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Standalone or managed care drug plans, postarthroplasty thromboprophylaxis, and risperidone for PTSD
SCIENCE SNIPPETS
Standalone or managed care drug plans, postarthroplasty thromboprophylaxis, and risperidone for PTSD L. Douglas Ried
Choice of standalone or managed care drug plans Cline et al.1 reported that “models of health insurance demand and plan choice applied in this context appear to be modestly effective. Rurality and state of residence were particularly important contributors to patients’ decisions.” The study described factors associated with (1) Medicare beneficiaries choosing to enroll in any Medicare Part D prescription drug plan (PDP) and (2) the choice of a Medicare Advantage Prescription Drug plan (MA-PD), given enrollment in Part D. Mailed surveys were sent to a stratified random sample of 5,000 community-dwelling adults aged 65 years or older. Nearly 75% of sample members elected to enroll in one of the Medicare Part D coverage options in 2007, with more than three times as many choosing a standalone PDP compared with an MA-PD (57.2% vs. 17.8%). Rurality, plan price, perceived future need for medications, and preferences emerged as important predictors of choosing to enroll in any Medicare Part D drug plan, while rurality, state of residence, and number of diagnosed medical conditions were associated with the decision to enroll in an MA-PD. Implications. Although rurality was important to patients’ choices in both cases, state of residence and diagnosed medical conditions were important to the MA-PD choice. Reasons for these differences (e.g., state of residence and managed care concentration in those states) should be examined. Warfarin or aspirin for postarthroplasty thromboprophylaxis? The Intermountain Joint Replacement Center Writing Committee noted that “patients with total joint arthroplasty (knee and hip) at standard risk for pulmonary embolism (PE) receiving aspirin had a higher rate of symptomatic PE and ve-
672 • JAPhA • 51 : 5 • S e p / O c t 2 011
nous thromboembolism (VTE) than did patients receiving anticoagulation.”2 The American Association of Orthopedic Surgeons (AAOS) guidelines for preventing PE, for both elevated (n = 129) and standard risk (n = 152), were compared with each other and with the American Association of Chest Physicians (ACCP) guidelines for PE prophylaxis. The ACCP group (n = 415) was used as the comparator. The ACCP and AAOS elevatedrisk guidelines are based on warfarin treatment, whereas the standard-risk AAOS guidelines feature aspirin. Both warfarin groups reported lower rates of PE and VTE than the AAOS group treated with aspirin. Symptomatic PE was diagnosed in 0.7% of those in the comparator group versus 4.6% in the standard-risk group (odds ratio [OR] = 6.6, P = 0.03). Symptomatic VTE was diagnosed in 1.2% of those in the comparator group versus 7.9% in the standard-risk group (adjusted OR = 7.0, P = 0.001). Rates of thromboembolism were similar for the warfarin-led AAOS and ACCP guidelines. Implications. Although thromboembolytic adverse events were rare, more aggressive prophylaxis was effective, even in patients with lower risk at surgery outset and those treated with aspirin. Risperidone for PTSD treatment A Department of Veterans Affairs (VA) study group that included two pharmacists concluded, “Among patients with military-related PTSD with SRI-resistant symptoms, 6-month treatment with risperidone compared with placebo did not reduce PTSD.”3 The 6-month, randomized, double-blind, placebo-controlled, multicenter trial compared the effective-
ness of adjunctive treatment with up to 4 mg risperidone once daily versus placebo for military-related posttraumatic stress disorder (PTSD). Veterans (n = 247) with ongoing symptoms despite at least two adequate serotonin reuptake inhibitor (SRI) treatments were enrolled. Change in the Clinician-Administered PTSD Scale (CAPS) scores from baseline to 24 weeks was –16.3 in the risperidone group and −12.5 in the placebo group (mean difference 3.74 [95% CI −0.86 to 8.35]; t = 1.6, P = 0.11). Mixed-model analysis of all time points showed no significant difference in CAPS score (P = 0.12). Compared with placebo, risperidone did not appear to improve depression or anxiety, Clinical Global Impression Score, or quality of life. Implications. Selective SRIs remain the only approved pharmacotherapies for treating PTSD. Adjunctive treatment with risperidone does not benefit the patient and does not appear to be warranted given the potential adverse effects associated with second-generation antipsychotics. L. Douglas Ried, PhD Editor-in-Chief, JAPhA Professor and Chair College of Pharmacy University of South Florida doi: 10.1331/JAPhA.2011.11541
References 1. Cline RR, Worley MM, Schondelmeyer SW, et al. PDP or MA-PD? Medicare Part D enrollment decisions in CMS Region 25. Res Social Adm Pharm. 2010;6:130– 42. 2. Intermountain Joint Replacement Center Writing Committee. A prospective comparison of warfarin to aspirin from thromboprophylaxis in total hip and total knee arthroplasty [published online ahead of print, May 27, 2011]. J Arthroplasty. 3. Krystal JH, Rosenheck RA, Cramer JA, et al. Adjunctive risperidone treatment for antidepressant-resistant symptoms of chronic military service-related PTSD: a randomized trial. JAMA. 2011;306:493– 502.
