Coinciding with the annual European Respiratory Society Congress, ERS 2012, Spiriva (tiotropium), the first once-daily long-acting inhaled anticholinergic maintenance treatment for patients with Chronic Obstructive Pulmonary Disease (COPD) will mark its 10th anniversary since launch. With over 25 million patient years of experience, once-daily Spiriva is the most prescribed COPD maintenance treatment worldwide. This unique position is rooted in the wealth of clinical trial data available to prove tiotropium’s clinical efficacy in reducing breathlessness (dyspnoea) and the risk of exacerbations as well as improving patients’ quality of life. Over the years, more than 175 clinical trials with tiotropium in COPD have been conducted investigating a broad range of patients in studies of up to four years.

“What is important to note is that from the first COPD patients to receive Spiriva over ten years ago, to the thousands who are currently prescribed it every day, Spiriva has made a significant and lasting contribution to our scientific understanding and management of COPD,” said Professor Antonio Anzueto, Professor of Medicine Pulmonary/Critical Care Medicine, University of Texas Health Science Centre at San Antonio, Texas, USA. “This has been chronicled through evidence from large scale clinical trials, notably UPLIFT and POET-COPD, which prove the efficacy of Spiriva in reducing the risk of exacerbations, improving lung function, reducing shortness of breath and increasing patient quality of life.”

Spiriva reduces the risk of exacerbations and improves lung function in low risk patients as defined by the new GOLD COPD Patient Group criteria.

Data presented at ERS 2012 provide further evidence from one of the pivotal long-term Spiriva trials, UPLIFT‡, demonstrating a reduced risk of exacerbations with Spiriva in low risk COPD patients (GOLD Patient Groups A and B). This adds to the body of evidence that Spiriva reduces the risk of exacerbations in all GOLD Patient Groups.

In the analysis of the UPLIFT trial presented at ERS 2012, the study investigators showed that in low risk COPD patients:

The hazard ratio(tiotropium vs. control) for time to first exacerbation was significantly improved; 0.76 (95% CI, 0.68; 0.86; P<0.0001) as were mean annual exacerbation rates with 0.43 (95% CI, 0.40; 0.48) vs. 0.61 (0.56; 0.66), rate ratio 0.72 (0.63; 0.81; P<0.0001).

The St George’s Respiratory Questionnaire (SGRQ) †† total score after four years was significantly improved by tiotropium vs. placebo: -3.63 (95% CI, -5.14; -2.12; P<0.0001).

The respective increase for trough FEV 1 was 110 mL for tiotropium (95% CI, 84; 136; P<0.0001).

In its recent report “Global Strategy for Diagnosis, Management, and Prevention of COPD", GOLD extensively revised their COPD severity classification to focus on the evaluation of exacerbation risk as well as analysis of COPD symptoms. This new evaluation now not only includes spirometry tests but also a combination of a patient’s severity of symptoms and a history of exacerbations. The new Global Initiative for Chronic Obstructive Lung Disease (GOLD) report recommends long-acting anticholinergics for every patient requiring maintenance therapy (first choice for Patient Groups B-D and second option for Patient Group A).10 This recommendation was based on data for the long acting anticholinergic tiotropium.

Professor Dr Claus Vogelmeier, professor of Medicine and Head of Pulmonary Division, Marburg University Hospital, Marburg, Germany said, “With a new emphasis in the updated GOLD report on managing exacerbations, Spiriva meets the criteria for all GOLD Patient Group COPD patients requiring maintenance therapy, including a positive effect on risk reduction of exacerbations. Reduction of exacerbations is key to improvement in COPD patient status as they have a major impact on patients’ quality of life and often lead to hospitalisation.”

“The data from the ERS Congress add further weight to COPD patient benefits as a result of tiotropium treatment, particularly the positive impact on exacerbations, quality of life and improved lung function,” said Dr Marc Miravitlles, Chest Physician and Senior Researcher, Department of Pneumology, Hospital Clinic, Barcelona, Spain. “COPD remains a debilitating, progressive and under-recognised lung disease and it is important that the most widely prescribed COPD treatment is central to future prospects for advancing treatment for the millions of patients with this condition.”

COPD is a progressive yet treatable disease that restricts patients’ lives over time and is a major cause of death and disability throughout the world. Symptoms include cough, sputum (mucus or phlegm) production, and breathlessness on exertion. Acute worsening of these symptoms, i.e. exacerbations (sometimes referred to as COPD lung attacks due to their severe impact on patients’ health) often occur and can restrict a patient’s ability to perform normal daily activities.

Spiriva, a long-acting anticholinergic medication, is the first inhaled maintenance treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva positively impacts the clinical course of COPD, helping to change the way patients live with their disease. It is the most prescribed maintenance therapy for COPD worldwide. Spiriva helps COPD patients breathe more easily by opening narrowed airways and helping to keep them open for 24 hours. Spiriva works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction.

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