<p>Patient-reported outcomes of dual bronchodilator fixed-dose combination versus bronchodilator monotherapy in individuals with COPD</p>

Abstract Introduction:NEPA is a fixed dose combination of the NK1-receptor antagonist (RA) netupitant and 5-HT3-RA palonosetron approved for prevention of chemotherapy-induced nausea and vomiting (CINV) in pts receiving highly emetogenic (HEC) on cisplatin-basis or moderately emetogenic Ctx (MEC). NEPA demonstrated safety and efficacy in platinum, anthracycline and cyclophosphamid based Ctx, These drugs are frequently used in regimens for hematology pts. A German non-interventional study investigated NEPA's efficacy and impact on quality of life in adult cancer pts by patient-related outcomes (PRO) and physicians' personal assessment under real life conditions. Primary objective was the evaluation of quality of life (QoL) in adults receiving NEPA for CINV prevention. Secondary endpoints were efficacy and safety of NEPA. Methods: Open label, non-interventional, prospective, national, multicenter study that evaluates CINV prevention and patients' QoL receiving NEPA in pts with either HEC or MEC on up to 2 consecutive Ctx days for at least consecutive 3 cycles. QoL was evaluated by the validated FLIE questionnaires at the end of each Ctx cycle. Efficacy was documented by the treating physicians and via patient diaries for 3 Ctx cycles within 24 hrs and on 4 additional d after Ctx. Safety, additional medication and physicians' overall satisfaction was reported via eCRF. Results: Between June 2015 and Sept 2017 a total of 2429 pts were enrolled with 1997 pts being eligible for the 2nd interim analysis. 1901 pts were included in the efficacy analysis in the 1st, 1808 pts in the 2nd and 1734 pts in the 3rd cycle. Median age was 58 (range of 28-89). A total of 630 evaluable pts received MEC (53% carboplatin based) and 1185 pts received HEC (88% anthracycline/ cyclophosphamide based), PRO with complete response (CR=no nausea, no vomiting, no rescue medication) was analyzed based on patient diaries. Diaries for PRO in MEC-pts (n=401) reported CR in 94% in cycle 1, 85% in cycle 2 and 86% in cycle 3. Efficacy, assessed by physicians (n=630 pts) on a 4-point scale, was rated very good/good for 91%, 93%, and 94% in cycle 1, 2 and 3, respectively. PRO of 896 pts with HEC reported 81% CR in cycle 1, 82% in cycle 2 and 83% in cycle 3. Efficacy, assessed by physicians (1185 HEC pts), was rated very good/good for 88%, 89%, and 90% in cycle 1, 2 and 3, respectively. A high percentage of patients receiving HEC or MEC did not suffer from any emesis (93%, 93% and 94% in cycle 1-3, respectively). Over 85%of pts reported no impact on daily QoL due to vomiting in all 3 cycles with HEC or MEC.The most common treatment emergent adverse events were constipation and insomnia of mild-moderate intensity. Conclusions: NEPA prevented CINV highly effective in the acute and delayed phase of HEC and MEC with no impact on daily life due to vomiting in >85% of pts. Physicians evaluation was concordant to PRO.Safety profile was good. Disclosures Karthaus: Riemser: Consultancy. Schilling:Riemser: Honoraria.

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The once-daily fixed-dose combination of olodaterol and tiotropium in the management of COPD: current evidence and future prospects

Therapeutic Advances in Respiratory Disease ◽

10.1177/1753466619843426 ◽

2019 ◽

Vol 13 ◽

pp. 175346661984342 ◽

Cited By ~ 1

Author(s):

Eric Derom ◽

Guy G. Brusselle ◽

Guy F. Joos

Keyword(s):

Statistical Significance ◽

Fixed Dose Combination ◽

Current Evidence ◽

Fixed Dose ◽

Chronic Obstructive ◽

Early Introduction ◽

Patient Reported ◽

Dose Combination ◽

Clinically Significant ◽

Long Acting

Long-acting bronchodilators are the cornerstone of pharmacologic treatment of chronic obstructive pulmonary disease (COPD). Spiolto® or Stiolto® is a fixed-dose combination (FDC) containing two long-acting bronchodilators, the long-acting muscarinic receptor antagonist tiotropium (TIO) and the long-acting β2-adrenoceptor agonist olodaterol (OLO), formulated in the Respimat® Soft Mist™ inhaler. A total of 13 large, multicentre studies of up to 52 weeks’ duration have documented its efficacy in more than 15,000 patients with COPD. TIO/OLO 5/5 µg FDC significantly increases pulmonary function compared with placebo and its respective constituent mono-components TIO 5 µg and OLO 5 µg. TIO/OLO 5/5 µg also results in statistically and clinically significant improvements in patient-reported outcomes, such as dyspnoea, use of rescue medication, and health status. Addition of OLO 5 µg to TIO 5 µg reduces the rate of moderate-to-severe exacerbations by approximately 10%. Compared with placebo and TIO 5 µg, TIO/OLO 5/5 µg significantly improves exercise capacity (e.g. endurance time) and physical activity, the latter increase being reached by a unique combination behavioural modification intervention, dual bronchodilatation and exercise training. Overall, the likelihood for patients to experience a clinically significant benefit is higher with TIO/OLO 5/5 µg than with its constituent mono-components, which usually yield smaller improvements which do not always reach statistical significance, compared with baseline or placebo. This supports the early introduction of TIO/OLO 5/5 µg in the management of patients with symptomatic COPD.

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Cefixime and Ofloxacin fixed dose combination induced petechial rash: a case report

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20164782 ◽

2016 ◽

Vol 6 (1) ◽

pp. 211

Author(s):

Sudhir Kumar ◽

Kirti Nirmal ◽

Amit Kumar Nirmal ◽

S. K. Bhattacharya

Keyword(s):

Case Report ◽

Male Patient ◽

Fixed Dose Combination ◽

Local Application ◽

Fixed Dose ◽

Petechial Rash ◽

Patient Reported ◽

Dose Combination

Petechial rash is a type of rash which is associated with many infectious and non-infectious conditions. We present a case of Petechial rash induced by administration of cefixime with ofloxacin tablet. A eighteen year old male patient reported to us with a presentation of rash with itching for three days on administration of the fixed dose combination of cefixime + ofloxacin along with paracetamol for the previous symptoms of fever with chills, headache and bodyache. Patient describes itching in the rash which is increasing. The duty doctor attended the patient and immediately stopped the further administration of the offending medication. The patient was prescribed tablet cetirizine orally along with calamine lotion for local application. The patient reported back in for follow-up and was without any residual rashes or other such complaints. He was advised to remember and cautious from the use of drugs in the offending category.

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