A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk.

BACKGROUND: Most individuals at high cardiovascular disease (CVD) risk worldwide do not receive any or optimal preventive drugs. We aimed to determine whether fixed dose combinations of generic drugs ('polypills') would promote use of such medications. METHODS: We conducted a randomized, open-label trial involving 623 participants from Australian general practices. Participants had established CVD or an estimated five-year CVD risk of ≥15%, with indications for antiplatelet, statin and ≥2 blood pressure lowering drugs ('combination treatment'). Participants randomized to the 'polypill-based strategy' received a polypill containing aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg. Participants randomized to 'usual care' continued with separate medications and doses as prescribed by their doctor. Primary outcomes were self-reported combination treatment use, systolic blood pressure and total cholesterol. RESULTS: After a median of 18 months, the polypill-based strategy was associated with greater use of combination treatment (70% vs. 47%; relative risk 1.49, (95% confidence interval (CI) 1.30 to 1.72) p < 0.0001; number needed to treat = 4.4 (3.3 to 6.6)) without differences in systolic blood pressure (-1.5 mmHg (95% CI -4.0 to 1.0) p = 0.24) or total cholesterol (0.08 mmol/l (95% CI -0.06 to 0.22) p = 0.26). At study end, 17% and 67% of participants in polypill and usual care groups, respectively, were taking atorvastatin or rosuvastatin. CONCLUSION: Provision of a polypill improved self-reported use of indicated preventive treatments. The lack of differences in blood pressure and cholesterol may reflect limited study power, although for cholesterol, improved statin use in the polypill group counter-balanced use of more potent statins with usual care.

Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk: the SPACE Collaboration.

BACKGROUND: An international collaboration of investigators will assess the benefits and risks of fixed dose combination (FDC) based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are being conducted, as the effectiveness and economic impact of a FDC-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. METHODS: Individual patient data (IPD) will be provided by participating trials for combined IPD meta-analysis. RESULTS: Primary outcomes will include self-reported current use of antiplatelet, statin, and combination (≥ 2) blood pressure lowering therapies at 12 months, and change in systolic blood pressure (SBP) and LDL cholesterol from baseline to 12 months. Non-inferiority margins of 3 mm Hg for SBP and 0.3 mmol/L for LDL cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events). CONCLUSION: The SPACE group of trials will assess, in a variety of healthcare settings, whether a FDC strategy for delivery of preventive medication has the potential to significantly improve prevention of cardiovascular disease in patients at high risk.

The effect of suit wear during an intensive therapy program in children with cerebral palsy.

PURPOSE: To examine the effects of suit wear during an intensive therapy program on motor function among children with cerebral palsy. METHOD: Twenty children were randomized to an experimental (TheraSuit) or a control (control suit) group and participated in an intensive therapy program. The Pediatric Evaluation of Disability Inventory (PEDI) and Gross Motor Function Measure (GMFM)-66 were administered before and after (4 and 9 weeks). Parent satisfaction was also assessed. RESULTS: No significant differences were found between groups. Significant within-group differences were found for the control group on the GMFM-66 and for the experimental group on the GMFM-66, PEDI Functional Skills Self-care, PEDI Caregiver Assistance Self-care, and PEDI Functional Skills Mobility. No adverse events were reported. CONCLUSIONS: Children wearing the TheraSuit during an intensive therapy program did not demonstrate improved motor function compared with those wearing a control suit during the same program.

Development of guidelines for determining frequency of therapy services in a pediatric medical setting.

PURPOSE: The purpose of this article is to describe guidelines for frequency of therapy services that were developed to help physical therapists and occupational therapists determine appropriate utilization of therapy services in a pediatric medical setting. DESCRIPTION: The guidelines were developed for use by physical and occupational therapists when treating inpatients and outpatients at a large urban Midwest pediatric teaching hospital. Factors for consideration when determining frequency of therapy were adapted from the existing literature. Four modes of service delivery were developed; intensive (3 to 11 times a week), weekly or bimonthly (1 to 2 times a week to every other week), periodic (monthly or less often but at regularly scheduled intervals), and consultative (episodic or as needed). Descriptions are provided in a table format with factors to consider when making treatment frequency decisions. IMPORTANCE: These guidelines have been helpful to therapists in this medical setting when communicating therapy needs and goals to families and other professionals.