PMID- 24678079
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140328
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 66
IP  - 6
DP  - 2005 Nov
TI  - Effects of oral fixed-dose combinations of telmisartan plus ramipril and losartan 
      plus ramipril in hypertension: A multicenter, prospective, randomized, 
      double-blind, phase iii trial in adult indian patients.
PG  - 630-42
LID - 10.1016/j.curtheres.2005.12.007 [doi]
AB  - BACKGROUND: A new oral fixed-dose combination (FDC) of telmisartan plus ramipril 
      is being introduced in India for the treatment of patients with stage 2 
      hypertension. OBJECTIVE: The aim of this study was to compare the effectiveness 
      and tolerability of an oral FDC of telmisartan plus ramipril with those of an 
      oral FDC of losartan plus ramipril in adult Indian patients with stage 2 
      hypertension. METHODS: This multicenter, prospective, randomized, double-blind, 
      Phase III study was conducted at 5 centers in India. Indian patients aged 18 to 
      65 years with uncomplicated stage 2 essential hypertension (systolic/diastolic 
      blood pressure [SBP/DBP], >160/>100 mm Hg) were enrolled. After a 2-week placebo 
      run-in period, patients were randomly assigned to receive telmisartan 40 mg plus 
      ramipril 5 mg (T + R) or losartan 50 mg plus ramipril 5 mg (L + R), PO (tablet) 
      QD (before the morning meal) for 8 weeks. Supine blood pressure (BP) was measured 
      at 0 (baseline) and 8 weeks of treatment. The primary end point was the mean 
      reduction from baseline in BP. Responders were classified as patients who had a 
      DBP <90 mm Hg at the end of 8 weeks of therapy. Tolerability was assessed using 
      spontaneous reports of adverse events (AEs) during the follow-up visits and 
      laboratory analyses performed at week 8. RESULTS: A total of 289 patients were 
      enrolled (155 men, 134 women; mean age, 50.74 years). Of these, 8 patients in the 
      T + R group and 7 in the L + R group were lost to follow-up and considered 
      withdrawals. At the end of week 8, the mean percentage reduction in SBP was 
      significantly greater in the T + R group compared with that in the L + R group 
      (24.1% vs 19.4%; P < 0.05). The mean percentage reduction in DBP was also 
      significantly greater in the T + R group compared with that in the L + R group 
      (17.3% vs 12.5%; P < 0.05). The response rates in the T + R and L + R groups were 
      statistically similar (79.1% vs 68.7%). The most common AEs in the T + R and L + 
      R groups were cough (9 [6.1%] and 11 [7.8%] patients, respectively) and headache 
      (7 [4.7%] and 8 [5.7%] patients, respectively). CONCLUSIONS: The results in this 
      study in Indian patients with stage 2 essential hypertension suggest that the FDC 
      of T + R controlled BP more effectively compared with the FDC of L + R over 8 
      weeks. The response rates were similar between the 2 groups. Both treatments were 
      well tolerated.
FAU - Jain, S D
AU  - Jain SD
AD  - Department of Medicine, Yerala Medical College, Mumbai, India.
FAU - Biradar, Sangram
AU  - Biradar S
AD  - Mohodevappo Rampure Medical College, Gulbarga, Karnataka, India.
FAU - Periyandavar, I
AU  - Periyandavar I
AD  - Lifeline Diabetes Centre, Adyar, Chennai, India.
FAU - Singh Sodhi, Sanjeet
AU  - Singh Sodhi S
AD  - Indus Hospital, Moholi, India.
FAU - Anwaruddin, K
AU  - Anwaruddin K
AD  - Zubeda Hospitals, Chetput, Chennai, India.
FAU - Gawde, Ashish
AU  - Gawde A
AD  - Glenmark Pharmaceuticals Ltd., Mumbai, India.
FAU - Baliga, Vidyagauri
AU  - Baliga V
AD  - Glenmark Pharmaceuticals Ltd., Mumbai, India.
FAU - Gandewar, Kailas
AU  - Gandewar K
AD  - Department of Preventive and Social Medicine, Lokmanya Tilak Memorial Medical 
      College and Lokmanya Tilak Memorial General Hospital, Mumbai, India.
FAU - Desai, Anish
AU  - Desai A
AD  - Glenmark Pharmaceuticals Ltd., Mumbai, India.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC3966013
OTO - NOTNLM
OT  - losartan
OT  - ramipril
OT  - stage 2 hypertension
OT  - telmisartan
EDAT- 2005/11/01 00:00
MHDA- 2005/11/01 00:01
PMCR- 2005/11/01
CRDT- 2014/03/29 06:00
PHST- 2005/10/15 00:00 [accepted]
PHST- 2014/03/29 06:00 [entrez]
PHST- 2005/11/01 00:00 [pubmed]
PHST- 2005/11/01 00:01 [medline]
PHST- 2005/11/01 00:00 [pmc-release]
AID - S0011-393X(05)00126-8 [pii]
AID - 10.1016/j.curtheres.2005.12.007 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2005 Nov;66(6):630-42. doi: 
      10.1016/j.curtheres.2005.12.007.