PARIS, February 14, 2012 /PRNewswire/ --
Approval brings promise of better prognosis and improved quality of life for millions of chronic heart failure patients in Europe
Servier today announced that the company's heart rate lowering agent, ▼Procoralan® (ivabradine), the first selective If channel inhibitor, has been approved by the European Commission for the treatment of patients with chronic heart failure.
"Heart failure patients with elevated heart rates are at a significantly greater risk of death or hospitalisation, and the poor quality of life experienced by these patients is associated with worse disease outcomes. The results of the SHIfT morbi-mortality clinical study demonstrated that Procoralan has the potential to not only improve clinical outcomes for patients with chronic heart failure but in addition could also improve physical and emotional wellbeing. We are convinced that Procoralan will become a valuable new option for healthcare professionals in the treatment of heart failure" said Dr. Emmanuel Canet, Head of Research and Development for Servier.
The European Commission's decision to authorise this new indication for Procoralan followed the review of data from the SHIfT trial, the largest-ever morbi-mortality study of treatments for chronic heart failure involving more than 6000 patients. It demonstrated that the treatment significantly reduced the risk of death and hospitalisation from heart failure, and improved the quality of life of people living with the disease.[2,3] This reduction in mortality was highly significant in patients with a heart rate of 75 beats per minute (bpm), or above, for whom Procoralan is now indicated.
Professor Michel Komajda, Co-Chairman of the SHIFT Executive Committee commented: "The decision to authorise this new indication for Procoralan is good news for doctors and patients, and is a significant step forward in the treatment of heart failure. While ACE inhibitors and beta-blockers remain the main stay in the treatment of heart failure, the results of the SHIfT trial demonstrate that a reduction in heart rate when elevated with Procoralan improves clinical outcomes and symptoms, prevents disease progression, and has beneficial effect on daily activities and the quality of life of heart failure patients".
About chronic heart failure
Chronic heart failure affects 15 million patients in Europe (2% to 3% of the overall population). It is a disabling condition and, despite improvements in treatment and management, generally has a poor prognosis. Heart failure impairs the heart's ability to pump effectively and to maintain sufficient circulation to meet the body's needs. It is most commonly caused by acute (myocardial infarction) or chronic (angina pectoris) ischaemia (coronary artery disease).[5,6]
About Ivabradine ▼Procoralan® (ivabradine)
Procoralan was launched in January 2006 for the treatment of stable angina. It is the only drug to selectively reduce heart rate by inhibiting one of the electrical signals that determine the heart rate, called pacemaker If current. Procoralan reduces heart-rate without significantly decreasing blood pressure or the ability of the heart muscle to pump blood.[7,8]
The additional indication extends its use to the treatment of chronic heart failure in patients with normal (sinus) rhythm and whose heart rate is 75 bpm or above, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Procoralan is already indicated in the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm unable to tolerate or with a contra-indication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.
Depending on the country, ivabradine is available as Procoralan(R), Coralan(R), Coraxan(R), or Corlentor(R).
NOTES TO EDITORS
About the SHIfT study
SHIfT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) is a randomised, double-blind placebo controlled study involving 6,505 people in 37 countries. This study set out to evaluate whether the addition of the If inhibitor, Procoralan, to optimal guidelines-based treatment improves cardiovascular outcomes in patients with moderate to severe chronic heart failure, reduced left ventricular ejection fraction and heart rate of 70 bpm or above.
SHIfT showed that the If inhibitor Procoralan reduced the risk of death from heart failure by 26% (p=0.014), and the risk of hospitalisation by 26% (p<0.0001). The benefits were seen even though the study patients were already taking currently recommended heart failure treatments. In the subgroup of patients with heart rate above 75 bpm at baseline, Procoralan reduced the risk of cardiovascular death by 17% (p=0.0166) and all cause death by 17%(p=0.0109).
A sub-study of 1944 patients from the main study population, showed that the reduction in heart rate achieved through treatment with Procoralan was associated with almost double the improvement in quality of life compared to the control group. This improvement was observed in both the disease related component and the social component of the scores.
Quality of life assessments were conducted using the Kansas City Cardiomyopathy Questionnaire, a 23-item, self-administered questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
In an echocardiography sub-study, Procoralan was shown to lead to a reduction in the heart's left ventricle end-systolic volume (the blood volume remaining in the left ventricle after contraction), which resulted in improved efficiency of the left ventricle and overall heart function.
Servier is France's leading independent pharmaceutical company and the country's second largest drug company. Servier is present in 140 countries. R&D at Servier spans a range of therapeutic fields, with the main areas of focus being cardiovascular disease, neuroscience, cancer, metabolic disorders, and rheumatology. In the field of cardiovascular disease in particular, Servier is one of the principal research organizations dedicated to the development of new medicines. Servier has a long-standing interest in the field of cardiovascular disease, as attested by the fact that 63% of Servier's global turnover from medicines is made up of drugs targeting cardiovascular diseases.
1. EMA announcement available at http://www.ema.europa.eu
2. Swedberg K, Komajda M, Böhm M et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet 2010; 376:875-85
3. Ekman I, Chassany O, Komajda M et al. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study. Eur Heart J. 2011; DOI:10.1093/eurheartj/ehr343. Available at: http://eurheartj.oxfordjournals.org
4. European Society of Cardiology (ESC). ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. European Heart Journal 2008; 29: 2388-2442.
5. NICE guidelines for the management of chronic heart failure in adults in primary and secondary care. Available at http://www.nice.org.uk/nicemedia/live/13099/50517/50517.pdf
6. Juenger J, Schellberg D et al. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart. 2002;87:235-241.
7. Procoralan Summary of Product Characteristics. http://www.emc.medicines.org.uk Last accessed May 2011
8. DiFrancesco D and Camm JA. Heart rate lowering by specific and selective I(f) current inhibition with ivabradine: a new therapeutic perspective in cardiovascular disease. Drugs 2004; 64(16): 1757-1765.
9. Tardif JC, O'Meara E, et al. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echography substudy. Eur Heart J. 2011, DOI: 10.1093/eurheartj/ehr311. Available at http://eurheartj.oxfordjournals.org/
For more information, please contact:
Claire Martin, Reynolds-MacKenzie
Katy Gray, Reynolds-MacKenzie