Background: Episodes of sudden uncontrollable somnolence have been reported in patients with Parkinson disease (PD) receiving dopamine agonists, including pramipexole and ropinirole, but controversy persists concernin...Background: Episodes of sudden uncontrollable somnolence have been reported in patients with Parkinson disease (PD) receiving dopamine agonists, including pramipexole and ropinirole, but controversy persists concerning their nature, severity, and frequency. Abstract:Objectives: To quantify the risk of sudden uncontrollable somnolence in patients taking specific PD medications and to define its predictors. Methods: We contacted 929 patients with PD and administered a 45-to 60-minute interview addressing medication use, adverse events, and the patient’s clinical status in the preceding 6 months. Their physicians completed record reviews detailing their clinical histories and drug regimens. The outcome of interest in this case-control study was an episode of somnolence that was uncontrollable, severe, and inappropriate, such as while driving or engaged in social activity. For multiple events, the first was chosen as the index event. For each case, we sampled control time from all respondents who had no event as of the index time for that case. Multiple logistic regression was used to adjust for potential confounders. Results: Episodes of uncontrollable somnolence were reported by 22%of all respondents. After controlling for age, sex, PD duration and severity, frailty, and other medication use, we found that patients receiving a dopamine agonist (pramipexole, ropinirole, or pergolide) were nearly 3-fold as likely to have episodes of sudden uncontrollable somnolence (odds ratio, 2.8; 95%confidence interval, 1.8-4.2) compared with all other PD medication users. Similar risks were seen for the 3 agents, pramipexole, ropinirole, and pergolide, each compared with levodopa alone (odds ratio, 2.2, 1.8, and 2.1, respectively), with a clear dose-response relationship for each. No increase in risk was seen with any other drugs studied. Conclusions: Dopamine agonists widely used for the management of PD significantly increase the risk of sudden uncontrollable somnolence in a dose-related manner. Greater attention to this potentially serious adverse effect will be necessary to improve the safety of use of this important category of PD drugs.展开更多
Background Non-interventional large-scale research on real-world patients who had a stroke requires the use of multiple data sources ensuring access to longitudinal data from large populations with clinically-detailed...Background Non-interventional large-scale research on real-world patients who had a stroke requires the use of multiple data sources ensuring access to longitudinal data from large populations with clinically-detailed information.We sought to establish a framework for longitudinal research on patients hospitalised with stroke by linking information-rich,deidentified inpatient data from the Paul Coverdell National Acute Stroke Program(PCNASP)to commercial and Medicare Advantage longitudinal claims data.Methods All stroke admissions in PCNASP between 2008 and 2015 were evaluated for linkage to longitudinal claims from a commercial insurer using an algorithm based on six available common data fields(patient age,gender,admission date,discharge date,discharge diagnosis and state)and a hospital match.We evaluated the linkage quality(via the percentage of unique records in the linked dataset)and the representativeness of the linked population.We also described medical history,stroke severity and patterns of medication use among the PCNASP-claims linked cohort.Results The linkage produced uniqueness equal to 99.1%.We identified 5644 linked and 98896 unlinked patients who had an ischaemic stroke hospitalisation in claims data.Linked patients were younger than unlinked(69.7 vs 72.5 years),but otherwise similar by medical history,prestroke medication use or lab values.Stroke severity was mild and most patients were discharged home.Prestroke and discharge use of antihypertensive and statins in the PCNASP were greater than their use as measured by filled prescriptions in claims.Conclusions High-quality linkage between the PCNASP and commercial claims data is feasible.This linkage identified differences between reported or recommended versus actual out-of-hospital medication utilisation,highlighting the importance of longitudinal data availability for research aimed to improve the care of patients who had a stroke.展开更多
文摘Background: Episodes of sudden uncontrollable somnolence have been reported in patients with Parkinson disease (PD) receiving dopamine agonists, including pramipexole and ropinirole, but controversy persists concerning their nature, severity, and frequency. Abstract:Objectives: To quantify the risk of sudden uncontrollable somnolence in patients taking specific PD medications and to define its predictors. Methods: We contacted 929 patients with PD and administered a 45-to 60-minute interview addressing medication use, adverse events, and the patient’s clinical status in the preceding 6 months. Their physicians completed record reviews detailing their clinical histories and drug regimens. The outcome of interest in this case-control study was an episode of somnolence that was uncontrollable, severe, and inappropriate, such as while driving or engaged in social activity. For multiple events, the first was chosen as the index event. For each case, we sampled control time from all respondents who had no event as of the index time for that case. Multiple logistic regression was used to adjust for potential confounders. Results: Episodes of uncontrollable somnolence were reported by 22%of all respondents. After controlling for age, sex, PD duration and severity, frailty, and other medication use, we found that patients receiving a dopamine agonist (pramipexole, ropinirole, or pergolide) were nearly 3-fold as likely to have episodes of sudden uncontrollable somnolence (odds ratio, 2.8; 95%confidence interval, 1.8-4.2) compared with all other PD medication users. Similar risks were seen for the 3 agents, pramipexole, ropinirole, and pergolide, each compared with levodopa alone (odds ratio, 2.2, 1.8, and 2.1, respectively), with a clear dose-response relationship for each. No increase in risk was seen with any other drugs studied. Conclusions: Dopamine agonists widely used for the management of PD significantly increase the risk of sudden uncontrollable somnolence in a dose-related manner. Greater attention to this potentially serious adverse effect will be necessary to improve the safety of use of this important category of PD drugs.
基金funded by the Division of Pharmacoepidemiology and Pharmacoeconomics,Department of Medicine,Brigham and Women’s Hospital,Harvard Medical School,Boston,MAsupported by a career development grant K08AG055670 from the National Institute on Agingsupported by a career development grant 5K08AG05338002 from the National Institute on Aging.
文摘Background Non-interventional large-scale research on real-world patients who had a stroke requires the use of multiple data sources ensuring access to longitudinal data from large populations with clinically-detailed information.We sought to establish a framework for longitudinal research on patients hospitalised with stroke by linking information-rich,deidentified inpatient data from the Paul Coverdell National Acute Stroke Program(PCNASP)to commercial and Medicare Advantage longitudinal claims data.Methods All stroke admissions in PCNASP between 2008 and 2015 were evaluated for linkage to longitudinal claims from a commercial insurer using an algorithm based on six available common data fields(patient age,gender,admission date,discharge date,discharge diagnosis and state)and a hospital match.We evaluated the linkage quality(via the percentage of unique records in the linked dataset)and the representativeness of the linked population.We also described medical history,stroke severity and patterns of medication use among the PCNASP-claims linked cohort.Results The linkage produced uniqueness equal to 99.1%.We identified 5644 linked and 98896 unlinked patients who had an ischaemic stroke hospitalisation in claims data.Linked patients were younger than unlinked(69.7 vs 72.5 years),but otherwise similar by medical history,prestroke medication use or lab values.Stroke severity was mild and most patients were discharged home.Prestroke and discharge use of antihypertensive and statins in the PCNASP were greater than their use as measured by filled prescriptions in claims.Conclusions High-quality linkage between the PCNASP and commercial claims data is feasible.This linkage identified differences between reported or recommended versus actual out-of-hospital medication utilisation,highlighting the importance of longitudinal data availability for research aimed to improve the care of patients who had a stroke.
