Clinical, if not statistical, significance?
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Positive airway pressure, whether delivered continuously (CPAP) or as adaptive servoventilation, doesn’t reduce the rate of cardiovascular (CV) events or death in patients who have sleep apnea, according to a report published online July 11 in JAMA.

Positive airway pressure (PAP) relieves the symptoms of sleep apnea and has been reported to improve cardiovascular risk factors such as hypertension, insulin resistance, and endothelial dysfunction. However, whether the treatment improves “hard” vascular outcomes such as stroke and MI has never been established, said Jie Yu, MD, of the department of cardiology, Peking University and the Ministries of Health and Education, Beijing, and his associates.

They performed a systematic review of the literature and a meta-analysis of 10 randomized clinical trials that compared PAP against standard care or a sham treatment and had at least 6 months of follow-up for CV events. The meta-analysis involved 7,266 participants who had either obstructive (5,683 patients) or central (1,583 patients) sleep apnea. There were 356 major adverse CV events and 613 deaths during a median follow-up of 6-68 months.

The use of PAP showed no significant association with a range of outcomes: major adverse CV events (relative risk, 0.77; P = .19), major adverse CV events plus hospitalization for unstable angina (RR, 0.92; P = .54), cardiovascular death (RR, 1.15; P = .30), all-cause mortality (RR, 1.13; P = .08), noncardiovascular death (RR, 0.85; P = .33), acute coronary syndromes (RR, 1.00; P = .99), stroke (RR, 0.90; P = .47), and heart failure (RR, 1.03; P = .60). This lack of treatment benefit persisted regardless of length of follow-up, adherence to treatment, or baseline score on the apnea-hypopnea index, the investigators said (JAMA. 2017 July 11. doi: 10.1001/jama.2017.7967).

PAP also failed to improve blood pressure, body mass index, any lipid parameter, glycemia, or quality-of-life scores on the EQ-5D. It did improve sleepiness and some measures of physical and mental well-being.

“The evidence from these [randomized clinical trials] suggests that the association [between] sleep apnea and vascular outcomes and death ... may represent disease processes that cannot be ameliorated by PAP delivered at the average intensity achieved in these clinical trials or by currently feasible methods in clinical practice,” Dr. Yu and his associates said.

Their findings also “emphasize the importance of proven therapies, such as blood-pressure lowering, lipid lowering, and antiplatelet therapy, in patients with sleep apnea, who should be treated according to established guidelines for patients at elevated cardiovascular risk,” they added.

This study was supported by the National Health and Medical Research Council of Australia. Dr. Yu reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.

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The estimated relative risk for the association between PAP and the composite outcome of acute coronary events, stroke, or vascular death was 0.77 in the study by Yu et al. It did not reach statistical significance but is similar to the estimated risk reduction associated with antiplatelet therapy, statins, and beta-blockers in preventing recurrent vascular events.

This magnitude of benefit could be of substantial clinical importance. Far from discouraging further research, this meta-analysis should be an impetus for more studies examining whether treatment of sleep apnea reduces vascular disease risk.

Daniel J. Gottlieb, M.D., is in the Medical Service at the V.A. Boston Healthcare System and in the division of sleep medicine at Harvard. He reported receiving personal fees from VIVUS. Dr. Gottlieb made these remarks in an editorial accompanying Dr. Yu’s report (JAMA. 2017;318:128-30).

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The estimated relative risk for the association between PAP and the composite outcome of acute coronary events, stroke, or vascular death was 0.77 in the study by Yu et al. It did not reach statistical significance but is similar to the estimated risk reduction associated with antiplatelet therapy, statins, and beta-blockers in preventing recurrent vascular events.

This magnitude of benefit could be of substantial clinical importance. Far from discouraging further research, this meta-analysis should be an impetus for more studies examining whether treatment of sleep apnea reduces vascular disease risk.

Daniel J. Gottlieb, M.D., is in the Medical Service at the V.A. Boston Healthcare System and in the division of sleep medicine at Harvard. He reported receiving personal fees from VIVUS. Dr. Gottlieb made these remarks in an editorial accompanying Dr. Yu’s report (JAMA. 2017;318:128-30).

Body

 

The estimated relative risk for the association between PAP and the composite outcome of acute coronary events, stroke, or vascular death was 0.77 in the study by Yu et al. It did not reach statistical significance but is similar to the estimated risk reduction associated with antiplatelet therapy, statins, and beta-blockers in preventing recurrent vascular events.

This magnitude of benefit could be of substantial clinical importance. Far from discouraging further research, this meta-analysis should be an impetus for more studies examining whether treatment of sleep apnea reduces vascular disease risk.

Daniel J. Gottlieb, M.D., is in the Medical Service at the V.A. Boston Healthcare System and in the division of sleep medicine at Harvard. He reported receiving personal fees from VIVUS. Dr. Gottlieb made these remarks in an editorial accompanying Dr. Yu’s report (JAMA. 2017;318:128-30).

Title
Clinical, if not statistical, significance?
Clinical, if not statistical, significance?

 

Positive airway pressure, whether delivered continuously (CPAP) or as adaptive servoventilation, doesn’t reduce the rate of cardiovascular (CV) events or death in patients who have sleep apnea, according to a report published online July 11 in JAMA.

Positive airway pressure (PAP) relieves the symptoms of sleep apnea and has been reported to improve cardiovascular risk factors such as hypertension, insulin resistance, and endothelial dysfunction. However, whether the treatment improves “hard” vascular outcomes such as stroke and MI has never been established, said Jie Yu, MD, of the department of cardiology, Peking University and the Ministries of Health and Education, Beijing, and his associates.

They performed a systematic review of the literature and a meta-analysis of 10 randomized clinical trials that compared PAP against standard care or a sham treatment and had at least 6 months of follow-up for CV events. The meta-analysis involved 7,266 participants who had either obstructive (5,683 patients) or central (1,583 patients) sleep apnea. There were 356 major adverse CV events and 613 deaths during a median follow-up of 6-68 months.

The use of PAP showed no significant association with a range of outcomes: major adverse CV events (relative risk, 0.77; P = .19), major adverse CV events plus hospitalization for unstable angina (RR, 0.92; P = .54), cardiovascular death (RR, 1.15; P = .30), all-cause mortality (RR, 1.13; P = .08), noncardiovascular death (RR, 0.85; P = .33), acute coronary syndromes (RR, 1.00; P = .99), stroke (RR, 0.90; P = .47), and heart failure (RR, 1.03; P = .60). This lack of treatment benefit persisted regardless of length of follow-up, adherence to treatment, or baseline score on the apnea-hypopnea index, the investigators said (JAMA. 2017 July 11. doi: 10.1001/jama.2017.7967).

PAP also failed to improve blood pressure, body mass index, any lipid parameter, glycemia, or quality-of-life scores on the EQ-5D. It did improve sleepiness and some measures of physical and mental well-being.

“The evidence from these [randomized clinical trials] suggests that the association [between] sleep apnea and vascular outcomes and death ... may represent disease processes that cannot be ameliorated by PAP delivered at the average intensity achieved in these clinical trials or by currently feasible methods in clinical practice,” Dr. Yu and his associates said.

Their findings also “emphasize the importance of proven therapies, such as blood-pressure lowering, lipid lowering, and antiplatelet therapy, in patients with sleep apnea, who should be treated according to established guidelines for patients at elevated cardiovascular risk,” they added.

This study was supported by the National Health and Medical Research Council of Australia. Dr. Yu reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.

 

Positive airway pressure, whether delivered continuously (CPAP) or as adaptive servoventilation, doesn’t reduce the rate of cardiovascular (CV) events or death in patients who have sleep apnea, according to a report published online July 11 in JAMA.

Positive airway pressure (PAP) relieves the symptoms of sleep apnea and has been reported to improve cardiovascular risk factors such as hypertension, insulin resistance, and endothelial dysfunction. However, whether the treatment improves “hard” vascular outcomes such as stroke and MI has never been established, said Jie Yu, MD, of the department of cardiology, Peking University and the Ministries of Health and Education, Beijing, and his associates.

They performed a systematic review of the literature and a meta-analysis of 10 randomized clinical trials that compared PAP against standard care or a sham treatment and had at least 6 months of follow-up for CV events. The meta-analysis involved 7,266 participants who had either obstructive (5,683 patients) or central (1,583 patients) sleep apnea. There were 356 major adverse CV events and 613 deaths during a median follow-up of 6-68 months.

The use of PAP showed no significant association with a range of outcomes: major adverse CV events (relative risk, 0.77; P = .19), major adverse CV events plus hospitalization for unstable angina (RR, 0.92; P = .54), cardiovascular death (RR, 1.15; P = .30), all-cause mortality (RR, 1.13; P = .08), noncardiovascular death (RR, 0.85; P = .33), acute coronary syndromes (RR, 1.00; P = .99), stroke (RR, 0.90; P = .47), and heart failure (RR, 1.03; P = .60). This lack of treatment benefit persisted regardless of length of follow-up, adherence to treatment, or baseline score on the apnea-hypopnea index, the investigators said (JAMA. 2017 July 11. doi: 10.1001/jama.2017.7967).

PAP also failed to improve blood pressure, body mass index, any lipid parameter, glycemia, or quality-of-life scores on the EQ-5D. It did improve sleepiness and some measures of physical and mental well-being.

“The evidence from these [randomized clinical trials] suggests that the association [between] sleep apnea and vascular outcomes and death ... may represent disease processes that cannot be ameliorated by PAP delivered at the average intensity achieved in these clinical trials or by currently feasible methods in clinical practice,” Dr. Yu and his associates said.

Their findings also “emphasize the importance of proven therapies, such as blood-pressure lowering, lipid lowering, and antiplatelet therapy, in patients with sleep apnea, who should be treated according to established guidelines for patients at elevated cardiovascular risk,” they added.

This study was supported by the National Health and Medical Research Council of Australia. Dr. Yu reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.

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Key clinical point: Positive airway pressure, whether delivered continuously (CPAP) or as adaptive servoventilation, doesn’t reduce the rate of cardiovascular events or death in patients with sleep apnea.

Major finding: The use of PAP showed no association with a range of outcomes: major adverse CV events (RR, 0.77), major adverse CV events plus hospitalization for unstable angina (RR, 0.92), cardiovascular death (RR, 1.15), all-cause mortality (RR, 1.13), noncardiovascular death (RR, 0.85), acute coronary syndromes (RR, 1.00), stroke (RR, 0.90), and heart failure (RR, 1.03).

Data source: A meta-analysis of 10 randomized clinical trials involving 7,266 adults who had either central or obstructive sleep apnea.

Disclosures: This study was supported by the National Health and Medical Research Council of Australia. Dr. Yu reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.

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