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Doctors in Taiwan have found that people who take a common type of blood pressure drug appear less likely to develop cancer than patients not taking the medication.
Their report adds to a conflicting array of studies on this type of medicine, called angiotensin II receptor blockers (ARBs), and one U.S. expert called the new results “unreliable.”
ARBs include Novartis’s Diovan, Merck’s Cozaar, and Avapro drug from Bristol-Myers Squibb and Sanofi-Aventis. Some 200 million people around the world are currently taking one of the drugs.
While previous research had tied them to a slight increase in cancer risk, “From our observation in the real world, ARBs are safe and may provide benefit beyond lowering blood pressure,” said Dr. Hsin-Bang Leu of Taipei Veterans General Hospital in Taiwan, whose findings appear in the American Journal of Cardiology.
Leu and colleagues studied more than 100,000 patients, identified from an insurance database, who had been diagnosed with high blood pressure between 1998 and 2006. Over an average of six years, eight percent developed some form of cancer.
The patients on ARBs — about 37 percent — had a considerably lower cancer risk. Even after accounting for the influence of other diseases and blood pressure meds, their chances of developing cancer were 33 percent lower than among patients not taking the drugs.
And the longer a patient had been on ARBs, the greater the apparent effect. After a year or more, for instance, the team found a 50 percent lower risk of cancer.
In an e-mail, Leu said it is possible that ARBs protect against cancer by thwarting certain molecular steps in the transition of normal cells to cancer cells, or in the spread of the rogue cells.
But a U.S. expert said he did not believe the drugs can stave off cancer.
“It is just an illusion due to poor research technique,” Dr. Ilke Sipahi of Case Western University in Cleveland told Reuters Health by e-mail.
He added that there were “major imbalances” between the patients receiving and not receiving ARBs.
“Patients receiving ARBs were receiving better care overall,” suggested Sipahi, who recently found in a review of the medical literature that the drugs were linked to an increased cancer risk.
“Poor treatment — perhaps including no advice on smoking cessation and poor socioeconomic status and unhealthy living conditions — led to the more frequent cancers in the control group.”
The Taiwanese researchers acknowledged that they were not able to account for these factors in the study. Still, Leu emphasized that patients who are taking ARBs should not worry about it increasing their risk of cancer.
Sipahi, too, cautioned against taking any drastic actions based on the research. “Patients should not stop or change any of their treatments without discussing these issues and their options with their physicians,” he said.
Last year, Bristol-Myers and Sanofi told Reuters “no signal for new cancers has been found” in the companies’ ongoing review of health problems reported in patients treated with Avapro.
Other common blood pressure drugs include “water pills,” or diuretics, as well as beta blockers such as atenolol and ACE inhibitors such as Pfizer’s Accupril.
SOURCE: http://bit.ly/fVy4pN American Journal of Cardiology, online January 24, 2011.
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NEW YORK (Reuters) – U.S. health regulators rejected Orexigen Therapeutics Inc’s weight-loss drug and requested a clinical trial to resolve heart safety concerns, dealing a blow to what stood to be the first new diet pill in a decade.
Orexigen shares fell 72.5 percent, or $6.59, to $2.50 as analysts projected a new study could take anywhere from two to five years to conduct with no guarantee of success.
“It’s clearly the worst-case scenario,” said Lazard Capital Markets analyst William Tanner.
Orexigen Chief Executive Officer Michael Narachi expressed surprise and disappointment at the decision and said the company would almost certainly need additional capital to fund a new study.
The setback raised new doubts about the drug industry’s ability to develop prescription weight-loss drugs, a field littered with disappointments, at a time when two out of three Americans are obese or overweight.
Hopes had run high for Orexigen’s Contrave, one of three obesity drugs under U.S. review, after a Food and Drug Administration advisory panel voted 13-7 in December to recommend approval.
After the panel backing, Contrave was thought to have the best shot at approval, compared with Vivus Inc’s Qnexa and Arena Pharmaceuticals Inc’s lorcaserin. Qnexa faces concerns over heart and birth-defect risks, while lorcaserin faces worries over cancer risk and had been seen as the furthest from approval.
But according to Orexigen, the FDA noted concern about Contrave’s cardiovascular effects when used long-term in a population of overweight and obese subjects.
The FDA told Orexigen it must conduct a study “of sufficient size and duration” to demonstrate that the risk of heart attacks, strokes and other major cardiovascular events does not undermine the drug’s risk-benefit profile, the company said.
Lazard’s Tanner said the odds of Orexigen pursuing a new study were well below 50 percent.
“I don’t know who would be willing to give them the dough to do this thinking that it is going to take a long, long time and what’s the likelihood you are going to get an outcome that is going to satisfy the FDA?” he said.
