Antihypertensive drugs (AHTDs) and statins are frequently administered together, but there is uncertainty on whether the presence of one affects the main effects of the other. This systematic review and meta-analysis assessed the effects of co-administered AHTDs and statins on blood pressure (BP) and cholesterol. MEDLINE, Cochrane Central Register of Controlled Trials and drug regulatory agency websites were searched, until January 2018. Twelve double-blind randomized controlled trials that allocated adults with or without hypertension and/or hyperlipidemia (n = 4434) to fixed doses of AHTD alone, statin alone and both drugs together, for ≥4 weeks, were included. BP lowering was similar with AHTD + statin compared with AHTD alone [systolic BP −0.1 mm Hg, 95% confidence interval (CI), −1.0 to 0.8, and diastolic BP −1.0 mm Hg, 95% CI, −2.3 to −0.2]. AHTD + statin compared with statin alone resulted in small reduction in low-density lipoprotein cholesterol (−3.9 mg/dL, 95% CI, −6.1 to −1.7), and this effect was largely associated with co-administration of amlodipine and atorvastatin or rosuvastatin. There was no difference in safety outcomes. Overall, it can be concluded that there is no clinically important difference in the effects of AHTDs and statins whether used separately or together for reduction in BP and low-density lipoprotein cholesterol.
Cardiovascular diseases (CVDs) are the leading cause of death globally, 1 and hypertension is the leading risk factor for CVD. 2,3 Antihypertensive drugs (AHTDs) are among the most commonly used prescription drugs worldwide. Drug regulatory agencies have approved many AHTDs primarily based on evidence of efficacy and safety from randomized controlled trials (RCTs). Although RCTs are considered the gold standard for generating evidence of effects of interventions, health care decisions based on only some of all the available RCTs are not considered credible. Systematic reviews (SRs) aim to identify all relevant literature on a topic, critically appraise, and summarize evidence to answer well-defined questions. Decisionmakers, guideline developers, and health care providers use SRs to inform decisions to improve health care. Mapping of SRs can be a useful one-stop resource for the consumers of evidence synthesis to enable evidence-informed research and health care decisions.
Objectives: Delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) and fingolimod are oral disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS). Direct comparisons of these agents are not possible due to a lack of head-to-head trials. In this study, comparative effectiveness research was conducted by indirectly comparing efficacy outcomes at 2 years with DMF or fingolimod treatment of RRMS in Phase 3 studies. MethOds: Individual patient data from the DEFINE and CONFIRM studies of DMF (pooled) and aggregate data from the FREEDOMS and FREEDOMS II studies of fingolimod (pooled using random effects meta-analysis) were utilised. Only results using the approved dosage of DMF (240 mg twice daily) and fingolimod (0.5 mg once daily) are reported. Matching-adjusted indirect comparison was conducted as described in Signorovitch et al (2010). Patients in the pooled DMF trials were weighted such that their average baseline characteristics (age, gender, time from onset of symptoms, Expanded Disability Status Scale score, number of relapses in previous year) matched those reported for patients in pooled fingolimod trials. After matching, weighted efficacy outcomes for patients treated with DMF were compared with summary efficacy outcomes for patients treated with fingolimod. Results: After matching, all baseline characteristics were balanced between the pooled DMF trials and the pooled fingolimod trials. At 2 years, annualised relapse rate ratio (95% confidence interval [CI]) for DMF vs placebo was 0.52 (0.43, 0.62) and for fingolimod vs placebo was 0.48 (0.42, 0.55). Twelve-week confirmed disease progression hazard ratio (95% CI) for DMF vs placebo was 0.70 (0.57, 0.85) and for fingolimod vs placebo was 0.76 (0.61, 0.95). Additional data, including comparison of DMF vs fingolimod, will be presented. cOnclusiOns: In a matching-adjusted indirect comparison, the efficacy of DMF was similar to that of fingolimod on clinical measures of relapse and disability progression.
Objectives: Asthma is one of the most common long term medical conditions and an important contributor to the burden of illness. People with asthma experience poor life satisfaction and require a range of health services to manage their condition. There is a need to assess the instruments by disease concept and interpret the dimension scores. The aim of this systematic review is to assess the impact of severe asthma on the quality of life (QoL). MethOds: A systematic search was conducted of the relevant published evidence from Embase and MEDLINE. Search limits were: articles in English, in human and published since year 2005. Retrieved citations were screened by two independent reviewers according to inclusion criteria: severe asthma and baseline QoL data either measured on generic scale or disease-specific scale. Results: A total 29 studies met the inclusion criteria. The majority of studies were observational (14 studies) while seven studies had cross-sectional design. The majority of studies were conducted in adult population (18 studies) while few studies were conducted in children (5 studies). Asthma Quality of Life Questionnaire (AQLQ) was the most frequently used scale among the included studies, assessed in 13 studies followed by St. George's Respiratory Questionnaire (SGRQ) in six studies. Seven studies reported total AQLQ data with mean scores ranging from 3.1-4.8, which reflect poor QoL. Across these domains, scores assessed on AQLQ -symptoms and AQLQ -activity limitations were lower as compared to AQLQ -emotional function and AQLQenvironmental stimuli. Data also suggested that patients with severe asthma have rapid deterioration in overall health status as compared to patients with mildmoderate asthma. cOnclusiOns: Patients with severe asthma had lower total QoL scores as assessed through different scales, indicating worse QoL. Symptoms and activity limitations are the two main domains that potentially affect the QoL in patients with severe asthma.
Financial constraints versus public desire for more-generous healthcare create a difficult dilemma for countries globally. As each market strives to manage its prescription drug market, highly specific market access requirements and challenges abound for drugmakers. Innovative developers must engage with payers much earlier in the product development cycle in order to optimize trial design to satisfy specific MA and payer requirements on demonstrating innovation (e.g. selecting the appropriate comparator, targeting the correct/local patient population, gathering the most compelling head-to-head). By exploring how pricing and reimbursement (P&R) decisions are made in many major and developing markets around the world, we have developed a Country Archetypes model that identifies similarities among payer requirements, and, vitally, determines where product value messaging can be leveraged to optimize market access strategy. Data on payer type and drug review processes, payer fragmentation, percentage of individuals covered by a health insurance system, size of the pharmaceutical market, percentage of government and individuals in healthcare spending, and use as a reference country for other nations were collected for 27 of the largest pharmaceutical markets in the world. Considerations around free pricing, health technology assessment, and review of pharmacoeconomic and outcomes research data rules were made, and further segmentations on decision impact, size of reimbursable market, out-of-pocket costs, role of health insurance and market fragmentation applied. Ultimately, from the 27 nations examined, six groups emerged, each comprising countries with commonalities across all measures, albeit distinct profiles that affect P&R: Accountants, Pragmatists, Evidence seekers, Deal-makers, Ceiling setters, and Independents. Our Country Archetype model is intended to help multinational pharmaceutical companies prepare for local reimbursement evaluations, and pinpoint where decision-makers can be found. With classifications based on the most important set of reimbursement criteria necessary to attain favorable access in each market, the keys to access can be found and turned.
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