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For Healthcare Professionals

SPIRIVA® RESPIMAT®

For COPD

Efficacy

Phase III clinical studies on SPIRIVA® RESPIMAT® treating 2,901 COPD patients included two 1-year, two 12-week and two 4-week double-blind, randomized, controlled trials. The 1-year trials were compared with placebo and the 12-week trials were compared with active drug (ipratropium) and placebo. All six trials evaluated patients’ lung function. The two 1-year studies also evaluated breathlessness, health-related quality of life and impact on acute exacerbations.1

  • SPIRIVA® RESPIMAT® is the only one-time daily LAMA indicated to reduce the risk of exacerbations and shown to reduce exacerbation-related hospitalizations1-7
  • Easy for you to prescribe, with all the support and resources your patients need to start and stay on SPIRIVA®

SPIRIVA® RESPIMAT® ameliorated the annual decline in lung function in patients with mild or moderate COPD vs. placebo2

In a multicenter, double-blind trial, 841 patients with COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 1 (mild) or 2 (moderate) severity were randomized to receive a once-daily inhaled dose (18 μg) of tiotropium (419 patients) or matching placebo (422) for 2 years. The FEV1 in patients who received tiotropium was higher than in those who received placebo throughout the trial (ranges of mean differences, 127 to 169 ml before bronchodilator use and 71 to 133 ml after bronchodilator use; P<0.001 for all comparisons). The annual decline in the FEV1 after bronchodilator use was significantly less in the tiotropium group than in the placebo group (29±5 ml per year vs. 51±6 ml per year; difference, 22 ml per year [95% CI, 6 to 37]; P = 0.006).

Efficacy_figure_1_renew

The hazard ratio for the first acute exacerbation of COPD in the tiotropium group, as compared with the placebo group, was significantly lower at 0.60 (95% CI, 0.50 to 0.80; P<0.001).

Efficacy_figure_2_renew

SPIRIVA® RESPIMAT® improves trough FEV1 response vs. placebo8

In two replicate, randomized placebo-controlled trials of SPIRIVA® RESPIMAT® (2.5 μg x 2 puffs) over 48 weeks, the following co-primary endpoints were evaluated: trough FEV1 response, Mahler TDI score, SGRQ score and COPD exacerbations per patient-year.8

The trough FEV1 response with SPIRIVA® RESPIMAT® was significantly higher than placebo (mean difference 127 mL; p<0.0001), with comparable improvements at day 1 and week 48.8

Efficacy_figure_3_renew

Adapted from Bateman et al 20103

This study included unlicensed doses not displayed in the graph

SPIRIVA® RESPIMAT® improves health-related quality of life vs. placebo8

The mean improvement in unadjusted SGRQ total score with SPIRIVA® RESPIMAT® at week 48 was significantly greater than placebo (–3.5 units; p<0.0001).8

The adjusted mean change from baseline to week 48 exceeded the accepted minimal clinically important difference of 4 units after treatment with SPIRIVA® RESPIMAT® (–5.1 units).8

SPIRIVA® RESPIMAT® reduces COPD exacerbations vs. placebo8

The COPD exacerbation rate per patient-year with SPIRIVA® RESPIMAT® was significantly lower than placebo (0.93 vs. 1.91; p=0.002).8

Efficacy_figure_4_renew

SPIRIVA® RESPIMAT® (tiotropium) does not have a licensed indication for exacerbations in COPD1

Benefits of treatment with SPIRIVA® RESPIMAT® may include a reduction in the risk of exacerbations.

The percentage of patients experiencing ≥1 exacerbation for SPIRIVA® RESPIMAT® was 37.2% and 44.1% for placebo (p<0.001).

SPIRIVA® improves lung function (FEV1) and helps prevent exacerbations independent of ICS use

risk_0_0

SPIRIVA® RESPIMAT® reduced the risk of exacerbations by 31%.1,3* It's the only one-time daily LAMA in a soft mist indicated to reduce the risk of exacerbations and shown to reduce exacerbation-related hospitalizations.1-7

Chart reprinted from Respir Med, 104(10):1460-1472. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium RESPIMAT® plus usual therapy in COPD patients. ©2010, with permission from Elsevier.

