GIANT study results show great need for prompt and effective treatment of chronic bronchitis patients

The GIANT study - initiated by Bayer Schering Pharma - evaluates the impact of acute exacerbations of chronic bronchitis (AECBs) on patients, as well as the efficacy and safety of the antibiotic Avalox (moxifloxacin HCl) in the real-world setting.

The Bayer Schering Pharma press conference, "The GIANT Awakens - Huge antibiotic study provides first-hand insight on how AECB patients in the Middle East region are treated," was held from 11.00h to 12:00h on 31st March 2008, in Dubai, United Arab Emirates.

A total of 46,891 valid patients were documented during the trial, of which 4,350 are from the Middle East region. The data clearly show that the quality of life of Middle East patients suffering from this weakening disease is tremendously affected. On average these Middle East patients experienced 2.8 acute exacerbations per year and each time their daily activities were negatively impacted for about four days. Moreover, patients suffered from severe sleep disturbances during this debilitating disease phase. Effective antibiotic treatment is needed to minimise the impact of these acute attacks on patients.

The antibiotic Avalox can help to reduce this burden. Strictly-controlled clinical trials such as MOSAIC have already shown that it provides substantial benefits over standard antibiotics in the treatment of AECB: Moxifloxacin helped more patients return to their healthy state but also extended the time interval between exacerbations.

"In the GIANT study we wanted to verify if these effects can also be seen in real life," explained Professor Antonio Anzueto. "We think that the GIANT results are very impressive since Middle East patients treated with moxifloxacin suffered, on average, one day less from AECB compared to previous treatment. This is an obvious benefit for the patient."

When an acute exacerbation starts, glands in the bronchi produce more mucus than usual which results in increased coughing as the body tries to clear it from the lungs.

In addition to developing a persistent cough, many patients will also experience acute breathlessness resulting in a significant decrease in their quality of life and sleep disturbance. As well as causing acute symptoms, exacerbations also contribute significantly to the acceleration of the course of the disease over time. Therefore, early diagnosis and effective treatment is needed to successfully manage this disease.

The Middle East GIANT data demonstrates that treatment with moxifloxacin resulted in rapid overall improvement (including symptoms such as fever, sputum purulence, fatigue, sleep disturbance) in all severity groups (~70% at day 3, and ~95% at day 5). "97% of patients were very satisfied or satisfied with this effective therapy," said Dr Marc Miravitlles, "78.3 % of physicians even rated the overall effect of moxifloxacin as better than the previous therapy and 95.8% assessed efficacy as either very good or good. These results re-confirm the findings from clinical trials."

Apart from providing regional information about AECB and its treatment, the Bayer Schering Pharma GIANT study also allows data to be compared across different regions of the world. For instance, the data illustrates that the typical patient profile differs slightly from region to region: The average patient in the Middle East is younger (48.5 years) than in Europe (60.5 years), Asia-Pacific (57.1 years) or Latin America (63.1 years).

This may explain why Middle Eastern patients seem, on average, to suffer less from AECBs as deduced from the number of days impacted by the condition (4 days compared to 7.6 for European, 4.2 for Asian-Pacific and 5.8 for Latin American) and the number of nights with sleep disturbances (3.2 versus 4.7 days for European, 2.8 for Asian-Pacific and 4.1 days for Latin American patients). However, despite some regional differences, it is obvious that AECB is a debilitating disease that urgently calls for appropriate management.

Given the trend of increased smoking among young teenagers in many countries , the prevalence of chronic obstructive pulmonary disease (COPD), which is normally the underlying condition of chronic bronchitis, is very likely to rise in the Middle East. Apart from cigarette smoking, an increased use of other tobacco products, such as the water pipe4, is also occurring. Accordingly, the likelihood of chronic bronchitis patients experiencing acute exacerbations will rise as will costs to the healthcare system if this trend is not combated.

Like other diseases, the treatment of COPD poses a substantial financial burden on the healthcare system. A considerable proportion of these costs relates to admitting and treating patients in the hospital. In Europe, for example, hospitalisation alone generates an annual cost of 2.9 billion Euro and a recent study in Singapore estimates the cost of a single COPD hospitalisation to be $856 USD.

"The financial impact of acute exacerbations of chronic bronchitis to healthcare systems is often underestimated. Therapies which offer the potential to substantially reduce the healthcare cost by providing fast symptom relief and recovery are needed," said Professor Anzueto. "The MOSAIC and GIANT studies have both shown that moxifloxacin is an efficacious and well-tolerated AECB therapy and may play a significant role in achieving this."