Study Compares Risk With Two Diabetes Drugs

/PRNewswire/ -- In contrast to previous reports, the risks of the composite endpoint of heart attack, heart failure, both, or death were the same - about 4 percent - for patients taking the diabetes drugs rosiglitazone or pioglitazone, according to a study published in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

"This study provides patients and their doctors with another source of information about rosiglitazone and pioglitazone (sold as Avandia and Actos, respectively) as they determine the best therapy for diabetes patients," said Debra Wertz, Pharm.D., lead author and outcomes research manager at HealthCore, Inc., the research subsidiary of health insurance company WellPoint, Inc.

This study evaluated more than 36,000 diabetes patients. Of the 28,938 patients who were propensity-score matched, a methodology used to provide an estimation of treatment-effects that is as unbiased as possible, 602 patients taking rosiglitazone and 599 taking pioglitazone over a 33-month period suffered either a heart attack, heart failure, both, or died. This translates to about 4 percent of all patients taking either medication. The individual specific adverse events were also not significantly different between the two groups, and were:

-- Heart attack - 96 patients on rosiglitazone and 121 patients on
pioglitazone;
-- Heart failure - 265 patients taking rosiglitazone and 243 taking
pioglitazone;
-- Heart attack and heart failure - 24 patients on rosiglitazone and 18
on pioglitazone; and
-- Death - 217 patients taking rosiglitazone and 217 taking pioglitazone.


The study included 36,628 patients who had submitted insurance claims to WellPoint affiliates for either of the two diabetes medications between 2001 and 2005. Patients' average age was 54, and 58 percent were male. Wertz and her team obtained death records from the National Death Index, a central database administered by the National Center for Health Statistics.

The investigators divided patients into two equal groups, one receiving rosiglitazone and the other, pioglitazone. After adjusting the data for (removing/minimizing the effect of) age, gender, prior heart and blood vessel diseases and diabetes-related complications and severity indicators, they compared the incidence of heart attack, heart failure and death for an average 14 months of treatment and 19 months of post-treatment follow-up.

Diabetes is a disease in which the body cannot adequately produce the hormone insulin or uses it improperly. The disease can cause a potentially dangerous buildup of sugar in the blood and also increases the risk of heart and blood vessel diseases, which are the main causes of death for people with diabetes.

Rosiglitazone, sold under the trade name Avandia by GlaxoSmithKline, and pioglitazone, sold as Actos by Takeda Pharmaceuticals, belong to the same class of drugs, called TZDs or thiazolidinediones. They help the body use insulin more effectively by boosting the body's sensitivity to the hormone and thus help control blood sugar.

This study has results different from earlier ones that found a greater risk of heart attack among rosiglitazone users compared to patients on other treatments or placebo. In 2007, the Food and Drug Administration decided that the benefits of rosiglitazone outweighed the risks, and it remained on the market although its use decreased significantly. In July 2010, an FDA advisory committee again reviewed numerous studies, including this study, and recommended that rosiglitazone remain on the market, although with additional warnings or restrictions. The FDA has not yet ruled on this latest recommendation.

"Besides its findings that rosiglitazone and pioglitazone have comparable risks, what distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths," Wertz said. The study also followed patients for a longer period of time than some of the earlier research, according to the investigators.

"One of the reasons we embarked on this analysis was to see if there were any differences in effect that we could identify between these two agents," said Mark J. Cziraky, Pharm.D., study co-author, and vice president of research development and operations at HealthCore. "We did not find that with the approach and methods we took within this population."

Other co-authors are Chun-Lan Chang, Ph.D.; Chaitanya A Sarawate, M.S.; Vincent J. Willey, Pharm.D.; and Rhonda L. Bohn, M.P.H., Sc.D.

Author disclosures are on the manuscript. WellPoint, Inc. funded this research.


An accompanying editorial, "Improving Surveillance for Drug Safety: Lessons from Rosiglitazone," by Frederick A Masoudi, M.D., M.S.P.H., is available.


Statements and conclusions of study authors published in American
Heart Association scientific journals are solely those of the study
authors and do not necessarily reflect the association's policy or
position. The association makes no representation or guarantee as to
their accuracy or reliability. The association receives funding
primarily from individuals; foundations and corporations (including
pharmaceutical, device manufacturers and other companies) also make
donations and fund specific association programs and events. The
association has strict policies to prevent these relationships from
influencing the science content. Revenues from pharmaceutical and
device corporations are available at http://www.americanheart.org/
corporatefunding.

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Teleflex Medical Introduces the Neb-U-Mask for the Treatment of Acute Asthma Exacerbations

(BUSINESS WIRE)--Teleflex Medical, a leading global supplier of disposable products for critical care and surgical applications, has received clearance from the FDA to market the Hudson RCI Neb-U-Mask®, a respiratory device that allows for the concurrent delivery of aerosolized medication and a high concentration of medical gases to treat acute asthma exacerbations.

Asthma is a chronic inflammatory disease of the airways. According to the National Asthma Education and Prevention Program, asthma affects more than 22 million people in the United States, and is one of the most chronic childhood diseases. It is estimated that asthma accounts for approximately 1 in every 250 deaths worldwide. Many of the deaths are preventable. Despite current available therapy with the use of bronchodilators and corticoids, alleviation of obstruction may not occur rapidly enough to prevent ventilatory failure and endotracheal intubation.

During an acute asthma attack, a patient may be given oxygen or heliox in combination with pharmacologic therapies. The challenge of this treatment approach is the lack of a device that allows for the simultaneous delivery of medical gases and aerosolized medication. In a study published in the Annals of Emergency Medicine in 2002, low oxygen saturation has been correlated inversely with the rate of hospitalization1, which puts caregivers in a difficult situation when faced with the choice of medication delivery over an interruption of high levels of oxygen therapy.

The Neb-U-Mask addresses this unmet clinical need by allowing the concurrent delivery of aerosolized medications and high concentrations of oxygen or heliox. The system is composed of an innovative wye design, featuring a nebulizer connection and MDI adaptor, a non-rebreathing mask with a 750ml gas reservoir bag, and color coded tubing. This patented design promotes positive patient outcomes by avoiding therapy interruption. The nebulizer connection features a valved port, which maintains a closed system when a nebulizer is not in use. This closed system design allows for delivery of high levels of oxygen or heliox gas mixtures.

“We are pleased to add the Neb-U-Mask to our extensive line of asthma management solutions,” said Whitney Reynolds, director of respiratory care marketing. “At Teleflex Medical our ultimate goal is to provide products and education programs to help patients with asthma live a normal, healthy, and productive life. But knowing that acute asthma attacks are prevalent, we must provide caregivers the tools they need to achieve positive patient outcomes.”

The system is available for sale today in both adult and pediatric versions. The system is conveniently packaged with a Micro Mist® nebulizer, allowing for a “grab and go” response in an emergency situation.

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Link Shown Between Thunderstorms and Asthma Attacks in Metro Atlanta Area by Team of Researchers from University of Georgia and Emory University

In the first in-depth study of its kind ever done in the Southeastern United States, researchers at the University of Georgia and Emory University have discovered a link between thunderstorms and asthma attacks in the metro Atlanta area that could have a “significant public health impact.”

While a relationship between thunderstorms and increased hospital visits for asthma attacks has been known and studied worldwide for years, this is the first time a team of climatologists and epidemiologists has ever conducted a detailed study of the phenomenon in the American South.

The team, studying a database consisting of more than 10 million emergency room visits in some 41 hospitals in a 20-county area in and around Atlanta for the period between 1993 and 2004, found a three percent higher incidence of visits for asthma attacks on days following thunderstorms.

“While a three percent increase in risk may seem modest, asthma is quite prevalent in Atlanta, and a modest relative increase could have a significant public health impact for a region with more than five million people,” said Andrew Grundstein, a climatologist in the department of geography at UGA and lead author on the research. Grundstein went on to say that “three percent is likely conservative because of limitations in this study.”

The next step for the UGA and Emory team will be, for the first time, to apply Doppler radar, modeling and observational data to the “thunderstorm asthma” problem based on what Grundstein calls an intriguing initial finding. He points out that “radar data coupled with the metro Atlanta database will allow us to correlate thunderstorm-asthma interactions that we are probably missing today.”

Paige Tolbert, professor and chair of the department of environmental and occupational health in the Rollins School of Public Health at Emory and a co-author of the just-published study, said the expertise of the two universities came together strongly in studying the problem.

“The Emory team has experience with a comprehensive emergency department database, and the UGA team can provide a much more refined characterization of thunderstorms than was performed in the previous studies of this question,” she said. “The study will thus provide new insight into the mechanisms under the phenomenon of thunderstorm-induced asthma.”

The research was published in the online edition of the medical journal Thorax. Other authors of the paper include: Marshall Shepherd and Thomas Mote from the UGA department of geography; Luke Naeher from the UGA department of environmental health science; and Stefanie Ebelt Sarnat and Mitchell Klein, who along with Tolbert are from the department of environmental and occupational health in the Rollins School of Public Health at Emory.

About 20 million Americans have asthma, according to the American Academy of Allergy, Asthma and Immunology. There also has been a dramatic increase in reported cases of the disease, with its prevalence increasing 75 percent between 1980 and 1994. Some 5,000 Americans die annually from asthma attacks.

Approximately 210,000 Georgia children under the age of 17 have asthma, according to the Division of Public Health of the Georgia Department of Human Resources. Some 65 percent of that number had an attack within the last year.

While associations between thunderstorm activity and asthma deaths and emergency room visits have been reported around the world, virtually no studies have been done in the American South, where hundreds of thousands suffer from asthma and thunderstorms are prevalent.

Some people may find it odd that thunderstorms, which supposedly “clear the air” of pollen and pollutants, are implicated in asthma attacks. The most prominent hypothesis as to why it happens, the authors of the paper say, is that “pollen grains may rupture upon contact with rainwater, releasing respirable allergens, and that gusty winds from thunderstorm downdrafts spread particles . . . which may ultimately increase the risk of asthma attacks.”

The team used thunderstorm occurrences from meteorological data gathered at Atlanta’s Hartsfield-Jackson International Airport and compared that information with the vast database of emergency room visits to arrive at the figure of a three percent increase in asthma-related emergency room visits following thunderstorms for the study period.

In all, during the 11-year period, there were 564 thunderstorm days, and in order to better understand the physical mechanisms that relate thunderstorms and asthma, the team also mined the information on total daily rainfall and maximum five-second wind gusts, which they used as “a surrogate for thunderstorm downdrafts and to indicate the maximum wind speed of the storm.”

In all, there were 215,832 asthma emergency room visits during the period and 28,350 of these occurred on days following thunderstorms. While the new study is the first of its kind in the South and does clearly indicate a relationship between thunderstorms and asthma in the metro Atlanta area, much more work remains, Grundstein said.

“Obtaining a better understanding of the mechanistic basis of the phenomenon of thunderstorm-induced asthma will allow for better intervention strategies and improved emergencies services planning,” said Stefanie Ebelt Sarnat of Emory. “This will be particularly important in the era of climate change.”

Grundstein added that in the Atlanta area conditions favorable for an estimated doubling of severe thunderstorms are expected within this century.

By Philip Lee Williams
University of Georgia