Clinical Briefs in Primary Care
Doxycycline Hyclate 20 mg Tablets and Metronidazole 0.75% Topical Lotion in the Treatment of Rosacea
Source: Sanchez J, et al. J Am Acad Dermatol. 2005;53:791-797.
The treatment of rosacea (ros) is based upon antibacterial therapy, usually either metronidazole or a member of the tetracycline family (eg, tetracycline, oxytetracycline, doxycycline, or minocycline). The use of full-dose tetracycline, although often effective in rosacea is also associated with adversities such as induction of skin photosensitivity or, in women (the group most commonly affected by ROS), yeast vaginitis.
Recent trials in adult acne have indicated that subantimicrobial doses of doxycycline (ie, 20 mg PO b.i.d.) have a favorable effect on acne, without altering GI, GU, or skin flora; hence, clinicians may capitalize upon an anti-inflammatory effect without unwanted alterations in microflora.
A trial of topical metronidazole 0.75% lotion plus either doxycycline 20 mg b.i.d. or placebo for 16 weeks was undertaken in 40 adults with rosacea.
At the conclusion of the trial, combination therapy was found superior to metronidazole alone for the total number of inflammatory lesions (the primary end point of the trial) and clinician’s global severity score. Subantimicrobial doses of doxycycline enhance outcomes when added to topical metronidazole for management of rosacea.
Left Atrial Radiofrequency Ablation During Mitral Valve Surgery
Source: Doukas G, et al. JAMA. 2005;294:2323-2329.
Radiofrequency ablation (rfa) is intended to prevent successful propagation of re-entrant circuits by creating lines of scar tissue between the pulmonary veins and the annulus of the mitral valve. This intervention is increasingly frequently offered to persons with atrial fibrillation who undergo mitral valve surgery, although it has not yet been subject to a large enough prospective randomized trial to derive a conclusive data set.
To that end, a randomized double blind trial was performed in the United Kingdom of patients (n = 97) with chronic (> 6 months) continuous atrial fibrillation. Mitral valve surgery alone was compared with mitral valve surgery plus RFA.
The primary end point was sustained sinus rhythm, which was attained in 44.4% of patients who received RFA, vs 4.5% of those who did not. Similarly, RFA was associated with more favorable BNP (brain natriuretic peptide) levels and improved exercise capacity. The additional procedure was not associated with any increased risks: postoperative complications and mortality were the same in both groups.
For persons with chronic continuous atrial fibrillation undergoing mitral valve surgery, RFA improves likelihood of sustained sinus rhythm, without adding to the morbidity or mortality burden.
Comorbid Depression with Mortality in Patients with DM
Source: Katon WJ, et al. Diabetes Care. 2005;28:2668-2672.
Diabetes mellitus (dm) has recently been recognized as comparable to having sustained an MI as a predictor of cardiovascular risk. Depression (DEP) has been shown to increase mortality, with up to a 6-fold increase in post-MI mortality seen in depressed vs non-depressed patients. Data on patients with DM have shown a high incidence of DEP, with resonant consequences; eg, persons with DM and DEP are likely to take less rigorous care of their DM, and hence have worse outcomes, and likewise, persons suffering morbid consequences of their DM are more likely to become depressed. Some longitudinal studies of DM and DEP have highlighted the consequences of their comorbidity, but are limited by such flaws as self-reporting, inadequately documented DM, and small numbers of patients.
The Pathways Study includes almost 5000 DM patients in a Seattle Washington HMO. A study of comorbid DEP and DM with consequent impact upon mortality was evaluated over 3 years. The mortality picture was clearly divergent: 3-year mortality was 8.3% in diabetics without DEP, 13.6% with comorbid minor DEP, and 11.9% with comorbid major depression. When adjusted for age, sex, and ethnicity, major DEP was associated with a statistically significant greater than 2-fold increase in mortality compared to diabetics without DEP. Whether treatment of DEP in DM improves mortality outcomes has not been determined.
Risk of Death in Elderly Users of Conventional vs Atypical Antipsychotic Medications
Source: Wang PS, et al. N Engl J Med. 2005;353:2335-2341.
