Impact of adherence to treatment with fluticasone propionate/salmeterol in asthma patients.

OBJECTIVE: Low adherence with asthma treatment may be associated with suboptimal outcomes and hence create a treatment gap in the real-life setting. The objective of this study was to assess the long-term association between adherence to treatment with fixed-dose fluticasone propionate/salmeterol (FSC) and the risk of exacerbations and health care utilization in patients with asthma. RESEARCH DESIGN AND METHODS: Observational single cohort study utilizing the Quebec Health Insurance databases. All patients (age >12 years) with a diagnosis of asthma (ICD9-CM 493.xx) between 2001 and 2010 were entered into the study cohort at the time of their first prescription for FSC at any dose. Follow-up continued to the last known claim or death. Adherence to treatment was ascertained as compliance (medication possession ratio ≥80%) and persistence (absence of treatment gap ≥30 days). MAIN OUTCOME MEASURES: Outcomes assessed were exacerbations defined as one of the following: use of oral corticosteroid (OCS), emergency room (ER) visit for asthma or hospitalization for asthma. Asthma related health care resource utilizations ascertained were number of prescription claims for rescue medications, ER visits, hospitalizations, intensive care unit (ICU) stay, intubations, and general practitioner (GP) and respirologist visits. RESULTS: A total of 19,126 patients were included in the study. The proportion of compliant and persistent patients were 42.7% and 29.3% respectively. Multivariate logistic regression analyses showed a significantly reduced adjusted odds of exacerbations for compliant (OR = 0.48; 95% CI: 0.44-0.54) and persistent patients (OR = 0.42; 95% CI: 0.38-0.48). Similarly, significantly lower rates of health care utilization were observed for compliant and persistent patients. CONCLUSIONS: The results of this large population-based study have shown that increased adherence to treatment with FSC is associated with lower risk for exacerbations, lower rescue medication use and lower health care utilization in asthma patients. Despite the typical limitations of an administrative database study including validity of the diagnosis, the fact that compliance and persistence are calculated based on filled claims which does not guarantee that the patients actually took their medications, and the absence of clinical and laboratory data, the findings have implications for physician and patient awareness of the importance of adherence in the management of asthma.

Impact of adherence to treatment with tiotropium and fluticasone propionate/salmeterol in chronic obstructive pulmonary diseases patients.

OBJECTIVE: Poor adherence to treatment may contribute to the treatment gap in chronic obstructive pulmonary diseases (COPD). The aim of the current study was to describe the association between adherence to treatment and the risk of COPD moderate (ME) and severe (SE) exacerbations, and health care utilization. RESEARCH DESIGN AND METHODS: Observational single cohort study utilizing the Quebec Provincial Health Insurance databases. All patients older than 40 years with a diagnosis of COPD between 2001 and 2010 were entered in the study cohort at the time of their first prescription for tiotropium (TIO) alone or co-administered with fluticasone propionate/salmeterol (TIO + FSC). Follow-up continued to the last known claim or death. Adherence was measured by the medication possession ratio (MPR) ≥80% and persistence defined as no treatment gap ≥30 days. MAIN OUTCOME MEASURES: ME was defined as use of an oral corticosteroid or antibiotic, SE as COPD related hospitalization or an emergency room (ER) visit. COPD related health care resource utilization ascertained was prescription of rescue medications, ER visits, hospitalizations, intensive care unit (ICU) admissions, intubations, and general practitioner (GP) and respirologist visits. RESULTS: There were 23,707 patients included in this study. Compliance and persistence with TIO for monotherapy patients were 61.1% and 47.6% respectively. For patients treated with TIO + FSC, compliance and persistence for TIO were 62.9% and 45.3% respectively, and for FSC they were 35.4% and 33.0%. Multivariate analyses showed a significant (P < 0.001) adjusted odds ratios for ME (OR(ME)) and SE (OR(SE)) for TIO compliant vs. non-compliant patients (TIO: OR(ME) = 0.543, OR(SE) = 0.712; TIO + FSC: OR(ME) = 0.436, OR(SE) = 0.570). Similarly for FSC compliance: OR(ME) = 0.546; OR(SE) = 0.749. Similar results were observed for persistence. Compliance and persistence with TIO and FSC were associated with significantly reduced rates of health care utilization. CONCLUSIONS: Despite the typical limitations of an administrative database study, the results of this large population-based study have shown that reduced adherence to treatment with TIO and FSC is associated with increased risk for exacerbations and higher health care utilization in COPD patients.

