The objective of the present trial was to compare the efficacy, safety, and tolerability of moxifloxacin (400 mg) given intravenously (i.v.) once daily followed by oral moxifloxacin (400 mg) for 7 to 14 days with the efficacy, safety, and tolerability of co-amoxiclav (1.2 g) administered by i.v. infusion three times a day followed by oral co-amoxiclav (625 mg) three times a day, with or without clarithromycin (500 mg) twice daily (i.v. or orally), for 7 to 14 days in adult patients with community-acquired pneumonia requiring initial parenteral therapy. The rates of drug-related adverse events were comparable in both groups (38.9% in each treatment group). The overall incidence of laboratory abnormalities was similar in both groups. Thus, it is concluded that monotherapy with moxifloxacin is superior to that with a standard combination regimen of a -lactam and a -lactamase inhibitor, co-amoxiclav, with or without a macrolide, clarithromycin, in the treatment of patients with community-acquired pneumonia admitted to a hospital.
Precipitation in the Congo Basin was examined using a version of the National Center for Atmospheric Research Community Earth System Model (CESM) with water tagging capability. Using regionally defined water tracers, or tags, the moisture contribution from different source regions to Congo Basin precipitation was investigated. We found that the Indian Ocean and evaporation from the Congo Basin were the dominant moisture sources and that the Atlantic Ocean was a comparatively small source of moisture. In both rainy seasons the southwestern Indian Ocean contributed about 21% of the moisture, while the recycling ratio for moisture from the Congo Basin was about 25%. Near the surface, a great deal of moisture is transported from the Atlantic into the Congo Basin, but much of this moisture is recirculated back over the Atlantic in the lower troposphere. Although the southwestern Indian Ocean is a major source of Indian Ocean moisture, it is not associated with the bulk of the variability in precipitation over the Congo Basin. In wet years, more of the precipitation in the Congo Basin is derived from Indian Ocean moisture, but the spatial distribution of the dominant sources is shifted, reflecting changes in the midtropospheric circulation over the Indian Ocean. During wet years there is increased transport of moisture from the equatorial and eastern Indian Ocean. Our results suggest that reliably capturing the linkages between the large‐scale circulation patterns over the Indian Ocean and the local circulation over the Congo Basin is critical for future projections of Congo Basin precipitation.
Introduction
Erectile dysfunction (ED) is a common condition with diverse sequelae affecting men and their women partners.
Aim
The FINDER study aimed to evaluate the efficacy and tolerability of the phosphodiesterase type-5 (PDE5) inhibitor, vardenafil, in a broad population of PDE5-naïve men with ED of different etiologies and severity and included their partners’ assessments of treatment with vardenafil.
Methods
Men with ED (N = 260) were randomized to receive either vardenafil or placebo in a multicenter, flexible-dose study.
Main Outcome Measures
Primary efficacy variables were patients’ responses to the Global Assessment Question (GAQ), and Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3).
Results
Compared with placebo, vardenafil significantly improved rates of successful “Yes” responses to SEP3 (“Did your erection last long enough for you to have successful intercourse?”) (49% placebo vs. 78% vardenafil at last period carried forward [LPCF]; P < 0.0001), SEP2 (“Were you able to insert your penis into your partner’s vagina?”) (65% placebo vs. 85% vardenafil at LPCF; P < 0.0001), and GAQ (36% placebo vs. 83% vardenafil at last observation carried forward; P < 0.0001). In addition, patients’ and their partners’ Treatment Satisfaction Scale (TSS) scores were statistically significantly improved across each of the TSS domains (satisfaction with orgasm, ease with erection, confidence, pleasure, erectile function satisfaction, and satisfaction with medication) in the vardenafil group compared with the placebo group.
Conclusions
Vardenafil improved sexual function to the extent that both patients and their partners expressed a considerable and agreed level of satisfaction with treatment.
OBJECTIVE
To evaluate the effect of vardenafil on both erectile function (EF) and treatment satisfaction (an aspect of quality of life) in men and their partners, as erectile dysfunction (ED) has a profound effect on patients’ quality of life and that of their partners, and treatment for ED tends to be focused on improving functional measures of EF.
PATIENTS, SUBJECTS AND METHODS
For this randomized, double‐blind, placebo‐controlled trial, men with ED for >6 months, according to the USA National Institutes of Health Consensus Statement, were recruited. In all, 611 patients were randomized to treatment with either vardenafil (10 mg for 4 weeks, titrated to preferred dose, 5, 10 or 20 mg, during the next 8 weeks, and maintained at preferred dose for the following 14 weeks), or placebo.
RESULTS
At 18 weeks (primary endpoint), the mean improvement in the EF domain of International Index of EF (IIEF‐EF) vs baseline was significantly greater with vardenafil than placebo (12.70 vs 1.69, P < 0.001). This was accompanied by significant benefits at 26 weeks and in various secondary variables relating to sexual satisfaction. Qualitative assessment of the treatment effect revealed three categories of importance to patients: effectiveness, confidence and quality of life. There were significant linear correlations between patients’ EF and treatment satisfaction, and between patients’ EF and their partners’ treatment satisfaction.
CONCLUSIONS
Functional improvements in response to vardenafil treatment are significantly correlated with treatment satisfaction for both patients with ED and their partners. These findings apply to patients with a wide range of baseline characteristics.
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