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Meta-Analysis
. 2013 May 31;2013(5):CD003002.
doi: 10.1002/14651858.CD003002.pub3.

Drug therapy for obstructive sleep apnoea in adults

Martina Mason  1 , Emma J Welsh, Ian Smith
Affiliations
Meta-Analysis

Drug therapy for obstructive sleep apnoea in adults

Martina Mason et al. Cochrane Database Syst Rev. .

Abstract

Background: The treatment of choice for moderate to severe obstructive sleep apnoea (OSA) is continuous positive airways pressure (CPAP) applied via a mask during sleep. However, this is not tolerated by all individuals and its role in mild OSA is not proven. Drug therapy has been proposed as an alternative to CPAP in some patients with mild to moderate sleep apnoea and could be of value in patients intolerant of CPAP. A number of mechanisms have been proposed by which drugs could reduce the severity of OSA. These include an increase in tone in the upper airway dilator muscles, an increase in ventilatory drive, a reduction in the proportion of rapid eye movement (REM) sleep, an increase in cholinergic tone during sleep, an increase in arousal threshold, a reduction in airway resistance and a reduction in surface tension in the upper airway.

Objectives: To determine the efficacy of drug therapies in the specific treatment of sleep apnoea.

Search methods: We searched the Cochrane Airways Group Specialised Register of trials. Searches were current as of July 2012.

Selection criteria: Randomised, placebo controlled trials involving adult patients with confirmed OSA. We excluded trials if continuous positive airways pressure, mandibular devices or oxygen therapy were used. We excluded studies investigating treatment of associated conditions such as excessive sleepiness, hypertension, gastro-oesophageal reflux disease and obesity.

Data collection and analysis: We used standard methodological procedures recommended by The Cochrane Collaboration.

Main results: Thirty trials of 25 drugs, involving 516 participants, contributed data to the review. Drugs had several different proposed modes of action and the results were grouped accordingly in the review. Each of the studies stated that the participants had OSA but diagnostic criteria were not always explicit and it was possible that some patients with central apnoeas may have been recruited.Acetazolamide, eszopiclone, naltrexone, nasal lubricant (phosphocholinamine) and physiostigmine were administered for one to two nights only. Donepezil in patients with and without Alzheimer's disease, fluticasone in patients with allergic rhinitis, combinations of ondansetrone and fluoxetine and paroxetine were trials of one to three months duration, however most of the studies were small and had methodological limitations. The overall quality of the available evidence was low.The primary outcomes for the systematic review were the apnoea hypopnoea index (AHI) and the level of sleepiness associated with OSA, estimated by the Epworth Sleepiness Scale (ESS). AHI was reported in 25 studies and of these 10 showed statistically significant reductions in AHI.Fluticasone in patients with allergic rhinitis was well tolerated and reduced the severity of sleep apnoea compared with placebo (AHI 23.3 versus 30.3; P < 0.05) and improved subjective daytime alertness. Excessive sleepiness was reported to be altered in four studies, however the only clinically and statistically significant change in ESS of -2.9 (SD 2.9; P = 0.04) along with a small but statistically significant reduction in AHI of -9.4 (SD 17.2; P = 0.03) was seen in patients without Alzheimer's disease receiving donepezil for one month. In 23 patients with mild to moderate Alzheimer's disease donepezil led to a significant reduction in AHI (donepezil 20 (SD 15) to 9.9 (SD 11.5) versus placebo 23.2 (SD 26.4) to 22.9 (SD 28.8); P = 0.035) after three months of treatment but no reduction in sleepiness was reported. High dose combined treatment with ondansetron 24 mg and fluoxetine 10 mg showed a 40.5% decrease in AHI from the baseline at treatment day 28. Paroxetine was shown to reduce AHI compared to placebo (-6.10 events/hour; 95% CI -11.00 to -1.20) but failed to improve daytime symptoms.Promising results from the preliminary mirtazapine study failed to be reproduced in the two more recent multicentre trials and, moreover, the use of mirtazapine was associated with significant weight gain and sleepiness. Few data were presented on the long-term tolerability of any of the compounds used.

