A case report, focused on vasopressor use and presented in this article, is likely to resonate with many critical care nurses. In this article the authors describe opportunities to enhance safety ...with vasopressor therapy. Specifically, the goal of improving communication among physicians, nurses, and pharmacists around desired endpoints for vasopressor therapy, triggers for reassessment of the therapeutic strategy and cause of the patients shock was identified as an area for improvement. A form piloted within an organization for use during multidisciplinary rounds and key findings is shared. Vasopressors constitute the mainstay of therapy for nearly every hemodynamically unstable patient in critical care. It is hoped that the lessons and information shared help empower critical care nurses to facilitate vasopressor stewardship within their facilities and, ultimately, enhance patient safety.
A case report, focused on vasopressor use and presented in this article, is likely to resonate with many critical care nurses. In this article the authors describe opportunities to enhance safety ...with vasopressor therapy. Specifically, the goal of improving communication among physicians, nurses, and pharmacists around desired endpoints for vasopressor therapy, triggers for reassessment of the therapeutic strategy and cause of the patient's shock was identified as an area for improvement. A form piloted within an organization for use during multidisciplinary rounds and key findings is shared. Vasopressors constitute the mainstay of therapy for nearly every hemodynamically unstable patient in critical care. It is hoped that the lessons and information shared help empower critical care nurses to facilitate vasopressor stewardship within their facilities and, ultimately, enhance patient safety.
The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most ...frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM).
In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.5 mg) (Prasterone, EndoCeutics) was examined on four coprimary objectives, namely percentage of parabasal cells, percentage or superficial cells, vaginal pH, and moderate to severe pain at sexual activity (dyspareunia) identified by the women as their most bothersome vulvovaginal atrophy symptom. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively.
After daily intravaginal administration of 0.50% DHEA for 12 weeks, when compared to baseline by the analysis of covariance test, the percentage of parabasal cells decreased by 27.7% over placebo (P < 0.0001), whereas the percentage of superficial cells increased by 8.44% over placebo (P < 0.0001), vaginal pH decreased by 0.66 pH unit over placebo (P < 0.0001), and pain at sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according to the involved mechanisms of intracrinology. The only side effect reasonably related to treatment is vaginal discharge due to melting of the vehicle at body temperature and this was reported in about 6% of the participants.
The daily intravaginal administration of 0.50% (6.5 mg) DHEA (Prasterone) has shown clinically and highly statistically significant effects on the four coprimary parameters suggested by the US Food and Drug Administration. The strictly local action of Prasterone is in line with the absence of significant drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment based upon the novel understanding of the physiology of sex steroids in women.
Background: Cardiovascular diseases (CVD) represent a heavy economic burden on individuals, health services, and society. Low adherence to antihypertensive (AH) agents is acknowledged as a major ...contributor to the lack of blood pressure control, and may have a significant impact on clinical outcomes and healthcare costs. Objectives: To evaluate the impact of low adherence to AH agents on cardiovascular outcomes and hospitalization costs. Methods: A cohort of 59,647 patients with essential hypertension was reconstructed from the Régie de l'assurance maladie du Québec and Med-Echo databases. Subjects included were between 45 and 85 years of age, without any evidence for symptomatic CVD, newly treated with AH agents between 1999 and 2002 and followed-up for a 3-year period. Adherence to AH agents was categorized as ≥80% or <80%. The adjusted odds ratio (OR) for CVD events between the 2 adherence groups was estimated using a polytomous logistic analysis. A 2-part model was applied for hospitalization costs. Results: Patients with low adherence were more likely to have coronary disease (OR, 1.07; 95% confidence interval CI, 1.00–1.13), cerebrovascular disease (OR, 1.13; 95% CI, 1.03–1.25), and chronic heart failure (OR, 1.42; 95% CI, 1.27–1.58) within the 3-year follow-up period. Among hospitalized patients, low adherence to AH therapy was associated with increased costs by approximately $3574 (95% CI, $2897–$4249) per person within a 3-year period. Conclusions: Low adherence to AH agents is correlated with a higher risk of vascular events, hospitalization, and greater healthcare costs. An increased level of adherence to AH agents should provide a better health status for individuals and a net economic gain.
The benefits of antihypertensive (AH) drugs on the risks of major cardiovascular outcomes have been demonstrated in clinical trials. However, approximately half of hypertensive patients do not adhere ...well to their prescribed AH therapy in actual practice. The purpose of this study was to assess the impact of adherence to AH agents on the incidence of cerebrovascular disease (CD) in real-world practice.
A cohort of 83 267 hypertensive patients was reconstructed from the Régie de l'assurance maladie du Québec databases. Subjects included were between 45 and 85 years old, initially free of cardiovascular disease, and newly treated for hypertension with AH agents between 1999 and 2004. A nested case-control design was conducted to study CD occurrence. Every case was matched for age and duration of follow-up with up to 15 randomly selected control subjects. The adherence to AH drugs was measured by calculating the medication possession ratio. Conditional logistic regression models were performed to assess the association between adherence to AH agents and CD adjusting for various potential confounders.
At cohort entry, the mean patient age was 65 years, 37.3% were male, 8.6% had diabetes, and 19.5% had dyslipidemia. High adherence (>/=80%) to AH drugs significantly decreased the risk of CD by 22% (rate ratio, 0.78; 95% CI, 0.70 to 0.87) compared with lower adherence. Male gender, occurrence of cardiovascular disease during follow-up, and dyslipidemia were risk factors for CD.
