PMID- 25956918
OWN - NLM
STAT- MEDLINE
DCOM- 20160201
LR  - 20220318
IS  - 1471-2261 (Electronic)
IS  - 1471-2261 (Linking)
VI  - 15
DP  - 2015 May 9
TI  - Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week 
      observational study (AdADOSE).
PG  - 35
LID - 10.1186/s12872-015-0037-x [doi]
LID - 35
AB  - BACKGROUND: Observational studies can provide important information on the 
      efficacy and safety of antihypertensive agents in the real-life clinical setting. 
      AdADOSE was a large observational study to assess the effectiveness of nifedipine 
      GITS in combination with other antihypertensive agent(s). The study was also the 
      first to examine the role of combination therapy with nifedipine GITS in the 
      Middle East, Pakistan and Russia, regions that are associated with particularly 
      high cardiovascular risk. METHODS: AdADOSE was a 12-week, international, 
      multicenter, prospective, observational study. Patients with hypertension (ie, 
      blood pressure [BP] >140/90 mm Hg, or >130/80 mm Hg in patients at high or very 
      high cardiovascular risk) received once-daily nifedipine GITS (30, 60 or 90 mg) 
      in combination with another antihypertensive or as add-on to existing therapy. 
      The primary study endpoint was the proportion of patients who achieved the target 
      BP of <140/90 mm Hg (or <130/80 mm Hg for those at high or very high 
      cardiovascular risk). Study outcomes are reported by descriptive statistics. 
      RESULTS: The study enrolled 4497 patients (n = 4477, safety population; n = 3430, 
      efficacy population). Baseline mean systolic/diastolic BP (SBP/DBP) was 
      166.4/99.7 mm Hg; 85.2 % of patients had received prior antihypertensive 
      treatment, and 90.6 % had >/= 1 concomitant diseases. Following combination 
      treatment with nifedipine GITS, target BP was achieved by 64.8% of patients 
      without concomitant diseases, and by 56.5%, 32.3% and 22.6% with 1, 2-3 and >3 
      concomitant diseases, respectively. The proportion of patients achieving target 
      BP was 51.5% in previously untreated and 33.7% in previously treated patients. 
      Nifedipine GITS combination treatment provided mean SBP/DBP changes of 
      -36.1/-18.8 mm Hg in all patients, -40.2/-21.5 mm Hg in previously untreated 
      patients, and -35.6/-18.4 mm Hg in previously treated patients, with similar BP 
      reductions irrespective of the number of concomitant diseases. Drug-related 
      adverse events (AEs) were reported in 2.6% patients. There were no serious AEs 
      and only 0.8% of patients discontinued due to drug-related AEs. CONCLUSIONS: 
      Combination therapy with nifedipine GITS in a real-life observational setting was 
      highly effective in reducing SBP/DBP in a range of hypertensive patients, with 
      low rates of treatment-related AEs. TRIAL REGISTRATION: at ClinicalTrials.gov 
      registration number NCT01118286 .
FAU - Motaweih, Ahmed K
AU  - Motaweih AK
AD  - Cardiovascular Medicine Department, Faculty of Medicine, Azhar University, Giza, 
      Egypt. ahmedmotaweih2015@gmail.com.
FAU - Usova, Elena
AU  - Usova E
AD  - Clinical Hospital 122, Saint Petersburg, Russia. usovaelena@mail.ru.
FAU - Hussain, Wajid
AU  - Hussain W
AD  - Department of Cardiology, Baqai Institute of Cardiovascular Diseases, Karachi, 
      Pakistan. wajiddr87@yahoo.com.
FAU - Dello, Ziad
AU  - Dello Z
AD  - Dallah Hospital, Riyadh, Saudi Arabia. ha61@hotmail.com.
FAU - Schmidt, Birgit
AU  - Schmidt B
AD  - Global NIS Department, Bayer Vital GmbH, Leverkusen, Germany. 
      birgit.schmidt1@bayer.com.
FAU - Petri, Thomas
AU  - Petri T
AD  - Global Medical Affairs Primary Care, Bayer Pharma AG, Muellerstr. 178, S102, 
      6.OG, R.244, 13353, Berlin, Germany. thomas.petri@bayer.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01118286
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150509
PL  - England
TA  - BMC Cardiovasc Disord
JT  - BMC cardiovascular disorders
JID - 100968539
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Calcium Channel Blockers)
RN  - I9ZF7L6G2L (Nifedipine)
SB  - IM
MH  - Aged
MH  - Antihypertensive Agents/adverse effects/*therapeutic use
MH  - Calcium Channel Blockers/adverse effects/*therapeutic use
MH  - Cardiovascular Diseases/etiology
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypertension/complications/*drug therapy
MH  - Male
MH  - Middle East
MH  - Nifedipine/adverse effects/*therapeutic use
MH  - Pakistan
MH  - Prospective Studies
MH  - Risk Factors
MH  - Russia
MH  - Treatment Outcome
PMC - PMC4448540
EDAT- 2015/05/10 06:00
MHDA- 2016/02/02 06:00
PMCR- 2015/05/09
CRDT- 2015/05/10 06:00
PHST- 2014/09/19 00:00 [received]
PHST- 2015/04/27 00:00 [accepted]
PHST- 2015/05/10 06:00 [entrez]
PHST- 2015/05/10 06:00 [pubmed]
PHST- 2016/02/02 06:00 [medline]
PHST- 2015/05/09 00:00 [pmc-release]
AID - 10.1186/s12872-015-0037-x [pii]
AID - 37 [pii]
AID - 10.1186/s12872-015-0037-x [doi]
PST - epublish
SO  - BMC Cardiovasc Disord. 2015 May 9;15:35. doi: 10.1186/s12872-015-0037-x.