Clinical Briefs in Primary Care
The short-term risks of bariatric surgery
Source: The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; et al. N Engl J Med 2009;361:445-454.
Long-term benefits from bariatric surgery have been definitely established. Nonetheless, perioperative risks associated with bariatric surgery are not insignificant, especially since persons undergoing bariatric surgery often suffer comorbidities of diabetes, hypertension, and dyslipidemia.
The LABS Consortium performed an observational study of short-term outcomes subsequent to bariatric surgery in the United States. From 2005 to 2007, data supplied by 10 different clinical sites (combined total n = 4776 first-time bariatric surgical procedures) provided information on the composite endpoint of 30-day major adverse outcomes (death, DVT, postoperative intervention, and extended hospital stay). Roux-en-Y bypass was performed on approximately 70% of subjects; the majority of the other patients underwent gastric banding.
Death occurred in 0.3% of subjects within 30 days; an additional 4% of subjects experienced at least one adverse event included in the composite primary endpoint. A previous history of DVT was associated with greater likelihood to incur a postoperative adverse event; additionally, the higher the BMI (mean BMI in this report = 46.5 kg/m2), the greater the frequency of adverse events.
Bariatric surgery has significant associated risks. For most appropriately selected patients, the long-term benefits far outweigh these risks, but patients need to be informed of the potential for serious adverse outcomes.
Parsing the death toll of COPD
Source: Zvezdin B, et al. Chest 2009;136:376-380.
Worldwide, COPD is the fourth leading cause of death; unless current trends reverse, the toll will rise. Mortality rates associated with hospitalized acute exacerbations of COPD have been as high as 30%; the mortality in the 1 year after hospitalization is as high as 43%. Some of this mortality is directly attributable to COPD; however, other prominent comorbidities (e.g., CVD, pulmonary embolism) are also responsible. Often, because post-mortem examination is limited, the cause of death can only be opined. To provide greater clarity, Zvezdin et al report on autopsies of 43 patients who died within 24 hours of COPD hospital admission.
The mean age of the study subjects was 70. According to autopsy results, more than half of the deaths were attributed to diagnoses other than COPD: heart failure (in 37%) and pulmonary embolism (in 21%). The authors also separate pneumonia as a "non-COPD" cause of death (occurring in 28%), defining COPD death as those individuals who die of respiratory failure due to COPD progression (14%).
If these results (from a Serbian tertiary care university hospital specializing in pulmonary diseases) are generalizable to U.S. populations, clinicians will need to exercise greater vigilance, enhanced preventive techniques, and intensified intervention for potentially fatal comorbidities when patients are admitted for acute COPD exacerbation.
Vardenafil and premature ejaculation
Source: Aversa A, et al. Int J Impot Res 2009;21:221-227.
Although clinicians are much more familiar with erectile dysfunction, over the lifespan premature ejaculation (PEJ) is more common. A much smaller percentage of men with PEJ seek help, attributable to factors such as embarrassment, absence of available FDA-approved medications, and lack of public awareness of PEJ as an important sexual health dysfunction.
The technical definition of PEJ is a matter of controversy, although most experts agree that consistent unintended/unwanted ejaculation within 1 min that causes distress is satisfactory for the diagnosis.
The most commonly used metric for measuring PEJ is intravaginal ejaculatory latency time (IELT), or the time after vaginal intromission at which ejaculation occurs. Population studies have suggested that in established heterosexual couples, typical IELT is 6-10 min. Subjects enrolling in PEJ trials typically have an IELT of 30-90 sec, or even ejaculation ante portis (prior to intromission). The above definition would, by construction, seem to exclude gay men or ejaculation involving other orifices/body parts, but the similarities of diagnosis and management of PEJ in gay couples suggest that IELT, while at times anatomically inconsistent, incorporates the broader concepts of early ejaculation in a variety of sexual settings.
SSRIs have an established role in management of PEJ. Success with SSRIs is greatest when taken on a maintenance schedule; however, patients would generally prefer as-needed administration, all things being equal.
Aversa et al studied men with PEJ (n = 42), all of whom consistently experienced IELT < 1 min. Patients were randomized (double-blind) to placebo or vardenafil 10 mg administered 15-30 min before sexual activity. The primary outcome was change in IELT.
