Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial.

Background: Pulmonary arterial hypertension (PAH) leads to reduced health-related quality of life (HRQoL). The objectives of this analysis were to evaluate the effect of macitentan on HRQoL in patients with PAH in the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) study. The association between baseline HRQoL and long-term outcomes was also investigated.

Transdermal Buprenorphine Relieves Neuropathic Pain: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Diabetic Peripheral Neuropathic Pain.

Objective: To evaluate the efficacy and safety of transdermal buprenorphine in patients with diabetic peripheral neuropathic pain (DPNP).

Research Design And Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial enrolled patients with type 1 or type 2 diabetes and stable glycemic control who had been experiencing moderate to severe DPNP for at least 6 months on maximal tolerated conventional therapy. Patients were randomly assigned to receive buprenorphine (5 μg/h) or placebo patches.

Incidence, Predictors and Outcomes of Major Bleeding in Patients Following Percutaneous Coronary Interventions in Australia.

Background: Major bleeding is a serious complication of percutaneous coronary intervention (PCI). We set out to investigate the incidence of major bleeding and its impact on hospitalisation and long-term mortality.

Method: We examined seven years of registry data encompassing 16,860 PCI procedures.

An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study.

Objective: There are limited controlled data for intragastric balloons (IGB) in obesity treatment. This randomized, controlled study evaluated the efficacy and safety of an IGB in obese individuals with metabolic syndrome (MS).

Design And Methods: Sixty-six adults (BMI: 30-40 kg/m(2)) were randomized to IGB for 6 months, with a 12 month behavioral modification (IGB Group; "IGBG"), or 12 month behavioral modification alone (Control Group; "CG").

Effect of immunosuppression for primary renal disease on the risk of cancer in subsequent renal transplantation: a population-based retrospective cohort study.

Background: To measure the risk of cancer in renal transplantation for recipients who had previously been treated with immunosuppressive agents for primary renal disease.

Methods: A retrospective population-based cohort study of 5970 renal transplant recipients in Australia registered on the Australia and New Zealand Dialysis and Transplant Registry between 1982 and 1997 and followed until 2007. Data about the incidence of a range of cancer types from this Registry were compared with cancer incidence data for the general population matched for cancer type, year of incidence, age, and gender derived from national cancer records.

Quality of life and healthcare resource use associated with angiographic vasospasm after aneurysmal subarachnoid hemorrhage.

Background And Purpose: In this analysis of data from a large clinical trial in aneurysmal subarachnoid hemorrhage, the impact of angiographic vasospasm (aVSP) on specific patient outcomes and inpatient healthcare resource use was assessed.

Methods: This was a post hoc analysis of exploratory end points collected for 409 patients with aneurysmal subarachnoid hemorrhage in the Clazosentan to Overcome Neurological Ischemia and Infarction Occurring After Subarachnoid Hemorrhage (CONSCIOUS-1) trial. Central reviewers graded severity of aVSP as none, mild, moderate, or severe based on comparison of catheter angiograms obtained at baseline and 7 to 11 days after aneurysmal subarachnoid hemorrhage.

A software program designed to educate patients on age-related skin changes of facial and exposed extrafacial regions: the results of a validation study.

Background: A software program called "HOYS" has been developed to depict various aspects and degrees of aging at 35 constituent subregions of seven distinct facial or exposed extrafacial regions. This program is underpinned by five-point photonumeric Likert scales characterizing skin surface and volume changes across five decades for each of the 35 subregions, and features an interactive skin-age assessment with a treatment-prioritization tool. In this study, the reliability and reproducibility of these scales was evaluated.

Funding linked to ongoing research: impact of the bosentan patient registry on pricing in Australia.

Objectives: Bosentan, a dual endothelin receptor antagonist (ERA), was the first oral drug approved for the treatment of pulmonary arterial hypertension (PAH), a rare disease with poor prognosis. In 2004 the Australian Department of Health agreed to fund bosentan on the pharmaceutical benefits scheme (PBS) on the condition that a registry was established to monitor mortality: if the observed mortality rate was higher than that claimed in the original funding submission then the price of bosentan would be reduced to maintain the original incremental cost-effectiveness ratio (ICER). This article presents the economic implications of the bosentan patient registry (BPR).

Hemodynamics in pulmonary arterial hypertension (PAH): do they explain long-term clinical outcomes with PAH-specific therapy?

Background: Pulmonary arterial hypertension (PAH) has witnessed dramatic treatment advances over the past decade. However, with the exception of epoprostenol, data from short-term randomized controlled trials (RCTs) have not shown a benefit of these drugs on survival. There remains a need to differentiate between available therapies and current endpoint responses which in turn, could be used to guide treatment selection and provide long-term prognostic information for patients.

United States cost-effectiveness study of two dry eye ophthalmic lubricants.

Purpose: Dry eye is thought to be the most common ocular problem in the United States. However, it is only recently that it has been recognized as a disease with significant economic burden and impact on quality of life. This article presents an economic model of cost-effectiveness of two ophthalmic lubricants commonly used in the treatment of dry eye-Systane and Refresh Tears.

Comparison of benefits and risks of rosuvastatin versus atorvastatin from a meta-analysis of head-to-head randomized controlled trials.

The benefit from statin therapy is proportional to the low-density lipoprotein (LDL) cholesterol reduction. However, adverse events appear to be related to dose rather than LDL cholesterol reduction. Although serious side effects are rare, any comparison of statins requires scrutiny of the relation between therapeutic effect and risk of side effects.

