PMID- 15903280
OWN - NLM
STAT- MEDLINE
DCOM- 20050628
LR  - 20191109
IS  - 1543-5946 (Print)
IS  - 1876-7761 (Linking)
VI  - 2
IP  - 4
DP  - 2004 Dec
TI  - A pharmacological surveillance study of the tolerability of policosanol in the 
      elderly population.
PG  - 219-29
AB  - BACKGROUND: Policosanol is a drug derived from sugar cane wax that has 
      cholesterol-lowering and antiplatelet properties. Randomized, controlled studies 
      are the gold standard for demonstrating drug efficacy, safety, and tolerability, 
      but postmarketing surveillance studies are encouraged for corroborating drug 
      effects. A valid proof of the safety of a drug is a well-documented, good 
      tolerability profile in older individuals, since this population is more prone to 
      drug-related adverse events (AEs). OBJECTIVE: This study investigated the 
      tolerability of policosanol in the elderly population by monitoring the incidence 
      and nature of AEs occurring in older Cuban patients treated with policosanol in 
      routine clinical practice. METHODS: All patients aged > or =60 years treated with 
      policosanol at 7 major medical centers from January 2000 to May 2003 were 
      included. Policosanol (5, 10, or 20 mg/d) was prescribed to patients eligible to 
      receive cholesterol-lowering and/or antiplatelet drugs, with the dosage 
      recommended according to their individual atherosclerotic risk. Patients had 
      follow-up visits approximately every 6 months. Data on AEs and other relevant 
      information, including changes in policosanol treatment, concomitant medications, 
      and discontinuations, were recorded on individual case-report forms. RESULTS: 
      This study included 2252 patients (1306 women, 946 men): 647 (28.7%), 244 
      (10.8%), and 173 (7.7%) patients had coronary, cerebrovascular, and peripheral 
      artery disease, respectively. A total of 1485 patients had hypercholesterolemia 
      (65.9%), 1322 (58.7%) had hypertension, and 323 (14.3%) had diabetes mellitus. Of 
      the enrolled patients, 1123 (49.9%), 644 (28.6%), and 485 (21.5%) received 
      policosanol 5, 10, and 20 mg/d, respectively. Treatment duration varied: 2169 
      (96.3%), 1861 (82.6%), 1116 (49.6%), and 412 (18.3%) patients were treated for 6, 
      12, 24, and 36 months, respectively. Thirty-one patients (1.4%) experienced 
      serious AEs, 18 of them fatal. Death was most often due to vascular events: 
      myocardial infarction (4 patients), sudden cardiac arrest (1), ventricular 
      arrhythmia (2), ischemic stroke (1), lung thromboembolism (1), cancer (5), 
      pneumonia (1), peritonitis (1), lung edema (1), and dehydration (1). Another 13 
      patients (0.6%) were hospitalized, and 61 (2.7%) reported moderate or mild AEs. 
      Overall, 21 patients (0.9%) discontinued prematurely from the study, 18 of them 
      due to a fatal serious AE. CONCLUSIONS: Long-term tolerability of policosanol in 
      elderly patients at high vascular risk was very good, as assessed under 
      conditions of routine clinical practice. These results are consistent with those 
      obtained in randomized, double-blind clinical studies of older patients treated 
      with policosanol.
FAU - Fernandez, Salome
AU  - Fernandez S
AD  - Centre of Natural Products, National Centre for Scientific Research, Playa, 
      Havana, Cuba.
FAU - Mas, Rosa
AU  - Mas R
FAU - Gamez, Rafael
AU  - Gamez R
FAU - Diaz, Arquimedes
AU  - Diaz A
FAU - Fernandez, Julio
AU  - Fernandez J
FAU - Deibis Orta, Santa
AU  - Deibis Orta S
FAU - Illnait, Jose
AU  - Illnait J
FAU - Castano, Gladys
AU  - Castano G
FAU - Mendoza, Sarahi
AU  - Mendoza S
FAU - Valdes, Francisco
AU  - Valdes F
FAU - Alvarez, Estrella
AU  - Alvarez E
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Geriatr Pharmacother
JT  - The American journal of geriatric pharmacotherapy
JID - 101190325
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Fatty Alcohols)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 142583-61-7 (policosanol)
SB  - IM
MH  - Aged
MH  - Anticholesteremic Agents/*adverse effects/therapeutic use
MH  - Fatty Alcohols/*adverse effects/therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Platelet Aggregation Inhibitors/*adverse effects/therapeutic use
MH  - *Product Surveillance, Postmarketing
EDAT- 2005/05/21 09:00
MHDA- 2005/06/29 09:00
CRDT- 2005/05/21 09:00
PHST- 2005/05/21 09:00 [pubmed]
PHST- 2005/06/29 09:00 [medline]
PHST- 2005/05/21 09:00 [entrez]
AID - S1543-5946(04)00029-7 [pii]
AID - 10.1016/j.amjopharm.2004.12.004 [doi]
PST - ppublish
SO  - Am J Geriatr Pharmacother. 2004 Dec;2(4):219-29. doi: 
      10.1016/j.amjopharm.2004.12.004.