Authors' conclusions: There is insufficient evidence to recommend the use of drug therapy in the treatment of OSA. Small studies have reported positive effects of certain agents on short-term outcomes. Certain agents have been shown to reduce the AHI in largely unselected populations with OSA by between 24% and 45%. For donepezil and fluticasone, studies of longer duration with a larger population and better matching of groups are required to establish whether the change in AHI and impact on daytime symptoms are reproducible. Individual patients had more complete responses to particular drugs. It is possible that better matching of drugs to patients according to the dominant mechanism of their OSA will lead to better results and this also needs further study.

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Conflict of interest statement

None known

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 1 Apnoea Hypopnea Index.
1.2
1.2. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 2 Apnoea Index.
1.3
1.3. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 3 Hypopnea Index.
1.4
1.4. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 4 Min SaO2.
1.5
1.5. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 5 Total sleep time.
1.6
1.6. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 6 Desaturation Index.
1.7
1.7. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 7 Arousal Index.
1.8
1.8. Analysis
Comparison 1 Protriptyline versus placebo, Outcome 8 Subjective reduction in daytime sleepiness.
2.1
2.1. Analysis
Comparison 2 Paroxetine versus placebo, Outcome 1 Apnoea Hypopnoea Index.
2.2
2.2. Analysis
Comparison 2 Paroxetine versus placebo, Outcome 2 Apnoea Index.
2.3
2.3. Analysis
Comparison 2 Paroxetine versus placebo, Outcome 3 Hypopnea Index.
2.4
2.4. Analysis
Comparison 2 Paroxetine versus placebo, Outcome 4 CPRS symptoms.
2.5
2.5. Analysis
Comparison 2 Paroxetine versus placebo, Outcome 5 Sleepiness.
2.6
2.6. Analysis
Comparison 2 Paroxetine versus placebo, Outcome 6 Adverse effects.
3.1
3.1. Analysis
Comparison 3 Mirtazapine versus placebo, Outcome 1 Apnoea Hypopnea Index.
3.2
3.2. Analysis
Comparison 3 Mirtazapine versus placebo, Outcome 2 ESS.
3.3
3.3. Analysis
Comparison 3 Mirtazapine versus placebo, Outcome 3 Arousals.
4.1
4.1. Analysis
Comparison 4 High dose mirtazapine + CD0012 versus placebo, Outcome 1 Apnoea hypopnea index.
4.2
4.2. Analysis
Comparison 4 High dose mirtazapine + CD0012 versus placebo, Outcome 2 ESS.
5.1
5.1. Analysis
Comparison 5 Ondansetron versus placebo, Outcome 1 Apnoea Hypopnea Index.
5.2
5.2. Analysis
Comparison 5 Ondansetron versus placebo, Outcome 2 Apnoea Index.
5.3
5.3. Analysis
Comparison 5 Ondansetron versus placebo, Outcome 3 SaO2 (>4% dips).
6.1
6.1. Analysis
Comparison 6 Buspirone versus placebo, Outcome 1 Apnoea Index.
6.2
6.2. Analysis
Comparison 6 Buspirone versus placebo, Outcome 2 Total sleep time.
6.3
6.3. Analysis
Comparison 6 Buspirone versus placebo, Outcome 3 MinSaO2.
7.1
7.1. Analysis
Comparison 7 Salmeterol versus placebo, Outcome 1 AHI.
7.2
7.2. Analysis
Comparison 7 Salmeterol versus placebo, Outcome 2 Minimum SaO2.
8.1
8.1. Analysis
Comparison 8 Aminophylline versus placebo, Outcome 1 Apnoea Index.
8.2
8.2. Analysis
Comparison 8 Aminophylline versus placebo, Outcome 2 Hypopnoea index.
8.3
8.3. Analysis
Comparison 8 Aminophylline versus placebo, Outcome 3 Min SaO2 in REM.
8.4
8.4. Analysis
Comparison 8 Aminophylline versus placebo, Outcome 4 Sleep efficiency.
9.1
9.1. Analysis
Comparison 9 Theophylline versus placebo, Outcome 1 Apnoea Hypopnea Index.
9.2
9.2. Analysis
Comparison 9 Theophylline versus placebo, Outcome 2 Min SaO2.
9.3
9.3. Analysis
Comparison 9 Theophylline versus placebo, Outcome 3 Total sleep time.
9.4
9.4. Analysis
Comparison 9 Theophylline versus placebo, Outcome 4 Desaturations >4%.
9.5
9.5. Analysis
Comparison 9 Theophylline versus placebo, Outcome 5 Self‐assessed sleep latency.
9.6
9.6. Analysis
Comparison 9 Theophylline versus placebo, Outcome 6 Reported number of awakenings.
9.7
9.7. Analysis
Comparison 9 Theophylline versus placebo, Outcome 7 Subjective sleep quality.
10.1
10.1. Analysis
Comparison 10 Acetozolamide versus placebo, Outcome 1 Apnoea Hypopnoea Index.
10.2
10.2. Analysis
Comparison 10 Acetozolamide versus placebo, Outcome 2 Desaturation Index.
10.3
10.3. Analysis
Comparison 10 Acetozolamide versus placebo, Outcome 3 Arousal Index.
11.1
11.1. Analysis
Comparison 11 Medroxyprogesterone versus placebo, Outcome 1 Apnoea Hypopnoea Index.
11.2
11.2. Analysis
Comparison 11 Medroxyprogesterone versus placebo, Outcome 2 Total sleep time.
12.1
12.1. Analysis
Comparison 12 Naloxone versus placebo, Outcome 1 Number of apnoeic episodes.
12.2
12.2. Analysis
Comparison 12 Naloxone versus placebo, Outcome 2 Percent of periods with arousals.
13.1
13.1. Analysis
Comparison 13 Naltrexone versus placebo, Outcome 1 AHI.
14.1
14.1. Analysis
Comparison 14 Almitrine versus placebo, Outcome 1 Apnoea Index.
14.2
14.2. Analysis
Comparison 14 Almitrine versus placebo, Outcome 2 Hypopnea Index.
14.3
14.3. Analysis
Comparison 14 Almitrine versus placebo, Outcome 3 Total sleep time.
15.1
15.1. Analysis
Comparison 15 Clonidine versus placebo, Outcome 1 Apnoea Hypopnea Index.
15.2
15.2. Analysis
Comparison 15 Clonidine versus placebo, Outcome 2 Min SaO2.
16.1
16.1. Analysis
Comparison 16 Mibefradil versus placebo, Outcome 1 Apnoea Hypopnea Index.
16.2
16.2. Analysis
Comparison 16 Mibefradil versus placebo, Outcome 2 Total sleep time.
16.3
16.3. Analysis
Comparison 16 Mibefradil versus placebo, Outcome 3 Mean change in Apnoea Hypopnea Index.
17.1
17.1. Analysis
Comparison 17 Nasal lubricant versus placebo, Outcome 1 AHI.
17.2
17.2. Analysis
Comparison 17 Nasal lubricant versus placebo, Outcome 2 Arousal index.
18.1
18.1. Analysis
Comparison 18 Sabeluzole versus placebo, Outcome 1 Total sleep time.
19.1
19.1. Analysis
Comparison 19 Physostigmine versus placebo, Outcome 1 Apnoea Hypopnea Index.
19.2
19.2. Analysis
Comparison 19 Physostigmine versus placebo, Outcome 2 Apnoea Index.
19.3
19.3. Analysis
Comparison 19 Physostigmine versus placebo, Outcome 3 Min SaO2.
19.4
19.4. Analysis
Comparison 19 Physostigmine versus placebo, Outcome 4 Total sleep time.
19.5
19.5. Analysis
Comparison 19 Physostigmine versus placebo, Outcome 5 Time to sleep onset.
20.1
20.1. Analysis
Comparison 20 Donezepil versus placebo, Outcome 1 Apnoea hypopnea index.
20.2
20.2. Analysis
Comparison 20 Donezepil versus placebo, Outcome 2 ESS.
20.3
20.3. Analysis
Comparison 20 Donezepil versus placebo, Outcome 3 Desaturation index.
20.4
20.4. Analysis
Comparison 20 Donezepil versus placebo, Outcome 4 Min SaO2.
20.5
20.5. Analysis
Comparison 20 Donezepil versus placebo, Outcome 5 Total sleep time.
21.1
21.1. Analysis
Comparison 21 Eszopiclone versus placebo, Outcome 1 AHI.
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Update of

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References to studies awaiting assessment

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