PMID- 21846154
OWN - NLM
STAT- MEDLINE
DCOM- 20120119
LR  - 20131121
IS  - 1179-187X (Electronic)
IS  - 1175-3277 (Linking)
VI  - 11
IP  - 5
DP  - 2011 Oct 1
TI  - Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients 
      inadequately controlled with valsartan/HCT combination: a placebo-controlled 
      study.
PG  - 327-33
LID - 10.2165/11591970-000000000-00000 [doi]
AB  - BACKGROUND: Hypertension frequently coexists with diabetes mellitus, resulting in 
      increased cardiovascular risk. Thus, BP control is crucial in decreasing 
      morbidity and mortality in this difficult-to-treat patient population. OBJECTIVE: 
      The objective of this study was to evaluate the efficacy and safety of aliskiren 
      in hypertensive patients with diabetes not adequately responsive to the 
      combination of valsartan and hydrochlorothiazide (HCT). METHODS: After a 1- to 
      4-week washout period, patients with a mean sitting diastolic BP (msDBP) >/=95 mmHg 
      were treated with valsartan 160 mg for 2 weeks followed by valsartan/HCT 160 
      mg/25 mg for an additional 4 weeks (single-blind active run-in period). Patients 
      whose msDBP remained >/=85 mmHg after the active run-in period were randomized (1 : 
      1) to receive aliskiren 150 mg (n = 184) or placebo (n = 179) as add-on therapy 
      for 6 weeks. Aliskiren was then force-titrated to 300 mg once daily for another 6 
      weeks. Efficacy variables were: the change in msDBP and mean sitting systolic BP 
      (msSBP) from baseline to week 12 endpoint, diastolic response (msDBP <80 mmHg or 
      reduction of at least 10 mmHg), and BP control rate (<130/80 mmHg). RESULTS: Of 
      the 363 patients randomized, 328 (90.4%) completed the study (aliskiren and 
      placebo groups: 89.7% and 91.1%, respectively). At week 12 endpoint, the least 
      squares mean (LSM) changes in msDBP (aliskiren vs placebo: -5.8 vs -4.8 mmHg; p = 
      0.2767) and msSBP (aliskiren vs placebo: -7.3 vs -4.8 mmHg; p = 0.0725) were 
      numerically greater in patients treated with aliskiren compared with those 
      treated with placebo; however, this difference was not statistically significant. 
      The proportion of diastolic responders (aliskiren and placebo: 68.5% and 72.9%, 
      respectively; p = 0.8482) and patients achieving BP control (aliskiren and 
      placebo: 16.0% and 16.4%, respectively; p = 0.7511) were similar for both groups. 
      Overall, 63 (34%) and 59 (33%) patients in the aliskiren and placebo groups, 
      respectively, experienced adverse events (AEs). The most commonly reported AEs 
      were headache (placebo group: 6.1%) and dizziness (aliskiren group: 4.4%). 
      Aliskiren was well tolerated. CONCLUSION: The reductions in BP with aliskiren 
      added to valsartan/HCT in this study were numerically greater compared with 
      placebo added to valsartan/HCT, although not statistically significant.
FAU - Drummond, W
AU  - Drummond W
AD  - Renaissance Clinical Research and Hypertension Center, Dallas, TX, USA. 
      rcrh@swbell.net
FAU - Sirenko, Y M
AU  - Sirenko YM
FAU - Ramos, E
AU  - Ramos E
FAU - Baek, I
AU  - Baek I
FAU - Keefe, D L
AU  - Keefe DL
LA  - eng
SI  - ClinicalTrials.gov/NCT00219102
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Am J Cardiovasc Drugs
JT  - American journal of cardiovascular drugs : drugs, devices, and other 
      interventions
JID - 100967755
RN  - 0 (Amides)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Fumarates)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - 1J444QC288 (Amlodipine)
RN  - 502FWN4Q32 (aliskiren)
RN  - RWP5GA015D (Potassium)
SB  - IM
MH  - Aged
MH  - Amides/administration & dosage/adverse effects/*therapeutic use
MH  - Amlodipine/administration & dosage/adverse effects/therapeutic use
MH  - Antihypertensive Agents/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Blood Pressure/*drug effects
MH  - Diabetes Mellitus, Type 1/*complications
MH  - Diabetes Mellitus, Type 2/*complications
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - *Drug Resistance
MH  - Drug Therapy, Combination/adverse effects
MH  - Female
MH  - Fumarates/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Hydrochlorothiazide/administration & dosage/adverse effects/therapeutic use
MH  - Hypertension/blood/complications/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Patient Dropouts
MH  - Potassium/blood
MH  - Single-Blind Method
EDAT- 2011/08/19 06:00
MHDA- 2012/01/20 06:00
CRDT- 2011/08/18 06:00
PHST- 2011/08/18 06:00 [entrez]
PHST- 2011/08/19 06:00 [pubmed]
PHST- 2012/01/20 06:00 [medline]
AID - 10.2165/11591970-000000000-00000 [doi]
PST - ppublish
SO  - Am J Cardiovasc Drugs. 2011 Oct 1;11(5):327-33. doi: 
      10.2165/11591970-000000000-00000.