Recruiting African Americans with peripheral artery disease for a behavioral intervention trial.

We report recruitment strategies for an NIH-funded trial focused on African Americans with peripheral artery disease (PAD). We present complete recruitment efforts for this 1-year trial, 5-year study. Eligibility included the following: African American, a resting ankle-brachial index (ABI) ⩽ 0.99, a short physical performance battery (SPPB) score of 10 or lower, English speaking, telephone access, and absence of coronary ischemia during a submaximal treadmill test. Recruitment included mailings of brochures to zip codes in which more than 50% of residents were African American, advertisements, community events, and physician/clinic referrals. We telephone-screened 3511 persons, of whom 792 did not recall the method by which they learned about the study. We randomized 174 participants. Mailings yielded the highest percentage of randomized participants (n=60, 34.4%), followed by television advertisements (n=42, 24.1%), followed by community events (n=24, 13.8%). In conclusion, to recruit African Americans with PAD for a clinical trial, investigators should consider mailings of brochures, television advertisements, and community events. CLINICALTRIALSGOV IDENTIFIER NCT01321086.

Nanoprodrugs of NSAIDs: Preparation and Characterization of Flufenamic Acid Nanoprodrugs.

We demonstrated that hydrophobic derivatives of the nonsteroidal anti-inflammatory drug (NSAID)flufenamic acid (FA), can be formed into stable nanometer-sized prodrugs (nanoprodrugs) that inhibit the growth of glioma cells, suggesting their potential application as anticancer agent. We synthesized highly hydrophobic monomeric and dimeric prodrugs of FA via esterification and prepared nanoprodrugs using spontaneous emulsification mechanism. The nanoprodrugs were in the size range of 120 to 140 nm and physicochemically stable upon long-term storage as aqueous suspension, which is attributed to the strong hydrophobic interaction between prodrug molecules. Importantly, despite the highly hydrophobic nature and water insolubility, nanoprodrugs could be readily activated into the parent drug by porcine liver esterase, presenting a potential new strategy for novel NSAID prodrug design. The nanoprodrug inhibited the growth of U87-MG glioma cells with IC(50) of 20 µM, whereas FA showed IC(50) of 100 µM, suggesting that more efficient drug delivery was achieved with nanoprodrugs.