Advertisement	October 29, 2014 Affairs of the Heart: Could ED Drugs Be Cardio-Protective?  Rome, Italy—Could a drug used to improve lovemaking also help the heart in other ways? New Italian research published in the open access journal BMC Medicine suggests that long-term daily treatment with phosphodiesterase-5 inhibitor (PDE5i), the main ingredient in erectile dysfunction medications, can provide protection at different stages of cardiovascular disease, with few side effects. The presence of PDE5 in the heart has led to previous research on whether the inhibitor, which blocks the enzyme preventing the relaxation of smooth muscle tissue, could treat nonurological conditions. Despite some promising results, according to the study led by researchers from Sapienza University of Rome, the studies were largely based on animals, and the cardio-protective effects of PDE5i remained unclear. For the review on the effectiveness and safety of PDE5i in providing cardiac protection, researchers conducted a meta-analysis of randomized controlled trials by searching for articles published between January 2004 and May 2014. With 24 suitable trials identified from four research databases: MEDLINE, EMBASE, Cochrane Library, and SCOPUS, study authors focused on 1,622 patients from mixed populations who were treated with PDE5i or a placebo. A parallel analysis of the effects of the inhibitor on the size and shape of the heart and its performance also was performed. Of the 1,622 subjects, 954 were randomized to PDE5i and 772 to placebo. “According to our analysis,” the authors write, “sustained PDE5 inhibition produced: (1) an anti-remodeling effect by reducing cardiac mass (–12.21 g/m2, 95% confidence interval (CI): –18.85; –5.57) in subjects with left ventricular hypertrophy (LVH) and by increasing end-diastolic volume (5.00 mL/m2; 95% CI: 3.29; 6.71) in non-LVH patients; (2) an improvement in cardiac performance by increasing cardiac index (0.30 L/min/m2, 95% CI: 0.202; 0.406) and ejection fraction (3.56%, 95% CI: 1.79; 5.33). These effects are parallel to a decline of N-terminal-pro brain natriuretic peptide (NT-proBNP) in subjects with severe LVH (–486.7 pg/ml, 95% CI: –712; –261). PDE5i administration also produced: (3) no changes in afterload parameters and (4) an improvement in flow-mediated vasodilation (3.31%, 95% CI: 0.53; 6.08).” Flushing, headache, epistaxis, and gastric symptoms were found to be the most common side effects. “This meta-analysis suggests for the first time that PDE5i have anti-remodeling properties and improve cardiac inotropism, independently of afterload changes, with a good safety profile. Given the reproducibility of the findings and tolerability across different populations, PDE5i could be reasonably offered to men with cardiac hypertrophy and early stage heart failure,” the authors conclude. “We found that the main ingredient in Viagra can be used as an effective, safe treatment for several patients with heart disease. Large clinical trials are now urgently needed to build on these encouraging findings,” added lead author Andrea Isidori. The authors call for a trial on sex-specific long-term response, including women, to determine if the inhibitor could be reasonably administered to patients who suffer from heart muscle thickening and early-stage heart failure. ​ Click here for October 29, 2014 USP Weekly News Update.
	U.S. Pharmacist Social Connect