PMID- 10704623 OWN - NLM STAT- MEDLINE DCOM- 20000502 LR - 20190718 IS - 0021-9150 (Print) IS - 0021-9150 (Linking) VI - 149 IP - 1 DP - 2000 Mar TI - Safety profile of atorvastatin-treated patients with low LDL-cholesterol levels. PG - 123-9 AB - Data pooled from 21 atorvastatin clinical trials have been analyzed to establish the safety of reducing low density lipoprotein cholesterol (LDL-C) levels below currently recommended minimum targets in hypercholesterolemic patients. Safety data for atorvastatin-treated patients with at least one LDL-C value < or =80 mg/dl (2.1 mmol/l) (n = 319) during treatment (mean LDL-C level throughout treatment was 91 mg/dl [2.4 mmol/l]) were compared to those from all atorvastatin-treated patients (n = 2502) and patients treated with lovastatin, simvastatin or pravastatin (n = 742). The frequency of treatment-associated adverse events (AEs) in the atorvastatin LDL-C < or =80 mg/dl (2.1 mmol/l) subgroup (24%) was comparable to the frequencies observed for all atorvastatin-treated patients (20%) and for patients receiving the other statins (24%). Patient withdrawals due to treatment-associated AEs (constipation, dyspepsia and flatulence being the most common) were consistent and low across treatment groups. No treatment-associated deaths occurred in any group. Safety data for 21 atorvastatin-treated patients with LDL-C < or =50 mg/dl (1.3 mmol/l) were also analyzed and found to be similar to all atorvastatin-treated patients and patients treated with the other statins. While recognizing the short-term nature of the data (all patients who received atorvastatin were treated for < or =1 year and approximately 30% were treated for < or =6 months), this analysis suggests that reducing LDL-C levels below 80 (2.1 mmol/l) or 50 mg/dl (1.3 mmol/l) with atorvastatin does not alter its safety profile, as measured by frequency of AEs, which remains similar to those of other statins. FAU - Bakker-Arkema, R G AU - Bakker-Arkema RG AD - Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, 2800 Plymouth Road, Ann Arbor, MI 48105-1047, USA. FAU - Nawrocki, J W AU - Nawrocki JW FAU - Black, D M AU - Black DM LA - eng PT - Comparative Study PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PL - Ireland TA - Atherosclerosis JT - Atherosclerosis JID - 0242543 RN - 0 (Anticholesteremic Agents) RN - 0 (Heptanoic Acids) RN - 0 (Lipoproteins, LDL) RN - 0 (Pyrroles) RN - 9LHU78OQFD (Lovastatin) RN - A0JWA85V8F (Atorvastatin) RN - AGG2FN16EV (Simvastatin) RN - KXO2KT9N0G (Pravastatin) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Anticholesteremic Agents/*administration & dosage/*adverse effects MH - Atorvastatin MH - Dose-Response Relationship, Drug MH - Female MH - Heptanoic Acids/*administration & dosage/*adverse effects MH - Humans MH - Hypercholesterolemia/diagnosis/*drug therapy MH - Lipoproteins, LDL/analysis/*drug effects MH - Lovastatin/administration & dosage MH - Male MH - Middle Aged MH - Pravastatin/administration & dosage MH - Pyrroles/*administration & dosage/*adverse effects MH - Randomized Controlled Trials as Topic MH - Severity of Illness Index MH - Simvastatin/administration & dosage MH - Treatment Outcome EDAT- 2000/03/08 09:00 MHDA- 2000/05/08 09:00 CRDT- 2000/03/08 09:00 PHST- 2000/03/08 09:00 [pubmed] PHST- 2000/05/08 09:00 [medline] PHST- 2000/03/08 09:00 [entrez] AID - S0021-9150(99)00294-4 [pii] AID - 10.1016/s0021-9150(99)00294-4 [doi] PST - ppublish SO - Atherosclerosis. 2000 Mar;149(1):123-9. doi: 10.1016/s0021-9150(99)00294-4.