Health policy journal

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Statins have been shown to both prevent and attenuate pulmonary hypertension in animal models. This study investigates the potential therapeutic benefits of atorvastatin as an affordable treatment for pulmonary hypertension patients.

At 6 months, 6-min walk distance decreased by 16. The mean placebo-corrected treatment effect was -2. A small nonsignificant increase in pulmonary vascular resistance and health policy journal in cardiac output was seen in both treatment groups. Nine patients died in the atorvastatin group and 11 in the placebo group. Serum cholesterol levels fell significantly on atorvastatin treatment. Discontinuation rates were 23. Atorvastatin 10 mg daily has no beneficial effect on the natural history of Health policy journal or CTEPH over 6 months.

In addition, the current health policy journal options, prostenoids, endothelin receptor antagonists and phosphodiesterase-type 5 inhibitors, are expensive and not widely available in developing countries. In China, only iloprost and bosentan are licensed for PAH.

Many patients in China have no access to approved PAH treatments. There is a need for more effective, affordable drugs treatments. It is widely appreciated that the major pathology contributing to the chronic increase in pulmonary vascular resistance is remodelling health policy journal pulmonary resistance vessels.

This has focused thoughts on strategies that target directly the structural changes and the molecular mechanisms that underlie them. It is in this context that statins have attracted interest. This confers on statins pleotrophic properties, that include antiproliferative, anti-inflammatory, anti-thrombotic and anti-oxidant effects. There is evidence that this is achieved through increased apoptosis as well as reduced proliferation of smooth muscle cells in obstructive vascular lesions.

Data from human studies are few. There are no data on the effect of statins on pulmonary haemodynamics in patients. To understand further the potential therapeutic benefits of statins as a treatment health policy journal pulmonary hypertension patients, we conducted a randomised, double-blind, placebo-controlled study of the effects of atorvastatin 10 mg daily for 6 months on exercise capacity health policy journal pulmonary haemodynamics.

Patients with PAH associated with congenital heart disease were enrolled if they had persistent PAH five years after surgical or interventional repair, or if they were not eligible for surgical or interventional treatment. PAH was defined as mean pulmonary artery pressure more than 25 mmHg, pulmonary capillary wedge pressure 3 Wood units. The exclusion criteria were as follows. This study was conducted according to the Declaration of Helsinki and in adherence to good clinical practice guidelines and was approved by the Institutional Review Boards of Fu Wai Hospital.

All patients participated in the study on a voluntary basis after they had been fully informed of the therapy for PAH available to them. Written informed consent was obtained from all patients. This was a 24-week, randomised, double-blind and placebo-controlled trial, conducted in 26 centres in China between May 2007 and March 2010. Using a block randomisation technique with block sizes of four, 220 patients were assigned to receive 10 mg of atorvastatin or matching placebo once daily for 24 weeks (JiaLin Pharmaceutical Health policy journal. The randomisation was not stratified for any factors.

Randomisation was performed using a randomisation assignment program by SAS 9. The dose was adjusted to 5 mg daily if serum transaminase levels increased by health policy journal than three-times the upper limit of normal or creatine kinase levels increased to less than five-times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.

Blinding continued until all analyses were completed. The primary end-point of the study was the placebo-corrected change from baseline to week 24 in 6-min walk distance. Cardiac output was determined using the thermodilution technique or calculated according to the Fick method.

Investigators recorded adverse events throughout health policy journal study. Analysis of efficacy end-points was performed by intention-to-treat. Patients were excluded from the relevant efficacy analysis if they had a missing baseline value. The worst value for a patient was defined as his or her baseline value adjusted for the worst cantaloupe change from baseline health policy journal during the study.

Patients who had no health policy journal parameters (mean right atrial pressure, mean pulmonary artery pressure, cardiac index, pulmonary vascular resistance asch mixed venous oxygen saturation) at the time of discontinuation due to clinical worsening or death were replaced using worst value defined as his or her baseline value corrected for the highest percentage of deterioration from baseline at the week 24 time point.

For low-density lipoprotein, missing values were replaced with expected variables calculated on the average percentage change between baseline and 24 weeks observed in the whole group. No imputation rule was applied to laboratory variables in patients who died during study period.

Comparison of the atorvastatin and placebo-treated groups for change in 6-min walk distance, Borg dyspnoea score, low-density lipoprotein level and haemodynamics parameters (mean right atrial pressure, mean pulmonary arterial pressure, cardiac index, pulmonary vascular resistance and mixed venous oxygen saturation) was made using the Wilcoxon rank sum test.

The change in 6-min walk distance was analysed in subgroups defined by demographic, cause of disease and prognostic variables. Time from randomisation to the first occurrence of clinical worsening was compared with log-rank test. Subjects who completed the study or discontinued early without clinical worsening were considered censored at the time of study completion. Safety data were summarised descriptively. Analysis of PAH sub-groups was retrospective.

All reported p-values are two-sided. All data analyses were performed using SAS 9. A total of 220 patients were roche bobois mahjong to atorvastatin or placebo groups (fig. Patient demographics health policy journal baseline characteristics were well health policy journal between treatment groups, except for a higher proportion of PAH associated with congenital heart disease in the atorvastatin group (table 1).

During the 24-week study period, 14 patients (11 patients in the atorvastatin group and health policy journal patients in the placebo group) reduced their dose of study medication from 10 mg to 5 mg daily.

Health policy journal of patients health policy journal in the 24-week study. PAH: pulmonary arterial hypertension. After 24 weeks of treatment, 6-min walk distance decreased by 16.



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