Additional file 1.
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Corrigendum to “Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON)” [Respir. Med. 170 (Aug-Sep 2020) 1...more
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Background COPD is a heterogeneous disease and patients may respond differently to therapies depending on baseline symptom burden. Methods This post-hoc analysis from the 52-week FLAME study investigated the impact of baseline symptom... more
Background COPD is a heterogeneous disease and patients may respond differently to therapies depending on baseline symptom burden. Methods This post-hoc analysis from the 52-week FLAME study investigated the impact of baseline symptom burden in terms of health status, dyspnoea, bronchitis status, eosinophil levels and smoking status on the subsequent risk of moderate or severe exacerbations. Health status was measured by St. George’s Respiratory Questionnaire (SGRQ) score (higher ≥46.6 and lower < 46.6) and COPD Assessment Test (CAT) score (higher ≥17 and lower < 17); dyspnoea and bronchitis were assessed via an electronic diary (eDiary). Differential response to once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 μg versus twice-daily salmeterol/fluticasone (SFC) 50/500 μg was assessed. Results Data from 3354 patients was analysed. The risk of exacerbations was lower in patients who had less severe health impairment (rate ratio [RR] [95% CI]): SGRQ-C, (0.88 [0.78, 0.99]); ...
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Objective In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start. More patients achieved biochemical control... more
Objective In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start. More patients achieved biochemical control with long-acting pasireotide versus continued treatment with octreotide/lanreotide (active control) at month 6. The current work assessed the extent of comorbidities at baseline and outcomes during a long-term extension. Design/methods Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled. Uncontrolled patients on active control were switched to pasireotide 40 mg, with the dose increased at week 16 of the extension if still uncontrolled (crossover group). Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group...
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Objective Monitoring of patients with Cushing’s disease on cortisol-lowering drugs is usually performed with urinary free cortisol (UFC). Late-night salivary cortisol (LNSC) has an established role in screening for hypercortisolism and... more
Objective Monitoring of patients with Cushing’s disease on cortisol-lowering drugs is usually performed with urinary free cortisol (UFC). Late-night salivary cortisol (LNSC) has an established role in screening for hypercortisolism and can help to detect the loss of cortisol circadian rhythm. Less evidence exists regarding the usefulness of LNSC in monitoring pharmacological response in Cushing’s disease. Design Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing’s disease (clinicaltrials.gov: NCT01374906). Methods Mean LNSC (mLNSC) was calculated from two samples, collected on the same days as the first two of three 24-h urine samples (used to calculate mean UFC [mUFC]). Clinical signs of hypercortisolism were evaluated over time. Results At baseline, 137 patients had evaluable mLNSC measurements; 91.2% had mLNSC exceeding the upper limit of normal (ULN; 3.2 nmol/L). Of patients with evaluable assessments at month 12 (n = 92), 17.4% h...
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Rationale: There is limited information on how stable state symptoms relate to future exacerbation burden in COPD patients. Methods: The 52-week FLAME study randomised patients with ≥1 exacerbation in past year to... more
Rationale: There is limited information on how stable state symptoms relate to future exacerbation burden in COPD patients. Methods: The 52-week FLAME study randomised patients with ≥1 exacerbation in past year to indacaterol/glycopyrronium (IND/GLY 110/50µg od) or salmeterol/fluticasone (SFC 50/500µg bid). Patients recorded respiratory symptoms in an electronic diary, enabling detailed characterisation of exacerbations (Figure). In this post-hoc analysis, all patients irrespective of study treatment were divided into groups of low or high baseline dyspnoea burden at run-in, with cut-off at median. Moderate/severe exacerbations were analysed. Results: Patients with low baseline dyspnoea had a lower annualised exacerbation rate (ratio of rates 0.76, 95%CI 0.67, 0.86; p Conclusions: Patients with low baseline dyspnoea experience less frequent COPD exacerbations and reduced exacerbation burden. Future studies of novel exacerbation therapies should target patients with high baseline dyspnoea levels.