ARMI News - Part 3

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: The ICS group

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: The ICS groupThe percentages of participants reporting bruises a 25% of the time are shown in Figure 2. Again, clear and significant (p < 0.05) differences are found between the good compliers in the ICS group and all of the other subgroups, with > 10% of the former and only approximately 5% of the latter reporting bruises a 25% of the time. Findings were roughly comparable across the visits from 24 to 42 months. Continue reading

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: Easy Bruising

The adverse skin conditions that are well-recognized to result from or be associated with systemic corticosteroid use are listed in Table 2. Among these, rash, easy bruising, and slow healing differ between the groups, suggesting some systemic absorption. The reports of rash, however, are significantly higher in the placebo group. Also in Table 2 are the reports of mild adverse skin conditions from the subsample of participants who were considered good compliers with their prescribed inhaler (at least 6 puffs per day of a recommended 12 puffs per day). In this subsample, only reports of easy bruising and slow healing differed significantly between the treatment groups. In the subsequent analysis, only easy bruising and slow healing were considered.
Data on participants who described any bruising are shown in Figure 1 by treatment group and compliance with the study drug, as measured by canister weights, at the semi-annual visits between months 24 and 42. Because relatively few questionnaires were administered at both the 18-month and 48-month visits, data from these visits are not shown. Continue reading

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: Results

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: ResultsDifferences in baseline characteristics between the ICS and placebo groups were assessed using t tests for continuous variables and x2 tests for categoric variables. Differences in the rates of new or worsening skin conditions were compared using the Wilcoxon rank-sum test.
The probabilities of reporting bruising or slow healing at some time during the study were analyzed according to the intention-to-treat principle. A logistic regression model was fit to assess the effect of treatment assignment on the probability of participants reporting bruising, adjusted for baseline age, gender, and interaction terms. Significant two-way and three-way interactions were present, which prevented reporting odds ratios of the covariates, and thus parameter estimates and p values are presented. Similar analyses were used for slow healing, although fewer covariates were entered into the final analysis. We also examined the effect of treatment on bruising and slow healing by compliance group. Continue reading

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: Assessment of Skin Changes

Every 6 months, beginning at the 18-month or 24-month visit, participants were administered a structured questionnaire in which they were asked whether, since their last clinic visit, they had experienced any skin rashes (and the percentage of time any skin rashes were present), any bruises on their skin more often than in previous years, and more dry skin than usual (a “dummy” question used to identify non-steroid-related positive responders). If they reported bruises they were queried as to the percentage of time the bruising had been present, the number of bruises that were usually present at one time, the usual location of the bruises, and the occurrence of trauma as a possible cause of the bruising. They were also questioned with regard to exposure to the sun and the wearing of sunscreen. Every 3 months, beginning at the 3-month visit, participants reported changes in their skin since the last clinic visit, including skin rashes, easy bruising, acne, slow healing of cuts or sores, or any other skin changes. Furthermore, they were asked to grade the severity of their skin changes, as follows: 0, not present; 1, mild (present and noticeable or annoying but does not interfere with normal activities); 2, moderate (interferes with normal activities or requires an outpatient visit to a physician, clinic, or emergency department); or 3, severe (prevents normal activities, requires major medical/surgical intervention or hospitalization, or is life-threatening). The participants were followed from randomization to a common ending date (April 30, 1999) 4.5 years after the initiation of the trial. Continue reading

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: Materials and Methods

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: Materials and MethodsStudy Sample
LHS II recruited 1,116 participants at 10 clinical centers in the United States and Canada. These were individuals who participated in LHS I (1,018 persons) or were screened for LHS I (98 persons), and were still smoking or had recently quit (< 2 years). Enrollment took place from November 1994 to November 1995. Other inclusion criteria were age between 40 and 69 years, and the presence of airflow obstruction (FEV1/FVC ratio, < 0.70; FEV1, between 30% and 90% of predicted normal values). Participants were excluded from the study if they had used ICSs or oral corticosteroids within 6 months, or if they had a medical condition that might interfere with participation in the trial. No participants reported using prescribed oral anticoagulants at baseline. Baseline characteristics were determined prior to randomization. Participants were randomized with equal probability to receive either TAA (six puffs bid [1,200 |j,g per day]), or a placebo of identical appearance. Participants and study staff were unaware of the study drug assignments. The methods and detailed entry criteria have been described elsewhere. Continue reading

Skin Manifestations of Inhaled Corticosteroids in COPD Patients: LHS

A few randomized, placebo-controlled clinical trials in persons with COPD have systematically evaluated the frequency of bruising as a complication of moderate-to-high doses of ICSs.-’ However, these relied mainly on nondirected complaints regarding adverse events or direct observation of large ecchy-motic areas (ie, > 5 cm) on the forearm only and may therefore have underestimated the true frequency of bruising in the study population. Moreover, potentially important cofactors that might be associated with bruising, such as age, gender, and compliance with ICS therapy, have not been analyzed in these studies. Furthermore, few studies have examined the impact of ICS therapy on other skin manifestations, such as skin healing, acne, and rash, which are known to be affected by systemic steroids. Continue reading

