Comparative effectiveness of pneumococcal vaccination with PPV23 and PCV13 in COPD patients over a 5-year follow-up cohort study.

Vaccination against Streptococcus pneumoniae is among the most effective measures for preventing pneumonia and reducing the rate of chronic obstructive pulmonary disease (COPD) exacerbations. The objective of this work was to evaluate the long-term effectiveness of PCV13 and PPV23 for preventing pneumonia and COPD exacerbations. The open-label, prospective, observational cohort study involved 302 male patients aged ≥ 45 years: PCV13 group (n = 123); PPV23 group (n = 32); and vaccine-naïve group (n = 147). The primary endpoint included the frequency of pneumonia episodes and COPD exacerbations per year over a 5-year follow-up period. The secondary endpoints included the dynamics of dyspnea severity (MMRC), the BODE index, FEV1, the CAT index, the SGRQ score, and the results of 6-min walk test. Vaccination with PCV13 and PPV23 significantly reduces the total rate of pneumonia during the first year after vaccination. Starting with the second year, clinical effectiveness in PPV23 group decreases compared with both PCV13 group and vaccine-naïve patients. Pneumonia by year 5 after vaccination was registered in 47% of patients in the PPV23 group, versus 3.3% of patients in the PCV13 group (p < 0.001); COPD exacerbations-in 81.3% versus 23.6%, respectively (p < 0.001). Vaccination with PCV13 significantly reduced and maintained the BODE index over the 5-year follow-up period. Although both vaccines have comparable clinical effects during the first year after vaccination, only PCV13 is characterized by persistent clinical effectiveness during the 5-year follow-up period. Patients older than 55 years who received PPV23 have significantly higher risks of having pneumonia episodes more frequently during the long-term follow-up.

Management of Cough in Patients with Chronic Obstructive Pulmonary Disease: Results of the Multicenter Randomized Placebo-Controlled Clinical Trial.

BACKGROUND: Chronic cough declines quality of life and increases risk of complications in patients with chronic obstructive pulmonary disease (COPD). Reducing cough severity and associated negative effects is important therapeutic goal in COPD. Rengalin with anti- and protussive activity is based on technologically processed antibodies to bradykinin, histamine and morphine. AIM: To evaluate efficacy and safety of Rengalin in treatment of cough in patients with COPD. METHODS: Patients (n=238, mean age 64.3±8.2 years) with stable COPD and persistent cough despite maintenance therapy (anticholinergics, beta-2-adrenergic agonists, inhaled corticosteroids) were included and randomized in the study. The severity of cough assessment (according to the "Cough Severity Score"), COPD impact on patient's life (COPD Assessment Test, CAT), and spirometry were performed at screening. Patients took Rengalin or Placebo 2 tablets 2 times daily for 4 weeks. The endpoints were proportion of patients who responded to treatment, dynamics of cough severity, and severity of COPD symptoms. Intention-to-treat (per protocol) analysis was performed. RESULTS: Positive response to Rengalin was recorded in 83.6 [85.7]% (vs 72.6 [72.7]% in Placebo group, p=0.0422 [p=0.0163]). Double decrease of cough severity was reported in 42.2 [43.8]% in Rengalin group (versus 32.7 [32.7]% in Placebo; p=0.1373 [p=0.0907]). The total CAT score decreased by 3.3±4.2 [3.6±3.9] points (versus 2.5±4.1 [2.5±4.2] in Placebo group); the difference between groups was 0.79±4.16 [1.04±4.02] points (p=0.0870 [p=0.0416]). The number of patients with adverse events (AEs) in Rengalin (n=13) and Placebo (n=12) groups did not have significant differences (p=1.00). No AEs with certain relationship with study drug were registered. CONCLUSION: Rengalin is an effective and safe drug in patients with stable COPD and persistent cough, despite stable doses of maintenance therapy according to the GOLD guidelines. Four-week therapy decreases severity of cough by two times in more than 40% of patients. TRIAL REGISTRATION: ClinicalTrials.gov (id: NCT03159091).