Introduction: SAMMPRIS was the first secondary stroke prevention trial to employ multi-modal protocol-driven aggressive medical management (AMM). Achievement of target SBP, LDL and physical activity were predictors of lower vascular event rates. We sought to determine the tolerability and medication requirements related to AMM.
Methods: Medications and adverse events (AEs) in all 451 SAMMPRIS patients were recorded by sites at baseline, 30 days, 4 monthly visits, and closeout. Start and stop dates were recorded for each medication and AE, with AEs classified by the site as possibly, probably, definitely, or unrelated to risk factor treatment. AEs were adjudicated centrally by consensus of 3 neurologists after the trial ended. Standard descriptive statistics were used.
Results: As Table 1 shows, most subjects were on statins and BP medications at baseline. The use of rosuvastatin, which was donated for the trial, increased during follow-up. ACE inhibitors were the most commonly used BP medication. AEs related to BP medications (e.g. standing BP drop > 15mm Hg or postural hypotension) occurred in 240 (53.2%) patients at any point in the trial (including baseline), of which 123 (27.3%) were symptomatic. Syncope occurred in 11 patients, with 3 considered probably or definitely related to study treatment. AEs related to lipid lowering medications occurred in 18.8% patients, 16.6% of which were myopathy symptoms and 1.3% were AST/ALT > 3 times normal, and there were no reported cases of rhabdomyolysis. AEs related to other risk factor treatments occurred in 17.5% patients (e.g. hypoglycemia secondary to glipizide).
Conclusion: In the SAMMPRIS trial, AMM required the use of multiple risk factor medications and was well tolerated by most patients, with AE rates similar to SPS3 and SPARCL.