2 Minute Medicine Rewind August 22, 2016
In 2010, it was estimated that 3.4 million American women between ages 50 and 69 had osteoporosis. This study aimed to investigate abaloparatide, a peptide that binds to the parathyroid hormone receptor, for its efficacy to prevent future vertebral fractures in women at risk for osteoporotic fracture. Postmenopausal women were eligible if they had a t-score between -5 and -2.5 at the lumbar spine or femoral neck, as well as radiographic evidence of 2 mild vertebral fractures, 1 moderate vertebral fracture, or if they had a low-trauma fracture event within the last 5 years. Postmenopausal women over 60 could also be included without the fracture criteria if they had a t-score between -5 and -3. 2,463 women from 28 sites in 10 countries were included in this phase 3, double-blinded, randomized controlled trial, with 824 being randomized to receive subcutaneous injections of abaloparatide, 821 receiving subcutaneous placebo injections, and 818 receiving teriparatide, all over an 18 month period. The primary endpoint of vertebral fracture rate was significantly lower in the abaloparatide group with a relative risk of 0.14 (95% CI: 0.05 to 0.39, p < 0.001) as compared to placebo. The abaloparatide group also had a lower estimated event rate for non-vertebral fractures (P = 0.049) and had significantly higher gains in bone mineral density (P< 0.001). It was concluded that subcutaneous abaloparatide lowers the risk for both vertebral and non-vertebral fractures over an 18 month period. However, more research is needed to fully understand abaloparatide’s clinical utility.
Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma
Acetaminophen is the most commonly used pediatric medication, but has been associated with asthma complications. This multicenter, double blind, parallel-group trial aimed to investigate the rate of asthma exacerbations in those using acetaminophen for fever or pain relief, as compared to those using ibuprofen. The study enrolled 300 children with mild persistent asthma, aged between 12 and 59 months, and they were randomized to receive standard asthma-controller therapy and either acetaminophen or ibuprofen. Over 48 weeks, participants received a median of 5.5 doses of either medication with no significant difference in the dose amount between the groups (P = 0.47). Asthma exacerbations that had to be treated with systemic glucocorticoids did not differ significantly between the two groups, yielding a 0.94 relative rate of asthma exacerbations for the acetaminophen group (95% CI: 0.69 to 1.28, P = 0.67). Additionally, no significant differences were found between the two groups for asthma-control days, unscheduled health care utilization for asthma, use of an albuterol inhaler, or adverse events. It was concluded that acetaminophen was not associated with more asthma exacerbations or worse control of asthma.
Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children
Children are often a central source of transmission of influenza, a virus with high morbidity and mortality. This study investigates whether the intranasal live attenuated influenza vaccine (LAIV) or the inactivated influenza vaccine (IIV) is superior in terms of herd protection, protection for the community as a whole. 52 Hutterite colonies (small, rural communities in Alberta and Saskatchewan, Canada) were selected, as they are tight-knit communities with significant interaction. 1,186 children from 1.5 to 15 years were given either the LAIV or IIV while 3,425 members of the community did not receive the vaccine. The primary end point was the number of participants with influenza A or influenza B confirmed by reverse-transcriptase polymerase chain reaction. 5.3% of participants in the LAIV group contracted influenza while 5.2% of those in the IIV group were confirmed to have the virus, yielding a hazard ratio of 1.03 (95% CI: 0.85 to 1.24). Additionally, the LAIV was shown to result in coverage of 76.9% of children while 72.3% of those who received the IIV were covered. It was concluded that neither LAIV nor IIV is superior in preventing influenza in communities.
Safety and Efficacy of Amiselimod in Relapsing Multiple Sclerosis (MOMENTUM)
2.5 million people are affected with multiple sclerosis, a disease that demyelinates neurons in the central nervous system, and more effective treatments are sought. In this study, amiselimod, a modulator of the sphingosine-1-phosphate receptor, is investigated for its utility and safety in treating relapsing-remitting multiple sclerosis. This double-blind phase 2 trial enrolled 415 patients, randomizing 105 of those patients to receive 0.1 mg doses of amiselimod, 103 to receive 0.2 mg, 104 to receive 0.4 mg, and 103 to receive placebo. The primary end point of gadolinium-enhanced T1-weighted lesions on MRIs, completed each month from weeks to 8 to 24, yielded no significant difference between the 0.1 mg amiselimod group and placebo (P=0.75) but did result in a significant median difference in lesion number of -1.0 for the 0.2 mg amiselimod group as compared to placebo (95% CI: -1.0 to 0.0, P=0.0021). The 0.4 mg amiselimod group also had a significant difference with a median lesion number difference of -1.0 (95% CI: -1.2 to 0.0, P=0.0003) when compared to placebo. Adverse events, most commonly headache and nasopharyngitis, were similar between the four patient groups and no more than one patient in any group had a serious adverse event. This study suggests that amiselimod, given at a 0.2 mg or 0.4 mg dose, is a potential treatment for multiple sclerosis and should also be investigated as treatment for other immune-mediated inflammatory diseases.
Modeled Fetal Risk of Genetic Diseases Identified by Expanded Carrier Screening
Currently, during the prenatal period, a small number of diseases are screened for, but expanded carrier screening would allow for more diseases to be added to that list by testing for carrier status. This study worked to find the risk for recessive conditions, specific to racial and ethnic background, that can be detected with this new method and compare the risks to the screening recommendations from professional organizations. 346,790 individuals of reproductive age who had received expanded carrier screening without specific indication were retrospectively analyzed for up to 94 diseases that cause intellectual disability or shortened lifespan if left untreated. It was found that, for most racial or ethnic backgrounds, more fetuses were identified as at-risk with expanded carrier screening than screening as recommended by the current guidelines (P < 0.001). Differences occurred between races and ethnicities, as only 6% (95% CI: 4 to 8%) of children of East Asian couples identified by expanded carrier screening as at-risk were also identified by screening based on the current guidelines while that figure was 87% (95% CI: 84 to 90%) for African or African-American couples. With a large population with diverse backgrounds, it is concluded that expanded carrier screening can help increase the detection of carriers for serious genetic conditions compared with current recommendations. However, prospective studies are needed to confirm this before expanded carrier screening is implemented.
Image: PD
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