SPIRIVA® RESPIMAT® reduces the risk of exacerbation-related hospitalizations1,3*

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SPIRIVA® RESPIMAT® significantly reduced the risk of exacerbation-related hospitalizations by 27%.1,3*

Chart reprinted from Respir Med, 104(10):1460-1472. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium RESPIMAT® plus usual therapy in COPD patients. ©2010, with permission from Elsevier.

Patients initiating SPIRIVA® RESPIMAT® had fewer COPD exacerbations and/or pneumonia diagnoses vs a LAMA DPI†‡§

chart2_3_0_0

COPD-related exacerbations and/or pneumonia diagnoses: any healthcare resource utilization event occurring within 14 days of each other that included a diagnosis of COPD or pneumonia, and further classified as:

  • Severe: a hospitalization or emergency department visit with a COPD and/or pneumonia diagnosis
  • Moderate: an ambulatory visit with a COPD and/or pneumonia diagnosis and a pharmacy claim for an ICS or a guideline-recommended respiratory antibiotic within 7 days

Patients initiating SPIRIVA® RESPIMAT® had significantly fewer 30-day readmissions vs a LAMA DPI9†§¶

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Readmissions: All-cause hospitalizations within 30 days of a COPD-related acute inpatient hospital discharge.

The Long-term effects of SPIRIVA® RESPIMAT® were similar to those of tiotropium HandiHaler10

In a long-term, large-scale, randomized, double-blind, active-controlled study, the efficacy and safety of tiotropium 2.5 μg (n=5,730) and 5 μg (n=5,711), delivered by RESPIMAT®, and tiotropium 18 μg, delivered by HandiHaler®, (n=5,694) were compared over a mean follow-up of 2.3 years.10 Below, we have only discussed tiotropium RESPIMAT® 5 μg (SPIRIVA® RESPIMAT®) compared with tiotropium HandiHaler® 18 μg (SPIRIVA® HandiHaler®). The tiotropium RESPIMAT® 2.5 μg dose is unlicensed, so results have not been discussed further.

The risk of first COPD exacerbation was numerically similar during the study with SPIRIVA® RESPIMAT® (47.9% of patients) and SPIRIVA® HandiHaler® (48.9% of patients), (hazard ratio (SPIRIVA® RESPIMAT®/SPIRIVA® HandiHaler®) 0.98; 95% CI, 0.93 to 1.03).10

The median number of days to the first COPD exacerbation was 756 days for SPIRIVA® RESPIMAT® and 719 days for SPIRIVA® HandiHaler®.10

A spirometry substudy, including 1,370 patients, found the bronchodilator effect of SPIRIVA® RESPIMAT® was similar to SPIRIVA® HandiHaler.10 The mean difference in trough FEV1 for SPIRIVA® RESPIMAT® versus SPIRIVA® HandiHaler® was −0.010 L (95% CI, −0.038 to 0.018 L).10 The bronchodilator effect of SPIRIVA® RESPIMAT® was sustained between weeks 24 and 120 and was noninferior to SPIRIVA® HandiHaler®.10

Footnotes:

