Clinical Briefs by Louis Kuritzky, MD
May 15, 2011 4 minutes read
Clinical Briefs
By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is an advisor for Endo, Kowa, Pricara, and Takeda.
Rethinking Postmenopausal HRT
Source: LaCroix AZ, et al. JAMA 2011; 305:1305-1314.
The final results of the women's Health Initiative trial (WHI) may not be the end of the story. Much-anticipated favorable cardiovascular outcomes from hormone replacement therapy (HRT) were conspicuously absent from the trial results at 7.1 years; when coupled with increases in stroke, thrombotic events, and breast cancer, most clinicians walked away from HRT. But the story doesn't end there.
Remember that the mean age of the WHI participants was 63 years; hence, most of the study subjects were more than a decade postmenopausal, not representative of the patients who typically seek relief of menopausal symptoms during the perimenopause and early menopausal years (usually ages 50-52 years).
The WHI included a large subset of hysterectomized women (n = 10,739) who received only estrogen therapy (i.e., no progestin). LaCroix et al report on extended post-trial follow-up of this population, adding another 5.8 years of observation to the original mean 5.9 years of the clinical trial.
At the 10.7 year mark, some of the initially described differences between estrogen and placebo were eradicated.Risk of coronary heart disease (CHD), deep vein thrombosis, stroke, hip fracture, and total mortality were not statistically significantly different in the two populations, even though initial results indicated some detrimental estrogen effects. At 10.7 years, there was a statistically significant 23% lower risk of breast cancer in women receiving estrogen replacement than placebo. As has been noted in previous recent publications about the WHI, younger women (age 50-59 years) had neutral or favorable outcomes for CHD, myocardial infarction, and total mortality, whereas older women incurred negative effects. Young (age 50-59 years) symptomatic women should have such considerations incorporated into decisions about HRT.
The Pistachio Diet for Erectile Dysfunction
Source: Aldemir M, et al. Int J Impot Res 2011;23:32-38.
Erectile dysfunction (ED) in mid-life males is recognized to stem most often from endothelial dysfunction, a commonplace consequence of dyslipidemia, diabetes, hypertension, or cigarette smoking. Pistachios have been shown to improve lipid fractions, but have not been studied in reference to functional improvement in endothelial function. To that end, Aldemir et al studied 17 men with established ED.
Study subjects ingested about 3½ ounces (570 kcal) of pistachios daily at lunch for 3 weeks. No other health interventions were used and subjects were asked to maintain similar exercise and other dietary patterns unchanged. At baseline and 3 weeks, the International Index of Erectile Function (IIEF) score and penile Doppler ultrasound were measured.
Compared to baseline, there was a statistically significant and clinically relevant increase in the IIEF score (from 36 at baseline to 54 at 3 weeks). Penile flow velocity improved by more than 20%. As had been confirmed in prior studies, favorable effects on total cholesterol, LDL, and HDL were seen.
The authors attributed the positive effects of pistachios potentially to antioxidant effects, as well as healthful lipid effects, the latter of which has previously been shown to promptly improve endothelial function. Because the studied "dose" of pistachios has substantial caloric impact (almost 600 calories), dietary restriction of other components for some patients might be necessary if they desire to add this amount of pistachios to their menu.
Bromocriptine for Type 2 Diabetes
Source: DeFronzo RA. Diabetes Care 2011;34:789-794.
Bromocriptine (BRO) is a new and novel treatment for type 2 diabetes (DM2). In contrast to other classes of DM2 pharmacotherapy, which act at well-defined receptor sites to induce insulin secretion or improve insulin sensitivity, BRO works in a more global fashion by resetting levels of dopaminergic and sympathetic tone within the central nervous system (CNS). For example, elevation of hypothalamic dopamine levels reduces sympathetic nervous system activity resulting in improved glucose tolerance, reduced free fatty acids, and enhanced insulin sensitivity. The CNS effects can be harnessed by ingesting BRO in a rapid-release form (the form currently approved for DM2 treatment) in the morning, which is believed to reduce metabolic consequences of the morning dopamine decline often seen in diabetics.
A large (n = 3,070) 1-year randomized, placebo-controlled trial added BRO to various diabetes regimens, including diet, oral agents, and/or insulin. The BRO treatment group enjoyed a 40% reduction in the pre-specified cardiovascular endpoint (a composite of myocardial infarction, stroke, death, coronary revascularization, and hospitalization for angina or congestive heart failure). Although the mechanism by which BRO results in improved cardiovascular outcomes is uncertain, reductions in blood pressure and heart rate might be contributors. BRO is generally well tolerated and provides another category of treatment that may be used in combination with essentially any other diabetes medication.
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