Risk Factors and Diabetic Neuropathy
Source: Chaturvedi N, et al. N Eng J Med. 2005;352:341-350.
Although we have recently enjoyed the FDA approval of two agents for treatment of diabetic peripheral neuropathic pain (duloxetine [Cymbalta], pregabalin [Lyrica]), as yet we have no treatment for diabetic peripheral neuropathy (DPN) itself. Trials in both type 1 and type 2 diabetes have shown that tight glycemic control reduces the incidence of DPN; additionally, tight blood pressure control has been shown to reduce the incidence of DPN in type 2 DM. Identification of potentially modifiable risk factors for development of DPN might aid clinicians in its prevention.
Studying subjects from the European Diabetes Prospective Complications Study (n = 3250), Chaturvedi and colleagues identified 276 cases of new onset neuropathy during an observation period of approximately 10 years. Multivariate analysis indicated that the greatest odds ratios for development of DNP were seen with duration of diabetes, A1C, BMI, and smoking.
Good glucose control is already a target to reduce incident DPN. When controlling for A1C and duration of diabetes, other prominent risk factors emerged. For instance elevated levels of LDL showed a 22-26% increase in odds ratio for DPN. Ultimately, the 2 factors with greatest increase in odds ratio for development of DPN were cardiovascular disease at the time of enrollment (ie, at baseline), in which case the odds ratio was almost triple, and microalbuminuria, which was associated with greater than a 2-fold increase.
Stress Reduction in African Americans Treated for HBP
Source: Schneider RH, et al. Am J Hypertens. 2005;18:88-98.
Cardiovascular disease remains the number one cause of mortality in America. The African American population shoulders a disproportionate burden of this mortality, likely due to a correspondingly increased incidence, severity, and prevalence of hypertension, and a greater degree of manifest target organ damage.
A diversity of available antihypertensive agents notwithstanding, only a fraction of hypertensive patients have reached and maintain currently identified blood pressure goals. Lifestyle modification may provide substantial reductions in blood pressure, but clinicians may commonly include only diet, exercise, and salt modulation as typical components. Schneider and colleagues evaluated whether stress reduction through Transcendental Medication might result in meaningful impact upon BP in African American men.
Study subjects (n = 150) were randomized to either Transcendental Meditation (TM) 20 minutes twice daily, progressive muscle relaxation, or health education classes, and were followed for 12 months. Compared to health education classes, the TM group enjoyed a significant reduction in antihypertensive medication. Although SBP did not differ significantly between treatment groups, diastolic BP was 2.7 mm Hg lower in the TM group. Looking just at the female subjects, TM impact was much more substantial, resulting in a BP change of -7.3/-6.9 vs -0.7/-3.0 BP change in subjects allocated to education classes. Transcendental Meditation is a specific meditation technique requiring specific, personal instruction. Whether other relaxation or meditation techniques might also be efficacious is unknown.
Folate Intake and the Risk of Hypertension
Source: Forman JP, et al. JAMA. 2005;293:320-329.
There are several ways in which folate could play a vital role in the maintenance of vascular health. Folate treatment lowers homocysteine, an acknowledged cardiovascular risk factor. Folate supplementation has also been shown to lower blood pressure and improve endothelial cell function on a short-term basis. Whether long-term dietary and supplemental intake of folate is ultimately related to development of hypertension (HTN) has not been studied.
The Nurses Health Study I and Nurses Health Study II comprise more than 150,000 individuals who have been studied observationally since the early 1990s; they are considered separate studies because the former is comprised of younger women (age, 27-44 at enrollment vs age 43-70). Amongst this population, during the observation period 7,373 persons developed new-onset HTN.
In younger women, those who consumed 1 mg or more of folate daily enjoyed half the relative risk of developing HTN compared to women who consumed 0.2 mg or less. In older women, the results were similarly favorable, but less dramatic (RR = 0.82).
The evidence base linking folate intake with vascular health is plausible. These observational data strengthen the association between folate nutriture and maintenance of normotension.
Recombinant Activate Factor VII for Acute ICH
Source: Mayer SA, et al. N Engl J Med. 2005;352:777-785.
