Mostrando las entradas con la etiqueta Novo Nordisk. Mostrar todas las entradas
Mostrando las entradas con la etiqueta Novo Nordisk. Mostrar todas las entradas

17 septiembre, 2011

Who defends lilly and novonordisk diabetes meds


Source: Pharmalot

conflictsofinterest212The scene at the European Association for the Study of Diabetes being held in Lisbon this week has included a heated debate over the extent to which a particular type of diabetes medicine called GLP-1 therapies can increase the risk of pancreatic and thyroid cancer. These include Byetta, which is sold by Eli Lilly and its partner, Amylin Pharmaceuticals, and Victoza, which is marketed by Novo Nordisk.
The issue has actually been percolating for more than a year (read here), although a review published two months ago in Gastroenterology that reviewed the FDA database of side effects showed patients taking Byetta had a much larger chance of developing pancreatitis, which can increase the risk of tumors (read the abstract). The drugmakers maintain their meds are safe.
And so there was a debate among researchers in attendance, including Peter Butler of the University of California at Los Angeles, who was one of the authors of the Gasterenterology study. One of his opponents was Michael Nauck, head of the Diabeteszentrum Bad Lauterberg in Germany, who told Bloomberg News that “the bulk of findings tends to speak against such an association. There is no general agreement.”
In fact, he believes the FDA database not only fails to establish a link to thyroid and pancreatic cancer, but may instead show the drugs could protect against other forms of cancer, such as prostate tumors. “Looking at same database and using very, very similar methods, I find evidence that some forms of cancer are reduced.”
Similarly, Matteo Monami, a physician at the University of Florence and Carreggi Teaching Hospital in Italy, told Bloomberg that the Gasteroenterology study is “erroneous analysis” and its results “are really not reliable at all.” He presented a study showing no increase in cancer or pancreatitis for so-called dipeptidyl peptidase-4 inhibitors such as Januvia.
However, what was not made clear is that both Nauck and Monami have ties to the drugmakers that sell the GLP-1 treatments. For instance, Nauck has worked as a consultant to both Lilly and Novo Nordisk, and also received clinical research grants from both drugmakers (look here). And Monami has received speaking fees from Lilly (see this).
Of course, it does not automatically follow that one or both researchers is biased due to their relationships with either drugmaker. Just the same, such ties would have been helpful to know, given that they were rather outspoken in defending the medications at an important meeting where the scientific community gathers to absorb and ponder research that is used to influence medical practice.

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13 julio, 2011

Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial

Age-standardised disability-adjusted life year...                          Image via WikipediaGriffin SJ, Borch-Johnsen K, Davies MJ, et al. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet. 2011 Jun 24. (Original) PMID: 21705063


BACKGROUND: Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening.
METHODS: In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40-69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practice`s study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549.
FINDINGS: Primary endpoint data were available for 3055 (99.9%) of 3057 screen-detected patients. The mean age was 60.3 (SD 6.9) years and the mean duration of follow-up was 5.3 (SD 1.6) years. Improvements in cardiovascular risk factors (HbA(1c) and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7.2% (13.5 per 1000 person-years) in the intensive treatment group and 8.5% (15.9 per 1000 person-years) in the routine care group (hazard ratio 0.83, 95% CI 0.65-1.05), and of all-cause mortality 6.2% (11.6 per 1000 person-years) and 6.7% (12.5 per 1000 person-years; 0.91, 0.69-1.21), respectively.
INTERPRETATION: An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death.
FUNDING: National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Wellcome Trust, UK Medical Research Council, UK NIHR Health Technology Assessment Programme, UK National Health Service R&D, UK National Institute for Health Research, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Novo Nordisk, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Merck.

13 junio, 2011

Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis

 
AUDIENCE: Endocrinology, Family Practice
ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators.
BACKGROUND: FDA may require a REMS for newly or already approved prescription drug product when FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks of the drug. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
RECOMMENDATION: Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation.
After initiation of Victoza, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting).
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online:www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Dear Healthcare Professional Letter, at: