Maria Shepherd10.22.10
Opportunity in Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) affects up to 18 million Americans, and people with OSA can stop breathing as many as 30 times or more each night.1 It is estimated that 10 million Americans have the condition but have not been diagnosed. OSA affects about 24 percent of middle-aged men and 9 percent of middle-aged women, according to Daniel J. Gottlieb, M.D., director of the Sleep Disorders Center at V.A. Boston Healthcare System.
Some studies suggest sleep apnea runs in families, and in children, sleep apnea has been linked to attention deficit/hyperactivity disorder, or ADHD. Other studies link sleep apnea to high blood pressure, heart attack, and stroke. In fact, up to 50 percent of people with sleep apnea also suffer from high blood pressure. In adults, the condition often is related to obesity, but it also can be caused by other disorders or structural defects in the throat.
Why Is This Important?
OSA creates co-morbidities that touch almost every disease state addressed by the pharma, biotech and medical device industries. Physicians treating sleep apnea are just beginning to discover that it is a complex disease and that patients with OSA are an underserved market. This is a significant opportunity for innovators in the medical device industry.
Heart Failure and OSA
According an article in Circulation, the journal of the American Heart Association, OSA raised the risk of heart failure for middle-aged (and older) men, and significantly raised the risk of coronary heart disease (CHD) in men up to age 70.
The study followed 1,927 men and 2,495 women (40 years old or older) that were free of heart problems when the study began. A total of 24 percent of the men and 11 percent of the women had at least moderately severe OSA. Researchers assessed participants’ health for a median follow-up of 8.7 years. The study found that men with severe OSA faced a 58 percent higher risk of developing heart failure than those without OSA. Men between 40-70 years old, with severe OSA, had a 68 percent higher risk of developing CHD than those without OSA.
Obesity and Sleep Apnea
The apnea-hypopnea index (AHI) is an index of severity that combines apneas and hypopneas (slow or shallow breathing).2 Combining them gives an overall severity of sleep apnea, including sleep disruptions and de-saturations (a low level of oxygen in the blood). AHI values typically are categorized as:
• Mild: 5-15
• Moderate: 15-30
• Severe: >30 Stroke and OSA
In a prospective study designed to determine whether the incidence of OSA in patients with recent stroke was significantly different from that of a control group with no major medical problems, OSA was found in 10 of 13 men with stroke (77 percent) and in only three of 13 men without stroke (23 percent; P=.0169).4 Seven of 11 women with stroke (64 percent) had obstructive sleep apnea, while only two of 14 women without stroke (14 percent) had obstructive sleep apnea (P=.0168).
The conclusion of this study was that patients with stroke have an increased incidence of OSA compared with control subjects and that hypoxia and hemodynamic responses to OSA may have predisposed these patients to stroke.
The incidence of OSA has correlated to the growth of obesity and all its co-morbid conditions. Pharmaceutical, biotech and medical device companies have a great opportunity to find treatments to stop or mitigate this complex disease state.
References:
1. www.nlm.nih.gov/medlineplus/sleepapnea.html#cat22.
2. Ruehland WR, Rochford PD, O'Donoghue FJ, Pierce RJ, Singh P, Thornton AT (February 2009). “The new AASM criteria for scoring hypopneas: impact on the apnea hypopnea index.” Sleep 32 (2): 150-7. PMID 19238001.
3. Valencia-Flores M., Orea A., Castano VA, et al (2000) Prevalence of sleep apnea and electrocardiographic disturbances in morbidly obese patients. Obes Res. 8: 262–269.
4. www.stroke.ahajournals.org/cgi/content/short/27/3/401.