Although all strokes are potentially debilitating, intracerebral hemorrhage (ICH) is often the most disabling. Encouraging medical advances offer promise for ischemic stroke, but no known medical interventions convincingly alter the consequences of ICH (30-day mortality greater than 30%, 80% of survivors losing functional independence). After the initial bleed, hematoma growth is felt to influence adverse outcome; hence, limiting hematoma progression or rebleed could favorably alter the course of ICH. Since activated factor VII (aF7) has proven efficacy as a pro-coagulant not only in hemophilia, but also in patients without known coagulopathy, it is a rational option for study.
Patients who had confirmed ICH within 3 hours of onset of symptoms (n = 399) were randomized to recombinant aF7 or placebo. Followup CT scans were obtained 24 and 72 hrs after IV administration of one of three dosage intensities of aF7. The primary outcome measure was percent increase in ICH volume.
ICH volume increase was significantly less in subjects who received the highest aF7 dose; and the closer to time of admission aF7 was administered, the greater the beneficial impact. Additionally, 3-month mortality was reduced by 38% in the aF7 group compared with placebo.
Serious arterial thromboembolic events (MI, Ischemic Stroke) were more frequent in persons who received aF7, but fatal or disabling thromboembolic events were not significantly different between the groups. These data are promising for the future of aF7 in ICH.
Amoxicillin-Clavulanate vs Ciprofloxacin for Cystitis in Women
Source: Hooton TM, et al JAMA. 2005;293:949-955.
Emerging pathogen resistance, particularly that of E. coli, has influenced the choice of treatment for urinary tract infection (UTI). Trimethoprim-Sulfamethoxazole (TMP-SMX) has probably been the most commonly used urinary antibacterial, often administered as a 3-day course. E. coli remains the most frequent pathogen, but is increasingly resistant to beta lactams and TMP-SMX. Although most organisms responsible for UTI retain sensitivity to quinolones, we desire to retain the long-term use of quinolones by avoiding overuse; hence we seek appropriate non-quinolone alternatives to TMP-SMX.
This trial compared amoxi-cillin/clavulanate 500/125 (AM/C) b.i.d. to ciprofloxacin (CIP) 250 mg b.i.d. for 3 days in adult women (n = 322) with uncomplicated acute cystitis. Culture data reflected a pathogen distribution similar to what is seen in many ambulatory settings: E. coli in 82%, Group b Streptococcus in 8%, Staphylococcus saprophyticus in 8%, and others (Klebsiella, Proteus) in 2%.
The clinical cure rate (determined at the 2-week follow-up visit) was 58% for AM/C vs 77% for CIP (P £ 0.001). Even when evaluating the population of women whose urine sensitivity testing indicated AM/C susceptibility, cure rates were superior for CIP. A 3-day course of AM/C is less effective than CIP for uncomplicated acute cystitis in adult women.
Why do Patients with ED Abandon Effective Therapy with Sildenafil?
Source: Klotz T, et al. Int J Impot Res. 2005;17(1):2-4.
The availability of highly effective safe oral agents for erectile dysfunction (ED) has immeasurably improved the management of male sexual health. Typically, studies indicate that 60-80% of men are satisfied with the efficacy of phosphodiesterase 5 inhibitors (PDE5i). Consistently, surveys of men with ED indicate a strong preponderance of preference for oral agents over other methodologies such as surgical, urethral pellets, injections, or vacuum constriction devices. Whether men who respond favorably to PDE5i continue long-term treatment with these agents has not been well studied.
Klotz et al prospectively studied men, mean age 63, with ED who had successfully used sildenafil. If men did not renew a prescription within 6 months, they were considered to have abandoned treatment and were surveyed by telephone to find the reason(s) why.
Almost one-third (31%) of subjects had not sought a refill within 6 months. The most common reason cited was lack of opportunity or desire for intercourse, in 45%. Next most common was failure of partner to show interest in sex (23%), followed by cost (12%).
Men who receive PDE5i generally initially report successful ability to have intercourse, but a substantial minority does not continue the medication. Whether the same results would be seen in populations of younger men has not been determined.
Although we have recently enjoyed the FDA approval of two agents for treatment of diabetic peripheral neuropathic pain (duloxetine [Cymbalta], pregabalin [Lyrica]), as yet we have no treatment for diabetic peripheral neuropathy (DPN) itself.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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