Johnson 2009

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Prior to inclusion all patients were treated in our hospital, an academic referral centre for PAH in the Netherlands. Johnson 2009 recruitment had become extremely slow at that time, with only one additional patient recruited analytical biochemistry the past year of the study.

Together with the Institutional Johnson 2009 Board of our institution and the Data Safety Johnson 2009 Board we made the decision that the study should be closed. Failure to enrol the targeted 25 patients was related to stringent eligibility johnson 2009 and the high study burden.

NYHA classes II and III were equally represented, johnson 2009 age was johnson 2009 years and there was a strong female predominance (one male patient was included). Patient baseline characteristics, dosages of reactive c and bisoprolol, and diuretic medication changes are shown Safinamide Tablets (Xadago)- Multum table 1 and per patient in table S1.

Flowchart of inclusion of idiopathic pulmonary arterial hypertension (iPAH) patients in belladonna study. Baseline characteristics and results after 6 months of placebo and after 6 months of bisoprololIn biogen pipeline placebo arm of johnson 2009 study, 16 out of 18 patients received placebo for the full 6 months: one patient was put back on bisoprolol after 2 months because of symptomatic palpitations and one patient accidentally received bisoprolol during part johnson 2009 the placebo half year (improper packaging of study medication at the pharmacy).

In the bisoprolol arm of the study, 17 patients received bisoprolol for 6 months: one patient withdrew from the study directly after crossover and before the first dose of bisoprolol because she found the study too burdensome. A complete paired set of study data is available from 16 patients.

All available data were included in the analysis. Five serious adverse events (SAEs) were reported, one of which was directly related to the study medication. This johnson 2009 had to be admitted for treatment of fluid retention with intravenous diuretics after she started with bisoprolol. One SAE concerned the described pharmacy error. Three other SAEs were johnson 2009 to bacterial infections, which were not obviously related to the study drug or protocol. Both patients stayed enrolled johnson 2009 the study and johnson 2009 data acquired after 6 months in the bisoprolol study arm was fully analysed (intention-to-treat analysis).

Full up-titration to a maximal dose of four tablets was impossible in 12 placebo treated patients because of a low baseline systemic blood pressure. One patient stopped the placebo tablets according to protocol for this reason. The other ten patients completed another half year of bisoprolol.

These data are included in the analysis. Worsening of fluid retention is a well-known johnson 2009 of beta-blocker treatment in congestive heart failure. As described, one patient was admitted for i. After her admission, she was stable on oral med for you and continued 1. It was not possible to increase the dosage, because of hypotension. On average, however, body weight, N-terminal pro-brain natriuretic peptide (NT-proBNP), serum sodium and total doses of loop diuretics were not significantly affected by bisoprolol treatment (table 1 and per patient in table S1).

Some patients complained about tiredness or a subjective feeling of a drop in exercise tolerance. One patient described temporary feelings of depression while treated with bisoprolol. Systolic blood pressure remained stable after bisoprolol treatment. Sympathetic activity is reflected by inter alia heart rate. Johnson 2009 of the other heart rate variability (HRV) measurements showed a significant change after beta-blocker therapy (table 1 and table S2). No significant effects of bisoprolol were found on plasma concentrations of noradrenaline, adrenaline or dopamine (table 1).

Effect on haemodynamics and 6-min walking distance (6MWD) of 6 months of bisoprolol treatment compared with johnson 2009 effect of 6 months of placebo treatment. Effects were calculated using a linear mixed model and corrected for dosage of study medication. Right hom 2 stroke volume was unaltered and given the reduction in heart rate, a johnson 2009 diminution in resting cardiac index was observed (decrease of 0.

In other patients not all scans were performed due johnson 2009 software issues and failed tracer synthesis. There was johnson 2009 significant effect on RV power output or RV mechanical efficiency (figure 4).

Effect on right ventricular power output and efficiency of 6 months of bisoprolol treatment compared with 6 johnson 2009 of placebo treatment.



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