PMID- 16053212
OWN - NLM
STAT- MEDLINE
DCOM- 20050922
LR  - 20131121
IS  - 0033-2240 (Print)
IS  - 0033-2240 (Linking)
VI  - 62
IP  - 1
DP  - 2005
TI  - [Clinical evaluation of pentaerythritol tetranitrate in two doses in patients 
      with stable angina pectoris].
PG  - 8-12
AB  - Pentaerythritol tetranitrate (PETN) has raised a great deal of interest in recent 
      years, because it is probably the only organic "tolerance-sparing" nitrate. 
      However, some clinicians doubt whether this drug is really effective in reducing 
      angina and ischemia. The aim of this study, therefore, was to evaluate the 
      clinical efficacy and adverse effects (AEs) of PETN in two doses: 50 mg (PETN-50) 
      and 100 mg (PETN-100), after single ingestion. Twenty-five male patients (pts) 
      with stable angina were enrolled in a randomized, double-blind and placebo (P) 
      controlled study. Ten of them received PETN-50 or P and fifteen of them PETN-100 
      or P. Antianginal efficacy of the drugs was evaluated by analyzing the parameters 
      of tolerance of effort and coronary reserve taken from serial exercise stress 
      tests on the treadmill performed before single oral ingestion, then after 2h and 
      6h. Simple hemodynamic parameters were also evaluated at rest and during 
      exercise. In comparison to P, PETN-50 did not change any parameter of tolerance 
      of effort and coronary reserve, nor any simple hemodynamic parameter (all values 
      statistically not significant - n.s.). However, in comparison to P, PETN-100 
      significantly improved the mean total walking time after 2h by 20.8% (p < 0.01) 
      and also after 6h by 11.3% (p < 0.05). Similarly, PETN-100 improved walking time 
      to angina after 2h by 18.8% (p < 0.05) and after 6h by 10.5% (p < 0.05). The drug 
      also improved walking time to ischemia after 2h by 32.5% (p < 0.01) and after 6h 
      by 13.8% (p < 0.05). PETN-100 did not significantly change the resting heart 
      rate, but it decreased resting systolic blood pressure in both positions 6h after 
      ingestion: in supine by 6.1% (p < 0.05) and in standing by 5.9% (p < 0.05). No 
      postural hypotension in any pt occurred. Diastolic blood pressure significantly 
      decreased only in standing position by 6.8% (p < 0.05) after 6h. During maximal 
      exercise no significant reduction of systolic blood pressure occurred, but there 
      was a significant reduction in diastolic blood pressure 6h after ingestion only. 
      This study shows the good clinical tolerance and safety of PETN in both doses. 
      There were no AEs after single ingestion of PETN-50 and AEs after ingestion of 
      PETN-100 included headaches in 3 pts only (in 1 pt after P) in the group of 15 
      pts. Thus no clinical activity of PETN-50 was shown. However, our investigations 
      suggest that PETN-100 is an active coronary drug, effective not less than 6 h 
      after ingestion, and well tolerated by pts. Further studies are needed to 
      evaluate the efficacy of PETN in long-term therapy.
FAU - Kosmicki, Marek A
AU  - Kosmicki MA
AD  - II Kliniki Choroby Wiencowej, Instytutu Kardiologii im. Prymasa Tysiaclecia, 
      Stefana Kardynala Wyszynskiego w Warszawie. Marek.7372069@pharmanet.com.pl
FAU - Malczewska, Beata
AU  - Malczewska B
FAU - Sadowski, Zygmunt
AU  - Sadowski Z
LA  - pol
PT  - Clinical Trial
PT  - English Abstract
PT  - Journal Article
PT  - Randomized Controlled Trial
TT  - Badania kliniczne czteroazotanu pentaerytrytylu w dwoch dawkach u pacjentow ze 
      stabilna choroba wiencowa.
PL  - Poland
TA  - Przegl Lek
JT  - Przeglad lekarski
JID - 19840720R
RN  - 0 (Vasodilator Agents)
RN  - 10L39TRG1Z (Pentaerythritol Tetranitrate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Angina Pectoris/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pentaerythritol Tetranitrate/*administration & dosage/*adverse effects
MH  - Treatment Outcome
MH  - Vasodilator Agents/*administration & dosage/*adverse effects
EDAT- 2005/08/02 09:00
MHDA- 2005/09/24 09:00
CRDT- 2005/08/02 09:00
PHST- 2005/08/02 09:00 [pubmed]
PHST- 2005/09/24 09:00 [medline]
PHST- 2005/08/02 09:00 [entrez]
PST - ppublish
SO  - Przegl Lek. 2005;62(1):8-12.