Skin Manifestations of Inhaled Corticosteroids in COPD Patients

Skin Manifestations of Inhaled Corticosteroids in COPD PatientsInhaled corticosteroids (ICSs) are generally recommended as first-line controller agents for the management of persistent asthma and also have been investigated in several large-scale randomized, controlled clinical trials for their possible efficacy in stable COPD patients, with partially favorable results in some studies, but not all. Because of their proven efficacy in asthma and their suspected benefits with regard to symptom improvement and reduced frequency of exacerbations in COPD patients, although not with respect to FEV1 decline with age, these agents are increasingly used in the management of COPD. Regular treatment with ICSs has recently been recommended as appropriate treatment for symptomatic COPD patients with severe-to-very severe COPD with repeated exacerbations. Enthusiasm for the use of ICSs in treating these diseases is tempered, however, by concern regarding potential systemic toxicity, including such side effects as reduced rate of bone growth in children, reduced bone mass, cataracts, and open-angle glaucoma. While the suppression of the hypothalamic-pituitary-adrenal (HPA) axis, as indicated by very sensitive tests, is a commonly recognized effect of ICSs, this effect is thought to be rarely of clinical significance, although it can serve as a marker of systemic absorption and thus potential systemic toxicity. Since the systemic effects of ICSs appear to be dose-dependent, the availability and increasing use of high doses of potent ICSs add to the concerns regarding systemic toxicity. Continue reading

Chronic Thromboembolic and Pulmonary Arterial Hypertension Share Acute Vasoreactivity Properties: Follow-up of Patients After This Initial Hemodynamic Evaluation

This concept is supported by data indicating that the mechanisms leading to PH in patients who have experienced repeated pulmonary thromboembolic events are not only mechanistic (ie, nonrecanalized thrombotic vessel occlusion), but possibly also are related to vascular remodeling that is located distal to the occluded ar-tery and in noninvolved adjacent pulmonary vessels, possibly leading to endothelial dysfunction. The vascular lesions in these noninvolved vessel segments were histologically indistinguishable from those in PAH patients. In line with this concept are observations that almost half of the patients with CTEPH did not have a history suggestive of acute pulmonary thromboembolism and that only 45% of patients have findings that are suggestive of previous venous thrombosis on lower extremity duplex ultrasound. In addition, the incidence of hereditary thrombophilia seems not to be increased in patients with CTEPH. Central pulmonary artery thrombi have been shown to occur also in patients with PAH.

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Chronic Thromboembolic and Pulmonary Arterial Hypertension Share Acute Vasoreactivity Properties: Follow-up of Patients After This Initial Hemodynamic Evaluation

Chronic Thromboembolic and Pulmonary Arterial Hypertension Share Acute Vasoreactivity Properties: Follow-up of Patients After This Initial Hemodynamic EvaluationAfter this diagnostic hemodynamic baseline examination, patients with PAH were treated with regular iILO (n = 18), bosentan (n = 16), and/or sildenafil (n = 2). The initial treatment of patients with CTEPH was with iILO (n = 20) and/or bosentan (n = 3). Five patients with CTEPH underwent successful pulmonary thrombendarterectomy after the initial vasoreactivity testing, nine patients declined the operation, major surgery was contraindicated in seven patients, and one patient underwent successful lung transplantation 2 years later. Therefore, the initial acute vasodilator response to iNO and/or iILO at the diagnostic baseline evaluation was not related to an improvement in WHO functional class or 6MWD. Again, there was no difference between the PAH and CTEPH patients. We found that the inhalation of iNO and/or iILO during the initial diagnostic right heart catheterization decreased MPAP and increased CI in patients with CTEPH and PAH who were in WHO functional classes III to IV, with the magnitude ofthe response as well as the number of responders being not different between CTEPH and PAH patients. Here

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Chronic Thromboembolic and Pulmonary Arterial Hypertension Share Acute Vasoreactivity Properties: Patient Characteristics

A total of 57 patients, 35 with PAH and 22 with CTEPH, were included in the study. Patient characteristics are presented in Table 1. Patients with CTEPH were on average older than those with PAH, and had lower CI, Sa02, and mixed venous saturation (Sv02). Other parameters did not vary significantly between the two groups. yaz birth control
iNO and iILO significantly decreased MPAP and PVR in both PAH and CTEPH patients, and to a comparable extent. The response to iNO and iILO, as well as the response between patients with PAH and those with CTEPH, were not statistically significant (Table 2, Fig 1).

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