, and Boston, MA. Of course, sun exposure varies depending upon geography and season, as well as skin type. In July, the amount of sun time to provide as much systemic vitamin D as 400 IU orally was the same in both cities (3 min at 12 noon). A darker-skinned individual would require 5 min.
During winter months, there were marked differences in required exposure time. In Miami, 6 min of sun vs 23 min of sun in Boston would be required. Since most individuals do not expose 25% of their body surface (the face is only 3.5%) to sun during the winter in cities like Boston, a correspondingly greater time exposure would be required ... an unlikely scenario.
Because of the concern about sun exposure and its relationship to photoaging and skin cancer, as well as the neglect of optimum sunscreen utilization, the authors of this article favor vitamin D supplementation over sun exposure as the safest way to maintain vitamin D adequacy.
Because it is recognized that type 2 diabetics (DM2) incur greater risk of CV outcomes than the general population, consensus groups have advocated BP < 130/80 mmHg as a preferred goal, in contrast to 140/90 mmHg for the general hypertensive population.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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