High adherence to AH therapy is associated with a reduced risk of CD outside the context of clinical trials in primary prevention.
This study aims to confirm the local effects of intravaginal prasterone on moderate to severe dyspareunia, a symptom of vulvovaginal atrophy (VVA) associated with menopause.
In a prospective, ...randomized, double-blind, placebo-controlled phase III clinical trial, we examined the effects of daily intravaginal prasterone (6.5 mg) on four co-primary objectives, namely, percentage of vaginal parabasal cells, percentage of vaginal superficial cells, vaginal pH, and moderate to severe dyspareunia identified by women as the most bothersome VVA symptom.
After daily intravaginal prasterone administration for 12 weeks, the percentage of parabasal cells decreased by 45.8% compared with placebo (P < 0.0001), the percentage of superficial cells increased by 4.7% over placebo (P < 0.0001), and vaginal pH decreased by 0.83 pH units compared with placebo (P < 0.0001). The severity of most bothersome dyspareunia decreased by 46% over placebo (P = 0.013) at 12 weeks, whereas moderate to severe vaginal dryness decreased by 0.43 severity score units (or 42%) compared with placebo (P = 0.013). On gynecologic evaluation, a 14.4% to 21.1% improvement in vaginal secretions, epithelial integrity, epithelial surface thickness, and color over placebo (P = 0.0002 to P < 0.0001) was observed. Serum steroids, in agreement with the physiology of intracrinology and menopause, remained well within reference postmenopausal concentrations. All endometrial biopsies at 12 weeks have shown atrophy.
Daily intravaginal prasterone (0.50%; 6.5 mg) treatment has clinically and statistically significant beneficial effects on the four co-primary objectives of VVA, according to US Food and Drug Administration guidelines. No significant drug-related adverse effect in line with the strictly local action of treatment has been reported, thus providing a high benefit-to-risk ratio for intravaginal prasterone.
Abstract Background Evidence from meta-analyses shows that statin therapy reduces all-cause mortality and nonhemorrhagic strokes. Nonadherence to statins may reduce this protective effect. The ...association between statin adherence and incidence of cerebrovascular disease remains unexplored outside the context of clinical trials. Objective To evaluate the impact of statin adherence on the occurrence of cerebrovascular disease in a real clinical setting. Methods A cohort of 112,092 patients was reconstructed using the Régie d'assurance maladie du Québec and Med-Echo databases. The Régie d'assurance maladie du Québec database contains information from 3 types of health-related data, such as demographic information, medical data, and the prescription claims file. The Med-Echo database contains data on acute care hospitalizations on all Quebec residents. All patients without cardiovascular disease aged 45-85 years who were newly treated with statins between 1999 and 2004 were eligible. A nested case-control design was used to study the occurrence of cerebrovascular disease. Adherence level was reported as a medication possession ratio. Conditional logistic regression models were used to estimate the rate ratio of cerebrovascular disease, adjusting for different covariables. Results The mean patient age was 63 years; 49% had hypertension, 21% had diabetes, and 41% were males. Nonadherence was prevalent because only 55% of the patients were exposed to ≥80% of the medication during follow-up. We did not observe any major differences, defined as more than 5%, between the groups, except for the sex, diabetes, and hypertension. High level of adherence to statins was associated with a reduction of cerebrovascular events (rate ratio: 0.74; 95% confidence interval, 0.65-0.84). Conclusions Our study suggests a relatively low level of adherence to statins, but more importantly, that adherence is associated with a risk reduction for cerebrovascular disease. Adherence to statin therapy needs to be improved, so that patients can benefit from the full protective effects of statin therapy.
The objective of this study was to provide evidence that the transformation of DHEA into both androgens and/or estrogens locally in cells of the three layers of the vagina (epithelium, lamina ...propria, and muscularis) would have effects of greater impact, including effects on sexual function, than only effects on superficial epithelial cells as achieved with estrogens.
This prospective, randomized, double-blind, and placebo-controlled phase III clinical trial has evaluated the effect of daily local intravaginal application of Prasterone (dehydroepiandrosterone; DHEA) for 12 weeks on the domains of sexual dysfunction, namely, desire/interest, arousal, orgasm, and pain at sexual activity, in 216 postmenopausal women with moderate to severe symptoms of vaginal atrophy.
A time- and dose-dependent improvement of the four domains of sexual function was observed. At the 12-week time interval, the 1.0% DHEA dose led, compared with placebo, to 49% (P = 0.0061) and 23% (P = 0.0257) improvements of the desire domains in the Menopause Specific Quality of Life and Abbreviated Sex Function questionnaires, respectively. Compared with placebo, the Abbreviated Sex Function arousal/sensation domain was improved by 68% (P = 0.006), the arousal/lubrication domain by 39% (P = 0.0014), orgasm by 75% (P = 0.047), and dryness during intercourse by 57% (P = 0.0001).
By a local action in the vagina, DHEA applied daily at doses at which serum steroids remain well within normal postmenopausal values exerts relatively potent beneficial effects on all four aspects of sexual dysfunction. Such data indicate that combined androgenic/estrogenic stimulation in the three layers of the vagina exerts important beneficial effects on sexual function in women without systemic action on the brain and other extravaginal tissues.
PDF