Non-reflex mediated changes in plantarflexor muscles early after stroke.

The aims of this study were to determine whether changes in the non-reflex component of spastic plantarflexors had developed 2 and 4 months after stroke and to study their relationship with the level of impairment. One group of adults with hemiparesis (HPs) was tested 2 and 4 months after the onset of stroke, and data were compared with a control group (CTLs) tested once. Twenty-two patients (14 males) admitted over a 4-month period in a rehabilitation centre (mean = 62 yrs +/- 14), and 11 (6 males) non-disabled (CTLs) subjects (mean = 57yrs +/- 12.8) agreed to participate in the study. The resistive torque (RT) recorded with a myometer during slow (8-10 degrees/s) passive dorsiflexions imposed manually served as the primary outcome, whereas, the Ashworth score (spasticity), ankle ROM and Fugl-Meyer motor subscore were used as secondary measures to determine the level of impairment. The mean RT values measured at 0 degrees dorsiflexion on the affected and unaffected sides were compared with those in CTLs. As expected, the RT values 2 and 4 months post-stroke on the unaffected side did not differ from corresponding values in CTLs. Significantly higher RT values on the affected side when compared to the unaffected side were found both at 2 months (39%; p < 0.05) and at 4 months (43%; p < 0.01). No significant difference existed on the affected side between the 2nd and 4th months. A high (r = 0.80) and significant (p < 0.0001) correlation coefficient was calculated between the changes in RT values recorded at 2 and 4 months. Low and not significant correlations were computed between these RT changes and factors such as the ROM (r = -0.24), the Ashworth score (r = 0.23) and the Fugl-Meyer lower extremity motor subscore (r = -0.26). Present results indicate that: (1) changes in the non-reflex component are already present 2 months after stroke but do not increase significantly between the 2nd and 4th months; (2) these changes are not related to the level of impairment; and (3) myometry testing at 2 months could be used as a preventive measure to detect patients more at risk of developing severe passive muscle stiffness.

Evaluating motor recovery early after stroke: comparison of the Fugl-Meyer Assessment and the Motor Assessment Scale.

This study compared the measurements of the Motor Assessment Scale (MAS) to that of the Fugl-Meyer Assessment (FMA), a reliable and valid test for motor function in stroke patients. Thirty-two patients (20 men, 12 women) with a mean age of 60 years, and a mean time since stroke of 64.5 days, were tested with the FMA and MAS on two consecutive days. The Spearman correlation coefficient for total FMA and total MAS scores was 0.96. For selected items, significant (p < 0.001) correlations ranged from 0.65 to 0.93, except for sitting balance (-0.10). Low negative correlations between sitting balance scores and other items (motor and sensation) were found only for the FMA test, suggesting that the FMA sitting balance test is not valid for measuring balance and is likely responsible for the low correlation. Comparison of scores (normalized in percent of maximal value) for corresponding items of the two instruments also indicated that the FMA measured a higher (Wilcoxon = p < 0.0001) level of motor recovery, (especially in more disabled patients), for both the upper (15.7%) and lower extremities (27.5%). Lastly, a cumulative frequency distribution analysis indicated that a larger proportion of patients was found in the lower class interval scores of the MAS in comparison to the FMA. These results (1) support the concurrent validity of the MAS for measuring motor recovery in acute stroke patients; (2) demonstrate the poor validity of the FMA sitting balance test, and (3) suggest that the FMA scale can better discriminate the level of motor recovery than the MAS in the early stage of recovery or in the more disabled subjects.

Serum testosterone and sexual activity and interest in men.

There is considerable interest in the relationship between testosterone and sexual behavior in men, but the few available data bearing on this issue are inconclusive. This study is an attempt to clarify the relationships among various components of sexuality and serum testosterone concentration through examination of these variables in a large homogenous group of men. Serum testosterone concentration was determined in two blood samples taken 1 week apart from 101 young adult men. Subjects reported their frequencies of various sexual activities and level of sexual interest. Testosterone concentrations in the two blood samples were highly correlated, indicating considerable intraindividual consistency. There was considerable variance among subjects in both mean testosterone and reported sexual activity. Testosterone concentration did not correlate with the sexual activity and interest variables. These results provide evidence that differences among men in circulating testosterone concentration within the normal range do not account for differences in sexual activity and interest. It is also unlikely that variations in sexual activity account for differences in testosterone concentration.