The Science Snippets column highlights research articles published by APhA Academy of Pharmaceutical Research and Sciences (APhA–APRS) and APhA Academy of Pharmacy Practice and Management (APhA–APPM) members in journals other than JAPhA. Members of both Academies are encouraged to forward the PubMed citation or an electronic version of their article, as soon as they appear or ahead of print, to Contributing Editor L. Douglas Ried, PhD, at [email protected].
w w w.j a p h a . o r g
Journal of the American Pharmacists Association
Standalone or managed care drug plans, postarthroplasty thromboprophylaxis, and risperidone for PTSD L. Douglas Ried
Choice of standalone or managed care drug plans Cline et al.1 reported that “models of health insurance demand and plan choice applied in this context appear to be modestly effective. Rurality and state of residence were particularly important contributors to patients’ decisions.” The study described factors associated with (1) Medicare beneficiaries choosing to enroll in any Medicare Part D prescription drug plan (PDP) and (2) the choice of a Medicare Advantage Prescription Drug plan (MA-PD), given enrollment in Part D. Mailed surveys were sent to a stratified random sample of 5,000 community-dwelling adults aged 65 years or older. Nearly 75% of sample members elected to enroll in one of the Medicare Part D coverage options in 2007, with more than three times as many choosing a standalone PDP compared with an MA-PD (57.2% vs. 17.8%). Rurality, plan price, perceived future need for medications, and preferences emerged as important predictors of choosing to enroll in any Medicare Part D drug plan, while rurality, state of residence, and number of diagnosed medical conditions were associated with the decision to enroll in an MA-PD. Implications. Although rurality was important to patients’ choices in both cases, state of residence and diagnosed medical conditions were important to the MA-PD choice. Reasons for these differences (e.g., state of residence and managed care concentration in those states) should be examined. Warfarin or aspirin for postarthroplasty thromboprophylaxis? The Intermountain Joint Replacement Center Writing Committee noted that “patients with total joint arthroplasty (knee and hip) at standard risk for pulmonary embolism (PE) receiving aspirin had a higher rate of symptomatic PE and ve-
672 • JAPhA • 51 : 5 • S e p / O c t 2 011
nous thromboembolism (VTE) than did patients receiving anticoagulation.”2 The American Association of Orthopedic Surgeons (AAOS) guidelines for preventing PE, for both elevated (n = 129) and standard risk (n = 152), were compared with each other and with the American Association of Chest Physicians (ACCP) guidelines for PE prophylaxis. The ACCP group (n = 415) was used as the comparator. The ACCP and AAOS elevatedrisk guidelines are based on warfarin treatment, whereas the standard-risk AAOS guidelines feature aspirin. Both warfarin groups reported lower rates of PE and VTE than the AAOS group treated with aspirin. Symptomatic PE was diagnosed in 0.7% of those in the comparator group versus 4.6% in the standard-risk group (odds ratio [OR] = 6.6, P = 0.03). Symptomatic VTE was diagnosed in 1.2% of those in the comparator group versus 7.9% in the standard-risk group (adjusted OR = 7.0, P = 0.001). Rates of thromboembolism were similar for the warfarin-led AAOS and ACCP guidelines. Implications. Although thromboembolytic adverse events were rare, more aggressive prophylaxis was effective, even in patients with lower risk at surgery outset and those treated with aspirin. Risperidone for PTSD treatment A Department of Veterans Affairs (VA) study group that included two pharmacists concluded, “Among patients with military-related PTSD with SRI-resistant symptoms, 6-month treatment with risperidone compared with placebo did not reduce PTSD.”3 The 6-month, randomized, double-blind, placebo-controlled, multicenter trial compared the effective-
ness of adjunctive treatment with up to 4 mg risperidone once daily versus placebo for military-related posttraumatic stress disorder (PTSD). Veterans (n = 247) with ongoing symptoms despite at least two adequate serotonin reuptake inhibitor (SRI) treatments were enrolled. Change in the Clinician-Administered PTSD Scale (CAPS) scores from baseline to 24 weeks was –16.3 in the risperidone group and −12.5 in the placebo group (mean difference 3.74 [95% CI −0.86 to 8.35]; t = 1.6, P = 0.11). Mixed-model analysis of all time points showed no significant difference in CAPS score (P = 0.12). Compared with placebo, risperidone did not appear to improve depression or anxiety, Clinical Global Impression Score, or quality of life. Implications. Selective SRIs remain the only approved pharmacotherapies for treating PTSD. Adjunctive treatment with risperidone does not benefit the patient and does not appear to be warranted given the potential adverse effects associated with second-generation antipsychotics. L. Douglas Ried, PhD Editor-in-Chief, JAPhA Professor and Chair College of Pharmacy University of South Florida doi: 10.1331/JAPhA.2011.11541
References 1. Cline RR, Worley MM, Schondelmeyer SW, et al. PDP or MA-PD? Medicare Part D enrollment decisions in CMS Region 25. Res Social Adm Pharm. 2010;6:130– 42. 2. Intermountain Joint Replacement Center Writing Committee. A prospective comparison of warfarin to aspirin from thromboprophylaxis in total hip and total knee arthroplasty [published online ahead of print, May 27, 2011]. J Arthroplasty. 3. Krystal JH, Rosenheck RA, Cramer JA, et al. Adjunctive risperidone treatment for antidepressant-resistant symptoms of chronic military service-related PTSD: a randomized trial. JAMA. 2011;306:493– 502.
The Science Snippets column highlights research articles published by APhA Academy of Pharmaceutical Research and Sciences (APhA–APRS) and APhA Academy of Pharmacy Practice and Management (APhA–APPM) members in journals other than JAPhA. Members of both Academies are encouraged to forward the PubMed citation or an electronic version of their article, as soon as they appear or ahead of print, to Contributing Editor L. Douglas Ried, PhD, at [email protected].
w w w.j a p h a . o r g
Journal of the American Pharmacists Association