Clinical Briefs in Primary Care
Are NSAIDs Different in the CHF Impact?
Source: Hudson M, et al. BMJ. 2005;330:1370.
Traditional NSAIDS have the potential to cause fluid retention and BP elevations, either of which can worsen heart failure (CHF). Coxibs, such as celecoxib and rofecoxib, have recently come under close scrutiny due to increased cardiovascular risk associated with their use, though not specifically increased CHF risk. Whether there might be a difference in impact upon CHF outcomes for persons who receive celecoxib or rofecoxib vs non-selective NSAIDs has not been widely studied, although an earlier trial indicated that receipt of a coxib prescription at discharge for CHF incurred an increase risk of rehospitalization in the next year compared to not receiving such treatment.
Hudson et al used a hospital database of discharge summaries in Quebec, Canada which included 2,256 persons aged 66 or older with CHF who had been prescribed an NSAID, celecoxib, or rofecoxib. The primary end point of the study was the risk of death and recurrent CHF. Comparing NSAIDs, rofecoxib, and celecoxib, the risk of CHF for celecoxib and traditional NSAIDs was no different. However, the hazard ratio for the primary end point was 1.27 for persons receiving rofecoxib vs celecoxib. Similarly, the hazard ratio for mortality was 1.44 for rofecoxib vs celecoxib. These data suggest that celecoxib is safer in persons with CHF than rofecoxib. Newer coxibs are being developed, and differences amongst them may be highly relevant.
Treatment of HTN and Cognitive Function: SCOPE
Source: Skoog I, et al. Am J Hypertens. 2005;18:1052-1059.
The study on cognition and prognosis in the Elderly (SCOPE) trial was comprised of adults aged 70-89 years (n = 4,937) with mild-to-moderate hypertension (HTN). Patient inclusion criteria for this double-blind, randomized, placebo-controlled trial also entailed cognitive function testing with the Mini Mental State Examination (MMSE). Persons with mildly reduced cognitive function have been shown to have greater risk for development of frank dementia. Whether treatment of HTN in persons with mild cognitive impairment might reduce the development of further cognitive decline is not well established.
SCOPE study subjects were treated with candesartan (CAN) or placebo for HTN. In the placebo group as well as the CAN treatment group, subjects were allowed open-label treatment with antihypertensives to control BP to a level of < 160/90, initially with HCTZ 12.5 mg/d. Subjects were subgrouped by mental status scores into high cognitive function (MMSE Score ³ 27/30) versus lower cognitive function (MMSE = 24-27/30).
After a mean of 3.7 years treatment, the incidence of frank dementia was higher in persons who had entered the trial with lower cognitive function at baseline. However, decline in cognitive function in this group was less amongst those treated with CAN than placebo (P = 0.04). As has been seen in other trials, CAN treatment reduced non-fatal stroke (28%).
These data are encouraging that in addition to reducing macrovascular end points, CAN treatment of HTN in persons with mildly impaired cognitive function may reduce further cognitive function decline.
Impact of Job and Marital Strain on BP
Source: Tobe SW, et al. Am J Hypertens. 2005;18:1046-1051.
A high level of job stress (job) has been linked both to increased frequency of hypertension (HTN) and worsened cardiovascular outcome. Marital stress has also been associated with impact upon both daytime and nighttime BP, as measured by 24-hr ambulatory BP (ABPM).
Study subjects (n = 248) were normotensive, predominantly white Canadian adult men and women (age, 40-65) without evidence of CAD, diabetes, or kidney disease at enrollment. Job diversity included clerical, technical, nurses, and physicians. Subjects were in established relationships and employed full time. Marital strain was measured by the Dyadic Adjustment Scale; job strain was measured using the Job Content Questionnaire. Both are validated stress scales. All subjects underwent ABPM on a typical’ work day.
By multiple regression analysis, job strain and marital strain independently were both statistically significant variables for higher BP. The combination of job strain and marital strain were synergistic in their association with higher BP impact. Encouragingly, lower marital strain was associated with a mollifying effect upon JOB-induced BP elevation.
Dietary Phytoestrogens and Lung Cancer Risk
Source: Schabath MB, et al. JAMA. 2005;294:1493-1504.