Maria Shepherd has 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. Following a career in senior management positions including vice president of marketing for Oridion Medical, director of marketing for Philips Medical and Boston Scientific, she founded Data Decision Group. Data Decision Group provides critical data to support sound decision making. The firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, and assesses prospective acquisitions. Shepherd has taught marketing and product development courses in the WPI/MassMEDIC Medical Device Certificate and HCMA programs, and can be reached at (617) 548-9892 or at mshepherd@ddecisiongroup.com
Obstructive sleep apnea (OSA) affects up to 18 million Americans, and people with OSA can stop breathing as many as 30 times or more each night.1 It is estimated that 10 million Americans have the condition but have not been diagnosed. OSA affects about 24 percent of middle-aged men and 9 percent of middle-aged women, according to Daniel J. Gottlieb, M.D., director of the Sleep Disorders Center at V.A. Boston Healthcare System.
Some studies suggest sleep apnea runs in families, and in children, sleep apnea has been linked to attention deficit/hyperactivity disorder, or ADHD. Other studies link sleep apnea to high blood pressure, heart attack, and stroke. In fact, up to 50 percent of people with sleep apnea also suffer from high blood pressure. In adults, the condition often is related to obesity, but it also can be caused by other disorders or structural defects in the throat.
OSA creates co-morbidities that touch almost every disease state addressed by the pharma, biotech and medical device industries. Physicians treating sleep apnea are just beginning to discover that it is a complex disease and that patients with OSA are an underserved market. This is a significant opportunity for innovators in the medical device industry.
According an article in Circulation, the journal of the American Heart Association, OSA raised the risk of heart failure for middle-aged (and older) men, and significantly raised the risk of coronary heart disease (CHD) in men up to age 70.
The study followed 1,927 men and 2,495 women (40 years old or older) that were free of heart problems when the study began. A total of 24 percent of the men and 11 percent of the women had at least moderately severe OSA. Researchers assessed participants’ health for a median follow-up of 8.7 years. The study found that men with severe OSA faced a 58 percent higher risk of developing heart failure than those without OSA. Men between 40-70 years old, with severe OSA, had a 68 percent higher risk of developing CHD than those without OSA.
The apnea-hypopnea index (AHI) is an index of severity that combines apneas and hypopneas (slow or shallow breathing).2 Combining them gives an overall severity of sleep apnea, including sleep disruptions and de-saturations (a low level of oxygen in the blood). AHI values typically are categorized as:
• Mild: 5-15
• Moderate: 15-30
• Severe: >30 Stroke and OSA
In a prospective study designed to determine whether the incidence of OSA in patients with recent stroke was significantly different from that of a control group with no major medical problems, OSA was found in 10 of 13 men with stroke (77 percent) and in only three of 13 men without stroke (23 percent; P=.0169).4 Seven of 11 women with stroke (64 percent) had obstructive sleep apnea, while only two of 14 women without stroke (14 percent) had obstructive sleep apnea (P=.0168).
The conclusion of this study was that patients with stroke have an increased incidence of OSA compared with control subjects and that hypoxia and hemodynamic responses to OSA may have predisposed these patients to stroke.
The incidence of OSA has correlated to the growth of obesity and all its co-morbid conditions. Pharmaceutical, biotech and medical device companies have a great opportunity to find treatments to stop or mitigate this complex disease state.
References:
1. www.nlm.nih.gov/medlineplus/sleepapnea.html#cat22.
2. Ruehland WR, Rochford PD, O'Donoghue FJ, Pierce RJ, Singh P, Thornton AT (February 2009). “The new AASM criteria for scoring hypopneas: impact on the apnea hypopnea index.” Sleep 32 (2): 150-7. PMID 19238001.
3. Valencia-Flores M., Orea A., Castano VA, et al (2000) Prevalence of sleep apnea and electrocardiographic disturbances in morbidly obese patients. Obes Res. 8: 262–269.
4. www.stroke.ahajournals.org/cgi/content/short/27/3/401.
Maria Shepherd has 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. Following a career in senior management positions including vice president of marketing for Oridion Medical, director of marketing for Philips Medical and Boston Scientific, she founded Data Decision Group. Data Decision Group provides critical data to support sound decision making. The firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, and assesses prospective acquisitions. Shepherd has taught marketing and product development courses in the WPI/MassMEDIC Medical Device Certificate and HCMA programs, and can be reached at (617) 548-9892 or at mshepherd@ddecisiongroup.com