Atypical antipsychotic medications (AAM) such as aripiprazole (Abilify), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) and ziprasidone (Geodon) are commonly prescribed for elders suffering dementia, delirium, psychosis, and affective disorders. Very recently (April 2005), clinicians have been advised that numerous placebo-controlled trials (n = 17) of AAM in elders indicate an increased risk—almost a doubling—of death. Additionally, despite common popular usage, AAM have never been indicated for treatment of dementia, and this non-approved’ status has also been highlighted by inclusion in the black box’ warning appended to all AAM.
This recent warning message might have led one to assume that the earlier conventional’ antipsychotic medications (CAM) are not fraught with such risk. Instead, the issue has not been well studied. CAM include such medications as chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), thioridazine (Mellaril), trifluoperazine (Stelazine), and haloperidol (Haldol).
A retrospective cohort study (n = 22,890) of adults older than age 65 in Pennsylvania who had received a new antipsychotic prescription (AAM or CAM) was undertaken. Results were adjusted for confounding variables such as coexisting illness (eg, diabetes, arrhythmias, cardiovascular disease, cancer). The primary study end point was the relative risk of death for persons receiving a CAM versus an AAM.
Treatment with a CAM was associated with an overall unadjusted hazard ratio for death within 180 days of 1.51. These data suggest that CAM are associated with even greater mortality risk than AAM.
Beta-Blockers to Prevent Gastro-esophageal Varices in Cirrhosis Patients
Source: Groszmann RJ, et al. N Engl J Med. 2005;353:2254-2261.
In patients with established esophageal varices (ESV), non-selective beta-blockers (BB) are effective in reducing risk of hemorrhage. This may be a result of decreased portal pressure through a combination of decreased cardiac output—a beta-1 effect, and reduced splanchnic blood flow—a beta-2 effect. Hence, selective BB (which are beta-1 selective) may or may not provide similar benefit.
Theoretically, BB might be useful to prevent the development of ESV, not just reduce bleeding from them. Groszmann et al studied a population (n = 213) of high-risk individuals for development of ESV: cirrhotics with portal hypertension as demonstrated by an elevated hepatic venous pressure gradient. This placebo-controlled trial involved administration of timolol (Blocadren) titrated to up to 80 mg/d with followup every 3 months for 54.9 months (mean). Study subjects underwent, in addition to hematology monitoring, endoscopy and measurement of hepatic venous pressure gradient on an annual basis.
The primary end point, development of ESV or ESV bleeding, was no different in the timolol group than placebo. Disturbingly, there were more serious adverse events in the timolol group than in the placebo group. Nonselective beta blockers are not effective for preventing the development of ESV in high-risk patients.
Effects of Protein, Monounsaturated Fat, and Carbohydrate Intake on Blood Pressure and Serum Lipids
Source: Appel LJ, et al. JAMA. 2005;294:2455-2464.
Identification of the best diet’ remains an elusive target. Cardiovascular disease (CVD) remains the #1 cause of death in the United States, and reduction in saturated fat (SAT) is commonly suggested as a tool for CVD prevention. If one is to reduce the amount of SAT, unless the total number of calories are also reduced, some other nutrient category must be correspondingly increased. Whether substituting carbohydrate, protein, or unsaturated fat for the omitted SAT provides better impact upon blood pressure (BP) and lipids is the object of this study.
Adults (n = 164) with either prehypertension or stage 1 hypertension were randomized to 3 periods of dietary management, in each of which SAT was substituted: protein-enriched, carbohydrate enriched, and unsaturated fat-enriched. Weight was maintained constant throughout each 6-week feeding.
Using the carbohydrate-enriched diet for comparison, both protein-enriched and monounsaturated fat-enriched diets resulted in favorable, very similar changes in lipids and blood pressure. Although the impact of dietary change upon BP and lipids was small, it was sufficient to reduce estimated 10-year CHD risk (Framingham scoring).
Doxycycline Hyclate 20 mg Tablets and Metronidazole 0.75% Topical Lotion in the Treatment of Rosacea; Left Atrial Radiofrequency Ablation During Mitral Valve Surgery; Comorbid Depression with Mortality in Patients with DM; Risk of Death in Elderly Users of Conventional vs Atypical Antipsychotic Medications; Beta-Blockers to Prevent Gastro-esophageal Varices in Cirrhosis Patients; Effects of Protein, Monounsaturated Fat, and Carbohydrate Intake on Blood Pressure and Serum LipidsSubscribe Now for Access
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