Unichem Laboratories today announced that the second phase of its post marketing surveillance studies of its hypertension brand, Loram, has proved the drug to be highly efficacious and safe.
Revealing the details of the study at a press meet in Mumbai, Dr. Shashank Joshi, the renowned medical practitioner and the Chief Investigator of the study, said, “Lord II, the second phase post marketing clinical trials of the drug, was conducted on 369 patients at eight centres in the country for a period of 12 weeks. The studies showed that a fall in blood pressure of 26.26/12.60 mmHg was achieved at the end of 12 weeks. Proteinuria in the patients showed 30 per cent reduction from baseline.”
Good to excellent tolerability and efficacy was seen in more than 93 per cent patients and all the doctors who participated in the study gave a unanimous decision of continuing the drug in 94 per cent of patients. The drug reduces Urinary Albumin Excretion (UAE) in majority of patients with microalbuminuria and proteinuria. Proteinuria reduced significantly in more than 29 per cent of patients during the pre and post studies.
Dr. Joshi noted today is the era of evidence-based medicine and multi-centric post marketing surveillance studies are rarely conducted in India. The study was an investigator-initiated study to show that Losartan plus Ramipril combination could save vulnerability of kidneys due to long-term usage of hypertension drugs, besides controlling the blood pressure significantly. The trials could achieve Joint National Commission JNC VII goal of blood pressure of less than 130/80 mm in such patients. The study was conducted from October 2004 to May 2005.
He said only minor side effects like mild cough were reported in a small percentage of the participants.
Ashok Jain, chief executive - Pharma of Unichem Laboratories told Pharmabiz that the drug Loram has become a Rs 10-crore brand already since its launch a few years ago. The first study showed significant encouragement to go for the second phase trials. Unichem’s another brand in the cardiovascular segment, Losar is a Rs 40-crore brand now. Unisearch, a division of Unichem, markets Loram.
Dr. Shailaja Kale of KEM hospital said cardiovascular diseases account for 2.3 million deaths in India during 1990, and is projected to double by 2020. India has an approximate number of 33 million adults with diabetes, which is likely increase to 57.2 million by 2025.