Lung cancer (LCA) remains the leading cause of cancer death in the United States, and has recently surpassed even heart disease as a cause of mortality amongst men who smoke. Past epidemiologic data suggested that dietary constituents such as vitamin A and beta-carotene might be important modulators of lung cancer risk, but unfortunately, interventional trials did not support the optimism generated by observational data.
Phytoestrogens (PHY) are compounds in the diet that have weak estrogen-like activity. The 3 main PHY classes are isoflavones (ISO), lignans (LIG), and cumestrans. Epidemiologic data have shown that in populations with a low incidence of LCA, plasma levels of ISO, and LIG are high.
Schabath et al studied the relationship between intake of PHY and LCA risk in a prospective case-control study (n = 3,409). Data were obtained by personal interviews querying food intake over a 9-year period of observation.
Amongst the study population, there was an equal frequency of never-smoking history: approximately 16%. This also helps to remind us that as many as 1 out of 6 lung cancer cases occur in non-smokers.
There was a linear inverse relationship between dietary PHY and LCA which proved to be statistically significant, but was primarily driven by data accrued in men. Those individuals in the highest intake of dietary PHY enjoyed a 46% relative risk reduction for LCA compared to controls. These data are consonant with previous information suggesting that estrogenic hormone therapy is protective for lung cancer in women. In nonsmokers, trends towards benefit were more prominent than in smokers or former smokers, but the small numbers of study subjects precludes definitive conclusions.
Effectiveness of Influenza Vaccine in the Elderly
Source: Jefferson T, et al. Lancet. 2005;366:1165-1174.
Efficacy and effectiveness are commonly used to differentiate results from clinical trials (efficacy) from results obtained in clinical practice (effectiveness). Such terms anticipate the fact that clinical trial populations may be a very select group: they may have medications provided free-of-charge, they often enjoy the assistance of abundant support personnel, and they may be especially motivated to complete therapy, as compared to clinical practice. In this report, Jefferson et al examined the effectiveness of influenza vaccine (FLUVAX) to prevent influenza clinical symptoms (FLU-Sx), hospitalizations, and death.
Data from 64 studies were evaluated, and included populations ranging from as few as 124 subjects to as many as 750,000.
The first comparison (> 1 million observations) indicated that for community-dwelling elders overall, inactivated FLUVAX was not effective against FLU-Sx. However, a similarly large population (> 750,000) analysis indicated statistically significant effectiveness in reducing hospitalizations for pneumonia or influenza; optimum effectiveness was seen when there was a good match between circulating virus and vaccine. The second comparison looked at effectiveness among high-risk community-dwelling elders, in which group all-cause mortality was favorably impacted by FLUVAX. The 3rd comparison looked at FLUVAX among healthy community dwelling elders, in which population FLUVAX reduced hospital admission for influenza or pneumonia by approximately half.
Based upon this large data set, the authors conclude that FLUVAX effectiveness is only modest.
Why Does Tadalafil Cause Back Pain?
Source: Seftel A, et al. Int J Impot Res. 2005;17:455-461.
All 3 currently available PDE5 inhibitors (sildenafil, tadalafil, vardenafil) have been reported to be associated with the adverse effect of back pain (LBP), albeit the reported frequency and severity of back pain with tadalafil (TAD) appears to be substantially greater than with the other 2 agents. Why LBP has been more commonplace with TAD remains unclear.
LBP associated with TAD usually occurs 12-24 hours post-dose, and resolves within 48 hours. The pain is typically described as diffuse, of mild-moderate intensity involving the lower back, gluteal region, and thigh, and worsened by assuming the recumbent position. Most cases respond to simple analgesics, although 0.4% of patients discontinue because of this adverse effect.
Seftel et al used a diversity of tools to study potential etiologies of TAD-induced LBP. There were no signs of tissue inflammation or altered low back blood flow as discerned through PET or MRI. No clinically relevant differences in any measured laboratory parameter were seen.
The etiologic origin of TAD-associated LBP remains unknown. Extensive laboratory and radiographic evaluation does not demonstrate any discernible inflammatory, vascular, or myopathic process.
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