Use of vardenafil provided a significant improvement in IELT (from 36 sec to 4.5 min) compared with placebo (IELT went from 42 sec to 54 sec). The tolerability of vardenafil is well established. Vardenafil appears to be a viable option for PRN treatment of PEJ.
Testosterone, depression, and hypogonadal men
Source: Shores MM, et al. J Clin Psychiatry 2009;70:1009-1016.
Subthreshold depression (sDEP), also known as minor depression, occurs in as many as 1 of 4 elderly patients. Although by definition the symptom burden of sDEP is less than major depressive disorder (MDD), it is more common than MDD and is still associated with diverse negative outcomes including decreased quality of life and function, and increased morbidity, mortality, and health care utilization.
Symptoms of hypogonadism include fatigue, decreased libido, and dysphoria, any of which may also be manifestations of depression. Shores et al studied the impact of testosterone replacement in hypogonadal men (total testosterone < 280 ng/dL) meeting DSM-IV criteria for sDEP.
This double-blind trial randomized adult men (n = 33) to testosterone gel 7.5 g/d or placebo for 12 weeks. The primary outcome was change in the HAM-D depression score.
At the end of the trial, testosterone-treated men had a significantly improved HAM-D score compared to placebo, and the percent with remitted sDEP was dramatically different (52.9% vs 18%) favoring testosterone.
No serious testosterone-attributable adverse effects were seen. Testosterone replacement shows benefit for improving sDEP in hypogonadal men.
Aspirin after colon cancer diagnosis
Source: Chan AT, et al. JAMA 2009;302:649-658.
Most colorectal cancers over express cyclo-oxygenase 2 (COX-2). Primary prevention with aspirin (ASA) is associated with reduced risk for colon cancer and colonic adenoma. Secondary prevention with ASA (and celecoxib) is effective in reducing risk of new adenomas in persons who have been previously diagnosed with colonic neoplasia. Because ASA has recognized toxicities, including cerebral hemorrhage and GI bleeding, it is important to determine whether use of ASA in high-risk subjects (persons previously diagnosed with colon cancer) provides net benefit for overall and/or colon cancer-specific mortality.
The Physicians' Health Study and the Nurses' Health Study are observational studies, providing a window of observation for the role of ASA in both primary and secondary prevention. A cohort within both populations took maintenance ASA prior to any diagnosis of colon cancer, and further information about effects of ASA in persons who developed colon cancer and continued with ASA subsequent to the cancer diagnosis (vs subjects who did not take ASA after a diagnosis of colon cancer) is presented here.
Of subjects who developed colon cancer (n = 1279) in these two study populations (combined), there were statistically significant differences in total mortality (35% vs 39%) and colon cancer-related mortality (15% vs 19%) favoring use of ASA. Concordant with current thinking on the putative mechanism of ASA benefit, the risk reduction was greatest in persons whose colon cancer overexpressed COX-2. Despite these favorable results, the authors caution that routine utilization of ASA post colon cancer might be considered premature since these data are observational; placebo-controlled randomized trials are needed for confirmation.
The Emperor's new vertebroplasty?
Source: Buchbinder R, et al. N Engl J Med 2009;361:557-568.
Vertebroplasty (VERT) has recently enjoyed increased popularity as treatment for painful osteoporotic vertebral fractures. Observational or open-label studies have provided most of the supportive information. Enthusiasm for other previously popular surgical procedures has been dampened when double-blind randomized trials have failed to confirm positive outcomes: Two randomized trials in the last 7 years comparing arthroscopy for knee osteoarthritis found no outcomes difference when compared to placebo.
Buchbinder et al performed a randomized, double-blind, sham procedure-controlled trial of VERT for painful osteoporotic fracture in 78 participants. The primary outcome was pain reduction, which did not differ at weeks 1, 3, or 24 after treatment between intervention and sham intervention.
The Buchbinder study was published immediately preceding another VERT trial in the New England Journal of Medicine examining pain and disability at 1 month post intervention, which similarly did not find positive outcomes. These trials call for closer evaluation of the (potential) value of VERT.
The short-term risks of bariatric surgery; Parsing the death toll of COPD; Vardenafil and premature ejaculation; Testosterone, depression, and hypogonadal men; Aspirin after colon cancer diagnosis; The Emperor's new vertebroplasty?Subscribe Now for Access
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