METHODS: MEDLINE, EMBASE, PubMed, Cochrane Controlled Trials Register, Web of Science, ProQuest, and the WHO Clinical Trials Registry were searched. Studies were included if they randomized adults with orthostatic hypotension to droxidopa or to control, and outcomes related to symptoms, daily activity, blood pressure, or adverse events. Data were extracted independently by two reviewers. Risk of bias was judged against the Cochrane risk of bias tool and quality of evidence measured using Grading of Recommendations Assessment, Development and Evaluation criteria. A fixed-effects model was used for pooled analysis.
RESULTS: Of 224 identified records, four studies met eligibility, with a pooled sample size of 494. Study duration was between 1 and 8 weeks. Droxidopa was effective at reducing dizziness [mean difference -0.97 (95% confidence interval -1.51, -0.42)], overall symptoms [-0.52 (-0.98, -0.06)] and difficulty with activity [-0.86 (-1.34, -0.38)]. Droxidopa was also effective at improving standing SBP [3.9 (0.1, 7.69)]. Rates of adverse events were similar between droxidopa and control groups, including supine hypertension [odds ratio 1.93 (0.87, 4.25)].
CONCLUSION: Droxidopa is well tolerated and effective at reducing the symptoms associated with neurogenic orthostatic hypotension without increasing the risk of supine hypertension.
REGISTRATION: PROSPERO ID CRD42015024612.
METHODS: A Markov model cohort simulation with a 6-month cycle length to predict acute coronary syndrome, stroke, and heart failure throughout lifetime was performed. A cohort of 399 patients was obtained from two prospective, cluster randomized controlled clinical trials implementing physician-pharmacist collaborative interventions in community-based medical offices in the Midwest, USA. Framingham risk equations and other algorithms were used to predict the vascular diseases. SBP reduction due to the interventions deteriorated until 5 years. Direct medical costs using a payer perspective were adjusted to 2015 dollar value, and the main outcome was quality-adjusted life years (QALYs); both were discounted at 3%. The intervention costs were estimated from the trials, whereas the remaining parameters were from published studies. A series of sensitivity analyses including changing patient risks of vascular diseases, probabilistic sensitivity analysis, and a cost-effectiveness acceptability curve were performed.
RESULTS: The lifetime incremental costs were $26 807.83 per QALY (QALYs gained = 0.14). The intervention provided the greatest benefit for the high-risk patients, moderate benefit for the trial patients, and the lowest benefit for the low-risk patients. If a payer is willing to pay $50 000 per QALY gained, in 48.6% of the time the intervention would be cost-effective.
CONCLUSION: Team-based care such as a physician-pharmacist collaboration appears to be a cost-effective strategy for treating hypertension. The intervention is most cost-effective for high-risk patients.