Pär Stjärne

The efficacy and safety of once-daily mometasone furoate nasal spray in nasal polyposis : a randomized, double-blind, placebo-controlled study

Conclusion. In subjects with mild-to-moderate nasal polyposis, treatment with mometasone furoate nasal spray (MFNS) 200u2009µg once daily (QD) significantly decreases nasal congestion, reduces polyp size, and improves quality of life. Objectives. To evaluate the efficacy and safety of MFNS, administered QD in the morning, in subjects with mild-to-moderate nasal polyposis. Subjects and methods. This randomized, double-blind, double-dummy, placebo-controlled clinical trial enrolled subjects with mild-to-moderate nasal polyposis at 12 centers in Denmark, Finland, Norway, and Sweden. Inclusion criteria were: ageu200a≥u200a18u2009years, a diagnosis of bilateral nasal polyps, and clinically significant nasal congestion. Following a 2–4-week run-in period, subjects were randomized to receive MFNS 200u2009µg QD or matching placebo for 16u2009weeks. Results. A total of 298 subjects were randomized to treatment. Of those subjects included in the intent-to-treat efficacy analysis (nu200a=u200a291), a statistically greater proportion of the MFNS group than the placebo group had improvements in investigator-assessed nasal congestion score between baseline and end point (the primary outcome) (74.3% vs 46.8%; pu200a<u200a0.001). Significant benefits of MFNS were also seen for secondary end points, including polyp size, sense of smell, peak nasal inspiratory flow, therapeutic improvement, and quality-of-life measures. MFNS was well tolerated, with no unusual or unexpected adverse events.

Local Capsaicin Treatment of the Nasal Mucosa Reduces Symptoms in Patients with Nonallergic Nasal Hyperreactivity

Ten patients with nonallergic nasal hyperreactivity were selected from the outpatient department at the ENT clinic of the Karolinska Hospital. Traditional treatment had been ineffective. Local capsaicin treatment (30 μM solution) was performed on 3 consecutive days after careful nasal decongestion and local anesthesia with naphazoline and lidocaine. The treatment was evaluated using a diary where the patients were asked to score their subjective symptoms of nasal discharge, nasal blockage, and sneezing on a visual analogue scale. At the follow-up, the desensitization to local capsaicin application of the nasal mucosa was also tested. After 1 month the patients reported a 63% and 69% reduction of nasal blockage and nasal discharge respectively, which was parallel to a desensitization of the nasal mucosa to capsaicin. The results were similar after 3 months. After 6 months the patients had reverted to a score similar to that before the treatment. At this time the response of the nasal mucosa to capsaicin was normalized. In conclusion, capsaicin treatment of the nasal mucosa in patients with nonallergic nasal hyperreactivity induces a long-lasting reversible desensitization and a parallel subjective reduction of symptoms.

Efficacy and safety of topical combinations of ipratropium and xylometazoline for the treatment of symptoms of runny nose and nasal congestion associated with acute upper respiratory tract infection

Background Rhinorrhea and nasal congestion are simultaneous symptoms associated with the common cold. This study investigated the efficacy and safety of a combination nasal spray of ipratropium and xylometazoline for simultaneous treatment of these symptoms. Methods The trial was a multicenter double-blind, parallel-group, randomized design on patients with common cold symptoms. Patients scored symptoms of runny nose and nasal congestion and recorded adverse events in a diary for up to 7 days. Patients also recorded tissue use. The five test treatments consisted of ipratropium, 0.6 mg/mL, and xylometazoline, 1.0 mg/mL; ipratropium, 0.6 mg/mL, and xylometazoline, 0.5 mg/mL; ipratropium, 0.6 mg/mL; xylometazoline, 1.0 mg/mL; and placebo solution. Results Eight hundred sixty-four patients were screened and 786 patients received treatment. One day after treatment there was a clear separation between the scores for the placebo and ipratropium treatment groups for rhinorrhea and between the placebo and xylometazoline treatment groups for congestion. Both ipratropium/xylometazoline 1.0 and ipratropium/xylometazoline 0.5 treatments were superior to xylometazoline with respect to rhinorrhea (p < 0.0001) and superior to ipratropium with respect to nasal congestion scores (p < 0.001). Both the ipratropium combination treatments had significantly lower tissue use than the xylometazoline treatment group (p < 0.0001). Adverse events were distributed equally between the treatments, except mucus tinged with blood, epistaxis, nasal passage irritation, and nasal dryness, which had a higher incidence in the three groups that received medicines containing ipratropium. Conclusion The results indicate that a combination medicine of ipratropium and xylometazoline is safe and effective for treatment of rhinorrhea and nasal congestion associated with common cold.

