By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville, and Associate Editor, Internal Medicine Alert.
Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage
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.
Mayer SA, et al. N Engl J Med. 2005; 352:777-785.
Amoxicillin- Clavulanate vs Ciprofloxacin for the Treatment of Uncomplicated Cystitis in Women
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.
Hooton TM, et al JAMA. 2005;293: 949-955.
Why do Patients with Erectile Dysfunction Abandon Effective Therapy with Sildenafil (Viagra)?
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
Klotz T, et al. Int J Impot Res. 2005;17(1):2-4.
Although all strokes are potentially debilitating, intracerebral hemorrhage is often the most disabling.
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