The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70.

BACKGROUND: This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after ≥2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. METHODS: Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing ≥2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. RESULTS: Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. CONCLUSIONS: Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination. Clinical Trials Registration. NCT02723773.

Probiotic treatment using a mix of three Lactobacillus strains for lumbar spine bone loss in postmenopausal women: a randomised, double-blind, placebo-controlled, multicentre trial.

BACKGROUND: Postmenopausal bone loss in the spine is associated with an increased risk of vertebral fractures. Certain probiotic treatment protects rodents from ovariectomy-induced bone loss. The aim of the present study was to determine if treatment with a combination of three bacterial strains protects against the rapid spine bone loss occurring in healthy early postmenopausal women. METHODS: This randomised, double-blind, placebo-controlled, multicentre trial was done at four study centres in Sweden. Early postmenopausal women were randomly assigned in a 1:1 ratio to receive probiotic treatment consisting of three Lactobacillus strains (Lactobacillus paracasei DSM 13434, Lactobacillus plantarum DSM 15312, and Lactobacillus plantarum DSM 15313; 1 x 1010 colony-forming units per capsule) or placebo once daily for 12 months. The primary outcome was the percentage change from baseline in lumbar spine bone mineral density (LS-BMD) at 12 months. The primary analysis was done in all participants with BMD measurements available both at baseline and at 12 months. Analyses of adverse events and safety included all participants who had taken at least one capsule of placebo or Lactobacillus. This trial is registered with ClinicalTrials.gov, NCT02722980, and is completed. FINDINGS: Between April 18 and Nov 11, 2016, 249 participants were randomly assigned to receive probiotic product or placebo, and 234 (94%) completed the analyses required for the primary outcome. Lactobacillus treatment reduced the LS-BMD loss compared with placebo (mean difference 0·71%, 95% CI 0·06 to 1·35). The LS-BMD loss was significant in the placebo group (-0·72%, -1·22 to -0·22), whereas no bone loss was observed in the Lactobacillus-treated group (-0·01%, -0·50 to 0·48). The adverse events were similar between the two groups. INTERPRETATION: Probiotic treatment using a mix of three Lactobacillus strains protects against lumbar spine bone loss in healthy postmenopausal women. FUNDING: Probi.

Symptoms and quality of life in patients with chronic obstructive pulmonary disease treated with aclidinium in a real-life setting.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a progressive disease with symptoms that can have a major impact on patients' physical health. The aim of this study was to evaluate quality of life (QoL), symptom severity and dyspnoea in COPD patients treated with aclidinium up to 24 weeks. METHODS: In this prospective non-interventional multicentre study (198 centres in Sweden, Denmark, and Norway), COPD patients (age ≥40 years) who started treatment with aclidinium (initial therapy, change of treatment, or add-on therapy) could be included. Health-related QoL was obtained by COPD assessment test (CAT). Symptoms were evaluated on a 6-point Likert scale. The modified Medical Research Council (mMRC) Dyspnoea Scale was used as a simple grading system to assess the level of dyspnoea/shortness of breath from0 to 4. Patients on treatment with aclidinium who completed baseline and at least one follow-up visit (week 12 or 24) were included in the study population. RESULTS: Overall, 1,093 patients were enrolled (mean 69 years, 54% females), one-third had ≥1 exacerbation the year prior to baseline. At enrolment, 48% were LAMA naïve. Mean (standard deviation, SD) CAT score decreased from 16.9 (7.7) at baseline to 14.3 (7.3) at week 24 (p<0.01) with a decrease in all individual CAT items (p<0.05). Mean difference in morning and night-time symptoms from baseline to week 24 was -0.60 (SD 2.51) and -0.44 (SD 2.48), respectively (both p<0.001). Mean (SD) mMRC Dyspnoea Scale changed from 1.6 (1.0) at baseline to 1.5 (1.0) at week 24 (p<0.001). CONCLUSION: In this observational study of a Nordic real-life COPD population, treatment with aclidinium was associated with a clinically important improvement in QoL and morning and night-time symptoms, most pronounced in the LAMA naïve group. However, there is still room for improvement in the management of symptomatic COPD patients.

A feasible lifestyle program for early intervention in patients with chronic obstructive pulmonary disease (COPD): a pilot study in primary care.

AIM: To evaluate the feasibility of a lifestyle program for early intervention in patients with COPD in a primary care population. METHODS: The study was performed in a Primary Health Care Centre in Western Sweden. During a four-week period, all smokers between 40-70 years of age were invited to answer a questionnaire and to perform spirometry. The intervention program included a specially designed smoking cessation program and programs for physical activity and diet. RESULTS: 84 smokers were included. 42% fulfilled the criteria for COPD. All of the COPD patients were in GOLD stage I and II. Among the COPD subjects, 38% were underweight and 56% had a low fat-free mass - both together indicating malnutrition and the need for nutritional treatment. By the end of the intervention program, 47% of the COPD patients had stopped smoking. CONCLUSIONS: The intervention program was feasible and effective with a very high smoking cessation rate.

Management of chronic obstructive pulmonary disease (COPD) in primary care: a questionnaire survey in western Sweden.

AIM: To assess the primary care management of chronic obstructive pulmonary disease (COPD) in relation to COPD guidelines. METHOD: A postal questionnaire was sent out to all Primary Health Care Centres (PHCCs) in western Sweden (n=232). The response rate was 75%. RESULTS: A majority of the PHCCs had a nurse and physician responsible for COPD care. They used spirometry equipment regularly, but only 50% reported that they calibrated it at least weekly. Less than 30% of the PHCCs reported access to a dietician, occupational therapist or physiotherapist. There was a structured smoking cessation program in 50% of the PHCCs. Larger PHCCs were more likely to use spirometry equipment regularly and to have specific personnel for COPD care. CONCLUSION: There is a need to establish structured programs for COPD care including smoking cessation programs for COPD patients with special trained staff. Larger PHCCs have a better infrastructure for providing guideline-defined COPD care.