Still no reliable consensus in management of blow-out fracture

BACKGROUNDnManagement of blow-out fractures (BOF) is addressed by different specialties. The general agreement is that patients with the potential for late enophthalmus development require early surgical intervention. In this study we wanted to: (i) evaluate the differences in opinions between the specialties that manage BOF and also whether there was a difference between surgeons from different countries, (ii) evaluate if surgeons handle these cases based upon their own individual criteria,(1) (iii) evaluate the correlation between the management of patients with orbital floor fractures and any late sequelae detected upon eye examination.nnnMATERIALS AND METHODSnEleven patients with BOF were selected from the records of the Department of ENT and Head & Neck Surgery, Karolinska University Hospital between 2003 and 2008. The cases were presented with a case history and CT scans to 46 surgeons from different countries and specialties and they were asked to give their opinions regarding the need for surgery, timing of surgery and the risk for late enophthalmus. We considered a group of surgeons to be in agreement if there was ≥ 75% agreement on whether or not to operate, when to operate and on the risk for late enophthalmus.nnnRESULTnThe surgeons agreed on the choice of management for the patients (whether or not to operate) in only 5 of the 11 cases. Similarly, in only 5 of the 11 cases did the surgeons agree upon the risk for late enophthalmus. There was a greater difference between specialities than between physicians from the participating countries.nnnCONCLUSIONnThere are considerable differences in opinions regarding the management of BOF due to a lack of a reliable consensus. The management of BOF appears to be based on both individual and local traditions. Guidelines based on a randomized prospective study in BOF are required.

European Summit on the Prevention and Self-Management of Chronic Respiratory Diseases: report of the European Union Parliament Summit (29 March 2017)

AbstractnOn March 29, 2017, a European Summit on the Prevention and Self-Management of Chronic Respiratory Diseases (CRD) was organized by the European Forum for Research and Education in Allergy and Airway Diseases. The event took place in the European Parliament of Brussels and was hosted by MEP David Borrelli and MEP Sirpa Pietikainen. The aim of the Summit was to correspond to the needs of the European Commission and of patients suffering from CRD to join forces in Europe for the prevention and self-management. Delegates of the European Rhinologic Society, European Respiratory Society, European Academy of Allergy and Clinical Immunology, European Academy of Paediatrics, and European Patients Organization EFA all lectured on their vision and action plan to join forces in achieving adequate prevention and self-management of CRD in the context of Precision Medicine. Recent data highlight the preventive capacity of education on optimal care pathways for CRD. Self-management and patient empowerment can be achieved by novel educational on-line materials and by novel mobile health tools enabling patients and doctors to monitor and optimally treat CRDs based on the level of control. This report summarizes the contributions of the representatives of different European academic stakeholders in the field of CRD.

MP-AzeFlu provides rapid and effective allergic rhinitis control in real life: A pan-European study.

BACKGROUNDnThe European Union has prioritized allergic rhinitis (AR) control. Contre les Maladies Chronique pour un Vieillissement Actif Allergic Rhinitis and its Impact on Asthma has endorsed the visual analog scale (VAS) as the AR control language and incorporated it into a new AR treatment algorithm. Concurrently, the Respiratory Effectiveness Group and the European Academy of Allergy and Clinical Immunology are striving to improve the quality of published real-life AR research. Our aim was to assess the effectiveness of MP-AzeFlu by using a VAS in a well-designed, real-life, pan-European study.nnnMETHODSnA total of 2988 patients (aged ≥ 12 years) with Allergic Rhinitis and its Impact on Asthma defined moderate-to-severe AR from Germany, Sweden, Romania, United Kingdom, Denmark, and Norway were included. Patients (except from the United Kingdom) assessed symptom severity by using a VAS from 0 mm (not at all bothersome) to 100 mm (very bothersome) on days 0, 1, 3, 7, and the last visit (∼day 14) in the morning before MP-AzeFlu use. Patients perceived level of disease control was assessed on day 3. A VAS score cutoff on day 3 for well controlled was determined, and the proportion of patients who achieved this response was calculated.nnnRESULTSnMP-AzeFlu was associated with a mean VAS score reduction from 73.7 mm at baseline to 23.4 mm by the last visit. This reduction was significant (p < 0.001) compared with baseline from day 1 and sustained until the last day of the study. By day 3, 50.3% of patients considered their symptoms well controlled; 18.2, 40.0, 66.6, and 75.9% of the patients achieved the ≤38 mm well-controlled VAS score cutoff on days 1, 3, 7 and the last day, respectively. The results were consistent across countries, age, phenotype, and severity.nnnCONCLUSIONnMP-AzeFlu provided effective and rapid symptom control in a real-life pan-European setting and aligned with the European Union, Contre les Maladies Chronique pour un Vieillissement Actif Allergic Rhinitis and its Impact on Asthma, the Respiratory Effectiveness Group, and the European Academy of Allergy and Clinical Immunology objectives, supporting MP-AzeFlu as the drug of choice for the treatment of moderate-to-severe AR.

