PMID- 30448890
OWN - NLM
STAT- MEDLINE
DCOM- 20190301
LR  - 20200225
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 18
IP  - 4
DP  - 2018 Dec
TI  - Post Hoc Analysis of the CONFIDENCE II, PROTECT I, SHAKE THE HABIT I and SHAKE 
      THE HABIT II Observational Studies in Mild to Moderate Hypertensive Patients 
      Treated with Perindopril and Atorvastatin Concomitantly.
PG  - 283-293
LID - 10.1007/s40268-018-0255-7 [doi]
AB  - BACKGROUND AND OBJECTIVES: Management of hypertension and dyslipidemia is 
      important when considering cardiovascular disease risk; however, achievement of 
      optimal lipid and blood pressure (BP) targets in clinical practice remains 
      inadequate. This analysis sought to estimate the frequency, effectiveness, and 
      safety of co-administrated atorvastatin and perindopril in routine care. METHODS: 
      We conducted a post hoc analysis of four Canadian, prospective, multi-center, 
      observational studies assessing real-life effectiveness and safety of 
      perindopril + atorvastatin in mild-to-moderate hypertensive patients with 
      concomitant dyslipidemia over 16 weeks. The safety population comprised patients 
      receiving one or more doses of free combination perindopril + atorvastatin; the 
      full analysis set (FAS) received perindopril + atorvastatin at baseline, with one 
      or more post-baseline systolic BP measurements while on treatment. RESULTS: A 
      total of 3541 and 3172 patients were included in the safety population and FAS, 
      respectively. At the last observation carried forward, significant reductions in 
      mean systolic BP (- 18.0 mmHg; p < 0.001) and diastolic BP (- 8.9 mmHg; 
      p < 0.001) were observed; target BP was achieved by 73.1% of patients. Emergent 
      adverse events (AEs) were reported in 8.0% of patients, the most common being 
      cough (4.5% of patients), headache (0.9%), and dizziness (0.8%). Four serious AEs 
      were reported among three (0.1%) patients. No differences were observed in 
      effectiveness or safety between studies. CONCLUSIONS: Concomitant 
      perindopril + atorvastatin therapy demonstrated similar efficacy across all 
      studies, with significant reductions in BP and achievement of target BP levels 
      observed in a real-world setting. Results align with known safety profiles of 
      atorvastatin and perindopril, with no unexpected AEs observed when compared with 
      data from treatment with the individual drugs.
FAU - Sampalis, John S
AU  - Sampalis JS
AD  - JSS Medical Research, 9400 boul. Henri-Bourassa Ouest, St-Laurent, QC, H4S 1N8, 
      Canada. jsampalis@jssresearch.com.
AD  - McGill University, Montreal, QC, Canada. jsampalis@jssresearch.com.
FAU - Psaradellis, Eliofotisti
AU  - Psaradellis E
AD  - JSS Medical Research, 9400 boul. Henri-Bourassa Ouest, St-Laurent, QC, H4S 1N8, 
      Canada.
FAU - Stutz, Melissa
AU  - Stutz M
AD  - JSS Medical Research, 9400 boul. Henri-Bourassa Ouest, St-Laurent, QC, H4S 1N8, 
      Canada.
FAU - Rickard, Jenaya
AU  - Rickard J
AD  - JSS Medical Research, 9400 boul. Henri-Bourassa Ouest, St-Laurent, QC, H4S 1N8, 
      Canada.
FAU - Rampakakis, Emmanouil
AU  - Rampakakis E
AD  - JSS Medical Research, 9400 boul. Henri-Bourassa Ouest, St-Laurent, QC, H4S 1N8, 
      Canada. submissions@jssresearch.com.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Antihypertensive Agents)
RN  - A0JWA85V8F (Atorvastatin)
RN  - Y5GMK36KGY (Perindopril)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Antihypertensive Agents/administration & dosage/*pharmacology
MH  - Atorvastatin/administration & dosage/*pharmacology
MH  - Blood Pressure/*drug effects
MH  - Canada
MH  - Cohort Studies
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Perindopril/administration & dosage/*pharmacology
MH  - Prospective Studies
MH  - Treatment Outcome
PMC - PMC6277322
COIS- This study was funded by l'Institut de Recherches Internationales Servier (IRIS). 
      JSS, EP, MS, JR, and ER were employees of JSS Medical Research Inc. Each of the 
      four studies included in this post hoc analysis were approved by an Independent 
      Review Board, with individual patient consent obtained.
EDAT- 2018/11/19 06:00
MHDA- 2019/03/02 06:00
PMCR- 2018/11/17
CRDT- 2018/11/19 06:00
PHST- 2018/11/19 06:00 [pubmed]
PHST- 2019/03/02 06:00 [medline]
PHST- 2018/11/19 06:00 [entrez]
PHST- 2018/11/17 00:00 [pmc-release]
AID - 10.1007/s40268-018-0255-7 [pii]
AID - 255 [pii]
AID - 10.1007/s40268-018-0255-7 [doi]
PST - ppublish
SO  - Drugs R D. 2018 Dec;18(4):283-293. doi: 10.1007/s40268-018-0255-7.