Contrave combines naltrexone, a medicine used to fight alcohol and drug addiction, with the antidepressant bupropion. It is intended to boost metabolism while curbing appetite and cravings. Japan’s Takeda Pharmaceutical Co Ltd holds North American marketing rights to Contrave.
Before Tuesday’s news, BioMedTracker had projected Contrave sales could reach $1.2 billion by 2018 if the drug reached the market.
SURPRISED AND DISAPPOINTED
“We are surprised and extremely disappointed with the agency’s request in light of the extensive discussion and resulting vote on this topic at the December 7 advisory committee meeting,” Narachi said in a statement.
He told analysts on a conference call that the company needed to meet with the FDA to understand the details required for the study.
But he said such studies tend to be “fairly large and take a fair amount of time.
“It’s safe to say we would need additional capital” to fund the study, Narachi said, noting the company had $100 million in cash at the end of September.
Among Orexigen’s major investors are Domain Associates LLC, S.A.C. Capital Advisors, and New Enterprise Associates, according to recent securities filings and Thomson Reuters data.
Many industry analysts thought Contrave was on track for approval in the coming months. In Orexigen studies of the drug, at least 35 percent of patients lost 5 percent or more of their body weight.
The research also showed a slight rise in blood pressure and pulse rates with Contrave vs. a placebo. The FDA panel of outside experts urged a long-term study of Contrave’s heart risks after approval.
While the agreement between Takeda and Orexigen calls for them to share responsibility for post-approval safety studies, Orexigen alone is responsible for pre-approval studies, such as the heart trial required by the FDA, Narachi said.
JPMorgan analyst Cory Kasimov said he would not be surprised if Takeda walks away from the drug.
Another analyst, Charles Duncan of JMP Securities, said Takeda still had time to profit from the drug because its patent life runs until 2024, and it might be in the Japanese company’s interest to pay for the trial.
“It is not the end of the road for Contrave,” Duncan said.
The fate of Contrave is key to California-based Orexigen, which focuses solely on obesity drugs and has no products on the market.
Kasimov said he would assign little value to Orexigen’s other obesity asset because it also contains bupropion.
Drugmakers trying to fight fat with a pill have been thwarted for decades by serious side effects, and few such products are available in the United States.
Vivus and Arena, whose obesity-drug candidates were rejected in October, are trying to meet FDA demands for more data on potential side effects.
Shares of Vivus closed down 15.42 percent, or $1.38, to $7.57 on Tuesday, while Arena’s beaten-down stock closed up 10 cents, or 6.33 percent, to $1.68.
“The calculus that people have to make as they embark on obesity drug development is that it’s probably going to take longer and it’s probably going to be more extensive,” Lazard’s Tanner said.
(Additional reporting by Esha Dey, Lisa Richwine and Daniel Bases; editing by Gerald E. McCormick, John Wallace, Lisa Von Ahn and Carol Bishopric)
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U.S. regulators have launched early investigations into potential risks of drugs from Sanofi-Aventis, Takeda Pharmaceutical Co and other companies, the Food and Drug Administration said on Monday.
The FDA released its quarterly list of investigations into possible drug-safety problems. The newest list covers probes launched between July and September 2010.
Appearing on the list does not mean the FDA has concluded a drug causes the listed problem, the agency said. It also “does not mean that FDA is suggesting that healthcare providers should not prescribe the drug or that patients taking the drug should stop taking the medication.”
The list was posted on the FDA’s website at: http://bit.ly/eKC2cp.
Among the probes, the agency is reviewing a possible interaction between Sanofi’s heart drug Multaq and the bloodthinner warfarin that could lead to an “increased anticoagulant effect.”
Sanofi said in a statement it was “confident in the overall safety profile of Multaq,” a drug used to treat abnormal heart rhythms called atrial fibrillation or atrial flutter.
“It is important to note that the FDA has not identified a causal relationship between Multaq use” and clotting time in patients taking warfarin, the company said.
Takeda’s diabetes drug Actos also is under FDA review for rhabdomyolysis, a potentially serious type of muscle injury.
The company said it was aware of 67 reports of rhabdomyolysis among about 15 million Actos patients. Most were reported in Japan, “where the condition is more broadly defined” than in the United States or Europe, Takeda spokeswoman Elissa Johnsen said.
“We will work closely with the FDA to better understand the risk of rhabdomyolysis in patients treated with Actos,” Johnsen said.
The FDA provided little detail on the cases. For most of the drugs, the agency said it was “continuing to evaluate this issue to determine the need for regulatory action.”
(Reporting by Lisa Richwine; Editing by Gerald E. McCormick, Tim Dobbyn and Sofina Mirza-Reid)
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