Biotronik (Berlin, Germany) earlier this year initiated the first trials of its combined home cardio-surveillance system, which enables the cardiologist to continue to monitor at distance the performance of patients with implanted pacemakers or defibrillators.
The trials, in about 300 patients from 30 to 90 years of age, were located in the U.S., Germany and France. Those patients in the trials had their existing pacemakers and defibrillators replaced by special Biotronik units, including the Philos DR-T pacemaker which records cardiac parameters and which is equipped with a transmitting antenna.
Every 24 hours the antenna transmits in numeric form via a special mobile telephone supplied to the patient and onward via a GSM network to the Biotronik center in Erlangen, Germany. This information could alternatively be sent by normal land-line, using a modem connected to the receiver or by internet. At the Biotronik center, the origin of the cardiac parameters is identified, the message converted to fax or e-mail and retransmitted direct to the cardiology clinic providing daily surveillance. The information provided includes all parameters necessary for the cardiologist to adjust the therapy if necessary or to regulate the pacemaker.
The preliminary clinical results, reported at this past summer's Cardiostim congress in Nice, France, have shown that this form of home surveillance is very effective, according to Professor Jacques Clements at the Hopital du Haut-L veque (Bordeaux, France). The trials now have been widened to include university hospitals at Rennes, Nancy, Lyon, Lille, Paris, Marseille and Tours in France, as well as six other European countries (Austria, Belgium, Germany, Italy, Netherlands and the UK).
A potential limitation, Clemelty said, is the volume of work engendered for the cardiologists. He pointed out that if the 450 patients with pacemakers at his hospital each were equipped with the Biotronik system, this would produce 450 faxes each day. He said, "if around 200 of these faxes need further attention, and one allocates five minutes to each of these, this adds up to two cardiologists working full time and we already suffer from an acute shortage of these specialists." Clearly, additional systems for identifying problem results requiring attention will be necessary if Biotronik's distance surveillance system is to become viable financially.
Heart transplantations in France
Cardiac transplantation techniques were developed in France by Professor Christian Chabrol at the Hopital de la Piti during the period 1970-80, following the first procedure in South Africa by Christian Bernard in 1967.
Today, there are 27 cardiac surgery centers in France carrying out about 300 transplantation procedures each year. Average mortality at the time of operation is 10% to 15%, depending on the patient's condition and the quality of the donor organ. Post-operation survival is about 78% at one year, 65% at five years, 42% at 12 years and 37% after 15 years.
Annual totals of transplantations peaked at 636 in 1990, but since then have gradually fallen to a current level of around 300. Two reasons for this have been put forward. One is the availability of better therapeutics, and resultant better stabilization of cardiac insufficiency patients and a consequent reduction in the number of transplantation requests from cardiologists themselves. Second is an increasing difficulty in supplies of suitable transplant hearts from the official French agency, the Etablissement Francais des Greffes (Lille, France), resulting from a lack of motivation from potential donor hospitals (a lot of work and increasing staff shortages) and a fall in the numbers of potential donors who have authorized organ donation.
New cardiovascular drugs update
AstraZeneca (London) allayed some investor concerns over its crucial new Crestor cholesterol drug when it said that there had been no side-effect problems so far at a 40 mg dose level. Share prices fell on news that further trials at the 40 mg dose were to be conducted and that patients had been taken off the 80 mg dose because of side effects.
The worries overshadowed strong second-quarter results that included a 13% increase in earnings per share to 45 cents and an 8% sales increase to $4.38 billion.
Tom McKillop, chief executive at AstraZeneca, said the company would shortly begin talks about Crestor with the FDA that would determine the timing and dosage of a U.S. launch, which analysts place probably in the third quarter of next year. AstraZeneca also has filed for approval with European regulators for Exanta, the company's new thrombolytic.
Aventis Pharma (Frankfurt, Germany) has announced the suspension of clinical trials on its Cariporide cardioprotector drug, which was projected to reach the market in 2006. The company took this action following recommendations from an independent commission on the protocols of pharmaceutical clinical trials, but has not commented on reasons for the suspension
Sanofi Synthelabo (Paris) has announced the successful launch of Arixtra, its anti-thrombosis drug which had produced first half sales of $3.5 million in the first half since its launch in March. Plavix, the anticoagulant co-marketed with Bristol-Myers Squibb (New York), Avapro and Stilnox (Ambien in the U.S.) all helped to push sales to $ 3.7 billion for the first half of 2002, and the group is now forecasting a 25% growth in net profits for the full year.
Novuspharma (Milan, Italy) has acquired rights to Profilix's (Oxford, England) anti-angiogenesis research program, which focuses primarily on products which inhibit hypoxia inducible factor 1alpha. The agreement, which follows a previous collaboration, gives Novuspharma full rights to the research, compounds and associated intellectual property.
NicOx (Sofia Antipolis, France) has released positive Phase I endoscopy results for NCX 4016, its nitric oxide-donating derivative of aspirin for the treatment of cardiovascular diseases and cancer. The data show that, in contrast to aspirin, NCX4016 does not induce macroscopic changes in the gastroduodenal mucosa.
Meristem Therapeutics (Clermont-Ferrand, France) has been granted a U.S. patent for its process for the production of human hemoglobin protein in plants. The patent describes the process of production of an human hemoglobin capable of reversibly binding oxygen.
Cordis gets CE mark for Cypher stent
Cordis (Miami Lakes, Florida) has received the CE mark for its Cypher sirolimus-eluting stent for treatment of de novo coronary artery lesions (less than or equal to 30 mm in length) in native coronary arteries with diameters ranging from 2.25 mm to 5.0 mm.
Sirolimus, the active drug released from the Cypher stent, is a natural antibiotic marketed by Wyeth Pharmaceuticals (Madison, New Jersey) under the name Rapamune and used to prevent renal transplant rejection. Researchers chose sirolimus for its cytostatic rather than cytoxic properties. Cordis said the stent is designed to inhibit proliferating cells, rather than destroy them.