Introduction Vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, was evaluated in a prospective trial in the primary care setting involving hypertensive men with ED who were receiving at least one antihypertensive medication. Aims To investigate the safety and efficacy of flexible-dose vardenafil therapy compared with placebo in PDE5 inhibitor-naïve subjects with arterial hypertension and ED. Methods In this multicenter, randomized, double-blind, placebo-controlled study, 354 patients received placebo or vardenafil (5–20 mg) for 12 weeks. Primary efficacy measures were diary responses to the Sexual Encounter Profile (SEP) questions 2 (vaginal insertion) and 3 (maintenance of erection). Additional efficacy measures included positive responses to the Global Assessment Question (GAQ). Results Compared with placebo, vardenafil significantly improved mean SEP2 and SEP3 success rates over the 12-week study period (intention-to-treat [ITT] and last observation carried forward [LOCF]) analysis). For LOCF, SEP2 and SEP3 were 83% for vardenafil vs. 58% for placebo and 67% for vardenafil vs. 35% for placebo, respectively (P < 0.0001 vs. placebo). Improved erections (GAQ) were experienced by 80% of vardenafil-treated patients at study end, compared with 40% for placebo (P < 0.0001, LOCF). The most commonly reported treatment-emerging adverse events were headache (3.1%) and flushing (1.6%), which were mild-to-moderate and transient in nature. Importantly, there were no significant changes in systolic and diastolic blood pressure or heart rate between the vardenafil and placebo groups. The average number of antihypertensives used per patient was 1.5 and 1.4 in the vardenafil and placebo groups, respectively. Both the incidence of adverse events and the ability to maintain an erection were unaffected by stratification into distinct subsets according to the class of antihypertensive medication being received. Conclusion Vardenafil significantly improves EF in hypertensive men treated with concomitant antihypertensive medication, is well tolerated, and does not significantly affect blood pressure.

Thromboxane released from activated platelets and prostacyclin of the vessel wall may act as potent antagonistic modulators of platelet aggregability and coronary vascular tone. Therefore, urinary excretion of their major metabolites, 2,3-dinor-thromboxane B2 and 2,3-dinor-6-ketoprostaglandin F1 alpha, was studied in 16 patients presenting with prolonged angina at rest. The 10 patients whose condition did not improve under vigorous antianginal treatment within 48 hours exhibited higher thromboxane metabolite excretion than did the 6 patients who responded to therapy (2,208 +/- 1,542 versus 609 +/- 312 ng/g creatinine; p less than 0.001). Elevated values were also found in four of eight patients with sustained postinfarction angina. Enhanced thromboxane metabolite excretion was frequently associated with angiographic evidence of thrombus formation. When nine patients were restudied in a stable phase after 11 +/- 5 months, thromboxane metabolite excretion was consistently normal or high normal. Excretion of prostacyclin metabolites was not depressed in any patient but correlated weakly with thromboxane (r = 0.41). Thus, enhanced thromboxane production as an index of platelet activation may identify patients with active thrombus formation who could benefit most from platelet inhibitory treatment.

High dose intravenous heparin is a highly effective and safe treatment for completely resolving left ventricular thrombi with high risk features for embolization. Most such thrombi disappear completely within 1 to 3 weeks of this treatment without embolic or hemorrhagic complications.

Intravenous coronary angiography with synchrotron radiation is a novel and minimally invasive technique for coronary imaging. At the Hamburger Synchrotronstrahlungslabor HASYLAB at DESY, a dedicated angiography system has been developed, which has been shown to provide detailed images of coronary artery segments. For each scan, two monochromatic X-ray images below and above the K-edge of iodine were recorded simultaneously. The two images were subtracted logarithmically to produce a maximal contrast enhancement of the iodine. To date, the procedure has been carried out on 379 outpatients. No complications occurred during or after the angiographic procedure, and hospitalization was not required in any subject. The acceptance by patient is extremely high. Five outside reviewers, blinded as to the clinical data or prior angiographic interpretation, reviewed the images for the presence or absence of 70% or more occlusion of a vessel. They reached a sensitivity of 79% and a specificity of 99%. The study has demonstrated that the synchrotron method has satisfactory sensitivity and very high specificity for severe stenoses. The new method has several advantages over magnetic resonance imaging (MRI), electron beam computed tomography (EBCT), and multi-slice computed tomography (MSCT). Neither vascular calcification (CT) nor the presence of metal stents (MRI) impairs the evaluation of perfusion of segments of the coronary arteries. Furthermore, the spatial resolution is three or four times higher using synchrotron angiography, and problems due to respiratory motion are eliminated.

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