Summary

The FDA have approved a combination of Aliskiren and Valsartan in a fixed dose preparation for the treatment of hypertension. Although initial safety data show efficacy and tolerability in an 8-week study, outcome data on real-life use and in "non-standard" cases of hypertension or other disorders suggests caution be the watchword. Where the 'R' fits into the 'ABCD' algorithm is unclear, as the B is already on the way out and it also lowers renin.

Analysis

The FDA have approved a combination of Aliskiren and Valsartan in a fixed dose preparation for the treatment of hypertension. Although initial safety data show efficacy and tolerability in an 8-week study, outcome data on real-life use and in "nonstandard" cases of hypertension or other disorders suggests caution be the watchword.
Whilst the combined approach seems valuable in targeting the RAAS at two sites, similar approaches with ACE-inhibition and AT-1 blockade have been disappointing.
Similarly, the potential for hyperkalaemia and worsening renal function in the real world is still unknown.
Where the 'R' fits into the 'ABCD' algorithm is unclear, as the B is already on the way out and it also lowers renin.
Caution should be the watchword until decent Phase 4 data are out there.

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