  • *Study Design: In a 1-year, randomized, double-blind, parallel-group study, 3991 patients with COPD were evaluated to compare SPIRIVA® RESPIMAT® and placebo on 
    coprimary endpoints: change in trough FEV1 from treatment Day 1 to Day 337 and time for first COPD exacerbation. Secondary endpoints were changes in trough FEV1 at Day 29 
    and 169 and trough FEV1 at Day 29, 169, and 336, the number of exacerbations per patient, the number of patients with ≥1 exacerbation, and the time for first exacerbation-
    related hospitalization. Exacerbations were defined as complex respiratory events or symptoms that lasted ≥3 days and required treatment with antibiotics and/or systemic 
    corticosteroid, or prompted the investigator to change the patient’s regular respiratory medication. Major inclusion criteria included patients diagnosed with COPD, 40 years of 
    age or over, a prebronchodilator FEV1 of ≤60% of predicted normal and a ratio of FEV1 to FVC of ≤70%, and a smoking history of 10 pack-years or more.3
  • †Study Design:  The objectives of this retrospective analysis were to describe real-world patients initiating a LAMA by inhaler device type (SMI or DPI) and to compare follow-up 
    healthcare costs and utilization.
    1.  Objectives were to evaluate by inhaler type differences in all-cause and COPD-related costs, all-cause and COPD-related HRU, severe and moderate acute COPD-related exacerbations, and time to initiation of triple therapy
    2. Claims data from the Optum Research Database of Medicare Advantage beneficiaries were used
    3. Cohorts were balanced on baseline characteristics
    4. COPD-related exacerbations consisted of ≥1 COPD-related healthcare utilization event, including COPD exacerbations and/or pneumonia diagnoses. They are classified as:
  •  Severe: A hospitalization or emergency department visit with a COPD or pneumonia diagnosis observed within the 14 days
  •  Moderate: An ambulatory visit with a COPD or pneumonia diagnosis and a pharmacy claim for an oral corticosteroid or a guideline-recommended respiratory antibiotic 
    within ±7 days of the visit (and no hospitalization within the 14 days)

  • Limitations of this study included:

    1.  COPD severity based on lung function, and other clinical characteristics such as smoking status, symptomology, and peak inspiratory flow rate are unavailable in claims
    2. Patients were required to have continuous enrollment with medical and pharmacy coverage for a minimum of 30 days following the index date. However, this did not guarantee that patients were treated with the index medication for at least 30 days
    3. Results from real-world studies are not intended for comparisons with clinical trials. Real-world studies were observational trials. Difference in study designs, patient populations, outcomes definitions, and methods of collecting data make it difficult to make comparisons with clinical trials or with each other. Real-world data should be viewed as complementary information
  • ‡A single exacerbation and/or pneumonia diagnosis episode can include multiple healthcare touchpoints as long as they are within 14 days of each other.
  • §Unadjusted total COPD-related costs were significantly lower for SPIRIVA® RESPIMAT®; after adjustments, the difference did not reach statistical significance. Unadjusted 
    COPD-related HRU (outpatient and emergency department visits and inpatient stays) was significantly lower for SPIRIVA® RESPIMAT®; after adjustments, only outpatient visits 
    were significantly lower. Unadjusted total all-cause costs were lower for SPIRIVA® RESPIMAT®; after adjustments, the differences were similar. Unadjusted all-cause HRU 
    (outpatient and emergency department visits and inpatient stays) was significantly lower for SPIRIVA® RESPIMAT®; after adjustments, the results were no longer significant. The 
    unadjusted time to initiation of triple therapy was similar in both groups; after adjustments, among patients who did not initiate triple therapy on the index date, the time to 
    triple therapy initiation was significantly longer for SPIRIVA® RESPIMAT®.
  • N values indicate the number of hospitalizations per treatment group. A total of 9062 patients were included in the readmissions analysis; SPIRIVA® RESPIMAT® 
    (n=1381) and LAMA DPI (n=7681).
  • CI, confidence interval; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; HR, hazard ratio; ICS, inhaled corticosteroid; LAMA, long-acting antimuscarinic 
    agent; SEM, standard error of the mean; SGRQ, St George's Respiratory Questionnaire; SMI, Soft Mist™ Inhaler; TDI, transition dyspnea index.

References

  1. SPIRIVA® RESPIMAT® Summary of Product Characteristics.

  2. Zhou Y, Zhong NS, Li X, et al. N Engl J Med. 2017 Sep 7;377(10):923-935.

  3. Bateman ED, Tashkin D, Siafakas N, et al. Respir Med. 2010;104(10):1460-1472.

  4. Incruse Ellipta [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; October 2017.

  5. Seebri [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals; January 2018.

  6. Tudorza [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2018.

  7. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.0wms.pdf.   Updated November 5, 2019. Accessed April 17, 2020.

  8. Bateman ED et al. Int J Chron Obstruct Pulmon Dis. 2010;5:197−208.

  9. Int J Chron Obstruct Pulmon Dis. 2020 Dec 7;15:3239-3250.

  10. Wise RA et al. N Engl J Med. 2013;369(16):1491−1501 and supplementary material.

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