Sinonasal malignancies in Sweden 1960-2010; a nationwide study of the Swedish population.

INTRODUCTIONnSinonasal malignancies (SNM) are rare and the prognosis is generally poor. Recently, a change in incidence for SNM has been reported. In this study, we investigated population-based trends for SNM in Sweden.nnnMETHODSnWe identified 3,221 patients from the Swedish National Cancer Registry diagnosed with primary malignancies arising from the nasal cavity, paranasal sinuses, or both, during the period 1960 through 2010. Incidence, gender and age, anatomical sites and relative survival were investigated.nnnRESULTSnThe incidence for SNM decreased except for sinonasal malignant melanoma (SNMM) and adenoid cystic cancer (even though a very small group) during the study period. More than 50 % of the malignancies involved the nasal cavity. The five-year relative survival was highest for adenoid cystic cancer followed by adenocarcinoma. SNMM and undifferentiated carcinoma had the poorest prognosis.nnnCONCLUSIONnWe found that the incidence for SNM has decreased during the study period 1960 through 2010, except for SNMM that has increased.

Incidence of IP and risk of malignant transformation in the Swedish population 1960-2010.

The true incidence of inverted papilloma (IP) is not yet known. From hospital-based studies, its incidence has been estimated to approximately 0.5/100,000 person years. Earlier hospital case studies have shown that IP can undergo a malignant transformation in 1–53xa0%. The frequency of its malignant transformation on a population basis is unknown. To our knowledge, no standardised incidence ratio (SIR) has been reported for malignancies among IPs. This study aims to investigate these incidences on a population basis. Using the data from the Swedish Cancer Registry (SCR), we have identified patients with IP and patients with Squamous Cell Carcinoma (SCC) diagnosed between 1960 and 2010 in Sweden. Incidence of IP and incidence of SCC among patients with IP and SIR were analyzed. Eight hundred and fourteen patients with IP were identified. The incidence of IPs reported to the SCR increased from 1960 to 2010. In this cohort, SCC was overrepresented, as compared with the general population. The incidence of IP in the Swedish population seems to have increased.

Multidisciplinary management of clival chordomas; long-term clinical outcome in a single-institution consecutive series

ObjectiveChordomas of the skull base have high recurrence rates even after radical resection and adjuvant radiotherapy. We evaluate the long-term clinical outcome using multidisciplinary management in the treatment of clival chordomas.MethodsBetween 1984 and 2015, 22 patients diagnosed with an intracranial chordoma were treated at the Karolinska University Hospital, Stockholm, Sweden. Sixteen of 22 were treated with Gamma Knife radiosurgery (GKRS) for tumour residual or progression during the disease course. Seven of 22 received adjuvant fractionated radiotherapy and 5 of these also received proton beam radiotherapy.ResultsFifteen of 22 (68%) patients were alive at follow-up after a median of 80xa0months (range 22–370xa0months) from the time of diagnosis. Six were considered disease free after >10-year follow-up. The median tumour volume at the time of GKRS was 4.7xa0cm3, range 0.8–24.3xa0cm3. Median prescription dose was 16 Gy, range 12–20 Gy to the 40–50% isodose curve. Five patients received a second treatment with GKRS while one received three treatments. After GKRS patients were followed with serial imaging for a median of 34xa0months (range 6–180xa0months). Four of 16 patients treated with GKRS were in need of a salvage microsurgical procedure compared to 5/7 treated with conventional or proton therapy.ConclusionAfter surgery, 7/22 patients received conventional and/or photon therapy, while 15/22 were treated with GKRS for tumour residual or followed with serial imaging with GKRS as needed upon tumour progression. With this multidisciplinary management, 5- and 10-year survivals of 82% and 50% were achieved, respectively.

Mometasone furoate nasal spray for nasal polyposis

Nasal polyposis occurs in 2–4% of the general population and is associated with significant socioeconomic costs due to severe nasal/airway symptoms that impair quality of life. Nasal corticosteroids are the first-line therapy for nasal polyposis. Mometasone furoate nasal spray is effective in relieving nasal symptoms, including nasal congestion and loss of sense of smell. This is the only intranasal corticosteroid spray to be approved in the USA for the medical treatment of nasal polyposis and the only once-daily corticosteroid spray approved for the treatment of nasal polyposis in the EU. Clinical trials have shown that mometasone furoate nasal spray has a favorable safety profile with no clinically relevant interactions with other tested medications.