Bosentan therapy in patients with pulmonary arterial hypertension: the relationship between improvements in 6 minute walk distance and quality of life.

Background And Objective: Bosentan, an oral, dual endothelin receptor antagonist, significantly improves functional status, haemodynamic measures and survival in patients with pulmonary arterial hypertension (PAH). However, there are limited data on the effect of bosentan on quality of life (QOL) and its relationship to changes in functional status, as measured by the 6 minute walk distance (6MWD).

Methods: A retrospective analysis was performed of a large, open-label, multicentre trial (VITAL) of bosentan in patients with PAH.

Safety and efficacy of a testosterone metered-dose transdermal spray for treating decreased sexual satisfaction in premenopausal women: a randomized trial.

Background: It is not known whether premenopausal women who report low sexual satisfaction and have low circulating testosterone levels will benefit from testosterone therapy.

Objective: To evaluate the effects of exogenous testosterone in premenopausal women reporting diminished sexual function.

Design: Randomized, double-blind, placebo-controlled, dose-ranging trial.

Impact of inhaled corticosteroids on cortisol suppression in adults with asthma: a quantitative review.

Background: Studies examining the effects of inhaled corticosteroids (ICSs) on cortisol suppression show inconsistent results, and there is uncertainty regarding the dose-response relationship between ICSs and cortisol suppression.

Objective: To determine, using meta-analysis, the extent of cortisol suppression after administration of clinically relevant ICS doses in adults with asthma.

Methods: Database searches (MEDLINE, EMBASE, and The Cochrane Library) using appropriate indexed terms were performed to identify eligible articles for review.

Quality of life in pulmonary arterial hypertension: improvement and maintenance with bosentan.

Background: Bosentan (an oral dual endothelin receptor antagonist) improves symptoms and cardiac hemodynamics and reduces clinical worsening in patients with pulmonary arterial hypertension (PAH). The VITAL study assessed the effect of bosentan on quality of life in patients with WHO Functional Class III or IV PAH (idiopathic or associated with connective tissue diseases).

Methods: Quality of life was assessed prospectively using the MOS SF-36 and AQOL questionnaires.

Public funding of bosentan for the treatment of pulmonary artery hypertension in Australia: cost effectiveness and risk sharing.

Objectives: In Australia, no therapeutic agents were subsidised for the treatment of idiopathic pulmonary artery hypertension (iPAH), a rare progressive and severe disease with short life expectancy, until 1 March 2004, when bosentan (a dual endothelin receptor antagonist of high cost) was listed on the Pharmaceutical Benefits Scheme (PBS). Bosentan, in addition to conventional therapy, has been shown to slow iPAH progression and improve clinical and haemodynamic status and symptomatology, compared with placebo and conventional therapy. The objective of this paper is to describe the process of the Australian Pharmaceutical Benefits Scheme listing for bosentan (Tracleer), which included a health economic model assessing the cost effectiveness of bosentan from a healthcare payer perspective, and a risk-sharing arrangement based on the establishment of a patient registry.

Assessment of the bioequivalence of a generic cyclosporine A by a randomized controlled trial in stable renal recipients.

Background: The aim of this study was to determine the bioequivalence of Cysporin, a generic cyclosporine A, compared with Neoral in stable renal transplant recipients.

Methods: Study design consisted of an open label, two-way crossover, randomized controlled trial of Cysporin versus Neoral in stable renal transplant recipients. In all, 33 patients were enrolled; 31 were randomized and 28 were evaluable.

CHART: congestive cardiac failure in hospitals, an Australian review of treatment.

Despite strong evidence supporting the use of angiotensin-converting enzyme inhibitors (ACED, beta-blockers, and spironolactone in heart failure, evidence suggests these drugs are under-used and under-dosed. The aim of the present study was to determine the impact of hospitalisation on heart failure pharmacotherapy in patients with congestive heart failure (CHF). A retrospective study was conducted, based on 300 consecutive admissions with the medical record diagnosis of heart failure, in each of seven grade one teaching hospitals.

Idiopathic- and scleroderma-related pulmonary arterial hypertension: outcomes and QOL on bosentan.

Idiopathic pulmonary arterial hypertension (previously known as primary pulmonary hypertension) is a devastating disease of insidious onset, late diagnosis, progressive functional disability and poor prognosis. However, treatment with pulmonary arterial hypertension-specific agents has already changed the outlook wherever these agents are accessible. The process of economic evaluation of treatment for idiopathic pulmonary arterial hypertension is challenging due to limitations common to clinical studies in rare diseases, such as small patient numbers limiting survival information, lack of directly comparable trials for the efficacy of different drugs and a paucity of quality of life measurements.

The relationship between quality of life, Mini-Mental State Examination, and the Instrumental Activities of Daily Living in patients with Alzheimer's disease.

Alzheimer's disease (AD) affects the cognitive function and capacity for independent living of the elderly, however little is known about the measurement of patient's overall health-related quality of life (HRQoL) and its relationship to these effects. We examined the relationship between patient/caregiver-rated HRQoL and cognition (using the Mini-Mental State Examination (MMSE)) or Instrumental Activities of Daily Living (IADL). One hundred AD patients participating in an open-label trial of donepezil were followed for 6 months.