title: Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE).
abstract: 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.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  at ClinicalTrials.gov registration number NCT01118286 .
authors.affiliation: Cardiovascular Medicine Department, Faculty of Medicine, Azhar University, Giza, Egypt. ahmedmotaweih2015@gmail.com.
authors.forename: Ahmed K
authors.initials: AK
authors.lastname: Motaweih
authors.affiliation: Clinical Hospital 122, Saint Petersburg, Russia. usovaelena@mail.ru.
authors.forename: Elena
authors.initials: E
authors.lastname: Usova
authors.affiliation: Department of Cardiology, Baqai Institute of Cardiovascular Diseases, Karachi, Pakistan. wajiddr87@yahoo.com.
authors.forename: Wajid
authors.initials: W
authors.lastname: Hussain
authors.affiliation: Dallah Hospital, Riyadh, Saudi Arabia. ha61@hotmail.com.
authors.forename: Ziad
authors.initials: Z
authors.lastname: Dello
authors.affiliation: Global NIS Department, Bayer Vital GmbH, Leverkusen, Germany. birgit.schmidt1@bayer.com.
authors.forename: Birgit
authors.initials: B
authors.lastname: Schmidt
authors.affiliation: Global Medical Affairs Primary Care, Bayer Pharma AG, Muellerstr. 178, S102, 6.OG, R.244, 13353, Berlin, Germany. thomas.petri@bayer.com.
authors.forename: Thomas
authors.initials: T
authors.lastname: Petri
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000209:etiology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008877:Middle East; D009543:Nifedipine / Q000009:adverse effects / Q000627:therapeutic use*; D010154:Pakistan; D011446:Prospective Studies; D012307:Risk Factors; D012426:Russia; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D009543:Nifedipine